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

ICH E6(R3) Guideline

(d) To permit monitoring and auditing by sponsors, inspections by regulatory authorities (domestic and foreign) and, in accordance with applicable regulatory requirements, review by IRBs/IECs, including providing direct access to source records and facilities, including to those of service providers. Any of the sponsor’s trial -related activities that are transferred to and assumed by a service provider should be documented in an agreement. The s ponsor’s trial -related activities that are not specifically transferred to and assumed by a service provider are retained by the sponsor. The sponsor should provide information to the investigator on any service provider identified by the sponsor to undertake any activities under the responsibility of the investigator. The responsibility for such activities remains with the investigator (see section 2.3.1). A sponsor may transfer any or all of the sponsor ’ s trial-related activities to a service provider in accordance with applicable regulatory requirements; however, the ultimate responsibility for the sponsor’s trial-related activities, including protection of participants ’ rights, safety and well-being and reliability of the trial data, resides with the sponsor. Any service provider used to perform clinical trial activities should implement appropriate quality management and report to the sponsor incidents that might have an impact on the safety of trial participants or/and trial results. The sponsor is responsible for assessing the suitability of and selecting the service provider to ensure that they can adequately undertake the activities transferred to them. The sponsor should provide the service providers with the protocol where necessary as well as any other documents required for them to perform their activities. The sponsor should ensure appropriate oversight of important trial-related activities that are transferred to service providers, including activities further subcontracted by the service provider. Trial-related activities performed by service providers should be conducted in accordance with relevant GCP requirements, which may be fulfilled by a service provider ’ s existing quality management processes that were not designed specifically to be GCP-compliant but are fit for purpose in the context of the trial. A clinical trial may have one or several sponsors where permitted in accordance with applicable regulatory requirements. In trials with more than one sponsor, the sponsors should have a documented agreement that sets out their respective responsibilities, in accordance with local regulatory requirements and/or practice. Where the documented agreement does not specify to which sponsor a given responsibility is attributed, that responsibility lies with all sponsors. The sponsor should have access to relevant information (e.g., SOPs and performance metrics) for selection and oversight of service providers.

3.6.4

3.6.5

3.6.6

3.6.7

3.6.8

3.6.9

3.6.10

3.6.11

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