Picture1

Submission Form for Research Human Involving Subject

Title

Initial Protocol Submission Form for Clinical Trial

Cover submission form for Clinical trial

Annex 1 Clinical Trial

Annex 4 ICF Checklist

File


Initial Protocol Submission Form for Survey Non Clinical Non Trial

Cover submission form for Survey, Non Clinical Trial

Annex 2 for survey, Non clinical trial

Annex 4 ICF Checklist

Protocol Resubmission Form for Clinical rial

Cover submission form for Clinical trial

Annex 1 Clinical Trial

Annex 4 ICF Checklist

Table of Revision

Protocol Resubmission Form for Survey , Non Clinical Trial

Cover submission form for Survey, Non Clinical Trial

Annex 1 Clinical Trial

Annex 4 ICF Checklist

Table of Revision


Protocol Amendment Submission form 

Continuing Review Application Form (Progress Report)

Study Report / Final Report Form

 Serious Adverse Event Form (SAE)

Suspected Unexpected Serious Adverse Reaction  Form (SUSAR)

Protocol Deviation Form

Study Termination Application Form

 Response to Participant Request Form

Confidential Agreement for Guest(s) / observer to Attend The Meeting