| Project proposal |
12 Copies |
| Curriculum Vitae of Investigators |
12 Copies |
| Brief description of proposal |
12 Copies |
| Patient information sheet |
12 Copies |
| Informed Consent form |
12 Copies |
| Investigator’s brochure for recruiting subjects |
12 Copies |
| Copy of advertisements/Information brochures |
12 Copies |
| Copy of clinical trial protocol and/or questionnaire |
12 Copies |
| Institutional Ethics Committee clearance |
12 Copies |
| Institutional Animal Ethics Committee clearance CPCSEA clearance, if any |
12 Copies |
| HMSC/DCGI/DBT/BARC clearance if obtained |
12 Copies |
