Patient Enrollment

The purpose of the Patient Enrollment stop is to formally enroll the participant in the clinical trial.

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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. 

Best Practices 

Mapping the Patient Journey

Technology and Data Strategy 

Data Connectivity 

Clarify data collection expectations - eSource to EDC? EMR direct to eSource?

Technology and Data Strategy 

Collaborate on Regulatory Gaps 

Data Connectivity 

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

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MRCT IRB/EC Considerations - Helpdesk

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MRCT IRB/EC Considerations - Notifications & Reminders

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Transcelerate Modernizing Clinical Trials Frameworks

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Transcelerate Modernizing Clinical Trials Direct-to-Patient Shipment Process Framework

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NIH - Informed Consent for Research Using Digital Health Technologies

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