Should We Treat the Safety Review of COVID-19 Study Participants Differently? UPDATE to FDA’s COVID-19 Clinical Trial Guidance on September 21st

9/22/2020

As sponsor or CRO monitors are continuing to monitor clinical trial sites remotely for the foreseeable future, additional clarification is needed for how to proceed while protecting subject safety and data integrity. The Food and Drug Administration (FDA) released an updated COVID-19 clinical trial guidance with clarification on the requirements for the investigator to review IND safety reports. The question and answer guidance shows how we must be very careful to not decrease the safety protection checks and balances we have in GCP between stakeholders. Why would we not review all IND safety reports received? You may remember the large number of SAEs we saw for early HIV trials.

Here is the New FAQ number 24 (previous question 24 moved to 25):

Question: Since subjects with COVID-19 may have many serious and unexpected adverse clinical events, is it acceptable for an investigator to review only the IND safety reports that may affect the investigator’s brochure (IB), informed consent, or protocol?

Answer summary: It is a regulatory responsibility for sponsors to send IND safety reports to investigators and for the investigators to review them. This is a matter of subject safety, since IND safety reports may identify a new potential risk of the investigational product. In turn, the investigator is required to report the IND safety report to the IRB. See 21 CFR 320.31(d)(3), 21 CFR 312.32, 21 CFR 312.60, and 21 CFR 312.66.

People with COVID-19 have the same rights as any study participant. The data also must be held to the same checks and balances. You may also enjoy our blog on “Is it Really Consent? Considerations in Consenting COVID-19 Patients to Clinical Trials.”

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Additional sources of information include our related recorded webinars:

1.    ‘Remote Monitoring Operations and Maintaining HIPAA, GCP, and COVID-19 Restrictions’ including a helpful Q&A reference free with purchase.

  • The focus is on the sponsor/CRO’s perspective.

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2.    ‘A Case for Sponsor Monitoring Remote Access to a Site’s EMR!’

  • The focus is on the site’s perspective.

  • Purchase here.

Recorded webinars will be available for 10 days after purchase.

- The Clinical Pathways Team

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