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

ICH E6(R3) Guideline

3.10.1.5 Risk Review

The sponsor should periodically review risk control measures to ascertain whether the implemented quality management activities remain effective and relevant, taking into account emerging knowledge and experience. Additional risk control measures may be implemented as needed.

3.10.1.6 Risk Reporting

The sponsor should summarise and report important quality issues (including instances in which acceptable ranges are exceeded, as detailed in section 3.10.1.3) and the remedial actions taken and document them in the clinical trial report (see ICH E3).

3.11

Quality Assurance and Quality Control

The sponsor is responsible for establishing, implementing and maintaining appropriate quality assurance and quality control processes and documented procedures to ensure that trials are conducted and data are generated, recorded and reported in compliance with the protocol, GCP and the applicable regulatory requirement(s).

3.11.1

Quality Assurance

Quality assurance should be applied throughout the clinical trial and includes implementing risk-based strategies to identify potential or actual causes of serious noncompliance with the protocol, GCP and/or applicable regulatory requirements to enable their corrective and preventive actions.

3.11.2

Audit

When performed, audits should be conducted in a manner that is proportionate to the risks associated with the conduct of the trial (see section 3.10.1.1).

The purpose of a sponsor’s audit, which is independent of and separate from routine monitoring or quality control functions, is to evaluate whether the processes put in place to manage and conduct the trial are appropriate to ensure compliance with the protocol, GCP and the applicable regulatory requirements.

3.11.2.1 Selection and Qualification of Auditors

(a) The sponsor should appoint individuals who are independent of the clinical trial/processes being audited.

(b) The sponsor should ensure that the auditors are qualified by training and experience to conduct audits properly.

3.11.2.2 Auditing Procedures

(a) The sponsor should ensure that the auditing of clinical trials/processes is conducted in accordance with the sponsor ’ s documented procedures on what

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