To participate in a clinical trial, a subject or subject’s legally authorized representative must provide informed consent (21 CFR Part 50).
Provision of consent not only grants permission for the clinical investigator to include the subject in a study but also for the sponsor/CRO to review the subject’s study records. Clinical research associates (CRAs) must verify informed consent prior to monitoring study data.
While paper informed consent has traditionally been the most common method for documenting the completion of the consent process, more sites have been using alternative methods for obtaining informed consent during the COVID-19 pandemic.
That includes electronic informed consent (e-consent).
How Should CRAs Review Informed Consent Remotely?
Remote review of informed consent is completed via secure, online data servers/software, review of scanned copies sent from the site, and live document review via videoconferencing programs. Regardless of the method used, it is critical to ensure that subject confidentiality is protected and that PHI requirements of the site, sponsor, and CRO (if applicable) are followed. This may include redaction, encryption, and/or additional security methods to ensure data privacy. In addition, CRAs should be prepared to record details of the informed consent process to support documentation of the review.
Once on-site visits resume, CRAs should perform additional review of the physical consent documents. While regulations do not require in-person review of the informed consent form, this type of review can add a level of quality assurance for both the site and sponsor.
How Can IMARC Assist With Remote Informed Consent Review?
As a leading contract research organization, IMARC can manage your remote monitoring or offer additional support to clinical research associates.
We can review your informed consent documents by obtaining encrypted access to your electronic files or via a secure file-sharing platform to ensure they comply with all relevant regulations.
We can identify errors or protocol deviations before they become bigger problems. We can even help you screen patients, obtain consent, or assist with follow-up communications to reduce your team’s workload.
To learn more about how our remote services can support your team, check out this short overview video.
Do you have any other ideas about how to review consent remotely?
Have you found certain review methods work better than others?
Have you encountered obstacles to this type of consent review?
Please let us know in the comments below.