Project Index page Format
A. Project Index Page Format
Project Index Page
Project Title
Index
No Document Name
( Please specify in “Page Nos” column NA if not applicable )
Page
Nos.
PI
Chk
Check
( SRS
use )
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.
