Advarra clients can now access a guidance document describing the revised Common Rule’s new ICF elements and other ICF changes as well as tips for implementing these requirements. This document is available in the Reference Materials section of the Advarra Center for IRB Intelligence (CIRBI) Platform.
In this guidance. Advarra outlines the necessary information that will need to be included in research subject to Common Rule requirements, including details for new studies approved on or after the January 21, 2019, revised Common Rule compliance date; for existing studies approved before January 21, 2019; and for FDA-regulated research subject that is not subject to Common Rule requirements.
The guidance also includes a checklist to assist clients in reviewing study materials to ensure the revised Common Rule requirements have been appropriately addressed.
For more information on the revised Common Rule, refer to OHRP’s revised Common Rule resources. For assistance in implementing these requirements for a new study submission, contact Business Development.