FDA updates guidance document on clinical trials during COVID-19

FDA updated its Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (April 17, 2020) with seven questions and answers providing clarifications on obtaining informed consent during the pandemic; considerations for remote clinical outcome assessments; remote site monitoring; electronic common technical document (eCTD) waivers; and other issues.

Highlights include:

Informed Consent: Investigators may use other methods if they so not have electronic informed consent capabilities: “if those methods allow for an adequate exchange of information and documentation, and a method to ensure that the signer of the consent form is the person who plans to enroll as a subject in the clinical investigation or is the legally authorized representative of the subject” e.g. via fax or email, with consent interviews taking place by phone.

Site Monitoring: FDA says its regulations “are not specific about how sponsors must conduct such monitoring and are therefore compatible with a range of approaches to monitoring,” 

Treatment administration: The updated guidance provides considerations for situations where patients are unable to travel to a trial site to receive investigational products that need to be administered via infusion, providing recommendations for documenting changes in trial protocol and shipping investigational products to health care providers.

Access the full guidance document here: Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency (updated April 17, 2020)