Accessibility Assistant
Project Index page Format
- Ethics Committee
- Introduction
- Notification
- Instructions for Research Project Submission Document Application
- Sample Project
- Amendments to Protocol / Communications Protocol
- Principal Investigator Change Protocol
- Application Letter for Release of Finances
- Submission Letter for Deposits towards Project
- Submission Letter for Serious Adverse Effects for Research Project
- Research Project & Amendments Processing Fees
- Research Project Document Submission Check List Format
- Acknowledgement Form Format
- Title Page Format
- Joint Undertaking by Principal Investigator and Sponsor Format
- Project Index page Format
- Covering Letter Format
- Project Summary Format
- Research Protocol Application Format
- Project Completion Letter Format
Project Index Page
| Project Title |
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 * | ||||
- * Mandatory
**
Health Ministry Screening Committee (HMSC) /
- Bhabha Atomic Research Centre (BARC) /
- Genetic Engineering Advisory Committee (GEAC) /
- Director General of Foreign Trade (DGFT)
- Etc.