IRB Members' Section

Welcome to the "IRB Members’ Section" of our Google site.

This section is dedicated to providing guidance for the RITM - Institutional Review Board. It aims to ensure consistent review processes and comprehensive IRB procedures.

The presented Standard Operating Procedures establish a fundamental basis for maintaining uniform and thorough research evaluations, ultimately ensuring ethical and dependable outcomes.

In this section, you will also find the assessment worksheet and administrative forms which support essential IRB operations, facilitating protocol reviews and the intricacies of submission procedures.

To view the RITM-IRB SOPs, simply click on the links below:

Introduction
SOP 1 - IRB Structure and Composition
SOP 2 - Initial Review Procedures
SOP 3 - Post Approval Review
SOP 4 - Documentation and Archiving
SOP 5 - Writing and Revising SOPs

To view the RITM-IRB Forms, please click on the links below:

CHAPTER 1: REC Structure and Composition

Form 1.1 IRB Membership Nomination Form
Form 1.2 Curriculum Vitae
Form 1.3 Appointment of IRB Members
Form 1.4 Confidentiality and Conflict of Interest Agreement for IRB Members
Form 1.5 Training Record
Form 1.6 Confidentiality and COI Agreement for IRB Secretariat

CHAPTER 2: Initial Review Procedures

Form 2.2 Document Receipt Checklist
Form 2.3 Worksheet for Initial Assessment of New Research Protocol
Form 2.4 Communication to Reviewer
Form 2.5 Communication to Investigator of Type of Review the Protocol will Undergo
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

CHAPTER 3: Post Approval Review

Form 3.2 Worksheet for Review of Proposed Amendments
Form 3.4 Worksheet for Continuing Review

CHAPTER 4: Documentation and Archiving

Form 4.1 Notification of Exemption from Review
Form 4.2 Notification of IRB Decision
Form 4.3 Notification of IRB Approval of New Research Application
Form 4.4 Notification of Approval of Amendment
Form 4.5 Notification of Renewal of Approval
Form 4.6 Notification of IRB Decision of Research Completion, Protocol Withdrawal and Early Termination
Form 4.7 Notification of IRB Decision of SAE Reports
Form 4.8 Notification of IRB Decision of PV/ PD Reports
Form 5.0 Site Visit Report
Form 5.1 Preparing the Meeting Agenda
Form 5.2 Minutes of Meeting

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