Policies and Standard Operating Procedures for the Institutional Review Board is newly revised and is an easy way for IRBs to document policies and procedures that reflect their organization’s philosophies, standards, and innovations while continuing to comply with federal regulations.
Institutional Review Boards must establish an institutional culture where studies are conducted in an ethical and scientifically rigorous manner. That is why it is important to create and maintain standard operating procedures that adhere to the regulations governing the oversight of human subjects.
This SOP template is provided in a three-ring binder with a CD-ROM containing an MS Word program for Windows users only and is based on the Code of Federal Regulations, guidance and ICH/GCP Consolidated Guideline, and the Association for the Accreditation of Human Research Protection Program’s (AAHRPP) standards for human subject protection.
Template features and topics include:
- Sample job descriptions for staff and IRB members
- Templates for IRB minutes, agendas, and review worksheets
- Chapters on informed consent, quality assurance, IRB organization, and responsibilities of investigators and sponsors
Policies and Standard Operating Procedures for the Institutional Review Boardis also designed to be compatible with the other SOP templates in the series, which include:
To preview the Table of Contents and other sample pages, click on the links below:
Table of Contents
Introduction
List of Attachments
IRB Policies and Procedure Maintenance
IRB Continuing Review, Criteria for Renewal
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