Management of Project Submission

This SOP is designed to describe and act as a guideline for research protocol submissions.

The scope includes the following

Submission for initial review.

Resubmission of protocols with modifications.

Protocol amendments and any other amendments.

Continuing review of approved protocols.

Project completion/termination.

All intramural projects/extramural/student projects/investigator initiated study proposals submitted (both hard and soft copies) for initial reviews should be first scientifically reviewed by institutional Research Committee (RC)/scientific committee SGPGI/departmental committee/doctoral committee before submitting to the Bioethics cell for ethical review in IEC meeting along with institute Research Committee (RC)/scientific committee SGPGI/departmental committee/doctoral committee approval document.

Detailed description of project submission

Check the application documents to ensure that all required forms and materials are contained within the submitted package Checking is done as per checklist of submissions for initial review.

Verify contents of the submitted package which should include (SGSOP 03/V1)

1. Project submission form

2. Study protocol

3. Other related documents necessary for initial review which include:

a. Case report form (CRF)

b. Participant Information documents, Consent Forms (CFs), Legally accepted guardian in case of patient incapable of giving consent e.g. unconscious, mentally deranged and parent consent forms (if children / adolescents between 8–18 years of age are participants in the trial) - in English and Hindi and any other language if necessary.

c. Consent Form.

d. Certificate of appropriate review committee of the Institute.

e. One page, recent, signed and dated curriculum vitae of the investigators indicating qualifications and relevant experience for a new investigator or investigator outside SGPGI or of the student (MD/MS/DM/MCh/PhD) who has submitted thesis/project.

f. Undertaking to comply with national and international GCP protocols for clinical trials

g. Investigator’s brochure.

4. Regulatory clearance as applicable from appropriate regulatory authorities i.e. DCGI, DGFT approval (for export of study samples), ICMR, DBT, DST- GEAC (use of recombinant DNA), other local government agencies5. Decision of other concerned Ethics Committees in case of collaborative research.

6. Details of funding agency /sponsors and fund allocation (patient care/staff/contingency/travel etc.) should be mention in budget section of Clinical trial Agreement.

7. All clinical trials with any stem cells shall have prior approval of Institutional Committee for Stem Cell Research and Therapy (IC-SCRT), Institutional Ethics Committee (IEC) and Drug Controller General of India (DCGI) for marketable product; and shall be registered with the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT); except that International Collaboration shall also have prior approval of NAC-SCRT and respective funding agency as per its procedure/or Health Ministry’s screening committee (HMSC).

8. For exchange of biological material in international collaborative study a MOU/MTA between the collaborating partners and clearance of Health Ministry Screening Committee (HMSC).

9. Clinical trial agreement (CTA) or MOU between the collaborators.

10. Insurance/Indemnity policies, indicating who are covered.

11. Clinical Trials Registry-India (CTRI), in case of new drug trial required at time of submission but in other cases this must be done after approval of the study but before initiation of recruitment

12. Any other information relevant to the study

13. Please see guidelines for device based studies in Appendices (AP18/V1) and include detailed as mentioned there.

State clearly the items missing in the package on the protocol submission/document receipt Form.

Information of change in funding agency/status of approved project

If there is change in funding status/agency of approved project; PI should inform same to IEC through the Bioethics cell stating the title of project, IEC code and date of approval and PI should also state that there are no changes in title, design, methodology. The Bioethics cell will notify to the IEC and PI will be given fresh approval letter for administrative purpose (if requested by PI).

Resubmission of protocols with corrections as per IEC suggestions

For resubmitted protocol, the PI will submit 6 copies of the amended Protocol and related documents along with justification for amendment, and clearly highlighted/demarcated sections which have undergone amendment.

The Bioethics cell will perform the steps as mentioned in initial review application. The protocol related documents which do not require to be changed and are already submitted to the IEC during initial review need not be submitted again.

The Bioethics cell will

a. Return one copy of the (AN14-V1/SGSOP 03/V1) to the applicant for their records

b. Count number of copies (Initially 6 hard copies and one soft copy for studies).