Project Index page Format
Index
| No | Document Name ( Please specify in
"Page Nos" column NA if not applicable )
| Page Nos.
| PIChk |
SRSChk |
1 | Research Project Format
* | | | |
| | a | Project
Summary
* | | | |
| | b | Research
Protocol Application Format
* | | | |
| | c | References
* | | | |
| | d | Patient
Information Sheet in 3 languages
* | | | |
| | e | Patient
Informed Consent Form in 3 languages
* | | | |
| | f | Case
Record Form / Questionairre / Patient Diary
* | | | |
| | | | | |
| 2 | Additional Documents ( As may be required )
| | | |
| | a. | Investigator
Brochure for Sponsored
project | | | |
| | b. | Clinical
Trial
Agreement | | | |
| | c. | Insurance
Policy with suitable
validity | | | |
| | d. | DGCI
Approval Letter for Phase I/ II/ III
study | | | |
| | e. | Investigator's
undertaking to DCGI (for Phase I, II, III,
studies) | | | |
| | f. | Ethics
Committee Clearance /status– ( Multicentric / Multinational study only ) Letter
from Ethics Committee / Letter from Sponsor for
status | | | |
| | g | Food
and Drug Administration (FDA) marketing/manufacturing license for herbal
drugs. | | | |
| | h | **Please
specify if Clearance of other Bodies as may be required ( Sample List enclosed
below
) | | | |
| 3 | Project Completion Letter
* | | | |
**
Health
Ministry Screening Committee (HMSC) /
- Bhabha Atomic Research Centre (BARC) /
- Genetic Engineering Advisory
Committee (GEAC) /
- Director
General of Foreign Trade (DGFT)