The ACTG Performance Evaluation Program is an established comprehensive monitoring and evaluation system. The overall intent and spirit of the performance evaluation program is to ensure that all sites and laboratories, as part of a major multicenter, multinational clinical trials group, contribute at an acceptable level to the successful development, implementation, execution, completion, and publication of clinical trials.
The ACTG Performance Evaluation Committee (PEC) administers the program and develops the evaluation tools to measure performance of the clinical research sites, laboratories, and other key components of the network. Information gleaned from the evaluation program informs the development of the network’s scientific agenda and provides reliable data for strategic planning.
Drawing insight and expertise from a membership that encompasses the network’s research sites, specialty laboratories, statistical and data management center, network coordination center, and community representatives, the PEC develops performance measures and standards that focus on the efficient use of resources, scientific quality, data integrity, safety, and the protection of research participants. The PEC ensures the evaluation is meaningful and conducted in a fair and transparent manner. To the extent possible, objective data generated by existing systems and processes defined in the Network’s Standard Operating Procedures (SOPs) comprise the bulk of the measures.
Performance evaluation is a continuous process. The PEC monitors performance data on a cycle of monthly data reviews, interim performance reviews, and formal annual performance evaluations. Continuous monitoring helps the PEC detect potential issues at an early stage and provide real-time technical support and recommendations for process improvements to ensure clinical research sites and specialty laboratories meet the network’s goals and expectations for high quality performance.
The current review schedule is shown in the following table:
Based on in-depth analysis of cumulative performance data, the PEC reports to the network leadership on the network performance overall and makes specific, practical recommendations concerning the performance of individual sites and laboratories. The leadership, in consult with DAIDS, formulates final decisions concerning modifications and possibly sanctions that may be needed to ensure that each site and laboratory contributes at an acceptable level to the overall strength of the network. Evaluation findings and the resulting decisions are communicated to the sites and laboratories in formal, individualized reports that detail performance data in each area subject to assessment.
Last updated: 03/09/17