A successful clinical trial program is typically comprised of a team of individuals who are committed to conducting high-quality clinical trials. All staff involved in clinical research must adhere to the regulations and understand the guidelines that govern clinical research. All research teams are led by a Principal Investigator (PI) and have research participants. Other key staff include, but are not limited to: Nurses, Study Coordinators, and Clinical Data Managers. This module will provide an overview of key roles of the research team. The module is divided into 3 required components (videos) and 3 recommended videos. Once you have completed all required parts, please link to the evaluation after which you will be directed to a certificate of completion for your education records.
At the conclusion of this module, learners will be able to:
Describe the role and responsibilities of the Investigator as described by OHRP, FDA, and ICH GCP.
Describe the role and responsibilities of the Research Nurse.
Describe the role and responsibilities of the Study Coordinator.
Describe the role and responsibilities of the Clinical Data Manager.
Describe the role and responsibilities of the pharmacist.
Responsibilities of the Clinical Trials Team (15 minutes)
Clinical Research Professional Organizations (7 minutes)