Purpose: focuses on practical aspects of the preparation and execution of clinical study initiation; identifying and describing key activities, processes, and critical personnel. Methods: provides a practical overview of the significant processes in starting research at a site and a clear understanding of the main components of study initiation: document management, logistics, and people management. Guidance, tools, and resources help the primary investigator and coordinator perform efficiently and understand how their responsibilities tie together with the tasks and duties of others. Conclusions: Organization and adequate time for the initiation process are critical to successful studies. Multiple activities must be orchestrated and performed concurrently, requiring use of study tools and efficient processes. Identification and use of numerous research resources improve efficiency of study initiation and decrease work load and frustration.
Dr. Susan Alderman, PhD, RN, Assistant Professor-Clinical, Clinical Research Director, University of Texas Houston, Cizik School of Nursing/McGovern Medical School