Resource Center

Go back to Resource Center

The training documentation form-Going beyond the basics for the national institute on drug abuse (NIDA) national drug abuse treatment clinical trials network (CTN)



Williams, Tracee; Kondapaka, Radhika; Shmueli-Blumberg, Dikla; Wright, Matthew; Salazar, Dagmar; Williams, Kayla; Collins, Julia; Jelstrom, Eve; Lindblad, Robert

SCT Annual Meeting

Liverpool, UK


Trial Management & Research Coordination Involving Research Partners Trial Management & Research Coordination

According to ICH GCP guidelines, investigators and research staff with delegated trial-related duties should be “qualified by education, training, and experience” (ICH E6 GCP, 1996) to maintain integrity and quality in clinical trials. Training documentation is essential to demonstrate compliance of the investigator and research staff of these guidelines. Nonetheless, many researchers and sponsors, in particular in multicenter trials, find it difficult to adequately and accurately document the staff training requirements. When multicenter trials are conducted within a network, it is important to develop a sustainable level of standardization in training requirements across sites and studies that demonstrate the competency of the individuals being trained. The Training Documentation Form (TDF) is a comprehensive document that tracks all training requirements for each study staff member correlated to their study role(s). The TDF clearly defines the training expectations and requirements from various stakeholders (e.g., the Sponsor, Institutional Review Board) as they relate to the responsibilities for each study role, and consistent with the Study Training Plan (STP) and Site Delegation of Responsibilities Log. When completed, the TDF demonstrates that staff members are qualified and fully trained for their study role(s) prior to performing delegated study activities. The TDF developed for the National Drug Abuse Treatment Clinical Trials Network (NIDA-CTN) by the Clinical Coordinating Center at The Emmes Corporation is a user-friendly modifiable electronic document that includes these basic elements critical to a TDF. It captures each staff member’s name, research site, and delegated study role(s). The TDF lists all training outlined in the STP and maps the minimal required training and certification prescribed per study role in a grid, based on the staff’s assigned role (e.g., study physician,) and assigned tasks (e.g., prescribe medication, data entry) for the study. The TDF efficiently organizes the training curriculum in accordance with the investigative team’s predetermined decisions as to the various roles and associated training requirements. It includes both general training (e.g., Human Subjects Protection) and protocol-specific training requirements (e.g., administration of investigational product, conduct of study assessments). The TDF also captures the dates that staff completed each required training task and the final date of overall training completion, the latter of which is documented on the Site Delegation of Responsibilities Log to serve as the staff’s starting date on the study. When all required training has been completed, the TDF is signed by the staff member and endorsed by both the site’s Principal Investigator and the research center’s training representative, who collectively confirm that staff members are ready to begin study responsibilities. The NIDA CTN has implemented this standardized TDF on seven studies since 2013, aiding in setting up expectations for training documentation across studies while minimizing the difficulty of preparing and tracking the training completed by research staff. The TDF has been welcomed by the quality assurance monitors and the research management teams and has lead to more efficient study start up as well as provided a valuable tool for documentation of research staff competency in delegated study activities. CTN Contract # HHSN271201500065C

Go back to Resource Center