Quality assurance of research protocols conducted in the community: The National Institute on Drug Abuse Clinical Trials Network Experience

Abstract

Background: Quality assurance (QA) of clinical trials is essential to protect the welfare of trial participants and the integrity of the data collected. However, there is little detailed information available on specific procedures and outcomes of QA monitoring for clinical trials.

A Peer Review Intervention for Monitoring and Evaluating sites (PRIME) that improved randomized controlled trial conduct and performance

“…The evaluation should incorporate site initiation and closeout as inexperienced sites and staff may require more assistance at these stages [23,31]. A major advantage of PRIME is that it can be undertaken by existing staff, which can enhance study cohesion and potentially reduce costs.…”

“…Monitoring of 11 sites by EORTC staff revealed that data accuracy was 82% and in 1991 visits each cost US $1,500 (excluding staff time) [22]. The only randomized trial of site initiation and monitoring (nested in an EORTC breast cancer trial) was stopped early thus preventing robust assessment of site monitoring [23].…”

The first decade of the National Drug Abuse Treatment Clinical Trials Network: Bridging the gap between research and practice to improve drug abuse treatment

“…While it is important that protocol development procedures are streamlined and efficient, in the CTN it is equally important that: 1) only properly vetted research of the highest scientific rigor and relevance for the practice of substance abuse treatment is conducted, 2) all necessary safeguards are in place to guarantee the safety of study participants and the integrity of data collected (Rosa, Campbell, Kleppinger, Sampson, Tyson, & Mamay-Gentilin, 2009), and 3) the work of the CTN is always a true collaboration among researchers, treatment providers, and NIDA. A helpful step during the development of many CTN protocols is the circulation of a study questionnaire.…”

Building an Evidence Base for Drug Abuse Treatment in Afghanistan: Lessons Learned and Implications for Future Research

“…Future studies should include in-person training on treatment log completion, along with ongoing monitoring and technical assistance by field teams to ensure accurate reporting. 26 Finally, language or cultural issues impacted data collection and patient reporting in a number of instances. For example, when patient ages were compared from pre-to post-test, there were higher than expected inconsistencies between time points.…”