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Quality Assurance of Research Protocols Conducted in the Community: The National Institute on Drug Abuse Clinical Trials Network Experience.

Clinical Trials 2009;6:151-161. [doi: 10.1177/1740774509102560]

Carmen L. Rosa, MS (Center for the Clinical Trials Network, NIDA), Aimee N.C. Campbell, MSW (Columbia University School of Social Work, LI Node), Cynthia Kleppinger (Division of Scientific Investigations, FDA), Royce Sampson, MSA, APRN-BC (Medical University of South Carolina, SC Node), Clare Tyson, MA, CCRA (Medical University of South Carolina, SC Node), Stephanie Mamay-Gentilin (Medical University of South Carolina, SC Node).

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. This article describes the experience of the National Institute on Drug Abuse's (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) in devising and implementing a three-tiered QA model for rigorous multi-site randomized clinical trials implemented in community-based substance abuse treatment programs. The CTN QA model combined local and national resources and was developed to address the unique needs of clinical trial sites with limited research experience. Between January 2001 and September 2005, the CTN implemented 21 protocols, of which 18 were randomized clinical trials, one was a quality improvement study and two were surveys. Approximately 160 community-based treatment programs participated in the 19 studies that were monitored, with a total of 6,560 participants randomized across the sites. During this time, 1,937 QA site visits were reported across the three tiers of monitoring. One study reported 109 protocol violations, examples of which are presented to highlight training, protocol violation monitoring, site visit frequency and intensity and cost considerations. The lessons learned from the CTN's experience include the need for balancing thoroughness with efficiency, monitoring early, assessing research staff abilities in order to judge the need for proactive, focused attention, providing targeted training sessions, and developing flexible tools. (Article (Peer-Reviewed), PDF, English, 2009)

Keywords: Community health services | CTN platform/ancillary study | Fidelity of implementation | Quality Assurance (QA) | Clinical Trials (journal)

Document No: 352, PMID: 19342468, PMCID: PMC2735249

Submitted by Quandra Scudder, NIDA CCTN (4/10/2009).

Campbell, Aimee N.C. search mail
Kleppinger, Cynthia search
Mamay-Gentilin, Stephanie search
Rosa, Carmen L. search mail
Sampson, Royce search mail
Tyson, Clare search mail

Supported by a grant from the National Institute on Drug Abuse to the University of Washington Alcohol and Drug Abuse Institute.
The materials on this site have neither been created nor reviewed by NIDA.
Updated 9/2009 --