The importance of methods for site performance evaluation in REPRIEVE, a longitudinal, global, multicenter trial.

ABSTRACT:

Background

REPRIEVE, the Randomized Trial to Prevent Vascular Events in HIV, is a multicenter, primary prevention trial evaluating whether a statin can prevent major cardiovascular events in people with HIV. REPRIEVE is conducted at >100 clinical research sites (CRSs) globally. Detailed, comprehensive, and novel methods for evaluating and communicating CRS performance are required to ensure trial integrity and data quality. In this analysis we describe a comprehensive multidimensional methodology for evaluating CRS performance.

Methods

The REPRIEVE Data Coordinating and Clinical Coordinating Centers developed a robust system for evaluation of and communication with CRSs, designed to identify potential issues and obstacles to performance, provide real-time technical support,

SUBMITTER: Fulda ES 

PROVIDER: S-EPMC9891172 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature