Researchers' Section

Welcome to the "Researchers' Section" of our Google site.

This portal is dedicated to serving the needs of researchers, providing easy access to the necessary forms for various purposes. These forms encompass a range of activities, including the submission of new applications, post-approval requests, and more. Here is a list of the available forms:

For New Applications:

Form 2.1: Request for Initial Review of New Research Protocol
Form 2.9: New Research Protocol Summary Sheet

For Resubmissions:

Form 2.8: Form and Worksheet for Resubmission

For Post-Approval Applications:

Form 3.1: Application for Review of Proposed Amendments
Form 3.3: Application for Continuing Review
Form 3.5: Report and Assessment of Research Completion
Form 3.6: Request for Protocol Withdrawal and Early Termination
Form 3.7: Assessment of SAE Report
Form 3.8: Report and Assessment of PD/PV Report
Form 3.9: Progress Report

Additional Forms:

Request for Access to IRB Files
Query Complaint Record

Additionally, you will find the Researchers' Guidance Document, offering step-by-step guidance on conducting your research with ethical and effective practices.

Lastly, we have included the assessment worksheets used in the evaluation of your submissions, ensuring adherence to our established standards.

CHAPTER 2: Initial Review Procedures

CHAPTER 3: Post Approval Review

CHAPTER 4: Documentation and Archiving

COI Declaration Form