ICH Harmonised Guideline for Good Clinical Practice E6(R3) - Step 4 Final

ICH E6(R3) Guideline

Monitoring of important data and processes (e.g., those related to primary endpoints and key secondary endpoints and processes intended to ensure participant safety) performed outside the investigator site (e.g., central image reading facilities, central laboratories) should be addressed in the monitoring plan.

3.11.4.4 Monitoring Procedures

Persons performing monitoring should follow the sponsor’s monitoring plan and applicable monitoring procedures.

3.11.4.5 Monitoring Activities

Monitoring in accordance with the sponsor’s requirements and monitoring plan should generally include the following activities across the clinical trial life cycle, as applicable.

3.11.4.5.1

Communication with Parties Conducting the Trial

(a)

Establishing and maintaining a line of communication between the sponsor and the investigator and other parties and individuals involved in the trial conduct (e.g., centrally performed activities). In general, each site should have an assigned monitor as their contact point. Informing the investigator or other parties and individuals involved in the trial conduct of relevant deviations from the protocol, GCP and the applicable regulatory requirements and, if necessary, taking appropriate action designed to prevent recurrence of the detected deviations. Important deviations should be highlighted and should be the focus of remediation efforts as appropriate. Informing the investigator or other parties and individuals involved in the trial conduct of entry errors or omissions in source record(s) and/or data acquisition tools and ensuring that corrections, additions or deletions are made as appropriate, dated and explained (if necessary) and that approval of the change is properly documented.

(b)

(c)

(d)

Actions taken in relation to the deviations, errors or omissions should be proportionate to their importance.

3.11.4.5.2

Investigator Site Selection, Initiation, Management and Close-out

(a)

Selecting the site and confirming that the investigator and individuals or parties involved in the trial conduct have adequate qualifications, resources (see sections 2.1, 2.2 and 3.7) and facilities, including laboratories, equipment and investigator site staff, to conduct the trial safely and properly. Confirming, with consideration of their delegated activities and experience, that the investigator, investigator site staff and other parties, and individuals involved in the trial conduct are adequately informed

(b)

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