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

ICH E6(R3) Guideline

2.12.12 The investigator/institution should retain the essential records for the required retention period in accordance with applicable regulatory requirements or until the sponsor informs the investigator/institution that these records are no longer needed, whichever is the longest. The investigator/institution should take measures to ensure availability, accessibility and readability and to prevent unauthorised access and accidental or premature destruction of these records (see Appendix C). 2.12.13 The investigator/institution should keep the sponsor informed of the name of the person responsible for maintaining the essential records during the retention period; for example, when the investigator site closes or an investigator leaves the site. 2.12.14 Upon request of the monitor, auditor, IRB/IEC or regulatory authority, the investigator/institution should make available for direct access all requested trial related records.

2.13

Reports

Upon completion of the trial, the investigator, where applicable, should inform the institution. The investigator/institution should provide the IRB/IEC with a summary of the trial’s outcome and, if applicable, the regulatory authority(ies) with any required reports.

3.

SPONSOR

The responsibility of the sponsor entails the implementation of risk-proportionate approaches to ensure the rights, safety and well-being of the trial participants and the reliability of the trial results throughout the clinical trial life cycle.

3.1

Trial Design

3.1.1

When planning trials, the sponsor should ensure that sufficient safety and efficacy data (e.g., from nonclinical studies and/or clinical trials and/or real-world sources) are available to support human exposure by the route, at the dosages, for the duration and in the trial population to be studied.

3.1.2

Sponsors should incorporate quality into the design of the clinical trial by identifying factors that are critical to the quality of the trial and by managing risks to those factors.

3.1.3

Sponsors should consider inputs from a wide variety of interested parties, for example, healthcare professionals and patients, to support the development plan and clinical trial protocols as described in ICH E8(R1) and when developing the informed consent materials and any other participant-facing information. The sponsor should ensure that all aspects of the trial are operationally feasible and should avoid unnecessary complexity, procedures and data collection. Protocols, data acquisition tools and other operational documents should be fit for purpose, clear, concise and consistent. The sponsor should not place unnecessary burden on participants and investigators.

3.1.4

23