revision history - crc · web viewthis sop applies to all short term human resource development...

Version No: 1.0 Clinical Research Centre of 15Date: <dd/mm/yyyy> Human Resource Development Activity SOP-R-G-2-01

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The Director, Clinical Research Centre

Standard Operating ProcedureAttending and Documenting Human Resource Development Activity

Document number: SOP-R-G-2-01Date registered: <dd/mm/yyyy>Revision number: 0Date revised:Version number: 1Date of version: <dd/mm/yyyy>Electronic hyperlink:Number of pages: 15Control status: CONTROLLEDControlled copy number: Master

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Signature:____________________<Name>Date: <dd/mm/yyyy>

REVISION HISTORY

Rev #

Section Revision Date

Reason for Revision Signature of Head Of QA Unit


TABLE OF CONTENTS

# Page #REVISION HISTORY 1TABLE OF CONTENTS 2

1. PURPOSE 32. SCOPE 33. ABBREVIATIONS 34. GLOSSARY 35. RESPONSIBILITY 3-46. REQUIRED AND RELATED DOCUMENTS 47. PROCEDURE 4-58. FLOWCHART 69. REFERENCES 710. APPENDIX 1 CRC-PS-06-B(01): Borang Permohonan Latihan Dalam

Perkhidmatan 8

APPENDIX 2 KKM/P&P/2013 (A) Training Evaluation Form 9-11

APPENDIX 3 KKM/P&P/2013 (B) Competency Assessment Form 12-15


1. PURPOSE

Clinical research and project-specific research trainings are crucial in developing and promoting a quality research culture as well as ensuring the professional and ethical conduct of research. This Standard Operating Procedure (SOP) describes the processes in place for National Clinical Research Centre (NCRC) staff to apply to participate in human resource development activities and to document such activities attended as per Good Clinical Practice (GCP) guidelines1-2.

2. SCOPE

This SOP applies to all short term human resource development activities including workshops, conferences, seminars, etc funded by Department’s operating budget or by a sponsor approved by Ministry of Health (MOH). The SOP is not applicable for approved training under the MOH’s Latihan Dalam Perkhidmatan and post-graduate.

3. ABBREVIATIONS

CRC Clinical Research CentreDI Director of InstitutionGCP Good Clinical PracticeHOD Head of DepartmentHRDA Human Resource Development Activity / ActivitiesISF Investigator Site FileISR Industry Sponsored ResearchLPO Local Purchase OrderMOH Ministry of HealthNCRC National Clinical Research CentreSOP Standard Operating Procedure

4. GLOSSARY

Term DefinitionInvestigator site file A file contains all essential documents held by principal investigator(s)

conducting a trial which individually and collectively permit the evaluation of the conduct of a trial and the quality of the data produced.

Short term course Full time course that includes study visits, seminars or workshops for a term not exceeding three calendar months including weekly holiday, public and academic holidays.

HRDA record A document that records HRDA that has been attended by staff.

5. RESPONSIBILITY

NCRC staff is responsible to identify and attend relevant Human Resource Development Activity (HRDA) required to conduct research and to satisfy the official requirement of a minimum of 7 days training per year. All investigators involve in an industry sponsored trial must attend relevant research HRDA as deemed necessary by the sponsor. Staff is responsible for preparation and submission of HRDA report within 7 working days of completion of a HRDA.


Head of Department (HOD) is responsible to ensure staff attends HRDA relevant to their official duties and that HRDA records are properly maintained. HOD is responsible to assess competency of staff within 3 months of completion of HRDA attended by the staff.

Director of Institution (DI) is responsible to approve HRDA application by staff.

Human Resource Unit NCRC is responsible to compile completed KKM/P&P/2013 (A) and KKM/P&P/2013 (B) forms and submits compiled forms to MOH’s Training Management Division at end of year.

6. REQUIRED AND RELATED DOCUMENT

# Document title1. WI-G-2-01-01: Work Instruction for Attending and Documenting Human Resource

Development Activity

7. PROCEDURE

Step # Process Responsibility1. Identifies suitable HRDA. Refers to WI-G-2-01-01 for

detailed procedures.Staff

2. Submits completed CRC-PS-06-B(01) HRDA application form (Appendix 1) to HOD for endorsement.

Staff

3. Decides on application and informs staff. HOD4. a) If endorsed, go to next step.

OR

b) If not endorsed:i. If still interested to appeal, prepares appeal and go

to step 2. OR

ii. If not interested to appeal, this procedure ends.

Staff

5. Submits HOD endorsed application form to DI for approval.

Staff

6. Decides on application and informs staff via HOD. DI7. a) If endorsed, go to next step.

OR

b) If not endorsed:i. If still interested to appeal, prepares appeal and go

to step 5.

OR

ii. If not interested to appeal, this procedure ends.

Staff

8. Makes preparations and attends HRDA. Staff9. Completes KKM/P&P/2013 (A)3 HRDA evaluation form Staff


Step # Process Responsibility(Appendix 2) within 1 week after the completion of HRDA.

10. Files copy in Unit’s HRDA file, staff’s personal file and investigator site file (for ISR only). Submits completed KKM/P&P/2013 (A) form to Human Resource Unit NCRC.

Staff

11. Compiles forms and submits compiled forms to MOH’s Training Management Division at end of year.

Human Resource Unit NCRC

12. Completes staff’s section of a KKM/P&P/2013 (B)4

competency assessment form (Appendix 3) 3 months after the completion of HRDA and submits to HOD for further action.

Staff

13. Completes relevant section of form. HOD14. Files copy in Unit’s HRDA file, staff’s personnel file and

investigator site file (for ISR only). Submits endorsed KKM/P&P/2013 (B) form to Human Resource Unit NCRC.

Unit’s filing clerk

15. Compiles forms and submitted to MOH’s Training Management Division at end of year.

Human Resource Unit NCRC


8. FLOWCHART

Start

Staff submits completed CRC-PS-06-B(01) form to HOD for endorsement

Staff makes preparations and attends HRDA

Staff completes KKM/P&P/2013 (A) form within 1 week after completion of HRDA

Staff identifies suitable HRDA

Staff submits HOD endorsed application form to DI for approval

End

HOD endorses application?

Yes

No

DI approves application?

Yes

No

Staff still interested to apply other HRDA

Yes

No

Staff files copy of report in Unit’s HRDA file, staff’s personal file and investigator site file (for

ISR only), and submits original to Human Resource Unit NCRC for submission to MOH

Training Management Division

HOD prepares HRDA competency report 3 month after staff ’s HRDA

HOD files copy of report in Unit’s HRDA file and submits original to Human Resource Unit NCRC

for submission to MOH Training Management Division

Staff still interested to apply other HRDA

Yes

No


9. REFERENCES

1) Guideline For Good Clinical Practice E6 (R1) (http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf)

2) Malaysian Guideline For Good Clinical Practice (3rd Edition) (http://www.crc.gov.my/pdf/GCP2_11.pdf)

3) Borang Soal Selidik Kajian Penilaian Keberkesanan Kursus Dalam Dan Luar Negara Kementerian Kesihatan Malaysia Untuk Pegawai Yang Menghadiri Kursus-KKM/P&P/2013(A)(http://latihan.moh.gov.my/uploads/Borang%20Soal%20Selidik_Calon2013.pdf)

4) Borang Soal Selidik Kajian Penilaian Keberkesanan Kursus Dalam Dan Luar Negara

Kementerian Kesihatan Malaysia Untuk Ketua Jabatan/Penyelia-KKM/P&P/2013(B) (http://latihan.moh.gov.my/uploads/Borang%20Soal%20Selidik_Ketua%20Jabatan2013.pdf)


APPENDIX 1 CRC-PS-06-B(01)


APPENDIX 2


APPENDIX 3

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