Participant Data Return

The Participant Data Return initiative seeks to develop pragmatic resources to enable sponsors return of meaningful individual data to clinical trial participants who opt in to receive it in order to build trust in the research enterprise by enabling access to an individual’s data for their personal care, as appropriate.

Rationale

Clinical trial participants would like more data returned to them during and after participation in clinical trials; however, the frequency, timing, and type of data returned to participants today is varied and not widespread.

Enabling meaningful participant data return options helps to establish trust in the research enterprise, facilitates partnerships, and supports ownership of an individual’s data in making future care decisions.

Work has been done to support sponsors in returning participant data but uncertainty around how, when and what types of participant data can be returned in a meaningful, secure, and safe manner while maintaining scientific integrity and submission timelines for approval remains.

TransCelerate plans to address these uncertainties to advance and accelerate the return of individual participant data in clinical trials.

Benefits

TransCelerate’s Participant Data Return solution may help sponsors:

Demonstrate respect and gratitude for the participant’s contributions to scientific advancements in research & development
Enhance patient partnerships, autonomy and flexible personalized clinical trial choices
Inform patients and increases awareness about clinical trials
Improve clinical trial engagement & the patient experience, facilitating recruitment and retention
Identify flexible alternatives on how to enable individual data return that can be built to scale and incorporated into business-as-usual processes
Achieve operational efficiencies

Available Solutions

Initiative Solutions

The following solutions are now available:

Participant Data Return Resource Pack

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