What information is NOT required by ICH E6 in relation to changes to a research protocol?

What information is NOT required by ICH E6 in relation to changes to a research protocol?

• A. Written approvals of protocol amendments
• B. Documentation of deviations from the approved protocol
• C. Approval of informed consent forms
• D. Detailed project schedules for research

Answer: (D)

The International Council for Harmonisation (ICH) E6 guidelines emphasize the need to maintain rigorous standards in clinical trials, including the management of protocol changes. The information that is required under these guidelines includes: - Written approvals of protocol amendments: This is necessary to ensure that any changes made to the research protocol have been formally reviewed and authorized by the necessary ethics and regulatory bodies. - Documentation of deviations from the approved protocol: It is essential to capture any deviations from the protocol to maintain the integrity of the data collected and to understand the circumstances under which these deviations occurred. - Approval of informed consent forms: Ensuring that the informed consent process is approved by relevant authorities is critical as it protects the rights and welfare of trial participants. In contrast, detailed project schedules for research are not explicitly required by ICH E6. While good practice suggests that timelines and schedules can improve the organization and execution of clinical trials, they do not fall under mandatory documentation as per the ICH E6 guidelines. Therefore, it is acceptable for project schedules to exist without a specific requirement for approval or documentation within the framework of protocol changes.

The International Council for Harmonisation (ICH) E6 guidelines emphasize the need to maintain rigorous standards in clinical trials, including the management of protocol changes. The information that is required under these guidelines includes:

• Written approvals of protocol amendments: This is necessary to ensure that any changes made to the research protocol have been formally reviewed and authorized by the necessary ethics and regulatory bodies.

• Documentation of deviations from the approved protocol: It is essential to capture any deviations from the protocol to maintain the integrity of the data collected and to understand the circumstances under which these deviations occurred.

• Approval of informed consent forms: Ensuring that the informed consent process is approved by relevant authorities is critical as it protects the rights and welfare of trial participants.

In contrast, detailed project schedules for research are not explicitly required by ICH E6. While good practice suggests that timelines and schedules can improve the organization and execution of clinical trials, they do not fall under mandatory documentation as per the ICH E6 guidelines. Therefore, it is acceptable for project schedules to exist without a specific requirement for approval or documentation within the framework of protocol changes.