7/09/2020
With clinical trial sites prolonging restricted access and sponsor or CRO monitors continuing to monitor clinical trials remotely, more clarification of how to proceed in the current environment while maintaining subject safety and data integrity and quality is needed. The Food and Drug Administration (FDA) released an updated COVID-19 clinical trial guidance with clarification on methods of obtaining informed consent from patients in isolation and an additional question and answer.
New question:
Question 24: “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: The systems used to obtain electronic signatures must be in compliance with 21 CFR Part 11. If the system cannot be verified to be in compliance, then another method should be used, such as a handwritten signature or a finger or stylus drawn signature that is witnessed and printed. These documents must be retained as per the regulations, either as paper originals or certified electronic copies using a validated system. Questions 10 and 11 describe ways that electronic signatures can be obtained.
Updated Questions:
Question 10: “How do I obtain signed informed consent from a hospitalized patient who is in isolation when a COVID-19 infection control policy prevents us from entering the patient’s room to collect a signed informed consent form?”
Answer summary: The updated answer clarifies that two methods may be acceptable. The patient can sign a paper informed consent and send a photograph to the site staff. Another method would involve a witness to the signature if an image of the signature is not able to be sent to the site staff. For either method, the informed consent discussion would occur over telephone or video conference. Documentation of informed consent should include the method used and the signature of the witness, if applicable.
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?”
Answer summary: As long as the consent process includes adequate time for the subject to ask questions and there is documentation that the consent took place before study procedures, remote methods of informed consent may be used. The signed document may be returned to the site staff by fax, photo, scanned in and send by secure email, or posted to secure internet storage.
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 by clicking here.
2. ‘A Case for Sponsor Monitoring Remote Access to a Site’s EMR!’
The focus is on the site’s perspective.
Purchase by clicking here.
Recorded webinars will be available for 10 days after purchase.
- The Clinical Pathways Team
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