Advarra’s IRB Handbook 

Advarra has updated its Institutional Review Board (IRB) Handbook for Investigators, Institutions, Sponsors, and Sponsors’ Representatives to version 7.1.   

Updates in the latest version of the IRB Handbook include: 

• Improved design and layout to enhance readability and usability. Please note that no content changes were made as part of this update. 

• Several new resources relevant to HIPAA, sIRB considerations, determining “engagement” under the Common Rule, and NIH requirements that your organization may find useful to explore. 
  

The revised Handbook is available in the Reference Materials section of the Advarra CIRBI Platform (login required). Customers are encouraged to check CIRBI for the latest version of the Handbook and applicable summary of changes. 

What is the purpose of the IRB Handbook? 

The purpose of the Handbook is to orient investigators, research personnel, sponsors, clinical research organizations (CROs), and site management organizations (SMOs) to the IRB’s policies, procedures, guidelines, and expectations, including information related to the initial review process through management of ongoing research activities and study closure. 

Because the Handbook includes links to external, web-based resources, Advarra recommends keeping an electronic version so that these hyperlinks remain accessible. 

If you have questions about the updated Handbook or resources available in Reference Materials, please contact your client services coordinator listed on each of your submissions.