In collaboration with the National Institute on Drug Abuse (NIDA) Center for Clinical Trials (CCTN) Clinical Trials Network (CTN) this Good Clinical Practice (GCP) online training was developed to prepare study staff responsible for the conduct of trials with human participants from protocol development through study closeout.
There are 12 modules, with content covering many aspects of research trials, for example, informed consent processes, assessing safety of participants, and provision of primary oversight of the study staff’s conduct. In addition to the general aspects of research trials, the NIDA CCTN CTN has incorporated content on confidentiality and protections of study participants enrolled in substance use trials. The material is based on US CFR, International GCP guidelines, and human subject protection requirements for conducting clinical research.
While this program is available to study staff participating in the NIDA Clinical Trials Network, the training is open-access to the public. Trainees are required to complete a quiz following each module, except for the Introduction module. To receive a certificate, all quizzes must be completed with at least 80% accuracy. Upon successful completion of all quizzes, the user will be given access to the link for the Certificate of Completion, which has an expiration date three years after the date of completion. NIDA CCTN CTN members complete the training in compliance with network policies and procedures. Users external to the NIDA CCTN CTN, international and domestic, complete the training per their own institutional, affiliate, and research advisory requirements.
In the past, determination of the effectiveness of new treatments for drug addiction and abuse occurred mainly in specialized research settings in which the environment was controlled and the patient population highly selected. Often, results obtained in these settings could not be duplicated at community drug treatment centers.
To address this problem, the National Institute on Drug Abuse (NIDA) established the National Drug Abuse Treatment Clinical Trials Network (CTN), a web of interconnected, mutually supporting researchers and clinicians who are dedicated to improving the quality of drug abuse treatment throughout the nation by testing the effectiveness of new treatments in “real world” settings.
The CTN is national in scope but anchored in community-level programs and regional research and training centers. NIDA serves as a resource for scientific and other expertise and provides administrative oversight of the CTN. This decentralized structure is intended to accelerate both the pace of research on drug abuse treatment and the application of research findings to improve the lives of individuals across the nation suffering as a result of drug abuse.
The CTN consists of multiple Nodes and more than 100 research sites. The Node typically resides in the Principal Investigator’s research institution or organization, is the recipient of the cooperative agreement award, and is responsible for the research activities conducted at its partner research sites. Each Node, along with its assigned research sites, encompasses a regional area and a variety of treatment settings, patient populations, and drug abuse problems.