NEW UPDATE to Appendix FAQ: FDA’s COVID-19 Clinical Trial Guidance on May 11th

5/12/2020

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As clinical research professionals proceed to work around COVID-19 restrictions while maintaining GCP, questions continue to arise. On May 11th, the Food and Drug Administration (FDA) released an updated Q&A section of their COVID-19 clinical trial guidance with three additional questions and answers included.

Some questions of note from the last two updates are:

  • Can investigational products (IP) be shipped to a location other than a site for infusion for the subjects, and what additional measures would be needed to ensure subject safety and data integrity?

    • It should be within the normal scope of practice for any physician who would infuse the IP. This would be considered the same as an investigator delegating the task and as such the physician should have appropriate qualifications. If they need to complete other study specific procedures that would contribute to data collection, then they would be considered sub-investigators. In any case, the investigator is responsible for oversight.

  • If a subject needs laboratory or imaging services and cannot get to a site, can a local one be used?

    • It may be permissible for them to use a local service if it is within the normal procedures for the lab or imaging center and it is being done for the safety of the subject. If the services are needed for endpoint evaluation, consultation with the FDA would be needed.

  • What are the recommendations for best practices for telehealth visits for subjects?

    • The identities of both parties should be confirmed, and the date, time, and location of all involved should be documented in the case report forms. Precautions to ensure privacy need to be implemented. Live streaming videos are not electronic records and do not need to follow 21 CFR Part 11.

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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