Roles and Responsibilities Under ICH GCP

Lesson Code: CTM-801. Describes the roles and responsibilities of the different parties involved in initiating, conducting, and overseeing clinical trials according to ICH Good Clinical Practice. After explaining the need for ICH GCP, the module describes the part played by sponsors, investigators and IRB/IEC. The roles of other key contributors to the clinical trial process are also described.

  • Category: Clinical Trials GCP - Intermediate



- Understand and explain at an overview level the meaning of the term: Good Clinical Practices (GCP)

- Describe the role and rights of participants in clinical trials

- Desccribe the roles and responsibilities of sponsors, investigators and IRB/IECs in clinical trials

- List the other key contributors in clinical trials

- Explain the principle of informed consent

- Describe the purpose, contents and development of the 'Trial Protocol'