6/03/2020
As clinical trials continue but restrictions remain in place, the Food and Drug Administration (FDA) continues to receive and compile questions about clinical trials conduct. On June 3rd, the FDA released an updated Q&A section of their COVID-19 clinical trial guidance with three additional questions and answers included.
New questions of interest are:
Question 22: “For a clinical trial that is not investigating treatments for COVID-19, if a trial participant diagnosed with COVID-19 experiences a serious adverse event associated with COVID19 during the trial, should that be reported as an IND safety report? Should these events be reported to the IRB?”
Answer summary: Because there is a potential for investigational products to increase susceptibility for contracting COVID-19 and not enough information exists to assume the contrary, the FDA suggests a data monitoring committee analyze unblinded data to compare the rates of SAEs between the treatment and control arms. These members should not be in contact with the members who would be analyzing trial data to ensure the integrity of the data. If it is not a randomized trial, the FDA suggests comparing numbers to a similar, external population.
Question 23: “What considerations apply to the electronic systems used to generate electronic signatures on clinical trial records, including informed consent documents, during the COVID-19 public health emergency?”
Answer summary: Electronic signatures must still comply with FDA regulations 21 CFR part 11. If a Part 11 compliant system is not available, another process needs to be used such as pen and paper. Visit our other related blogs for additional information about informed consent signatures during COVID-19 restrictions as this was covered in previous questions.
Visit our blog here that includes question 10, “How do I obtain a signed informed consent from a patient who is in isolation and the COVID-19 infection control policy would prevent us from removing a document signed by the patient from their hospital room?”
Visit our blog here that includes question 11, “How do I obtain informed consent from a patient unable to travel to a clinical trial site where electronic informed consent is not an option?”
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.
Purchase here.
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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