Which entities does the ICH E6 guideline apply to?

Which entities does the ICH E6 guideline apply to?

• A. Investigators only
• B. Research sponsors only
• C. Investigators, sponsors, and IRBs
• D. IRBs only

Answer: (C)

The ICH E6 guideline is designed to provide a comprehensive framework applicable to multiple stakeholders involved in the conduct of clinical trials. It encompasses not just investigators, but also research sponsors and institutional review boards (IRBs). This broad applicability ensures that all parties involved in the clinical trial process adhere to common standards for good clinical practice (GCP), which promotes the protection of the rights, safety, and well-being of trial participants, as well as the integrity of trial data. By including investigators, sponsors, and IRBs, the guideline ensures a cohesive approach to clinical trial oversight and management. Investigators are responsible for conducting the trials and ensuring compliance with GCP, while sponsors play a crucial role in the design, funding, and overall direction of the trials. IRBs are essential for overseeing the ethical aspects of clinical research, including the review of protocols and consent forms to protect participant rights. This collective focus fosters collaboration and communication among the entities, which is vital for the successful execution of clinical trials. The inclusion of all three groups in the guidelines reflects the importance of a multidisciplinary approach to clinical research.

The ICH E6 guideline is designed to provide a comprehensive framework applicable to multiple stakeholders involved in the conduct of clinical trials. It encompasses not just investigators, but also research sponsors and institutional review boards (IRBs). This broad applicability ensures that all parties involved in the clinical trial process adhere to common standards for good clinical practice (GCP), which promotes the protection of the rights, safety, and well-being of trial participants, as well as the integrity of trial data.

By including investigators, sponsors, and IRBs, the guideline ensures a cohesive approach to clinical trial oversight and management. Investigators are responsible for conducting the trials and ensuring compliance with GCP, while sponsors play a crucial role in the design, funding, and overall direction of the trials. IRBs are essential for overseeing the ethical aspects of clinical research, including the review of protocols and consent forms to protect participant rights.

This collective focus fosters collaboration and communication among the entities, which is vital for the successful execution of clinical trials. The inclusion of all three groups in the guidelines reflects the importance of a multidisciplinary approach to clinical research.