Patient Enrollment
The purpose of the Patient Enrollment stop is to formally enroll the participant in the clinical trial.
Description
- Patient enrollment is the process of formally accepting a potential participant into a clinical trial after completing consent and confirming eligibility.
- At this point, the patient may be randomized to a specific treatment arm, depending on the trial design.
- The clinical trial site needs to ensure all supplies and assessments are available (including IP) prior to enrolling a participant.
DCT-specific Considerations/Inputs
Assess the need to integrate with the IRT / DCT platform.
Clarify data collection expectations - eSource to EDC? EMR direct to eSource?
Collaborate on Regulatory Gaps
Consider optionality offerings: based on trial design, what assessments will happen at the next visit, where will they be conducted, and what trial supplies will be needed? e.g., is IP being shipped to the patient’s home? Or to a local pharmacy for administration? Is data being collected with a wearable - can the participant begin the trial before that is available to them?
Tools
Regulatory Documents
FDA/U.S.
Europe/EMA
Reference Documents
MRCT IRB/EC Considerations - Full Document
ViewMRCT IRB/EC Considerations - Helpdesk
ViewMRCT IRB/EC Considerations - Notifications & Reminders
ViewTranscelerate Modernizing Clinical Trials Frameworks
ViewTranscelerate Modernizing Clinical Trials Direct-to-Patient Shipment Process Framework
ViewNIH - Informed Consent for Research Using Digital Health Technologies
View