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

ICH E6(R3) Guideline

3.2

Resources

The sponsor should ensure that sufficient resources are available to appropriately conduct the trial.

3.3

Allocation of Activities

Prior to initiating clinical trial activities, the sponsor should determine the roles and allocate their trial-related activities accordingly.

3.4

Qualification and Training

The sponsor should utilise appropriately qualified individuals for the activities to which they are assigned (e.g., biostatisticians, clinical pharmacologists, physicians, data scientists/data managers, auditors and monitors) throughout the trial process.

3.4.1

Medical Expertise

The sponsor should have medical personnel readily available who will be able to advise on specific trial-related medical questions or problems.

3.5

Financing

The financial aspects of the trial should be documented in an agreement between the sponsor and the investigator/institution.

3.6

Agreements

3.6.1

Agreements made by the sponsor with the investigator/institution, service providers and any other parties (e.g., independent data monitoring committee (IDMC), adjudication committee) involved with the clinical trial should be documented prior to initiating the activities.

3.6.2

Agreements should be updated when necessary to reflect significant changes in the activities transferred.

3.6.3

The sponsor should obtain the investigator ’ s/institution ’ s and, where applicable, service provider’s agreement s:

(a) To conduct the trial in accordance with the approved protocol and in compliance with GCP and applicable regulatory requirement(s);

(b)

To comply with procedures for data recording/reporting;

(c) To retain the essential records for the required retention period in accordance with applicable regulatory requirements or until the sponsor informs the investigator/institution or, where applicable, the service provider that these records are no longer needed, whichever is longest;

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