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

• Form 2.1 Request for Initial Review of New Research Protocol

• Form 2.3 Worksheet for Initial Assessment of New Research Protocol

• Form 2.6 Worksheet for the Review of New Research Protocol

• Form 2.7 Worksheet for the Review of Informed Consent and Other Documents

• Form 2.8 Form and Worksheet for Resubmissions

• Form 2.9 New Research Protocol Summary Sheet

CHAPTER 3: Post Approval Review

• Form 3.1 Application for Review of Proposed Amendments

• Form 3.2 Worksheet for Review of Proposed Amendments

• Form 3.3 Application for Continuing Review

• Form 3.4 Worksheet 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 Protocol Deviation/ Violation Report

• Form 3.9 Progress Report

CHAPTER 4: Documentation and Archiving

• Form 6.1 Request for Access to IRB Files

• Form 6.2 Query Complaint Record

COI Declaration Form