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)