format# 1 - sanjay gandhi postgraduate institute of medical … · college/ iso-nabl certified lab/...

Format# 1

CHECK-LIST: IAEC Project, SGPGIMS, Lucknow

Title of the Project: (………………………………….)

Consent of Listed Personnel in Project: I am consenting to be part of this project.

Affiliation to Animal Project

Name, Department, Institute Sign & Date

PI

Co-PI

Exp. 1

Exp. 2

Exp. 3

Attachments:

Document Name Yes No Remarks

1. Check List: IAEC Project, SGPGIMS, Lucknow: 1 Original Copy

2. Project Receiving: 1 Original Copy

3. PI Undertaking: 1 Original Copy

4. DRC Minutes: 1 Original Copy

5. Checklist for CPCSEA: 1 Original Copy (For Large Animal Study

only)

6. CPCSEA Form B: 10 copies (1 original + 9 Xerox)

7. CV of PI/Co PI/Experimenter: 10 copies (1 original + 9 Xerox) (if not submitted previously)

8. IBSC (Institutional Bio-Safety Committee) Clearance: 10 copies

(1 original + 9 Xerox) (if required)

9. Clearance of any other Committee viz. Stem Cell Ethics, Human Ethics etc.: 10 copies (1 original + 9 Xerox) (if required)

10. Soft Copy in CD of above documents

11. Whether online Project fee submission required (For Projects to be referred to CPCSEA)

CPCSEA Registration No. and valid up to Registration# 57/GO/Re/SL/Bi/S/99/CPCSEA Valid Up to: 27.04.2022

Funding Source

Type of research:

1. Academic Research ( ), 2. In-house R&D ( ), 3. Drug Development & Research ( )

4. Preclinical toxicity study ( ), 5. Multicenter research collaborative study ( ) 6. Education ( ), 7. Contract Research ( )

To Be Filled By Office, Member Secretary, IAEC

Date of Project Receiving Name & Signature of Receiver

Format# 2

SANJAY GANDHI POST GRADUATE INSTITUTE OF MEDICAL SCIENCES Raebareli Road, Lucknow- 226 014 UP (India)

(CPCSEA Registration # 57/GO/Re/SL/Bi/S/99/CPCSEA)

Project Receiving

To, Date:

Prof./Dr/Mr./Ms.

Designation

Department

SGPGIMS, Lucknow

Sir/Madam,

Your Animal study project with a title “……………………..” has been received on date……………

This protocol will be shared with IAEC members in upcoming IAEC meeting.

You will be duly informed about date and venue to join the meeting for necessary

discussions and/or power point presentation / clarifications, if any, to the IAEC members.

Thanks and Regards,

Sincerely yours,

Dr. A. K. Baranwal

(Member Secretary, IAEC, SGPGIMS)

Format# 3

Department of ………………………………………......

SANJAY GANDHI POST GRADUATE INSTITUTE OF MEDICAL SCIENCES

Raebareli Road, Lucknow- 226 014 UP (India)

UNDERTAKING BY THE PRINCIPAL INVESTIGATOR

1. TITLE OF THE PROJECT:

2. NAME, DESIGNATION AND DEPARTMENT OF THE PRINCIPAL INVESTIGATOR:

3. OTHER MEMBERS OF THE RESEARCH TEAM:

Co-PIs:

Experimenters: (JRF/SRF etc.)

4. NAME AND ADDRESS OF ANY OTHER INSTITUTION WHERE PARTS OF THE STUDY

WILL BE DONE

Endorsement by the PI:

1. I confirm that I will initiate the study only after obtaining all regulatory clearances including

IAEC approval.

2. I confirm that the Co-PI and other experimenters of the study team have been informed

about their obligations and are adequately qualified, experience and trained.

3. I own the responsibility to supervise the study and ensure that all the requirements related to

the successful termination of the study are met according to approved project and the

CPCSEA guidelines of animal welfare and ethics.

4. I will not implement any deviation in conduct of the procedure without prior consent of the

IAEC.

5. I will submit the progress report/final report on regular basis.

Signature of Principal Investigator

Date

Format# 4


Recommendation of Departmental Research Committee (DRC) Meeting

1. Date of DRC Meeting

2. Title of Research Project:

3. Name of Principle Investigator:

4. Name of Co-Investigator/s and other Experimenters

5. Specific Comments (on scientific merit/ethics related issues only)

6. Recommendations –

a) Recommended (without any stipulations)

b) Recommended (with suggestions for modification, please specify here)

c) Recommended for rejection with specific grounds (Please specify here)

(Name, Signature & Stamp of Members) – At least 50% of Departmental

Faculties should be present

…………………….. ……………………………. ……………………………….

…………………….. ……………………………. ……………………………….

…………………….. ……………………………. ……………………………….

(Name, Signature & Stamp of Regular HOD)

Format# 5


(CPCSEA Registration # 57/PO/ReBi/SL/99/CPCSEA)

Form B (per rule 8(a)* for Submission of Research Protocol (s)

Application for Permission for Animal Experiments

Application to be submitted to the CPCSEA, New Delhi after approval of Institutional

Animal Ethics Committee (IAEC)

Section- I

1. Name and address of establishment

2. Registration number and date of

registration

3. Name, address and registration

number of breeder from which

animals acquired (or to be

acquired) for experiments

mentioned in parts B & C

4. Place where the animals are

presently kept (or proposed to be

kept).

5. Place where the experiment is to be

performed (Please provide CPCSEA

Reg. Number)

6. Date and Duration of experiment

7. Type of research involved (Basic

Research / Educational/ Regulatory/

Contract Research)

Signature

Name and Designation of Investigator

Date:

Place:

Page-

Section- II

Protocol form for research proposals to be submitted to the Institutional

Animal Ethics Committee/ CPCSEA, for new experiments or extensions of

ongoing experiments using animals.

1. Project / Dissertation / Thesis Title:

2. Principal Investigator / Research Guide / Advisor:

a. Name

b. Designation

c. Dept / Div/ Lab

d. Telephone No.

e. E-mail Id

f. Experience in Lab animal experimentation

3. List of all individuals authorized to conduct procedures under this proposal.

a. Name

b. Designation

c. Department

d. Telephone No.

e. E-mail Id

f. Experience in Lab animal experimentation

4. Funding Source / Proposed Funding Source with complete address (Please attach

the proof)

5. Duration of the animal experiment.

a. Date of initiation (Proposed)

b. Date of completion (Proposed)

6. Describe details of study plan to justify the use of animals (Enclose Annexure)

7. Animals required

a. Species and Strain

b. Age and Weight

c. Gender

d. Number to be used (Year-wise breakups and total figures needed to be

given in tabular form)

e. Number of days each animal will be housed.

Page-

8. Rationale for animal usage

a. Why is animal usage necessary for these studies?

b. Whether similar study has been conducted on in vitro models? If yes, describe

the leading points to justify the requirement of animal experiment.

c. Why are the particular species selected?

d. Why is the estimated number of animals essential?

e. Are similar experiments conducted in the past in your establishment?

f. If yes, justify why new experiment is required?

g. Have similar experiments been conducted by any other organization in same

or other in vivo models? If yes, enclose the reference.

9. Describe the procedures in detail:

a. Describe all invasive and potentially stressful non-invasive procedures that

animals will be subjected to in the course of the experiments

b. Furnish details of injections schedule Substances:

Doses :

Sites :

Volumes :

c. Blood withdrawal Details:

Volumes :

Sites :

d. Radiation (dosage and schedules):

e. Nature of compound/Broad Classification of drug/NCE:

10. Does the protocol prohibit use of anesthetic or analgesic for the conduct of painful

procedures? If yes, justify.

11. Will survival surgery be done?

If yes, the following to be described.

a. List and describe all surgical procedures (including methods of asepsis)

b. Names, qualifications and experience levels of personnel involved.

c. Describe post-operative care

d. Justify if major survival surgery is to be performed more than once on a single

animal.

12. Describe post-experimentation procedures.

a. Scope for Reuse :

b. Rehabilitation (Name and Address, where the animals are proposed to be

rehabilitated) :

c. Describe method of Euthanasia (if required in the protocol) :

d. Method of carcass disposal after euthanasia :

Page-

13. Describe animal transportation methods if extra-institutional transport is

envisaged.

14. Use of hazardous agents (use of recombinant DNA-based agents or potential

human pathogens requires documented approval of the Institutional Biosafety

Committee (IBC). For each category, the agents and the biosafety level required,

appropriate therapeutic measures and the mode of disposal of contaminated food,

animal wastes and carcasses must be identified).

If, your project involved use of any of the below mentioned agent, attach copy of

the approval certificates of the respective agencies:

a. Radionucleotides (AERB)

b. Microorganisms / Biological infectious Agents (IBSC)

c. Recombinant DNA (RCGM)

d. Any other Hazardous Chemical / Drugs

Page-

Investigator’s Declaration

1. I certify that the research proposal submitted is not unnecessarily duplicative

of previously reported research.

2. I certify that, I am qualified and have experience in the experimentation on

animals.

3. For procedures listed under item 10, I certify that I have reviewed the

pertinent scientific literature and have found no valid alternative to any

procedure described herein which may cause less pain or distress.

4. I will obtain approval from the IAEC/ CPCSEA before initiating any changes in

this study.

5. I certify that performance of experiment will be initiated only upon review and

approval of scientific intent by appropriate expert body (Institutional Scientific

Advisory Committee / funding agency / other body).

6. I certify that I will submit appropriate certification of review and concurrence

for studies mentioned in point 14.

7. I shall maintain all the records as per format (Form D) and submit to

Institutional Animal Ethics Committee (IAEC).

8. I certify that, I will not initiate the study before approval from IAEC/ CPCSEA

received in writing. Further, I certify that I will follow the recommendations of

IAEC/ CPCSEA.

9. I certify that I will ensure the rehabilitation policies are adopted (wherever

required).

Signature

Name of Investigator

Date:

Format# 6

One Page CV: PI/Co-PI/Experimenter IAEC Study Project,SGPGIMS, Lucknow

1. Affiliation to Animal Study Project: PI / Co-PI / Experimenter

2. IAEC Project Title:

3. Personal Details:

Title: Dr , Mr , Ms

Last Name First name Middle Name

Date of Birth (dd/mm/yy): Sex: M , F

4. Contact Details:

Mobile: Email:

Tel (Office): Tel (Res):

5. Professional Details:

Designation:

Work Place/Institution Affiliated:

Professional Address: Address for Correspondence:

Same as professional address

6. Academic Qualifications (Current to Previous)

Degree / Certificate Year Institution, Country

7. Experience in Animal Research:

8. Other Relevant Research Experience:

Place: Date: Signature:

Format# 7

Check-List with Form-B for Submission of Research Protocol (s)

Check-List (To be submitted for consideration of CPCSEA)

Title of the protocol

Name and address of the Institute

submitting proposal, with Ref No. if any

CPCSEA Registration No. and valid upto

Status of Institute and its accreditation, if

any

DST/ICMR/DBT/CSIR/Public funded

Institution/ State/ Central University/

College/ ISO-NABL certified lab/ GLP

certified lab/ others

Type of research work 1. Academic Research

2. In-house R&D

3. Drug Development & Research

4. Preclinical toxicity study

5. Multicenter research collaborative study

6. Education.

7. Contract Research

Name & Address of CPCSEA Nominee and

Link Nominee and date of appointment

[Date of change of Nominee (if any)]

Composition of IAEC as per approved

guidelines and the names and addresses of

the establishment / members to which

they represent

Whether detailed signed minutes of IAEC

by members including nominee attached

with the protocol

Recommendations of IAEC

Recommendation of Institutional Bio Safety

Committee (IBSC)

Recommendations of Review Committee on

Genetic Manipulation (RCGM)

The date of last inspection of Animal House

Facility and approval details conveyed by

CPCSEA

Name of the PI with designation,

qualification and work experience with

animals.

Name of the Co-PI with designation,

qualification and work experience with

Large Animals.

Source of procurement of animals, types,

number, age & sex

Information regarding import / export of

animals / material before and after

experimentation

A signed declaration by PI is attached with

proposal? Signature of Chairman IAEC /

Principal Investigator

Signature of Chairman IAEC / Principal Investigator

Format# 8

Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow

Form D: Record of Animals Acquired and Experiment Performed

(to be maintained by the Investigator)

Date No. of animals

acquired (specify

Species, Sex and

Age)

Name, Address and

Registration No. of

the Breeder from

whom acquired with

Voucher/ Bill No.

Date and IAEC

approval number

Duration of

experiment

Name and

address of the

person

authorized to

conduct the

experiment

Signature of the

Investigator

certifying that all

conditions

specified for such

an experiment

have been

complied

Format# 9

SANJAY GANDHI POSTGRADUATE INSTITUTE OF MEDICAL SCIENCES, LUCKNOW

Annual PROGRESS REPORT

1. Project Code Number

2. Title of the project/study

3. Principal Investigator (Name & Department)

4. Date of project approval by IAEC

5. Type of IAEC Approval:

Approved for animal experimentation

Approved for submission to funding agency (whether fund sanctioned?)

6. Date of start of study

7. Approved duration of study protocol

8. Duration of this report

9. Whether previous year reports submitted

10. Name of Funding Agency

11. Animals approved

Species

Age/Sex

Numbers

12. Number of animals utilized in this duration (attach the Xerox of Form D)

13. Objectives of the study

14. Progress report as per objectives (attach separate sheet)

15. Report/publications/conference presentation, if any

Name of Principal Investigator

Department

Signature & Date

Format# 10


Report of Serious Adverse Events (SAE)




4. Description of SAEs

Serious Adverse Event Suspected/Non suspected

No. of animal affected

Start Date

End Date

Severity Action taken

Result of action

Effect on study

Severity: * Mild, ** Moderate, *** Severe

5. PI’s summery on SAE and further recommendations


Department

Signature & Date

Format# 11


FINAL REPORT /PROJECT CLOSURE REPORT




4. Date of project approval by IAEC

5. Date of start of study

6. Approved duration of study protocol

7. Whether previous year reports submitted

8. Name of Funding Agency

9. Animals approved

Species

Age/Sex

Numbers

10. Number of animals utilized (attach the Xerox of Form D)

11. Whether lesser than approved number of animals used? If yes, describe the rationale behind

12. Whether study terminated before approved duration? If yes, describe the rationale behind

13. Objectives of the study

14. Progress report as per objectives (attach separate sheet)

15. Report/publications/conference presentation, if any

16. Whether any SAE observed and reported

17. Outcome of the Project


Department

Signature & Date

Format# 12

ANIMAL HOUSE SANJAY GANDHI POST GRADUATE INSTITUTE OF MEDICAL SCIENCES


Requisition Form: Animal Part 1 (Request)

Approved IAEC Protocol #: Valid till (date): PI: Animal Details:

Strain & Species : Number of Animal Approved : Number of Animal Utilized :

Sex :

Age/Weight : Number of Animal Requested : Experiment Duration (days) :

Note 1. Form D will be maintained by the authorized experimenter-as per IAEC Protocol.

2. Authorized experimenter will ensure animal husbandry, experimentations, usage and disposal of the

experimental animals as per descriptions in IAEC Protocol.

Date of Requisition : Date of Requirement : Requester’s Name : Designation & Department :

CUG, Intercom, Mobile No. :

Sign, Date & Seal

Part 2 (Animal Availability and Cost Calculation) Animal available / Not Available

Cost of Animal (Rs.) : Cost of Maintenance (Rs.) : Total Cost (Rs.) : In words :

Officer-in-charge, Animal House

Part 3 (Payment)

To, Cashier (FO’s Office)

Please deposit Rs. ................................................................................................... against this requisition.

Nodal-in-Charge, Animal House

ANIMAL HOUSE SANJAY GANDHI POST GRADUATE INSTITUTE OF MEDICAL SCIENCES


Part 4 (Payment Details and Animal Allotment) Payment Date: Receipt #: (Attach Xerox) Animal Allotments:

Date Numbers

Officer-in-charge, Animal House

Part 5 (Animal Receiving) Date Numbers Name & Sign

format# 1 - sanjay gandhi postgraduate institute of medical … · college/ iso-nabl certified lab/...

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