The Participant Data Return initiative solutions can be utilized by sponsors to identify considerations that will facilitate leadership commitment and enable individual data return that can be built to scale and incorporated into business-as-usual processes, in alignment with individual organizational objectives, needs, and requirements.
Participant Data Return Assets
Participant Data Return Resource Pack
A document that provides access to a consolidated set of resources from across the clinical research ecosystem that can assist with returning individual data globally.
Individual Participant Data Return (iPDR) Package
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.
To optimize the use of this package, the Individual Participant Data Return Team recommends referencing the solutions in the order in which they appear below.
A presentation to educate key internal stakeholders of the potential value of returning participant data in clinical studies and to obtain support to operationalize within sponsor organization.
Provides considerations for implementing the return of individual data.
Provides a customizable template example of how a study team might capture important operational details for enabling individual data return at a study or program level.