Site Closeout

The intent of the Site Closeout stop is to wrap up any outstanding activities with any PIs and sites, including any final patient assessments and study data, medications, supplies, etc.

DTRA_Tubestop Icons_Red-21

DCT-specific Considerations/Inputs

If non-traditional and/or virtual sites were used then site close out, final monitoring, regulatory review and archiving processes may occur either virtually or at locations in addition to traditional research sites. The expectations for archiving materials post trial are similar for all sites.  


Description


Tools


Regulatory Documents

FDA/U.S.

U.S. FDA Final Guidance Document: Conducting Clinical Trials With Decentralized Elements Guidance for Industry, Investigators, and Other Interested Parties - September 2024

View

Europe/EMA

EMA Recommendation on Decentralized Elements in Clinical Trials

View

Reference Documents

TransCelerate Modernizing Clinical Trial Conduct Solutions

View