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. 

 

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   
 gFood 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.


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