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

ICH E6(R3) Guideline

2.4.2

Before initiating a trial, the investigator/institution should have a documented and dated approval/favourable opinion from the IRB/IEC for the trial protocol, informed consent materials, participant recruitment procedures (e.g., advertisements) and any other trial-related information to be provided to participants. As part of the investigator ’s/institution’s or sponsor’ s (in accordance with applicable regulatory requirements) submission to the IRB/IEC, a current copy of the Investigator ’ s Brochure or basic product information brochure should be provided (see Appendix A, section A.1.1). If the Investigator ’ s Brochure or basic product information brochure is updated during the trial, the IRB/IEC should receive the current version in accordance with applicable regulatory requirements. As the trial progresses, the investigator/institution or sponsor should provide any updates to the participant information to the IRB/IEC in accordance with applicable regulatory requirements. The investigator or the sponsor should submit documented summaries of the trial status to the IRB/IEC in accordance with local regulatory requirements or upon request. The investigator or the sponsor should promptly communicate to the IRB/IEC (see section 1.4.8) and, where applicable, to the institution any changes significantly affecting the conduct of the trial and/or increasing the risk to participants.

2.4.3

2.4.4

2.4.5

2.4.6

2.5

Compliance with Protocol

2.5.1

The investigator/institution should sign the protocol or an alternative contract to confirm agreement with the sponsor.

2.5.2

The investigator should comply with the protocol, GCP and applicable regulatory requirements.

2.5.3

The investigator should document all protocol deviations. In addition to those identified by the investigator themselves, protocol deviations relevant to their trial participants and their conduct of the trial may be communicated to them by the sponsor (see section 3.11.4.5.1(b)). In either case, the investigator should review the deviations, and for those deviations deemed important, the investigator should explain the deviation and implement appropriate measures to prevent a recurrence, where applicable (see section 3.9.3). The investigator should follow the protocol and deviate only where necessary to eliminate an immediate hazard(s) to trial participants. In case of deviations undertaken to eliminate immediate hazard to trial participants, the investigator should inform the sponsor promptly. The investigator should report information on the immediate hazard, the implemented change and the subsequent proposed protocol amendment, if any, to the IRB/IEC and, where applicable, regulatory authorities (see section 1.1).

2.5.4

2.5.5

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