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Lokmanya Tilak Municipal Medical College

and Lokmanya Tilak Municipal General Hospital

Sion Mumbai

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Home / Ethics Committee / Project Index page Format

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.
Ref Check
( SRS use )
1. Covering Letter *
2. Application Processing Fee Receipt Xerox *
3. Curriculum vitae of Principal Investigator *
4. 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 *
5. 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 )
6. Project Completion Letter
7. Complete project submission on CD ( Word 2003 ) 1 copy only
  • * Mandatory

**
Health Ministry Screening Committee (HMSC) /

  • Bhabha Atomic Research Centre (BARC) /
  • Genetic Engineering Advisory Committee (GEAC) /
  • Director General of Foreign Trade (DGFT)
  • Etc.