CTN Webinar: Preparing for Close-Out of Studies and Sites.
Presented by Christie Thomas (PR Node), Matthew Wright and Dikla Blumberg, PhD Yesko (both from the CTN Clinical Coordinating Center).
Produced by the National Drug Abuse Treatment Clinical Trials Network's Clinical Coordinating Center, April 29, 2015.
Proper close-out of a multisite clinical trial is as important as the implementation process; both phases require adequate preparation for timely and efficient conduct. In the CTN, study close-out involves careful logistical coordination among key stakeholders and role groups, such as the Sponsor, Lead Node, local nodes, research sites, Clinical Coordinating Center, Data and Statistics Center, and vendors.
This 90-minute presentation reviewed the essential aspects of study and site close-out for clinical trials, by discussing shared activities as well as other supportive tasks. The instructors are Christie Thomas, MPH, of the National Drug Abuse Treatment Clinical Trials Network Pacific Region Node; Matthew Wright of the CTN Clinical Coordinating Center, and Dikla Blumberg, PhD, also of the CTN Clinical Coordinating Center.
Learning objectives included:
Discuss planning for trial close-out, and identify critical activities that make for timely and efficient close-out
Define roles and responsibilities, regulatory obligations, documentation requirements, and other processes to consider at the end of a study.
Review lessons learned in the close-out of other CTN studies.
This webinar is targeted to all research staff engaged in close-out activities for studies and sites and those interested in learning what to expect at study close-out. (Webinar, Video, PDF, English, 2015)