Submission Form for Human Subject – Mochtar Riady Institute for Nanotechnology

Title

Initial Protocol Submission Form for Clinical Trial

Cover submission form for Clinical trial

Annex 1 Clinical Trial

Annex 4 ICF Checklist

File

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Initial Protocol Submission Form for Survey Non Clinical 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 Trial

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 2 for survey, Non 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