Tubestop - Patient Consent & Oversight

Description

The consent process for a clinical trial is a way to ensure that participants understand the risks and benefits of participating in the trial before they make a decision to enroll. Typically a participant will complete screening procedures to verify they are eligible for a study after completing the consent process.

The consent process is an important part of every clinical trial. It helps ensure that participants understand the risks and benefits of participating in the trial before they make a decision to enroll. The consent process must be conducted in a way that is understandable to the participant and that respects their autonomy.

The consent process typically includes the following steps:

Informed consent: The participant is given information about the trial, including the purpose of the trial, the procedures involved, the risks and benefits of participating, and their rights as a participant.
Consent: The participant signs a consent form indicating that they understand the information they have been given and that they agree to participate in the trial. A witness may also sign the consent form, along with the study site member helping the patient with the consent process.
Questions: The participant has the opportunity to ask questions about the trial before they sign the consent form.

DCT-specific Considerations/Inputs

Need to include consent to release medical records, if required to verify eligibility
Need to verify patient and site staff identity, mutually
Need to consider tokenization language, and explaining the process to access data from other sources as part of the trial data
Remote setting. Considerations for hand off between Patient Pre-screen and Patient screening.
Relationship / engagement solutions if the site is hybrid or a rully remote option is used.
Determine if any in-home assessments need to be conducted to verify entry criteria. May require coordination with vendors / clinical supplies / lab kits and collection.
Ensure all trial team members administering consent are fully trained on the process.
Document any participant questions in eSource
Clarify data collection expectations - eSource to EDC? EMR direct to eSource?
Clarify who needs to view enter data in the DCT platform, to review, to monitor, to query.

U.S. FDA Final Guidance Document: Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties - September 2024

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21 CFR Part 50 and Guide to Informed Consent

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FDA Guidance Document: Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers Guidance for Institutional Review Boards, Investigators, and Sponsors (Dec 2016)

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