SCRS Site Management Module E6(R2) and (R3) Update Supplement Delegation and Training Section 4.2.5: The investigator is responsible for supervising any individual or party to whom the investigator delegates trial-related duties and
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Presentation Transcript
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SCRS Site Management Module E6(R2) and (R3) Update Supplement Delegation and Training<br>
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Section 4.2.5: “The investigator is responsible for supervising any individual or party to whom the investigator delegates trial-related duties and functions conducted at the trial site.”
Many of the addendum changes to Investigator Responsibilities are a clarification of the existing GCP requirements and expectations of regulators). These expectations of the PI are now explicitly stated and oversight of all individuals delegated study tasks – including contracted staff working for an investigator on a clinical trial should be included in the Investigator’s oversight plan and actions should be taken to ensure compliance. The investigator is responsible for implementing corrective and preventive action in the event of noncompliance. E6(R2) Updates<br>
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Section 4.2.6: “If the investigator/institution retains the services of any party to perform trial-related duties and functions, the investigator/institution should ensure this individual or party is qualified to perform those trial-related duties and functions and should implement procedures to ensure the integrity of the trial-related duties and functions performed and any data generated.”
The enhanced oversight requirements apply to investigators delegating tasks and institutions using services of third parties when conducting a clinical study . For example, the protocol requires specialty assessments which cannot be conducted at the primary location due to equipment needs and/or staff qualifications (e.g. ophthalmology or dental assessments are required for a diabetes study conducted at a primary care center). These responsibilities for enhanced oversight were not explicitly stated in ICH GCP previously, however it is an expectation that investigators oversee the conduct of the study at these additional locations to ensure that there is compliance to the protocol and GCP/local authority requirements. This includes the implementation of effective corrective and preventive actions which may be necessary in response to noncompliance or issues. The PI is clearly responsible for ensuring that all parties involved in trial-related activities are qualified and procedures are in place to meet the requirements of ICH GCP . E6(R2) Updates<br>
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Section 2.3.2: "Trial-related training to persons assisting in the trial should correspond to what is necessary to enable them to fulfil their delegated trial activities that go beyond their usual training and experience."
Section 2.3.3: "The investigator should ensure a record is maintained of the persons and parties to whom the investigator has delegated significant trial-related activities."
ICH E6(R3) reinforces that delegated staff must be qualified and competent, with training that is fit-for-purpose and documented. In trials involving digital technologies or remote workflows, training should also include use of systems (e.g., ePRO, eSource), data security, and communication protocols.
Expectations include:
Maintaining delegation logs with role-specific training evidence.
Assessing ongoing competency, especially for high-risk tasks.
Recognizing that in a risk-based model, some tasks (e.g., consent verification) may carry higher risk and demand more frequent oversight or retraining. E6(R3) Updates<br>
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This is to certify that:
(insert name)
Has completed reviewing the Topic: ICH E6(R2) and (R3): Guideline for Good Clinical Practice, Delegation and Training Module Update Supplement, on:
(insert date)
Disclaimer: SCRS does not certify, qualify, endorse, represent or warrant that any clinical trial Investigator or clinical trial site personnel that has completed this Information Program are competent to work on any particular clinical trial or clinical trials generally or are competent to oversee others during clinical trial execution. Certificate of Completion<br>
