standard operating - st. luke's medical centerrbd.stluke.com.ph/ierc_data/file/sl ierc sop...

2012 Edition

INSTITUTIONAL ETHICS

REVIEW COMMITTEE

STANDARD OPERATING PROCEDURES

SL-IERC SOP 2012 V1 | 2

INTRODUCTION to the First Edition

In 1995, St. Luke’s Medical Center established the Research and Biotechnology Division (RBD), a

pioneering effort imbued with the vision to develop state-of-the-art technologies and harness the latest

scientific developments to the diagnosis, monitoring and treatment of patients in the Philippines and

Asia as well. This move, the first of its kind in the country, provides St. Luke’s with the leading edge to

develop a responsive, well attuned and timely healthcare services for the medical community and

concerned public. The full support of St. Luke’s administration to research is evidenced by its many firsts

in dengue research, molecular diagnostics, genomics, medical bioinformatics and stem cell research.

RBD’s multidisciplinary infrastructure offers a comprehensive one-stop shop for all services pertaining to

the conduct of clinical trials. This commitment to world-class excellence in research led to the creation

of an ethics review mechanism that ensured the protection of the rights and privacy of all human

subjects.

The St. Luke's Institutional Ethics Review Committee (IERC) is responsible for the review of clinical trial

protocols and other clinical research proposals in order to safeguard the rights, dignity and welfare of

human participants. It operates under the guidance of the Philippine Health Research Ethics Board

(PHREB). Its membership is multidisciplinary and includes medical doctors, a lawyer, a scientist, a

religious and a lay person who is independent of the institution. The St. Luke’s IERC conducts regular

ethical review of clinical trials and research prior to their implementation at the medical center, as well

as facilitates their expedited review when the immediate need for ethical clearance arises. The Vice-

President of the Research and Biotechnology Division serves as a member of the IERC, enjoying an open

and healthy dialogue on all issues related to clinical research. The Center for Clinical Trials serves as the

Secretariat

Work on this Manual began during a Writing and Planning Workshop held in Lake Island Resort,

Binangonan, Rizal on 22-23 August 2008 attended by the Center for Clinical Trials staff and some RBD

scientists, representatives from the Division of Ancillary Services, Human Resources and the Division of

Nursing. The draft was consolidated into the final written form and was approved by the President/CEO

of St. Luke’s Medical Center in January 2012.

This St. Luke’s Manual of Standard Operating Procedures (SOPs) sets a standard of excellence for the

ethical review of any research or clinical trial involving human subjects conducted by the medical staff,

scientists and faculty at St. Luke’s Medical Center. It aims to serve as a reference for ethics reviewers,

principal investigators, sponsors, research administrators, and institutional authorities on the judicious

and safe conduct of clinical research. With this Manual, its creators, led by RBD Vice-President Dr.

Filipinas F. Natividad, hope to raise the bar of research excellence at St. Luke’s and to provide greater

access to compassionate care for all its clients.

The Manual of Standard Operating Procedures (SOPs) of the St. Luke’s Institutional Ethics Review

Committee (IERC) of St. Luke’s Medical Center was prepared in accordance with international, national

and institutional guidelines.

INSTITUTIONAL ETHICS REVIEW COMMITTEE

Standard Operating Procedures


I hereby submit this Manual of the St. Luke’s-Institutional Ethics Review Committee Standard

Operating Procedures (SL-IERC SOPs) to be the official guide of the Institutional Ethics Review

Committee of St. Luke’s Medical Center.

FILIPINAS F. NATIVIDAD, PhD Vice-President Research and Biotechnology Division St. Luke’s Medical Center

I hereby recommend acceptance of this Manual of the St. Luke’s-Institutional Ethics Review

Committee Standard Operating Procedures (SL-IERC SOPs) to be the official guide of the Institutional

Ethics Review Committee of St. Luke’s Medical Center.

AUGUSTO G. REYES, MD Chairman St. Luke’s Institutional Ethics Review Committee

This Manual of the St. Luke’s Institutional Ethics Review Committee Standard Operating Procedures

(SL-IERC SOPs) is hereby officially accepted to serve as a guide of the Institutional Ethics Review

Committee of St. Luke’s Medical Center.

JOSE F.G. LEDESMA President and CEO St. Luke’s Medical Center

INSTITUTIONAL ETHICS REVIEW COMMITTEE SOP Acceptance Page


I. SL-IERC STANDARD OPERATING PROCEDURES


Sop Table Of Contents

CHAPTER STANDARD OPERATING PROCEDURE (SOP) TITLE PAGE

1. Preparation of SOPs and Guidelines for the Institutional Ethics Review Committee (IERC)

1.1. Preparation and Amendment of SOPs……………………………………………….. 1.2. Preparation Guidelines on SOPs………………………………………………………… 1.3. Documentation Control System of SOPs…………………………………………….

7 9

11

2. SOPs of the Institutional Ethics Review Committee (IERC) 2.1. Composition, Duties and Responsibilities of the IERC………………………… 2.2. Confidentiality Agreements and Conflict of Interest Disclosure…………. 2.3. Training of IERC Members and Personnel………………………………………….. 2.4. Selection of Resource Persons…………………………………………………………… 2.5. Honorarium of IERC Members and Secretariat………………………………….. 2.6. Composition, Duties and Responsibilities of IERC Secretariat of the SLMC QC and GC……………………………………………………………………..

13 17 18 20 21

22

3. Procedures for Initial Protocol Submissions and Ethical Review 3.1. Initial Protocol Submissions………………………………………………………………… 3.2. Initial Submission of Application through the Center for Clinical Trials

(CCT) Web portal……………………………………………………………………………….. 3.3. Preliminary Review By IERC Members Prior to Presentation……………. 3.4. Full Review of Protocols…………………………………………………………………… 3.5. Expedited Review…………………………………………………………………………….. 3.6. Implementation of Newly- Approved Protocols………………………………..

25

28 30 32 34 36

4. Continuing Review and Monitoring of Protocols 4.1. Review of Protocols That Require Major Revisions

after Presentation……………………………………………………………………………. 4.2. Review of Protocol Amendments……………………………………………………. 4.3. Review of Progress Reports…………………………………………………………….. 4.4. Monitoring of Serious Adverse Events…………………………………………….. 4.5. Early Termination of Clinical Trials/Researches Due to Protocol

Violations………………………………………………………………………………………… 4.6. Site Monitoring Visit…………………………………………………………………………

39 40 42 44

46 48

5. Administrative Procedures 5.1. Preparation of Notice of Meeting and Agenda………………………………… 5.2. Preparation and Distribution of Minutes of Meetings……………………… 5.3. Emergency/Special Meetings………………………………………………………….. 5.4. Preparation for a Regular Meeting………………………………………………….. 5.5. Conduct of a Regular Meeting…………………………………………………………. 5.6. Management of Communication…………………………………………………….. 5.7. Management of Administrative Files, Logbooks and Forms……………..

51 54 56 58 60 62 63


II. LIST OF SL-IERC FORMS

III. GLOSSARY……………………………………………………………………………………………………………..…… 106

FORM DESCRIPTION FORM # PAGE

1. Agreement on Confidentiality and Conflict of Interest Form SL-IERC FORM#01A 67

2. Agreement on Confidentiality and Conflict of Interest Form (for Preliminary Reviewer)

SL-IERC FORM#01B 68

3. Initial Protocol Review Submission Form SL-IERC FORM#03A 69

4. Initial Protocol Review Submission Acknowledgment Form SL-IERC FORM#03B 70

5. CT Tracking Form SL-IERC FORM#04 71

6. Preliminary Technical Review Form SL-IERC FORM#05A 72

7. Preliminary Ethics Review Form SL-IERC FORM#05B 74

8. Notice of Meeting SL-IERC FORM#06A 78

9. Notice of Emergency Meeting SL-IERC FORM#06B 79

10. Notice of Preliminary Review Form SL-IERC FORM #07 80

11. Invitation to Present SL-IERC FORM #08 81

12. IERC Attendance Sheet SL-IERC FORM #09A 82

13. Attendance Sheet for Presentors SL-IERC FORM #09B 83

14. Principal Investigator Acknowledgment Form SL-IERC FORM #10 84

15. Evaluation Checklist SL-IERC FORM #11 85

16. Notice of Action SL-IERC FORM #12A 87

17. IERC Composition SL-IERC FORM #12B 88

18. Ethical Clearance (Clinical Trial) SL-IERC FORM#13A 89

19. Ethical Clearance (Clinical Research) SL-IERC FORM#13B 90

20. Request for Ethical Clearance Renewal SL-IERC FORM#13C 91

21. Ethical Clearance Renewal Form SL-IERC FORM#13D 92

22. SAE Form SL-IERC FORM#14A 93

23. SAE Tracking Form SL-IERC FORM#14B 94

24. Protocol Deviation/Violation SL-IERC FORM#15 95

25. Continuing Review Report Form SL-IERC FORM#16 96

26. Tentative Agenda SL-IERC FORM#17A 98

27. Final Agenda SL-IERC FORM#17B 100

28. DSMC Report SL-IERC FORM#18 102

29. Site Monitoring Visit Checklist SL-IERC FORM#19 103


CHAPTER 1

Date: 00/00/00

1. Preparation of Standard Operating Procedures (SOPs) and Guidelines for the Institutional Ethics Review Committee (IERC)

1.1. Preparation and Amendment of SOPs 1.2. Preparation Guidelines on SOPs 1.3. Documentation Control System of SOPs


REVIEW COMMITTEE


1. PURPOSE To describe the manner in which SOP shall be formulated, reviewed, approved, distributed, and amended.

2. SCOPE From identification of the SOP to be formulated or amended, writing of the SOP, to the review and approval process.

3. FLOW CHART

PROCESS PERSON/S RESPONSIBLE

Vice President (VP) for Research and Biotechnology Division (RBD)

VP for RBD/Center for Clinical Trials (CCT) Administrator/SOP team of CCT

SOP team of CCT

and Secretariat

IERC Chair and Members

President and CEO

Secretariat IERC Chair and Members Secretariat

4. PROCEDURE 4.1. Identification of the SOP to be formulated or amended

4.1.1. The Vice President of the Research and Biotechnology Division (RBD) through the Center for Clinical Trials or the IERC may propose the formulation of a new SOP or the amendment of an existing SOP.

4.1.2. The proposal shall include the rationale for the new SOP or for the amendment and shall be discussed as part of the Agenda of an IERC regular meeting.

4.1.3. The decision on the proposal shall be made through a consensus of the IERC.

INSTITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCEDURE

Preparation and Amendment of SOP

SL-IERC SOP # 1.1 Effective Date: January 2012

Identification of SOP to be written

Writing of SOP

Formatting of SOP

Review and Amending of SOP

Approval

Distribution

Implementation





4.2. Writing, Formulation, Formatting and Approval of the SOP 4.2.1. The Vice-President of RBD and the SOP Team of CCT shall be responsible in writing or

amending the SOP. 4.2.2. The final draft of the new/amended SOP shall be included in the Agenda of the IERC

regular meeting and shall be formally approved by a consensus. 4.2.3. The President and CEO shall sign and date the approved SOP upon recommendation of

the IERC Chair and the Vice-President of RBD. 4.2.4. The signed SOP shall be assigned a Control SOP Number and shall be incorporated in

the SOP file.

4.3. Distribution and Implementation 4.3.1. The Secretariat shall keep the original signed and dated controlled copy as part of the

Updated SOP Manual. 4.3.2. The Secretariat shall provide uncontrolled copies to IERC members and other

authorized personnel. 4.3.3. The IERC Chair and Members and Secretariat shall be responsible for the

implementation of the approved new or amended SOP. 4.3.4. The Secretariat shall maintain the revision history for all amended SOP, including the

Revision date and Version Number.

5. EFFECTIVITY The new or amended SOP shall be effective immediately upon the recommendation of the IERC, Chair and approval of the President and CEO.

---Nothing Follows---



Preparation Guidelines on SOP


1. PURPOSE To describe the format, contents, and numbering of SOP

2. SCOPE

From description of the format to the numbering of the SOP.

3. FLOW CHART

PROCESS RESPONSIBILITY

Vice President (VP) for Research and Biotechnology Division (RBD)

Center for Clinical Trials Administrator /Secretariat

VP for RBD SOP team of CCT IERC Chair and members

4. PROCEDURE 4.1. The IERC shall follow a standard format for a written SOP. Each page shall have the

following:

Logo of SLMC in the upper left portion

Research and Biotechnology Division below the SLMC Logo

INSITUTIONAL ETHICS REVIEW COMMITTEE STANDARD OPERATING PROCECURE in bold upper case letters as header at the center

Title of the specific SOP below the header

SOP number in the upper right portion

Effectivity date below the SOP number

Pagination and Revision history as Footer

4.2. The standard contents of the main text of the SOP shall have the following parts:

Purpose

Scope

Flow Chart

Procedure

Standardization of the SOP format,

contents and signatories

Numbering of SOP

Implementation





5. Description of Contents

5.1.1. Purpose- This states the aim of the SOP 5.1.2. Scope- This shows the initial activity involved until the entire procedure ends 5.1.3. Flow Chart -This gives the chronological order of the various steps involved in the

procedure, and the person or groups of persons who are responsible for each step. 5.1.4. Procedure -This is a detailed description of the various steps as outlined in the Flow

Chart. 5.1.5. Optional parts -References and attachments shall be included when appropriate.

5.2. Signatories of SOPs

5.2.1. The signatories of the SOPs shall include the following:

Prepared by the VP of RBD/CTA of CCT

Recommended by the IERC Chair/VP of RBD

Approved by the President and CEO 5.2.2. The signatories shall appear at the last page of the SOP after the phrase “Nothing

Follows”.

5.3. Numbering of SOPs 5.3.1. All SOP shall be identified by a document code that contains letters and numbers,

i.e. SL-IERC SOP #XX 5.3.2. Only the final version of an SOP shall be given a document code. 5.3.3. The original version of an SOP shall have the following in the footnote: SL-IERC SOP

Year- v1 5.3.4. When an SOP undergoes revision, it retains the same document code, but the

footnote shall indicate the year of revision and version number shall as follows: Year-v2

5.3.5. A revised SOP shall have a new effectivity date

6. IMPLEMENTATION These guidelines shall serve as reference in the preparation and writing of SOP for the St. Luke’s Institutional Ethics Review Committee (SL-IERC).

---Nothing Follows ---



Documentation Control System for SOPs


1. PURPOSE To establish a system to properly maintain and control IERC SOPs

2. SCOPE

From stamping of controlled copies to distribution of uncontrolled copies .

3. FLOW CHART


CCT Administrator CCT Administrator CCT Administrator

4. PROCEDURE 4.1. The CCT shall establish a system of filing, retrieving and releasing of SOP copies.

4.1.1. The CCT shall be the central repository of all SL IERC SOPs. 4.1.2. The CCT shall stamp an original signed SOP as “CONTROLLED COPY”. 4.1.3. The CCT shall ensure that any SOP that is reproduced and circulated is stamped as

“UNCONTROLLED COPY”. 4.2. The CCT shall be the control center and repository for all SL IERC SOPs.


Establishment of a system of filing/

retrieving/releasing of SOP copies

Stamping of original signed copies

as “CONTROLLED COPIES”

Distribution of

UNCONTROLLED COPIES


Date: 00/00/00 INSTITUTIONAL ETHICS

REVIEW COMMITTEE

2. SOPs of the Institutional Ethics Review Committee (IERC)

2.1. Composition, Duties and Responsibilities of the IERC 2.2. Confidentiality Agreements and Conflict of Interest

Disclosure 2.3. Training of IERC Members and Personnel 2.4. Selection of Resource Persons 2.5. Honorarium of IERC Members and Secretariat 2.6. Composition, Duties and Responsibilities of IERC 2.7. Secretariat of the SLMC QC and GC

CHAPTER 2


1. PURPOSE

To ensure a standard process of selection of members, the criteria for membership, the organizational structure and the duties and responsibilities of the Chair and members.

2. SCOPE

From selection of membership to specifying duties and responsibilities of SLMC-QC/GC IERC.

3. FLOW CHART


VP for RBD

President and CEO of SLMC

VP of RBD

VP of RBD

IERC Chair, VP of RBD and President and CEO

4. PROCEDURE

4.1. Method of Selection and Terms of Reference

4.1.1. The VP of RBD shall recommend the constitution for SL-IERC. 4.1.2. The President and CEO shall officially appoint the Chair and members of the IERC. 4.1.3. Members shall be appointed for a term of 2 years. 4.1.4. There shall be no limit as to the maximum number of terms a member is

reappointed. 4.1.5. Members who do not attend 3 successive meetings may be replaced upon

recommendation of the IERC Chair.


Composition, Duties and Responsibilities of the SLMC QC and GC

Institutional Ethics Review Committee


Recommendation for constitution of IERC membership

Appointments and Terms of appointments and disqualification of

the IERC members

Description of the Duties and Responsibilities of the IERC Chair

and members

Description of the Duties and Responsibilities of the Secretariat

and Administrative staff

Resignation, Disqualification and Replacement of an IERC member


4.2. Membership of the IERC shall be multidisciplinary and multi-sectoral with the following minimum composition in accordance with the guidelines set by the Philippine Health Research Ethics Board:

A physician with experience in medical research

A member of a religious community

A lawyer, who represents concerns of the community

A scientist

A layperson independent from the institution. 4.3. Both male and female genders shall be represented in the IERC

4.4. The Vice President for RBD shall be a regular member of IERC.

4.5. The President and CEO may appoint additional members to the IERC.

5. ROLES AND RESPONSIBILITIES OF THE IERC

5.1. The IERC shall review essential documents of clinical trials and researches involving human subjects (i.e. all Phases of Clinical Trials including Investigator-Initiated, Observational, Registry and Post Marketing Surveillance Studies) submitted to RBD to safeguard the rights, dignity and welfare of human participants.

5.2. The IERC shall ensure that clinical trials and researches shall be conducted in accordance with Philippine laws and National Ethical Guidelines for Health Research 2011 by Philippine National Health Research System (PNHRS), International Conference on Harmonization (ICH) for Good Clinical Practice and Association for the Accreditation of Human Research Protection Programs, Inc. Please see ICH GCP Guidelines and Philippine National Ethical Guidelines for Health Research 2011 handbook and Reviewing Clinical Trials: A guide for Ethics Committees 2010 as reference.

5.3. The IERC shall recommend the approval of investigator-initiated researches if:

all ethical issues have been addressed

protocol is compliant with GCP

recommended revisions have been incorporated

5.3.1. protocol without any issues and recommendations after the presentation.

5.3.2. protocol with issues and recommendation upon review of the response to the Notice of Action issued by the IERC Secretariat to the Principal Investigator during the next scheduled meeting. Please refer to Quality Procedures on the Ethical Review Clinical Trial Protocols and SL-IERC SOP#4.1 Review of Protocols that Require Major Revisions.

5.4. It shall issue the Ethical Clearance Form to indicate IERC approval following the review of the Protocol.

5.4.1. The Ethical Clearance shall indicate the dates of review, approval and validity.

5.4.2. The Ethical Clearance shall be valid for 2 years according to location of trial ( e.g. St. Luke’s Medical Center- Quezon City and Global City and other institutions upon request)










5.4.3. Extension of the Ethical Clearance shall be granted upon:

written request of the sponsor

submission of progress report

favorable evaluation by Clinical Research Monitor

payment of extension fee

5.5. It shall monitor and submit reports on adverse events/serious adverse events/ unexpected adverse events to the Medical Director-QC or Medical Director-GC. (Please refer to policy on Monitoring of Clinical Safety of Investigational Drugs).

5.6. It shall perform continuing review/audit of each ongoing trial at intervals appropriate to the degree of risk to human subjects or at least once a year (based on the IERC review approval date) using the IERC Continuing Review Report Form issued by the office of the Center for Clinical Trials. (See SOP on Continuing Review Procedures)

5.7. It shall identify a resource person or a known expert to provide additional information about a study when necessary.

6. RESPONSIBILITIES OF THE IERC

Each Member of the IERC shall have the following responsibilities:

Attend IERC meetings regularly and participate in the review and evaluation of research protocols and other related requests as part of a full or expedited review.

Participate in the monitoring of approved protocols.

Participate in the review of monitoring reports, progress and final reports, and amendments presented during IERC meetings

Make himself familiar with the SOPs of the SL-IERC

Attend seminars, workshops and conferences in research ethics to enhance his competencies as member of the IERC

Submit an updated CV at the start of each new appointment

Declare any conflict of Interest on any of the research protocols submitted for review.

Maintain confidentiality of the documents and deliberations of the IERC meetings.

7. RESPONSIBLITIES OF THE IERC CHAIR

The IERC Chair shall have the following responsibilities:

Finalize the agenda and preside in all IERC meetings.

Conduct a preliminary review of all protocols and decide on the nature of review

Ensure that a final decision on all protocols reviewed is made, and break a tie whenever a stalemate in IERC voting occurs

Sign the Ethical Clearance Form

Sign the following communications: Notice of Meetings, Notice of Action to Principal Investigators and Sponsors

Represent St. Luke’s in ethics-related symposia or meetings that require institutional participation






Ensure that appropriate decisions/actions made by the IERC whenever there are unanticipated problems (issues that include but are not limited to research participants complaints, findings of non-compliance during an FDA audit, loss of records or study drugs, higher than expected occurrences of adverse, unanticipated adverse events that are at least possibly related to the study, drug accountability problems, unanticipated change in Principal Investigator, etc.)

Submit annual reports on the accomplishments of the IERC to PHREB

Communicate decisions of the IERC to research proponents.

8. Resignation, Disqualification and Replacement of Members

8.1. An IERC member may resign from the committee at any time during his term through an official letter addressed to the Chair.

8.2. An IERC member may be recommended by the Chair for disqualification for any of the following reasons:

8.2.1. Failure to attend 3 consecutive meetings of the IERC without any valid reason

8.2.2. Failure to disclose Conflict of Interest

8.2.3. Violation of the Confidentiality Rule

8.3. Replacement of the resigned ERC member shall be made by the President/CEO, as per provision of the “ Policy on IERC”




STANDARD OPERATING PROCEDURE

Confidentiality Agreement and Disclosure of Conflict of Interest

SL-IERC

SOP # 2.2

Effective Date:

January 2012

1. PURPOSE To ensure that the members of the Institutional Ethics Review Committee (IERC) read, understand, accept, sign and date a Confidentiality Form and a Conflict of Interest Disclosure.

2. SCOPE From providing the forms to filing of signed and dated documents

3. FLOW CHART


Secretariat

IERC members

Secretariat

4. PROCEDURE:

4.1. The Secretariat shall provide each IERC member a copy of the Agreement On Confidentiality And Conflict Of Interest. (Refer to SL-IERC Form # 01A)

4.2. IERC members read the forms and affix their signature, indicating the date of signing.

4.3. The Secretariat files the signed documents in the respective Reference Binders of each IERC member and the Master File.


Provision of forms for Confidentiality Agreement

and Disclosure of Conflict of Interest to IERC members

Reading/signing/dating of 2 copies of the forms

Filing of signed documents to Member’s Referendum Binder

and providing copies to respective member




Training of IERC Members and Staff

SL-IERC

SOP # 2.3

Effective Date:

January 2012

1. PURPOSE

To ensure that members of the IERC and Secretariat team regularly attend seminars/training/ workshops/conferences to maintain and enhance their competence and skills through an updated knowledge of research ethics and guidelines.

2. SCOPE

From identification of to attendance in, seminars/training/workshops/conferences on ethics, ethics review committees, and other related topics.

3. FLOW CHART


Secretariat

VP for RBD/IERC

VP for RBD

President/CEO

IERC members and staff

Secretariat

Identifying availability and schedule of Seminars/Trainings/Workshops/Conferences

Approval to attend local

Seminars/Training/Workshops/Conferences

Approval to provide funding for international Training/Workshop/Conferences

Attendance in Seminars/Trainings/Workshops/ Conferences

Filing of Training Certificates

Identifying personnel to attend

Seminars/Training/Workshops/Conferences




Training of IERC Members and Staff

SL-IERC

SOP # 2.3

Effective Date:

January 2012

3.1. The Secretariat regularly obtains information on availability and schedule of training courses, workshops, and conferences on ethics, ethics review committees, and other related topics.

3.2. The VP for RBD and IERC Chair shall identify members of the IERC and the Secretariat team who will attend Seminars/Training/ Workshops and Conferences.

3.2.1. For attendance in local venues, the Vice President for RBD shall make the official approval.

3.2.2. For regional and international venues, the Vice President for RBD shall make the appropriate request for financial support and approval by the President/CEO.

3.3. IERC members and Secretariat Team who attend any Seminars/Training/ Workshops and Conferences shall submit their certificate or proof of attendance for filing by the Secretariat.

---Nothings Follows---



Resource Persons


1. PURPOSE

To describe the procedure for getting the services of an expert to serve as Resource Person on matters outside the expertise of members of the Institutional Ethics Review Committee (IERC)

2. SCOPE

From identifying the need and the expert to providing compensation for the Resource Person

3. FLOW CHART


IERC

IERC

Resource Person/VP for RBD

Resource person

Accounting Dept./Secretariat

4. PROCEDURE

4.1. When deemed necessary, the IERC may invite an expert to serve as resource person for the review of a specific protocol.

4.2. The VP of RBD shall have the prerogative to appoint the resource person as an independent consultant upon recommendation of the IERC/IERC Chair.

4.3. The resource person shall sign a Service Agreement upon his/her appointment.

4.4. The resource person shall participate in the review of a specific protocol and give his/her inputs on specific issues related to his expertise.

4.5. The resource person shall not have any voting rights.

4.6. The resource person shall receive an honorarium, the amount of which shall be determined by the VP for RBD, for his/her services rendered.

4.7. Secretariat shall request Accounting Department to prepare honorarium for Resource Persons.

4.8. Secretariat gives the honorarium to Resource Person.


Determination of need for a

Resource Person

Identification of expert and invitation to serve as Resource

Person

Signing of Service Agreement

Participation in appropriate

Meeting

Payment of honorarium


1. PURPOSE

To ensure that the members of the Institutional Ethics Review Committee (IERC) and Secretariat are granted honoraria for their work in the committee.

2. SCOPE

From recommendation for grant of honorarium for, to acknowledgment receipt of honorarium by the members of the Institutional Ethics Review Committee (IERC) and Secretariat.

3. FLOW CHART


VP of RBD

President and CEO

Secretariat

Accounting Department

IERC/Secretariat

4. PROCEDURE

4.1. The Vice-President for Research and Biotechnology Division shall recommend to the President/CEO the granting of honorarium to the IERC and Secretariat for their work in the committee. The honorarium shall cover an amount for review of protocols, for attendance and participation in meetings and other IERC activities and a year-end bonus

4.2. The VP for RBD shall recommend increase in the honorarium depending on the workload.

4.3. The Secretariat shall prepare request for honorarium forwarded to SLMC Accounting Department.

4.4. The IERC members and Secretariat shall sign a voucher upon receipt of honorarium check from the Accounting Department.



Honorarium of IERC and Secretariat


Recommendation for grant of honoraria of IERC members and

Secretariat

Approval/Disapproval

Dispensation of honorarium

Acknowledgment of honorarium

Request for preparation of honorarium



Composition, Duties and Responsibilities of IERC Secretariat of the SLMC QC and GC


1. PURPOSE

To identify the roles of the staff of the IERC Secretariat and Administrative Staff and delineate their duties and responsibilities.

2. SCOPE

From the identification of the staff of IERC Secretariat and Administrative Staff and delegation of their duties and responsibilities.

3. FLOW CHART


VP for RBD

VP for RBD

4. PROCEDURE

The IERC Secretariat and Administrative Support Staff

4.1. Composition: The staff of the St. Luke’s –Center for Clinical Trials (SL-CCT) shall serve as the IERC Secretariat and the administrative support staff of the IERC

4.2. Responsibilities of the Secretariat

4.2.1. Receives, documents, and records all applications for protocol review

4.2.2. Prepares the tracking form and assigns a tracking number for all protocols received

4.2.3. Forwards submitted protocol to ERC Chair for initial review in order to determine type of review process

4.2.4. Prepares agenda and Notices of Meetings of ERC

4.2.5. Collates all essential documents for ERC meetings and distributes these to ERC members

4.2.6. Prepares and distributes communications to, and coordinates with, all Principal Investigators regarding schedule of protocol presentation

4.2.7. Takes and prepares Minutes of ERC Meetings

4.2.8. Keeps and maintains archives of the following: Dossier of each reviewed protocol, minutes of meetings, file of ERC members

4.2.9. Answers queries from Clinical Research Organizations (CROs), Sponsors, and Investigators on matters relevant to the functions/activities/schedules etc. of the ERC

4.2.10. Maintains confidentiality of all documents of the ERC

Identification of Staff and Administrative Staff for the

IERC Secretariat

Delegation of duties and

responsibilities



Composition, Duties and Responsibilities of IERC Secretariat of the SLMC QC and GC


4.3. Responsibilities of the Administrative Support Staff

4.3.1. Prepares reports and other matters to be presented at ERC meetings

4.3.2. Requests the use and assures the availability, of venue for ERC meetings

4.3.3. Prepares request for food and beverages to be served during ERC meetings

4.3.4. Assures functionality of audiovisual equipment for presentors

4.3.5. Prepares requests for honorarium of ERC members

4.3.6. Arrange transport service for ERC members not affiliated with SLMC

4.3.7. Performs other functions as requested by ERC members



CHAPTER 3

Date: 00/00/00

Procedures for Initial Protocol Submissions and Ethical Review

3.1. Initial Protocol Submissions 3.2. Initial Submission of Application through the

Center for Clinical Trials (CCT) Web portal 3.3. Preliminary Review By IERC Members Prior to

Presentation 3.4. Full Review of Protocols 3.5. Expedited Review 3.6. Implementation of Newly- Approved Protocols


REVIEW COMMITTEE



Initial Protocol Submissions


1. PURPOSE

To ensure a standard process of submission of protocols for review, particularly the responsibilities and procedures for initial review.

2. SCOPE

From submission of protocol dossier up to the classification of the type of review.

3. FLOWCHART


Secretariat

Secretariat

Secretariat

VP for RBD/IERC Chair

Receipt of Documents for review with the accomplished CT Initial Protocol

Submission Form

Evaluation for Completeness of submitted dossier using CT

Initial Protocol Review Acknowledgement Form

submittedDocument

If not complete, information sent to concerned PI,

Sponsor or Proponent

If complete, acceptance and assignment a CT Tracking Number

Initial Review to

determine type of

Review





1. PROCEDURE

1.1. Receipt of documents for review. 1.1.1. The Secretariat receives the protocol dossier at the Center for Clinical Trials which

includes the following:

Accomplished Initial Protocol Submission Form (Refer to SL-IERC Form#02)

Letter of intent addressed to IERB Chair

9 copies of the following (if applicable): Protocol with the following attachments

- Informed Consent Form (English and Tagalog) - Case Report Forms - Investigator’s Brochure

1 copy each of the following (If applicable): - Pharmacokinetics - Subject Worksheets/Patient Diary/Alert Cards (English and Tagalog

versions) - Questionnaire (English and Tagalog Versions)

Philippine Food and Drug Administration Approval

Certificate of Product Registration in the Philippines for Post Marketing

Surveillance Studies(PMSS)

Curriculum Vitae of Investigators

GCP Certificates of Investigators

Certificate of Insurance

1.1.2. The Secretariat logs the protocol submission using the CT Tracking Form. (Refer to SL-IERC Form #04)

1.2. Evaluation of completeness of the dossier based on the IERC Initial Protocol Review

Acknowledgement Form. (Refer to SL-IERC Form #03)

If the dossier is incomplete, Secretariat communicates with the concerned PI, sponsor or proponent through phone or email. This is logged in the appropriate Tracking Form.

If the dossier is complete, the Secretariat assigns a CT Tracking Number to the protocol. CT Tracking Number is composed of the letters, C T , last 2 digits of the year; running number starting with 1 (eg. CT 11 001) 11 is for 2011; 001 is First protocol received for the year, etc.

1.3. Classification of type of review

1.3.1. The Secretariat shall inform the VP for RBD for the receipt of a new protocol. 1.3.2. The IERC Chair and the VP for RBD shall determine if the protocol is for Full Board

review or for Expedited Review. 1.3.3. The Secretariat shall prepare the appropriate communication as to the type of

review.


1.3.3.1. If protocol is for full review, the Secretariat shall inform the Principal

Investigator/Sponsor/Proponent the type of review to be done and schedule the presentation of the protocol in a regular IERC meeting. (Refer to SL-IERC SOP#3.3)

1.3.3.2. If protocol is for expedited review, the Secretariat shall send a Notice of Referendum to the IERC members .






1. PURPOSE To establish a documented procedure for assessing protocols submitted through the web portal

2. SCOPE

From the submission of application for protocol review via the web portal to the classification of type of review

3. FLOWCHART


Secretariat

Electronic Reply from

web portal

Secretariat

Sponsor/CRO/Principal

Investigator

Secretariat

Secretariat

VP of RBD/IERC Chair


Initial Submission of Application through the Web portal


Daily checking of web portal

applications

Automatic reply generated

Submission of hard copies of

documents for review

Assessment of completeness of submission using CCT Initial Review

Submission Form documents

Assignment of a CT Tracking Number

Acknowledgment of receipt of Application

Classification of type of review


4. PROCEDURE 4.1. Application through the web portal

4.1.1. Sponsor/CRO/PI logs in to the CCT web portal on the SLMC Website and fills up the Initial Protocol Submission Form. (Refer to SL-IERC Form#02)

4.1.2. The completed Initial Protocol Submission Form is submitted electronically 4.1.3. An automatic acknowledgement is generated by the web portal upon

submission of the on-line application. 4.1.4. The Secretariat shall inform the applicant through email to submit required

documents in order to complete his on-line application. (Refer to SL-IERC SOP #3.1)

4.2. Submission of requirements for application 4.2.1. The applicant shall submit hard copies of the required documents to complete

his application to the CCT office either by hand carry or courier. 4.2.2. The applicant may check the status of his application in the webportal. 4.2.3. The Secretariat shall assess the completeness of submitted documents using CCT

Initial Protocol Submission Form. 4.2.4. The Secretariat assigns a CT Tracking Number for the submitted protocol.

4.3. Classification of type of review (Refer to SL-IERC SOP# 3.1)



Initial Submission of Application through the Web portal




Preliminary Review By IERC Members Prior To Protocol Presentation


1. PURPOSE

To establish a documented procedure for the preliminary ethical review of clinical trial/research protocols prior to presentation by the Principal Investigator/Proponent

2. SCOPE

From the receipt of the Clinical Trial Protocol/ Research dossier to the presentation by the Principal Investigator/proponent during the IERC meeting

3. FLOW CHART


Secretariat

IERC members

IERC members

Secretariat

Principal Investigator/Proponent

4. PROCEDURE

4.1. The Secretariat shall provide each member of the IERC, one week in advance, copies of all clinical trials/research protocols scheduled for presentation in a regular or special meeting of the ERC

4.2. Each member of the IERC shall make his/her own individual review by using the IERC Preliminary Technical and Ethics Review Forms (Refer to SL-IERC Form #05A & SL-IERC Form#05B) 4.2.1. Evaluate on Comment of the Technical aspects 4.2.2. Evaluate the Informed Consent Form 4.2.3. Comment on the Assent Form if the protocol includes children as participants

Distribution of Protocol Dossier

to IERC members

Individual Review

Submission of IERC Preliminary Review Forms during IERC Meeting

Filing of documents in

Study Binders

Presentation of Protocol



Preliminary Review By IERC Members Prior To Protocol Presentation


4.2.4. Make a Risk Assessment by checking the appropriate box as follows:

High Risk - if study can lead to an unexpected/unplanned loss of life, or permanent impairment of quality of life, or may lead to serious legal action against Principal Investigators and/or institution

Medium Risk - if the result requires notification to ethics committee

Low risk - if the consequences can be dealt with by routine operations 4.2.5. Individual member signs and dates all pertinent documents and submits to

Secretariat. 4.2.6. Secretariat files all relevant documents in appropriate protocol binders.

4.3. The Principal Investigator/Research Proponent presents the protocol during the IERC

meeting and answers the issues raised by the committee members during the interpolation.

4.4. The IERC may disapprove the Clinical Trial/Research protocol if there are unresolved issues. The IERC decision may be any of the following as in SL-IERC SOP #3.4.

Approved

Approved with modification

Disapproved




Full Review of Protocols


1. PURPOSE

To describe the procedure for full review of submitted clinical trial protocols/research proposals

2. SCOPE From presentation of the protocol /proposal in a regular IERC meeting to filing of Notice of Action in appropriate folder

3. FLOWCHART


4. PROCEDURE

4.1. Presentation of Protocol/Proposal

4.1.1. The Principal Investigator/Proponent shall present his protocol/proposal before the IERC en banc .

4.1.2. The Principal Investigator/Proponent shall discuss the 7 basic factors for ethical review as follows:

Social or Scientific Value

Scientific Validity

Fair Subject Selection

Favorable Risk-Benefit Ratio

Independent Review

Informed Consent

Respect for Potential and Enrolled Subjects 4.1.3. At any time during the presentation, the members of the IERC may interrupt and ask

a question. 4.1.4. The interpolation can still proceed after the presentation. 4.1.5. The IERC Chair or the Vice President of RBD shall present the issues raised by those

who are absent, if these have not been previously resolved

Presentation of Protocol/Proposal

Interpolation

Evaluation of Protocol/Proposal

Deliberation

Decision by consensus

Notice of Action

Secretariat

IERC

IERC

IERC

Secretariat/Principal

Investigator/Proponent

IERC



Full Review of Protocols


4.2. Evaluation of the Protocol/Proposal

4.2.1. Members of the IERC shall make their final evaluation after the interpolation by filling up the “IERC Evaluation Sheet”, which should be signed and dated (Refer to SL- IERC Form# 11).

4.2.2. The Secretariat shall collect the IERC Evaluation Sheets from those who are present in the meeting.

4.2.3. IERC Chair shall summarize the issues and recommendations on the protocol/ proposal based on the following:

deliberation that ensued after the presentation

comments on the evaluation sheets collected from the members present

evaluation of members who are absent

4.3. The decision of the committee shall be made by consensus as follows:

Approved for Clinical Trial Agreement and Ethical Clearance

Deferred Approval pending Response to issues/recommendations

Disapproved

4.4. Notice of Action

4.4.1. The Secretariat shall prepare the Notice of Action (NOA) (Refer to SL-IERC Form #12A) stating the decision of the committee for appropriate action of the Principal Investigator/Proponent and shall ask the IERC Chair to sign.

4.4.2. The Secretariat shall deliver the NOA to the appropriate recipient with an Acknowledgement Receipt.

4.4.3. The Secretariat shall file the document in the appropriate folder.

---Noting Follows---



Expedited Review


1. PURPOSE

To provide criteria for classifying study protocols for expedited review, as well as instructions for

expedited review and approval of study proposals with minimum risk to participants.

2. SCOPE From classifying protocols for review to the process of expedited review and approval.

3. FLOWCHART


VP for RBD/IERC

Secretariat

IERC Chair and VP of RBD

Secretariat

IERC

Secretariat

IERC Chair

Secretariat

Establishment of criteria for expedited review

Evaluation of protocols submitted for Initial Review

submitted Document Classification of protocols for

expedited review

Conduct of expedited review by referendum

Reporting of results of the referendum during the regular IERC meeting

to the IERC

Sending of Notice of Action

Preparation of summary of recommendations

Sending of Notice of Preliminary Review/Referendum to IERC



Expedited Review


4. PROCEDURE 4.1. The following criteria shall be used as basis for classifying protocols for expedited review:

Protocols that entail only a minimal risk to the human participants and to the community

Post marketing surveillance studies that are conducted as a requirement of FDA Philippines

Protocols that are retrospective in data collection methodology.

4.2. Evaluation and classification of protocols for expedite review 4.2.1. The VP for RBD shall evaluate if a submitted protocol is qualified for expedited review

based on the above criteria and makes recommendation to the IERC Chair. 4.2.2. The IERC Chair shall classify a protocol for expedited review. 4.2.3. The Secretariat shall prepare and shall send a Notice of Referendum to members of

the IERC.

4.3. Conduct of expedited review 4.3.1. The Secretariat shall send copies of the protocol to members of the IERC. 4.3.2. The IERC members shall be given two weeks to evaluate. 4.3.3. The recommendations of the reviewers may be any of the following:

Approved

Disapproved

With revisions

For presentation 4.3.4. The Secretariat shall get the results of the review, shall summarize the

recommendations and shall inform the IERC Chair.

4.4. The IERC Chair shall report the outcome of the referendum to the IERC during a regular meeting. 4.4.1. The protocol is approved or disapproved if majority of the members recommends

approval or disapproval, respectively. 4.4.2. If the majority recommends presentation by the PI, the protocol shall undergo the

usual regular process of review by the IERC.

4.5. The Secretariat shall send a Notice of Action to the proponent.



Endorsement of documents and

Study Binder

Completion of Requirements for

Ethical Clearance

Preparation and Issuance of Ethical Clearance

Site/Study Initiation Visit

1. PURPOSE To establish a standardized procedure for implementation of newly-approved protocols/researches

2. SCOPE From approval of protocol to issuance of ethical clearance and other relevant documents

3. FLOWCHART


Secretariat

Principal Investigator/Secretariat

Secretariat/IERC Chair

Sponsor/PI/Secretariat

4. PROCEDURE 4.1. Endorsement of Study Binder (For Research Projects)

4.1.1. The Secretariat shall issue the following documents to the Principal Investigator:

Approved protocol with stamp of IERC approval

ICF, approved version with stamp of IERC

Other documents submitted for approval

List of IERC members present during the review

Copy of the signed Principal Investigator Acknowledgment Form

4.1.2. The Principal Investigator/Project Leader shall be responsible for keeping, maintaining and updating a Study Binder containing the above documents

4.1.3. The Study Binder shall be made available for purposes of monitoring and continuing review.

4.2. The Ethical Clearance 4.2.1. The Ethical Clearance for an approved protocol shall be issued upon completion of

the following requirements:

For sponsored trials: a fully executed Clinical Trial Agreement (Refer to RBD-CCT SOP on Clinical Trial Agreement)

For investigator-initiated trials: Grant Approval with budget (Refer to Notice of Grant Approval Template)


Implementation of Newly-Approved Protocols




Implementation of Newly-Approved Protocols


4.2.2. The Secretariat shall prepare the Ethical Clearance Form (SL-IERC Form #13A or SL-IERC Form#13B) for signature of the IERC Chair.

4.2.3. The Secretariat shall give the original signed Ethical Clearance to the Principal Investigator and shall keep the receiving copy on file.

4.3. Commencement of the Trial/Research

4.3.1. The approved Clinical Trial/Research shall officially start only after:

Issuance of the Ethical Clearance

Signing of the CTA/Notice of Grant Award

Identification of Study Team/Signing of Delegation of authority

Site/Study initiation visit

4.3.2. The recruitment of trial/study participants shall start only after the Site/Study initiation Visit.



CHAPTER 4


REVIEW COMMITTEE

Continuing Review and Monitoring of Protocols 4.1. Review of Protocols That Require Major Revisions

after Presentation 4.2. Review of Protocol Amendments 4.3. Review of Progress Reports 4.4. Monitoring of Serious Adverse Events 4.5. Early Termination of Clinical Trials/Researches Due to

Protocol Violations 4.6. Site Monitoring Visit


1. PURPOSE

To describe how study protocols with major revisions are managed, re-reviewed and approved

by the IERC.

2. SCOPE

From preparation of Notice of Action (NOA) and receipt of Response to Notice of Action, to re-

review by the IERC of study protocols that require major revisions

3. FLOWCHART


Secretariat

IERC

Secretariat

4. PROCEDURE

4.1. Notice of Action and Response

4.1.1. The Secretariat shall prepare the Notice of Action (Refer to SL-IERC Form# 12A) for the Principal Investigator/ Proponent.

4.1.2. Principal Investigator/ Proponent shall acknowledge the Notice of Action by signing the Acknowledgement Receipt.

4.1.3. Principal Investigator/ Proponent shall be given a time frame of one month to give a response to the Notice of Action.

4.2. Review of Response to Notice of Action

4.2.1. The Response of the Principal Investigator/ Proponent to the Notice of Action shall be included in the Agenda for the next IERC meeting.

4.2.2. IERC Chair shall present the response for discussion by the committee. 4.2.2.1. If IERC accepts the response as satisfactory, the study/protocol shall be

considered approved. 4.2.2.2. If the IERC does not accept the revisions as satisfactory, Principal

Investigator/ Proponent, shall be asked to make further revisions and the new revisions shall

be subjected to the same process of protocol review.



Review of Protocols that require major revisions after presentation


Preparation and sending of Notice of

Action (NOA) to Principal

investigator/Proponent

Review of Response to NOA

Communication to Principal Investigator/Proponent re IERC decision



Review of Protocol Amendments


1. PURPOSE

To describe how amendments to study protocols are reviewed and approved by the IERC.

2. SCOPE From submission of letter of request for approval of amendments, to the review and approval by the IERC

3. FLOWCHART


Secretariat

Secretariat

IERC

Secretariat

Principal Investigator/ Proponent/Sponsor

4. PROCEDURE

4.1. Letter of request for approval of amendments 4.1.1. The Principal Investigator/ Proponent/Sponsor sends a letter to IERC Chair

requesting approval of proposed amendments to a protocol. 4.1.2. Secretariat shall receive and log request in the Incoming Logbook and in the

appropriate Tracking Form and Study Binder 4.2. Review of Request for Approval of Amendment

4.2.1. Secretariat shall include request for approval of Amendment in the next IERC meeting.

Receipt of Letter of Request from Principal Investigator/Proponent

Review of Request for Approval of Amendment

Submission of clean copy of

amended protocol

Submission of Letter of Request for For Approval of Amendments

Communication to Principal Investigator/Proponent re IERC

decision


4.2.2. IERC Chair shall present the request to the committee and asks if there are

objections to the amendment 4.2.2.1. If none, the amendment/s shall be considered approved. 4.2.2.2. If there are objections, Principal Investigator/Proponent shall make

clarifications.

4.3. The Secretariat shall prepare Notice to Principal Investigator/Proponent re action of the IERC.

4.4. Upon approval, the Principal Investigator/Sponsor/Proponent shall be required to submit a clean copy of the amended protocol with the new version number and date of approval.



Review of Protocol Amendments



Preparation and distribution of Memorandum re: Submission of Progress Reports using the CRRF

(Downloadable at CCT web portal)

Report

Review of Progress Reports

Communication to Principal Investigator/Proponent re:

Continuing Review

Filing of Continuing Review Documents

1. PURPOSE To describe the procedure of continuing review of studies involving human participants in order to ensure the continuous protection of their rights and safety, and to provide instructions on preparation of Progress Reports

2. SCOPE From submission of progress reports using Continuing Review Report Form (CRRF) and updates on Serious Adverse Events (SAEs) to tracking of reports received.

3. FLOWCHART


VP for RBD Secretariat

IERC

Secretariat

Secretariat

4. PROCEDURE

4.1. Progress Reports

4.1.1. The VP of RBD shall send a Memorandum requesting all PI’s of on-going studies to submit their Annual Progress Reports (Continuing review Report Forms) based on their anniversary (IERC Review Approval Date) that shall include the following: (Refer to SL-IERC Form# 16)

Progress of the study

Occurrence of Serious Adverse Events

Occurrence of Unexpected Adverse Events (UAEs)

Rate of accrual of participants

Protocol deviations

Protocol violations





4.1.2. VP for RBD prepares memorandum to all PIs for submission of Progress Reports 4.1.3. The Secretariat sends the Memorandum to all PIs 4.1.4. The Secretariat compiles the progress reports from Ongoing Clinical Trials/Projects

for inclusion in the Agenda of regular IERC meeting.

4.2. Review of Progress Report

4.2.1. IERC Chair presents the Progress Reports at a regular IERC meeting. 4.2.2. IERC identifies Clinical Trials/Projects that are high risk protocols requiring

continuing review 4.2.3. IERC identifies Clinical Trials/Projects with no Progress Reports.

4.3. Communication to Principal Investigators/Project Leaders

4.3.1. The Secretariat informs Principal Investigators/Project Leaders of the continuing review of their clinical trials/researches

4.3.2. The Secretariat informs Principal Investigators/Project Leaders who have not submitted Progress Reports

4.4. The Secretariat files continuing review documents in the respective Study Binders and in the SAE binders.







Monitoring of Serious Adverse Events


1. PURPOSE

To describe the procedure for reporting, monitoring and evaluation of serious adverse

events (SAEs) that affect the health, welfare and safety of human participants.

2. SCOPE

From the receipt of SAE Report Form (Refer to SL-IERC Form #14A) to evaluation/review of

the report by the IERC

3. FLOWCHART


Secretariat

3.1. SAE Report Forms 3.1.1. Principal investigators, sponsors, and CROs, shall follow guidelines on submission of

SAE reports in accordance with Monitoring of Clinical Safety of Investigational Drugs.

3.1.2. The Secretariat shall receive, acknowledge and date the SAE Report. 3.1.2.1. The Secretariat shall log the SAE Report in a Logbook for SAEs and in the

SAE Tracking Form filed in each Study Binder. (Refer to SL-IERC Form # 14B) 3.1.2.2. The SAE report indicate if the SAE is:

Unrelated to study

Unlikely related to study

Possibly related to study

Definitely related to study

Receipt of SAE Report Form Logging of SAE Report

Notification of IERC Chair

Inclusion of Report in the Agenda of IERC Meeting

Presentation of SAE Reports for Discussion

Review and Monitoring of SAE Report

Evaluation of SAE Reports

Preparation, Signing and Delivery of NOA

Secretariat

IERC Chair

IERC Chair and members

Secretariat and IERC Chair

Filing of Report and NOA in respective study binder and SAE

binder

Secretariat


3.2. The Secretariat shall forward a copy of the Report to the IERC Chair for immediate action. 3.2.1. The IERC Chair shall call for an emergency meeting of the IERC if there is an urgent

need for early termination of a study because of the SAE reports. 3.2.2. If SAE Report indicates “Unrelated” or “Unlikely” related to study, Secretariat shall

include the Report in the IERC agenda for information. 3.2.3. If SAE Report indicates “Possibly” or “Definitely” related to study, Secretariat shall

include the Report in the IERC agenda for review and evaluation.

3.3. Review of SAE Reports 3.3.1. Chair of IERC shall present the SAE reports that are for review and discussion. 3.3.2. The IERC shall make a decision by consensus to:

Request an amendment to the protocol or the Consent Form

Request further information

Suspend or terminate the Study

3.4. Notification of IERC action 3.4.1. If the decision of the IERC is any of the above, the Secretariat shall prepare a Notice

of Action to the Principal Investigator. 3.4.2. Secretariat shall ask the IERC Chair to sign NOA. 3.4.3. Secretariat shall deliver NOA to Principal Investigator.

3.5. Secretariat shall file the report and NOA in appropriate Study Binder and SAE Binder.



Monitoring of Serious Adverse Events




Early Termination of Clinical Trials/Researches Due To Protocol Violations


1. PURPOSE

To describe the procedure and provide the guidelines for termination of clinical trials/researches

due to protocol deviations or violations

2. SCOPE

From the preparation of Report by the Data Safety Monitoring Committee (DMSC) to taking

action by the IERC (Refer to SL-IERC Form #18)

3. FLOWCHART


4. PROCEDURE

4.1. The Data Safety Monitoring Committee (DSMC) of the Center for Clinical Trials shall prepare a report on protocol deviations and violations

4.1.1. The DSMC shall submit its report to the IERC. 4.1.2. Secretariat shall include DSMC Report as part of the IERC agenda.

4.2. IERC Chair shall present DSMC Report for discussion by the committee

Preparation of Report

Inclusion of DSMC Report in IERC Meeting Agenda

Presentation of DSMC Report for Discussion

Decision by consensus

Filing of DSMC Report in the appropriate Study Binder

Secretariat

IERC Chair

IERC

Secretariat Notice of action

DSMC

Secretariat


4.2.1. The IERC shall make a decision to terminate a previously approved clinical trial/research based on the following considerations:

Safety reports indicate that continuing the study will worsen the condition of, as well as increase risks to, the study participants

Principal Investigator or the sponsor initiates the recommendation for early termination

There are other considerations that impact on the risk/benefit ratio, and that affect patient safety

4.2.2. The IERC shall make a decision by consensus on the recommendation for early

termination. 4.3. Secretariat shall prepare a Notice of Action to Principal Investigator.

4.3.1. Secretariat shall ask the IERC Chair to sign NOA. 4.3.2. Secretariat shall deliver the NOA to the Principal Investigator.

4.4. Secretariat shall file a report in appropriate Study Binder.



Early Termination of Clinical Trials/Researches Due To Protocol Violations




Site Monitoring Visit


1. PURPOSE To describe the procedures as to identification of site and PI to be monitored and how a study site should be visited and monitored with regards to its performance and GCP.

2. SCOPE From identifying the site to be monitored up to the recording and filing of the final report.

3. FLOWCHART


IERC Chair/Secretariat

Secretariat

IERC

Secretariat

Designated person/s/Committee

Designated person/s/Committee

IERC /Secretariat

Secretariat

IERC

Secretariat

Secretariat

Secretariat

Identification of Principal Investigator (PI) and site to be visited and monitored

Informing IEC Chair /IERC

Discussion

Designation of person/s to conduct the site monitoring visit (maybe a group already formed

and identified to conduct visits)

Notification of PI/site of the monitoring visit

Review of informed consent and other pertinent documents

Preparation of report after the site monitoring visit

Presentation of report/findings to the IERC

IERC Deliberation and action on findings

Inform PI of findings and actions/sanctions of the IERC

Follow-up on action taken by PI after one month

File reports on respective protocol file



Site Monitoring Visit


4. PROCEDURE

4.1. Criteria for selection of PI/site to be monitored 4.1.1. Number of clinical trials/studies handled by the Principal Investigator 4.1.2. Receipts of serious adverse events report on a clinical trial 4.1.3. Failure to submit progress report or final report 4.1.4. New Principal Investigator/site 4.1.5. Inquiry/complaint of clinical trial/study participant

4.2. Preparation of the Visit

4.2.1. The Secretariat shall inform the principal investigator of intended monitoring visit of the Monitor or the designated committee.

4.2.2. Secretariat or monitor shall prepare the Monitoring Checklist and other materials needed for the monitoring visit.

4.3. During the Visit, the Monitor or designated committee shall: 4.3.1. Review the informed consent and make sure that the most recent version is being

used. 4.3.2. Review 25% of the participants files that participants are signing the right informed

consent 4.3.3. Observe the informed consent process if possible. 4.3.4. Review the files and documents and ensure that they are being filed properly and

with confidentiality

4.4. After the Visit 4.4.1. The monitor or the team shall write a report based on the monitoring Checklist. 4.4.2. The Secretariat shall file a copy of the report on the site-monitoring file and this shall

be forwarded to the IERC for review. 4.4.3. The Secretariat shall forward a copy of the audit report to the Principal Investigator/site.

4.5. Presentation of the audit report to the Institutional Ethics Review Committee

4.5.1. The IERC shall deliberate on the audit findings of the monitor or designated committee.

4.5.2. The Secretariat shall relay to the Principal Investigator action of the IERC on the audit findings presented to them.

4.6. IERC secretariat shall follow-up on the action taken by the Principal Investigator. 4.7. IERC secretariat shall keep record of report, decisions and action taken on the respective

protocol file.



CHAPTER 5


REVIEW COMMITTEE

Administrative Procedures 5.1. Preparation of Notice of Meeting and Agenda 5.2. Preparation and Distribution of Minutes of

Meetings 5.3. Emergency/Special Meetings 5.4. Preparation for a Regular Meeting 5.5. Conduct of a Regular Meeting 5.6. Management of Communication. 5.7. Management of Administrative Files, Logbooks and

Forms


1. PURPOSE To describe the procedures for the preparation of the notice and agenda of a regular IERC meeting

2. SCOPE

From the setting of the agenda and date of the meeting, to the distribution of meeting materials

to IERC members, and filing of essential communication documents

3. FLOWCHART


Secretariat and Chair

Secretariat and all IERC members

Secretariat

Secretariat

Secretariat

Secretariat


Administrative Procedures- Preparation of Notice of Meeting and Agenda


Setting of Meeting Agenda

Setting date of the IERC

Meeting

Preparation and Distribution of

meeting materials

Notification and Confirmation of attendance of IERC members,

Notification of Presentors

Preparation of venue, dietary request , transport service and

honorarium for the meeting

Filing of all essential

documents


4. PROCEDURE

4.1. Setting of Agenda of Meeting

4.1.1. The Secretariat, in consultation with the IERC Chair, shall prepare the Tentative Agenda (Refer to SL-IERC # 17A) for the Regular Meeting of the IERC.

4.1.2. The standard agenda for a regular IERC meeting shall include the following:

Invocation

Call to Order

Verification of Quorum

Declaration of Conflict of Interest

Approval of Agenda

Reading and Approval of Minutes of the Previous Meeting

Matters Arising from the Previous Meeting

Presentation and Review of Protocols

Report on Adverse Events

Matters for Approval/Action – DSMC Reports

Matters for information Protocol Deviations Other Correspondences

o Study Updates o Reports o Renewal o Others

Safety Reports/CIOMS/SUSARS Investigator’s Brochures Study Close-out Notification

Other Matters

Schedule of Next IERC Meeting

Adjournment

4.2. Schedule and Date of IERC meetings 4.2.1. Regular meetings of the IERC shall be held on the 2nd Wednesday of each month at

8:00 in the morning, RBD conference Room, Annex 3, 5th Floor. 4.2.2. The schedule and date of IERC Meetings shall be posted at the RBD Bulletin Board on

the 2nd Floor bridge way and at the Clinical Trials Web portal

4.3. Notification of IERC members and Notification of Presentors 4.3.1. The Secretariat shall send a “Notice of Meeting” (Refer to SL-IERC # 06A) to all

members of the IERC signed by the IERC Chair to confirm the schedule of the IERC meeting.

4.3.2. The Secretariat shall confirm attendance of IERC members through phone and/or text message.








4.3.3. The Secretariat shall send a letter of “invitation to present” (SL-IERC Form#08) to all

proponents one week before the scheduled presentation for review by the IERC, with specific instructions to include the following ethical issues:

Social or scientific value

Scientific validity

Fair subject selection

Favorable risk ratio

Independent review

Informed consent

Respect for Potential and enrolled subjects

4.4. Preparation of venue and requests from other concerned Divisions 4.4.1. The Secretariat shall reserve the use of the RBD Conference Room for the IERC

meeting 4.4.2. The Secretariat shall prepare the following requests:

Dietary Request Form to Food and Nutrition Department

Transport Request Form to Transport Services Department

Check Preparation Request for IERC honorarium to Accounting Department

4.5. Distribution of meeting materials 4.5.1. The Secretariat shall prepare for each IERC member, a binder containing the

following documents for the meeting:

The Tentative Agenda for the Meeting

Minutes of the Previous Meeting

Copy of all protocols for review

4.5.2. The IERC Chair shall receive a copy of the following for discussion

Secretariat Report which contains list of SAEs, Request for Amendments, DSMC Reports

Correspondences, Response to Notice of Action

Other Matters for Approval

4.5.3. The Secretariat shall distribute the binder to each IERC Member at least 1 week prior to the scheduled meeting.

4.6. Filing of essential documents

4.6.1. The Secretariat shall file the following essential documents:

Notice of meeting

Invitation to Presentors

Approved Agenda

Approved Minutes

Action for Continuing review of protocols




Administrative Procedures- Preparation and Distribution of Minutes


1. PURPOSE

To describe the procedures for the preparation of the draft minutes and its final approval

2. SCOPE From the preparation of the draft minutes to filing of the approved minutes

3. FLOWCHART


Secretariat

Secretariat

Secretariat

IERC Chair

Secretariat/IERC members

Secretariat

4. PROCEDURE

4.1. Recording of Minutes 4.1.1. The Secretariat shall record the proceedings of an IERC meeting. 4.1.2. Minutes of an IERC meeting shall be recorded in an MP3 recorder. 4.1.3. The Secretariat shall copy the MP3 record to a compact disc, and shall label the

compact disc with a sticker indicating the date (year, month, day). 4.1.4. The Secretariat shall place a compact disc in a CD clear sheet as electronic file of the

Minutes in the IERC Secretariat office.

Minutes recorded in an MP3 are copied to a Compact Disc CD)

Preparation of draft of the Minutes based on MP3 record

Printing of final version of the Minutes and

distribution to IERC Members

Sending of the draft of the Minutes to the IERC Chair for revisions/corrections

Revisions/corrections in the

Minutes made

Filing of Approved Minutes



Administrative Procedures- Preparation and Distribution of Minutes


4.2. Preparation of draft copy of the Minutes

4.2.1. The Secretariat shall prepare the draft copy of the Minutes using the following format:

Date and venue of the meeting

Persons present/ERC members who are absent

Person presiding

Declaration of Quorum

Time that the meeting started

Items discussed as stated in the final agenda

Schedule of the next IERC Meeting

4.2.2. The Secretariat shall send the draft of the Minutes to the IERC Chair for revisions/corrections.

4.3. Revisions and corrections in the drafts of the Minutes 4.3.1. The IERC Chair shall make corrections in the draft of the Minutes. 4.3.2. The Secretariat shall incorporate the corrections and print the final version of the

Minutes. 4.3.3. The IERC Chair and person who prepared the minutes shall sign the final version of

the Minutes 4.3.4. The Secretariat shall distribute the printed final version of the Minutes to individual

IERC members together with the Tentative Agenda of a regular meeting.




Administrative Procedure-Emergency/Special Meetings


1. PURPOSE

To describe the procedures to identify events/situations that would require an emergency/special meeting and the conduct of such meetings.

2. SCOPE From evaluating events or situations, making a decision, giving notice, and conducting emergency meetings, to adjournment and communication of decisions made.

3. FLOWCHART

ACTIVITY PERSON/S RESPONSIBLE

IERC Chair, IERC members, Medical

Director, VP for RBD, Quality Officer of SLMC

IERC Chair

Secretariat

IERC Chair

Secretariat

4. PROCEDURE

4.1. Evaluating events/situations and deciding to call for an emergency meeting of the IERC: 4.1.1. The following events/situations will require an emergency meeting of the IERC:

Occurrence of an unexpected serious adverse event that will be life-threatening to study participants

Recall of study drug by regulatory authorities

Other urgent issues as identified by IERC team, CCT team, SLMC administration officials.

Evaluating events/situations

Making a decision to have an Emergency Meeting

Sending of Notice of Emergency Meeting

Conduct of Meeting

Communication of decision and

filing of documents



Administrative Procedure-Emergency/Special Meetings


4.1.2. After an evaluation of the event/situation, the IERC Chair shall call for an emergency

meeting of the IERC 4.1.3. The Secretariat shall send a Notice of Emergency Meeting to IERC members,

including resource persons, if needed. 4.1.4. The Secretariat shall prepare the Agenda and relevant materials for the emergency

meeting

4.2. Conduct of Meeting 4.2.1. The Secretariat shall record and take minutes of the meeting. 4.2.2. The IERC Chair shall determine the presence of a quorum. 4.2.3. The IERC Chair shall immediately present the relevant issues for discussion and shall

ensure that the issues are resolved in the meeting. 4.2.4. The IERC shall make a final decision on the issues by consensus.

4.3. Communication of decision and filing of documents

4.3.1. The Secretariat shall prepare the Notice of Action to be signed by the IERC Chair 4.3.2. The Secretariat shall deliver the NOA to the person concerned. 4.3.3. The Secretariat shall file the relevant materials and documents appropriately




Administrative Procedure- Preparation for a Regular IERC Meeting


1. PURPOSE

To describe the procedures for the preparation for a regular IERC meeting

2. SCOPE From making the room reservation to the start of the meeting

3. FLOWCHART


4. PROCEDURE

4.1. Preparation of venue and requests to other concerned Divisions 4.1.1. The Secretariat shall reserve the use of the RBD Conference Room for the IERC

meeting 4.1.2. The Secretariat shall prepare the following requests:

Dietary Request Form to Food and Nutrition Department

Transport Request Form to Transport Services Department

Check Preparation Request for IERC honorarium to Accounting Department

Reservation of venue, Preparation of requests from Food & Nutrition, Transport service and

Accounting Departments

Preparation of meeting materials (Agenda, Minutes of previous meetings, Protocols for

review) and consolidation in a binder

Distribution of binders to IERC Members

Follow up reminders to IERC Members/PIs /Food and Nutrition Dept./Transport

Services/ Accounting

Preparation of venue and distribution of individual evaluation sheets to IERC members

Arrival of IERC Members and Presentors/PI

Secretariat

Secretariat

Secretariat

Secretariat

IERC Members and

Presentors/PIs

Chair of IERC Start of Meeting

Secretariat



Administrative Procedure- Preparation for a Regular IERC Meeting


4.2. Preparation and distribution of meeting materials

4.2.1. The Secretariat shall prepare a binder containing the following documents for the meeting for each IERC member:

The Tentative Agenda for the Meeting

Minutes of the Previous Meeting

All protocols for review 4.2.2. In addition, the IERC Chair shall receive a copy of the following for discussion

Secretariat Report which contains list of SAEs, Amendments, Safety Reports,

Correspondences

Other Matters for Approval 4.2.3. The Secretariat shall distribute the binder to each IERC Member at least 1 week prior

to the scheduled meeting.

4.3. Before the day of the meeting, the Secretariat shall be responsible for: 4.3.1. Determining if there will be a quorum for the meeting 4.3.2. Requesting submission of Preliminary Evaluation Form from members who will not

attend the meeting 4.3.3. Preparing the Final Agenda for distribution on the day of the meeting (Refer to SL-

IERC Form# 15B) 4.3.4. Making follow up reminders to the following departments:

Food and Nutrition

Transport Service Dept.

Accounting Dept.

Housekeeping Dept. 4.3.5. Preparation of the following:

Individual Evaluation Sheets

MP3 recorder

Laptop and LCD projector

References on Research Ethics

4.4. Day of the Meeting 4.4.1. The administrative support staff shall see to it that

venue is ready

pertinent documents are available(i.e. Final Agenda and protocols for review) are placed on the table

breakfast is set on the buffet table 4.4.2. The Secretariat shall usher the IERC members to the meeting room . 4.4.3. The Secretariat shall usher the Presentors to the Reception area where they can

have breakfast while waiting to be called. 4.4.4. The Secretariat shall give the Preliminary Review Forms, if any, to the IERC Chair

4.5. Start of Meeting

4.5.1. The Secretariat shall occupy a seat in the meeting room and shall turn on the MP3 recorder placed beside the IERC Chair.

4.5.2. The IERC Chair shall ask the Secretariat if there is a quorum. 4.5.3. The IERC Chair shall proceed to start the meeting . (Refer to SL-IERC SOP on

Conduct of a Regular IERC Meeting)




Administrative Procedure- Conduct of a Regular IERC Meeting


1. PURPOSE To describe the procedures for the conduct of a regular IERC meeting

2. SCOPE From start of the meeting to adjournment

3. FLOWCHART


4. PROCEDURE

4.1. Start of meeting 4.1.1. The IERC meeting shall be conducted in accordance with the sequence as prepared

in the Agenda. 4.1.2. After the Invocation, the Chair shall call the meeting to order 4.1.3. The Chair shall ask the Secretariat if there is a quorum.

If there is a quorum, the Chair shall call the meeting to order.

If no quorum exists, the Chair shall declare that the committee shall proceed with the meeting but that the absent members have to submit their comments and recommendations for completeness of review.

4.1.4. The Chair shall ask if any member of the IERC has a conflict of interest in any of the proposals for review.

If there is no declaration of any conflict of interest, the Chair shall proceed with the next item in the Agenda.

If any member of the IERC declares a conflict of interest in any of the protocols for review, the Chair shall appropriately manage the conflict by asking the concerned member not to participate during the decision-making for the specified protocol.

4.1.5. The Chair shall present the Tentative Agenda for approval/revision.

Meeting Proper/Recording of minutes/Assistance to Principal Investigators for their oral presentation

Adjournment

IERC Chair

Secretariat

Secretariat

Secretariat

Compilation of Evaluation Sheets

Distribution of IFF to presentors

Collection of IFF from presentors

Secretariat

Call to Order



Administrative Procedure- Conduct of a Regular IERC Meeting


4.2. Conduct of meeting

4.2.1. The IERC Chair shall

present the Minutes of the Previous Meeting for Reading and Approval

discuss matters arising from the minutes

4.2.2. Presentation of ClinicalTrial Protocols/Research Proposals 4.2.2.1. The IERC Chair call and introduce the presentor 4.2.2.2. The IERC Chair shall facilitate interpolation 4.2.2.3. Before the presentor leaves, the Secretariat shall request him to fill up and

sign the following:

the Principal Investigator Acknowledgement Form as a reminder of his responsibilities as PI (Refer to IERC Form No.10)

an Internal Feedback Form (IFF) to serve as his evaluation of the services provided by the Secretariat (Refer to HRD-ODD-PAMS-4-03-00)

4.2.3. The IERC Chair shall present other items as listed in the Agenda 4.2.3.1. Items for review and discussion:

Protocol Amendments

Site Specific Informed Consent Forms

Serious Adverse Events

Posters/Advertisement for patient recruitment

Other administrative matters 4.2.3.2. Items for information 4.2.3.3. Other Matters

4.3. Adjournment

4.3.1. The Chair shall adjourn the meeting after confirmation of the date of the next Regular Meeting.

4.3.2. The Secretariat shall

turn off the MP3 recorder

distribute honorarium checks and relevant documents to members of the IERC.

call transport service to bring community member to her office/residence.

call Housekeeper to clean the meeting venue.

collect all binders and keep these on file at the IERC Office.




Administrative Procedures- Management of Communications


1. PURPOSE

To describe the procedures that will ensure proper logging, distribution and documentation of

all communications to and from the IERC, as well as communications related to functions of the

Center for Clinical Trials.

2. SCOPE From the distribution and receipt, to recording and filing of communications.

3. FLOWCHART: The Secretariat is responsible for all the following activities:

4. PROCEDURE

4.1. Secretariat shall classify all communications as follows:

Incoming or outgoing

Protocol-related or non-protocol-related

4.2. Incoming/Outgoing Communications

4.2.1. The Secretariat shall record all incoming communications in a Logbook

chronologically

4.2.2. The Secretariat shall distribute outgoing communications to appropriate recipients.

4.3. Protocol Related/Non-protocol related

Protocol-related communications: respective protocol binders.

Non-protocol-related communications: Center for Clinical Trials Administration files.


Classification of communications into protocol-related and non-protocol-related, incoming and

outgoing

For incoming, protocol-

related communications:

Filing of communications in

appropriate binders

For outgoing communications: Distribution to appropriate

recipients

For incoming, non-protocol-

related communications:

Transmission to Center for

Clinical Trials Administrative

Office

Recording of all communications in a Logbook



Administrative Procedures- Management of Administrative Files, Logbooks and Forms


1. PURPOSE To describe the procedures for the management of administrative files, logbooks and forms. These include manuals, references, Tracking Forms and other administrative files.

2. SCOPE From generation to disposal of administrative files, logbooks and forms.

3. FLOWCHART


IERB Chair and Members Secretariat, Center for Clinical Trials Office

Secretariat

Secretariat

Secretariat

4. PROCEDURE

4.1. The IERC Secretariat accumulates documents that are not Protocol-related such as:

reference materials

letters to IERB Chair

members and investigator profiles

logbooks and files

forms 4.2. The IERC Secretariat shall sort out documents to separate those that are protocol-related

and non-protocol-related or administrative in nature.

Generation of various documents and

records

Sorting of accumulated

documents and records

Maintenance and storage of documents and records in

appropriate files

Archiving, destruction and

disposal of unnecessary files


4.3. The IERC Secretariat shall maintain the following Logbook files:

Active Study files shall include files of on-going researches and shall contain: CCT Tracking Form SAE Tracking Form Correspondence

o Submission Letter o Invitation to present o Notice of Action (NOA) o Response to NOA o Ethical Clearance o Presentor’s Acknowledgment o IERC Members Composition

Submissions o Protocol o Investigator’s Brochure o Informed Consent Forms o Sample CRF o Patient Recruitment materials/Ads/Posters o Principal Investigator’s CV o GCP Certificate o Malpractice Insurance o PFDA approval o Amendments o SAE Reports o Line Listing of CIOMS/Safety Reports/SUSARS o Protocol Deviations

Archived Files shall include completed Protocols/Terminated/Withdrawn/Closed-out Researches and shall contain:

Files of SAEs, SUSARs and CIOMS Meeting Agenda, Attendance, and Minutes of IERC meetings Progress Report Files Forms and List of Forms IERC SOPs

4.4. Destruction and disposal of documents

4.4.1. The Secretariat shall destroy the following documents for shredding:

unused protocols and related documents

archived documents beyond the retention period

4.4.2. After shredding, all dry waste are collected using black bag. (Refer to Waste

Management Policy-MED-***-ICS-1-02-03)



Administrative Procedures- Management of Administrative Files, Logbooks and Forms



SL-IERC FORM


REVIEW COMMITTEE


LIST OF SL-IERC FORMS

Form Description Form #

1. Agreement on Confidentiality and Conflict of Interest Form (For IERC Members)

SL-IERC FORM#01A

2. Agreement on Confidentiality and Conflict of Interest Form (For Independent Reviewer)

SL-IERC FORM#01B

3. Initial Protocol Review Submission Form SL-IERC FORM#02

4. Initial Protocol Review Submission Acknowledgment Form SL-IERC FORM#03

5. CT Tracking Form SL-IERC FORM#04

6. Preliminary Technical Review Form SL-IERC FORM#05A

7. Preliminary Ethics Review Form SL-IERC FORM#05B

8. Notice of Meeting SL-IERC FORM#06A

9. Notice of Emergency Meeting SL-IERC FORM#06B

10. Notice of Preliminary Review Form SL-IERC FORM #07

11. Invitation to Present SL-IERC FORM #08

12. IERC Attendance Sheet SL-IERC FORM #09A

13. Attendance Sheet for Presentors SL-IERC FORM #09B

14. Principal Investigator Acknowledgment Form SL-IERC FORM #10

15. Evaluation Checklist SL-IERC FORM #11

16. Notice of Action SL-IERC FORM #12A

17. IERC Composition SL-IERC FORM #12B

18. Ethical Clearance (Clinical Trial) SL-IERC FORM#13A

19. Ethical Clearance (Clinical Research) SL-IERC FORM#13B

20. Request for Ethical Clearance Renewal SL-IERC FORM#13C

21. Ethical Clearance Renewal Form SL-IERC FORM#13D

22. SAE Form SL-IERC FORM#14A

23. SAE Tracking Form SL-IERC FORM#14B

24. Protocol Deviation/Violation SL-IERC FORM#15

25. Continuing Review Report Form SL-IERC FORM#16

26. Tentative Agenda SL-IERC FORM#17A

27. Final Agenda SL-IERC FORM#17B

28. DSMC Report SL-IERC FORM#18

29. Site Monitoring Visit Checklist SL-IERC FORM#19



(SL-IERC FORM#01A)

Agreement on Confidentiality and Conflict of

Interest Form (For IERC Members)


(SL-IERC FORM#01B)

Agreement on Confidentiality and Conflict of

Interest Form (For Preliminary Reviewer)


(SL-IERC FORM#02)

Initial Protocol Review Submission Form


(SL-IERC FORM#03)

Initial Protocol Review Submission

Acknowledgment Form


(SL-IERC FORM#04)

CT Tracking Form


(SL-IERC FORM#05A)

Preliminary Technical Review Form

Page 1 of 2


(SL-IERC FORM#05A)

Preliminary Technical Review Form

Page 2 of 2


(SL-IERC FORM#05B)

Preliminary Ethics Review Form

Page 1 of 4


(SL-IERC FORM#05B)


Page 2 of 4


(SL-IERC FORM#05B)


Page 3 of 4


(SL-IERC FORM#05B)


Page 4 of 4


(SL-IERC FORM#06A)

Notice of Meeting


(SL-IERC FORM#06B)

Notice of Emergency Meeting


(SL-IERC FORM#07)

Notice of Preliminary Review/Referendum


(SL-IERC FORM#08)

Invitation to Present


(SL-IERC FORM#09A)

IERC Attendance Sheet


(SL-IERC FORM#09B)

Attendance Sheet for Presentors


(SL-IERC FORM#10)

PI Acknowledgement Form


(SL-IERC FORM#11)

Evaluation Checklist

Page 1 of 2


(SL-IERC FORM#11)

Evaluation Checklist

Page 2 of 2


(SL-IERC FORM#12A)

Notice of Action


(SL-IERC FORM#12B)

IERC Composition as

Attachment to Notice of Action


(SL-IERC FORM#13A)

Ethical Clearance (Clinical Trial)


(SL-IERC FORM#13B)

Ethical Clearance (Clinical Research)


(SL-IERC FORM#13C)

Request for Ethical Clearance Renewal Form


(SL-IERC FORM#13D)

Ethical Clearance Renewal Form


(SL-IERC FORM#14A)

SAE Report Form


(SL-IERC FORM#14B)

SAE Tracking Form


(SL-IERC FORM#15)

Protocol Deviation/Violation Form


(SL-IERC FORM#16)

Continuing Review Report Form

Page 1 of 2


(SL-IERC FORM#16)

Continuing Review Report Form

Page 2 of 2


(SL-IERC FORM#17A)

Tentative Agenda

Page 1 of 2


(SL-IERC FORM#17A)

Tentative Agenda

Page 2 of 2


(SL-IERC FORM#17B)

Final Agenda

Page 1 of 2


(SL-IERC FORM#17B)

Final Agenda

Page 2 of 2


(SL-IERC FORM#18)

Data Safety Monitoring Committee Report Form


(SL-IERC FORM#19)

Site Monitoring Form

Page 1 of 2


GLOSSARY


REVIEW COMMITTEE



REVIEW COMMITTEE

SOP GLOSSARY

Adverse events - any untoward or undesirable medical occurrence in a patient or participant in clinical investigation after use or administration of an investigational product. This is not necessarily caused by the treatment. See also adverse drug reaction, serious adverse event and unexpected adverse event.

Amendment to the

protocol

- A written description of a change(s) to, or formal clarification of a protocol and changes on any other supporting documentation made from the originally approved protocol by the research ethics review body after the study has began. See protocol amendment.

Approval - favorable or affirmative decision of the Research Ethics Committee following a review of the protocol and other required documents and thus research may already be started and undertaken as set forth by the ethics committee, CPG, the institution, and relevant regulatory terms.

Assent - authorization for one’s own participation in research given by a minor or another subject who lacks the capability to give informed consent. The assent is a requirement for research in addition to consent given by a parent or legal guardian; It is agreement by an individual not competent to give legally valid informed consent like a child or cognitively impaired person to participate in research. See also child’s assent and surrogate assent.

Benefits - any direct or indirect good effect or something of positive value to health or welfare from the research study to the participants; something that promotes or enhances well-being. See also

direct benefits, indirect benefits and beneficence.

Center for Clinical

Trials

This is one of the Centers of the Research and Biotechnology Division of St. Luke’s Medical Center-Quezon City that has the mandate for the administration and management of clinical trials at St. Luke’s. The budget of the IERC Secretariat is channeled through this Center

Clinical research - is a study undertaken involving a particular person or group of people with the purpose of increasing knowledge and determining how well treatment or diagnostic test works in a particular patient population. The NIH-USA defines clinical research as: Patient-oriented research involves a particular person or group of people or uses materials from humans. This research can include: Studies of mechanisms of human disease; Studies of therapies or interventions for disease; Clinical trials and Studies to develop new technology related to disease. Epidemiological and behavioral studies examine the distribution of disease, the factors that affect health, and how people make health-related decisions. Outcomes and health services research seeks to identify the most effective and most efficient interventions, treatments, and services.”

Clinical trials - is a planned scientific research or study among human volunteers to determine the effects of treatment or diagnostic test on their safety, efficacy, and its effect on quality of life. It is also a systematic study on pharmaceutical products in human subjects (including patients and other volunteers) in order to discover or verify the effects of and/or identify any adverse reactions to investigational products, and/or to study the absorption, distribution, metabolism, and excretion of the products with the object of ascertaining their efficacy and safety (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products) It is also defined as investigative work to evaluate new drugs, medical devices, biologics, or other interventions to patients in strictly scientifically controlled settings. Clinical trials may be designed to assess the safety and efficacy of an experimental therapy, to assess whether the new intervention is better than standard therapy, or to compare the efficacy of two standard or marketed interventions. See also clinical research.

Clinical Trial

Agreements

- are the legally binding agreements between a sponsor and an institution (site) as to how certain business and property rights will be dealt with between the parties. These agreements are separate from Investigator Agreements and Confidentiality Agreements and are not regulated by FDA or disclosable to FDA. CTAs are important because they allocate risk, responsibility, financial support, and obligations of the parties; and they protect the rights of the parties.

Conditional

approval

- approval of the protocol by the Ethics Committee to proceed after certain conditions or modifications set by the EC are met.

Dossier - a file containing detailed records on a particular person or subject. (Merriam-Webster)

Drugs - a substance used as medication or used in the diagnosis, cure, mitigation, treatment or prevention of disease.

Ethical clearance - a certification that a research proposal has complied with ethical requirements; action of an ethics review committee on a research protocol that signifies approval and permission to proceed with the research. See approval


Good clinical

practice guidelines

(GCP)

- an international ethical and scientific quality standards for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with these standards provide public assurance that the rights, safety, and well-being of trial subjects are protected, consistent with the principles that have their origin in the International Declaration of Helsinki, and that the clinical trial data are credible. These are standards and procedures for clinical trials that encompass the design, protocol approval, monitoring, termination, audit, analyses, reporting, and documentation of human studies. It defines the responsibilities and activities of the sponsor, principal investigators and monitor involved in the clinical trials. The GCP ensures that the studies are scientifically and ethically sound, and all the clinical properties of the product under investigation are properly documented. For complete information, reference is made to the published WHO and International Conference on Harmonization Code of Good Clinical Practice. (Department of Health Administrative Order No. 47-A series of 2001, [August 30, 2001); It is a standard for clinical studies which encompasses the design, conduct, monitoring, termination, audit, analyses, reporting and documentation of the studies and which ensures that the studies are scientifically and ethically sound and that the clinical properties of the pharmaceutical products (diagnostic, therapeutic or prophylactic) under investigation are properly documented (World Health Organization, Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products).

Guidelines - a set of rules or recommendations intended to effect a course of action.

Health research - generation of new knowledge (biomedical, clinical, social) to identify and deal with health problems, health systems and policies as well as those that impact on health such as socioeconomic, environment, energy and agricultural policies (PNHRS TWG Chairs, Feb 2004). This is composed of investigational activities that aim to generate data that shall contribute to improvement in the diagnosis, prevention and management of diseases, and in the delivery of care and for the enhancement of the quality of life of individuals and health conditions in communities. See also clinical research.

High-risk group - social group known to have a high prevalence of a health problem because of shared environmental, occupational, nutritional or genetic factors including practices that contribute to ill-health.

Human subjects - See research participants and respondent

Resource Person - an expert who gives advice(s), comment(s) and suggestion(s) upon review of the study protocols; with no affiliation to the institute(s) or investigator(s) proposing the research proposal.

Informed consent - the process of obtaining approval to participate in an investigative study or permission to a medical intervention. Consent must be freely given in verbal, video or written form. An important part of the process is the adequacy, appropriateness, and timeliness of the information for decision-making; It is “a decision to participate in research, taken by a competent individual who has received the necessary information; who has adequately understood the information; and who, after considering the information, has arrived at a decision without having been subjected to coercion, undue influence or inducement, or intimidation” (CIOMS, 2002).

Informed Consent

Document

- A document that describes the rights of the study participants, and includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

Ethical

principles

- “refers to those general judgments that serve as a basic justification for the many particular ethical prescriptions and evaluations of human actions” (The Belmont Report: Ethical

Principles and Guidelines for the Protection of Human Subjects of Research: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1979) US NIH, Office of Human Research Subjects) Three basic principles,

among those generally accepted that are particularly relevant to the ethics of research involving human subjects are the principles of respect of persons, beneficence and justice. See respect of persons, beneficence and justice, autonomy and non-maleficence

Ethics review - the evaluation of a research protocol by an ethics review committee to promote the safety and protection of the dignity of human participants. This a systematic process by which this independent committee evaluates a study protocol to determine if it follows ethical and scientific standards for carrying out biomedical research on human participants. It checks if the protocol complies with the guidelines to ensure that the dignity, rights, safety and well-being of research participants are promoted.

Ethics review

committee

- also called research ethics committee (REC), institutional ethics review board - (IERB), independent ethics committee (IEC) or institutional review board (IRB) - committee

constituted to review the ethical aspects of a research proposal and its possible implementation. This is an independent body whose responsibility is to ensure the protection of the rights, safety and well-being of human participants involved in a trial and to provide public assurance of that protection. See also research ethics committee

Expedited

review

- is an ethics review of research protocol by the IRB chair or a designated voting member or subgroup of voting members rather than by the entire IRB. This is done for some research involving no more than minimal risk and maybe for minor changes in approved research, annual renewals of approved projects, approval of protocol amendments, research conducting health record review, and for confirming changes required by the ethics committee for approval of the protocol.

Food and Drug

Administration

(FDA)

- the new name and the reorganized and strengthened Bureau of Food and Drugs by virtue of the "Food and Drug Administration (FDA) Act of 2009" or Republic Act No. 9711 of August 18, 2009, “An act strengthening and rationalizing the regulatory capacity of the Bureau of Food and Drugs (BFAD) by establishing adequate testing laboratories and field offices, upgrading its equipment, augmenting its human resource complement, giving authority to retain its income, renaming it the Food and Drug Administration, amending certain sections of Republic Act No. 3720, as amended, and appropriating funds thereof.” The FDA (Section 5) shall have the following centers and offices: (a) The Centers shall be established per major product category that is regulated, namely: (1) Center for Drug Regulation and Research (to include veterinary medicine,vaccines and biologicals); (2) Center for Food Regulation and Research;"(3) Center for Cosmetics Regulation and Research (to include household hazardous/urban substances);and (4) Center for Device Regulation, Radiation Health, and Research. These Centers shall regulate the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of, and/or, where appropriate, the use and testing of health products. The Centers shall likewise conduct research on the safety, efficacy, and quality of health products, and to institute standards for the same. See also Bureau of Food and Drugs.

Full board

review

- review of proposed research at a convened meeting at which a majority of the membership of the IRB are present, including at least one member whose primary concerns are in nonscientific areas. For the research to be approved, it must receive the approval of a majority of those members present at the meeting

Institutional

Ethics Review

Committee or

Board

- ethics review committee organized in a particular institution to ensure that health research is conducted according to international ethical principles, national and institutional guidelines. This is an independent body constituted of medical, scientific, and non-scientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trial protocol and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects. [ICH E6 1.31] See research ethics committee, ethics review committee


Investigator - a person responsible for the conduct of the critical trial at a trial site. If trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and be called the principal investigator (ICH Harmonized Tripartite Guideline, Guideline for Good Clinical Practice (E6, R1); It is a person responsible for the trial and for the rights, health and welfare of the subjects in the trial. The investigator should have qualifications and competence in accordance with local laws and regulations as evidenced by an up-to-date curriculum vitae and other credentials. Decisions relating to, and to provisions of, medical or dental care must always be the responsibility of a clinically competent person legally allowed to practice medicine or dentistry (WHO Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products); The investigator must be a qualified scientist who undertakes scientific and ethical responsibility, either on his/her behalf or on behalf of an organization, for the ethical and scientific integrity of a research project at a specific site or group of sites See principal investigator

Investigator’s

Brochure

- compilation of all relevant clinical and non-clinical information and data on the investigational product.

Minimal risk - A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination. (IRB Guidebook, US DHHS in http://www.hhs.gov/ohrp/irb/irb_glossary.htm Downloaded on June 19, 2010 ) The definition of minimal risk for research involving prisoners differs somewhat from that given for non institutionalized adults. [See 45 CFR 46.303(d) and Guidebook Chapter 6, Section E, "Prisoners."]

Monitor - a person appointed by and responsible to the sponsor or contract research organization for monitoring and reporting progress of the trial and for verification of data (WHO, Guidelines for Good Clinical Practice (GCP) for trials of pharmaceutical products)

Monitoring - is the process of checking or scrutinizing research participants’ health status during a clinical trial, and/or to oversee the progress of a trial or research and/or to check researcher's compliance with the protocol and regulatory requirements with in which the protocol is given ethical approval

Philippine Health

Research Ethics

Board

- was created on March 1, 2006 through DOST Special Order No. 091 series of 2006 as a policy-making body for research ethics in the Philippines

Principal

investigator

- the chief or person primarily responsible for the implementation of a research project See also investigator

Privacy - is the right or claim or state or ability or condition of an individual or group or institution to conceal or seclude or hide themselves or information about themselves and thus reveal or expose themselves selectively; It is a conceptual space defining the individual’s boundary as a person, intrusion of which is limited by human rights and by law. It is right to determine when, how, and to what extent information about someone is communicated to others

Protocol - a document that provides the background, rationale, and objective(s) of a biomedical research project and describes its design, methodology, and organization, including ethical and statistical considerations. Some of these considerations may be provided in other documents referred to in the protocol. (WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22); a document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. (International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.44).


- The formal design or plan of an experiment or research activity; specifically, the plan submitted to an IRB for review and to an agency for research support. The protocol includes a description of the research design or methodology to be employed, the eligibility requirements for prospective subjects and controls, the treatment regimen(s), and the proposed methods of analysis that will be performed on the collected data. (IRB

Guidebook, US DHHS in http://www.hhs.gov/ohrp/irb/irb_glossary.htm

downloaded on June 19, 2010 ) See also research protocol)

Protocol

amendment

- a written description of a change(s) to, or formal clarification of a protocol. (WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22) See amendment to protocol

Protocol approval

by sponsor

- the affirmative action of the sponsor on the protocol development when the technical and ethical reviewers have finally approved all the changes of the protocol. This usually act as the signal for the submission of the protocol and the other required documents to an IRB, national regulatory authorities and research sites as applicable. See also approval

Regulatory

requirements

- necessary prerequisites for the approval and conduct of clinical trial by a national regulatory authority. For example, for pharmaceutical and biologic products it means obtaining a “permit for clinical investigational use” which is a “registration document issued by the FDA for the purpose of allowing the conduct of Phase I, Phase II, and Phase III clinical trials of investigational biologic products in the country” DOH Administrative Order No. 47-A series of 2001”Rules and Regulations on the registration including approval andconduct of clinical trials, and lot or batch release certification of vaccines and biologic products.” See Permit for clinical investigational use.

Research ethics

committee

- is an independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility it is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving / providing favorable opinion on, the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. International Conference on Harmonization (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.27) See also Institutional Ethics Review Committee, Cluster research ethics committee, ethics review committee

Research

participants or

subjects

- An individual who participates in a biomedical research project, either as the direct recipient of an intervention (e.g., study product or invasive procedure), as a control, or through observation. The individual may be a healthy person who volunteers to participate in the research, or a person with a condition unrelated to the research carried out who volunteers to participate, or a person (usually a patient) whose condition is relevant to the use of the study product or questions being investigated. (WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22)

Research protocol - a document that provides the background rationale and objective(s) of a biomedical research project and describes its design, methodology and organization, including ethical and statistical considerations. Some of these considerations may be provided in other documents referred to in the protocol. See also protocol

Risk - the probability of discomfort or harm or injury (physical, psychological, social, or economic) occurring as a result of participation in a research study. Both the probability and magnitude of possible harm may vary from minimal to significant. Risks to research participants must be justified by the anticipated benefits to the subjects or to society. The investigator(s) and IRB must assess the risks and benefits of proposed research. See also minimal risk.

Risk-benefit ratio - The risk to individual participants versus the potential benefits. The risk/benefit ratio may differ depending on the condition being treated. (clinicaltrial.gov/ct2/info/glossary)

http://www.hhs.gov/ohrp/irb/irb_glossary.htm


Risk factors - are variables or conditions that increase the risk or chances of disease or infection; determinants of disease development. Also see risk.

Serious adverse

event

- or serious adverse drug reaction is an adverse event that results to death, life- threatening incident or causes immediate risk of death from the event; results to

inpatient or prolongation of hospitalization, causes significant disability, incapacity, and

congenital anomaly or another episode which is considered a significant hazard to the

participant. See also adverse event or unexpected adverse event. Also, any untoward

medical occurrence that at any dose: - results in death, - is life-threatening, - requires

inpatient hospitalization or prolongation of existing hospitalization, -results in persistent

or significant disability/incapacity, or - is a congenital anomaly/birth defect

(International Conference on Harmonisation (ICH) - Guideline for Good Clinical Practice

(GCP) E6 (R1), art. 1.50) See adverse event, adverse drug reaction

Study Document - means all records, accounts, notes, report, data and ethics communications (submission, approval and progress reports) collected, generated or used in connection with the Study, whether in written, electronic, optical or other form, including all recorded original observations and notations of clinical activities such as CRFs and all other reports and records necessary for the evaluation and construction of the Study.

Unexpected

adverse event

- is an adverse reaction that has not been anticipated, nor previously experienced, or observed, and is not consistent with the informed consent, information sheets or applicable product information in the investigator’s protocol or brochure, product or package insert or summary of product characteristic. See also adverse event and serious adverse event

Voluntary - free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity. (IRB Guidebook, US DHHS in http://www.hhs.gov/ohrp/irb/irb_glossary.htm downloaded on June 19, 2010)

Vulnerability - refers to a substantial incapacity to protect one's own interests owing to such impediments as lack of capability to give informed consent, lack of alternative means of obtaining medical care or other expensive necessities, or being a junior or subordinate member of a hierarchical group. (CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, General Ethical Principles)

Vulnerable

persons/groups

- are individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. (International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.61) Vulnerable persons are those who are relatively (or absolutely) incapable of protecting their own interests. More formally, they may have insufficient power, intelligence, education, resources, strength, or other needed attributes to protect their own interests. (CIOMS, International Ethical Guidelines for Biomedical Research Involving Human Subjects, Geneva 2002, Commentary on Guideline 9) These are also classes of individuals who have characteristics that lessen their capacity to protect their own interests or promote their own welfare; These are “persons whose situation or characteristics may make them unable to provide free and informed consent to participate in research. This group includes children, institutionalized persons, those who have cognitive impairments, and those in a position of inferiority” (http://www.pre.ethics.gc.ca.engish/tutorial/glossary.cfm#c down loaded on July 9, 2010)

Web portal - is a web site that brings together information from diverse sources in a unified way. (Wikepedia)

http://en.wikipedia.org/wiki/Web_site


St. Luke’ s Medical Center


For more information, please contact:

IERC SECRETARIAT

Direct Line: (632) 7275562 Trunkline: (632) 7230101 Locals: 7391/5562 Fax: (632) 7275562 Email: [email protected] Visit our website at: www.stluke.com.ph

Annex III, 5th Floor 279 E. Rodriguez Sr. Boulevard Quezon City 1102 Philippines