Responsibilities of the Research Team
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, Advanced Practice Providers and Clinical Data Managers. This module will provide an overview of key roles of the research team. The module is divided into 3 required parts and 2 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.
Module Objectives
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 participant.
- Describe the role and responsibilities of the Research Nurse/Clinical Research Coordinator.
- Describe the role and responsibilities of the Clinical Data Manager.
- Identify clinical research professional organizations.
Required | ||||
Part 1 | Principal Investigator (26 minutes) | |||
Part 2 | Clinical Trials Team Members (14 minutes) | |||
Part 3 | Clinical Research Professional Organizations (6 minutes) | |||
Recommended | ||||
What is a Principal and Sub-Investigator? (4 minutes) Introduction to Clinical Research Nursing: Changing and Transforming Patient Care (26 minutes) |