Documents Needed For Approval
Appropriateness of investigator:
The ethics committee shall review the CV of the investigator, including qualifications, current designation and experience to determine whether he / she has appropriate capability to undertake the research in question (including clinical trials).
| Sr. No. | Document to be Submitted |
|---|---|
|
1 |
Application/Cover Letter Signed by PI |
|
2 |
Study Protocol |
|
2A |
Study Protocol Summary of Changes (only if an amendment is being submitted) |
|
2B |
Protocol Signature Page |
|
3 |
Investigators Brochure |
|
3A |
Investigators Brochure Summary of Changes (only if an amendment is being submitted) |
|
3B |
Investigators Brochure Signature page |
|
4 |
Participant Information Sheet & Informed Consent/assent Form (English) |
|
5 |
Participant Information Sheet & Informed Consent/assent Form (Vernacular Language) |
|
6 |
Participant Information Sheet & Informed Consent/assent Form (Back Translation from Vernacular Language to English) |
|
7 |
Participant Information Sheet &Informed Consent/assent Form (Hindi) |
|
8 |
Participant Information Sheet & Informed Consent/assent Form (Back Translation from Hindi to English) |
|
9 |
Participant Information Sheet & Informed Consent/assent Form – Translation & Back Translation certificates |
|
10 |
All participant facing documents- English, Vernacular Language and Hindi. Along with their back translations & certificates of translation and back translation ( Please mentions each document in separate row) Eg- Audio Video Consent/assent , Diary |
|
11 |
Any advertisements/recruitment materials to be used for recruitment of participants- – English, Vernacular Language & Hindi. Along with their back translations & certificates of translation and back translation ( Please mentions each document in separate row) |
|
12 |
Submission letter to Indian Regulatory Body (applicable for regulated drug trials) |
|
13 |
Approval letter from Indian Regulatory Body (applicable for regulated drug trials). |
|
14 |
Clinical Trial Insurance policy and certificate |
|
15 |
Clinical Trial Agreement (Draft has to be submitted prior to signatures. Signing will happen after EC review & decision. Final Signed document has to be submitted prior to site initiation visit) |
|
16 |
Clinical Trial Registry of India Permanent Number (Temporary number may be submitted, however permanent number has to be submitted prior to consent/assenting the first study participant) |
|
17 |
Case report form template |
|
18 |
Principal Investigator (PI) Curriculum Vitae, Medical registration certificate & GCP Training Certificate |
|
19 |
Investigators Undertaking (FDA 1572 if applicable) |
|
20 |
Financial Disclosure form of PI |
|
21 |
Acknowledgement Ethics Committee Fees |