An approach to virtual clinical trial site visits: Lessons from the MeTeOR trial.

ABSTRACT:

Objective

To provide a framework for conducting clinical trial site visits virtually over videoconference, and to report on our experience doing so during the twelve-year follow-up of the Meniscal Tear in Osteoarthritis Research (MeTeOR) trial.

Design

Using published FDA guidance and prior literature, we created a structure for virtual site visits that prioritized monitoring for protocol compliance, safety, and data integrity. We conducted site visits in three stages: preparation for the visit, the virtual meeting itself, and follow-up. The preparation phase involved a review of relevant site-specific documents and a written report on the findings prior to the visit. The virtual visit itself was focused on any questions the site staff had about the pre-visit report, observin

SUBMITTER: McHugh CG 

PROVIDER: S-EPMC9926209 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature