FDA released a new guidance today that reflects items that have appeared across several past guidance documents. It is entitled “Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an Investigational New Drug/Investigational Device Exemption is Needed”
Among other items, the guidance addresses:
- IRB’s role in assessing the qualifications of clinical investigators
- Suggested methods for assessing investigator and research sites
- The role of IRBs in the determination of whether an IND/IDE is required
To review the full FDA guidance, click here.