Helping Research Professionals

Protecting research participants is challenging, that’s why we’re here to help!

IND Safety Reports and IRBs

HRP recently engaged in extensive correspondence with the FDA regarding the following statements that appeared in one of the later iteration’s of the FDA’s guidance document “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”: Where an IND safety report is required to be submitted to FDA under 21 CFR 312.32, the investigator must [emphasis added] also send that IND safety report to the IRB. The IRB may have additional reporting requirements regarding COVID-19 during the clinical trial. And In addition, investigators are required under 21 CFR 312.66 to report all “unanticipated problems involving risk to human subjects or others” to the IRB. FDA considers a serious and unexpected adverse event that meets the criteria for sponsor reporting to FDA...

FDA Announces ClinicalTrials.Gov Enforcement Action

FDA recently announced enforcement action taken due to noncompliance with ClinicalTrials.gov requirements.  While the enforcement action noted in the FDA announcement was directed at an industry sponsor, FDA made clear that responsible parties of all types, including academic institutions, hospitals, and individual researchers, must ensure compliance with the requirements for registration and reporting of summary results.  Organizations who conduct clinical trials subject to the FDA and NIH rules should evaluate the systems that they have in place to ensure compliance and to promptly respond to any Pre-Notice or Notice of Noncompliance.  For more information please see the FDA announcement.