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.


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’s Participant Data Return initiative solutions are intended to address these uncertainties.

The Participant Data Return Resource Pack provides access to a consolidated set of resources from across the clinical research ecosystem that can assist with returning individual data globally.

The Individual Participant Data Return Package provides general considerations to enable data return to clinical study participants​ and includes three components – a Socialization Presentation, Considerations Guide and Template.


Potential benefits from individual participant data return may include:

  • Building trusted partnerships with and demonstrating the value of and respect for the participant.
  • Facilitating more diverse and inclusive participation in clinical studies, thereby improving health equity and access.
  • Enhancing conversations between clinical study participants and their care providers of choice to make more informed decisions about clinical care / research.
  • Decreasing burden on the participant and care systems by potentially reducing duplication of procedures or investigations, where scientifically and clinically feasible.
  • Empowering participants to be equal partners in improving health outcomes.

Available Solutions

For more information and to explore our solutions, visit our Initiative Solutions page.

Related Initiatives

Patient Experience

The Patient Experience (PE) Initiative seeks to facilitate and accelerate the industry’s progression towards a future where the patient experience is enhanced in clinical trials and patient burden is reduced.

Modernizing Clinical Trial Conduct

The Modernizing Clinical Trial Conduct Initiative will use data and experience to develop practical guidance and solutions to enable the successes of continuity solutions implemented during COVID-19 while collaboratively engaging with major stakeholders including regulators, patients, sites, and industry groups.

Clinical Research Access & Information Exchange

Clinical Research Access & Information Exchange seeks to provide a better window into information about clinical research and trial options and to contribute to a more rewarding clinical trial experience via better exchange of information with trial participants.