Good Clinical Practice: A Question and Answer Guide2024/2025 Edition - 242

GCP: A Question & Answer Reference Guide
9.5
Q. Should companies that have active clinical quality assurance programs file, in the trial master file,
documents regarding quality assurance pre-audit visits, pre-audit findings, and other documents that
refer to any QA audit findings, such as internal audits?
A. With one exception, all information regarding QA audits should be stored in files maintained by the QA or
regulatory affairs department separate from the trial master file. These documents should include audit plans, audit
reports, audit follow-up, and applicable correspondence with the investigator site and/or service provider.
The only documents that should be stored in the trial master file are audit certificates. Most companies place
the following information on such certificates: investigator or service provider audited, audit location, scope of
services within audit, date, auditor(s), and purpose of the audit. The trial master file might contain a number of
audit certificates related to that particular study. These certificates may also be placed in study binders at sites, as
well as in clinical study reports submitted to regulatory agencies. Although not mandatory, Audit Certificates are
recommended by the ICH GCP Guideline.
Usually, audit reports are not shared with others outside a small cadre of clinical and regulatory staffers. One
exception to this rule involves " for-cause " audit results, which may need to be shared with a wider audience,
including the FDA sponsor and institution upper-level management, and sponsor's legal department. For-cause
audits are those that focus on a site or service provider at which there have been serious and/or pervasive documented
GCP non-compliance for a particular study.
9.6
Q. Are non-regulatory agency site audits ever conducted without a sponsor's knowledge?
A. Occasionally a CRO, SMO, academic institution, or other private entity will conduct an audit of a site without a
sponsor's knowledge. These audits are conducted as part of their routine Quality Assurance Program or to correct
suspected deficiencies. In some cases, findings from these " internal " audits should be shared with sponsors, since
there may be actions that a sponsor's clinical management should take to inform regulatory agencies, to close sites,
and/or to resolve significant GCP problems.
9.7
Q. What considerations be considered when choosing an auditor?
A. ICH GCP E6 (R3) Draft specifically includes " auditors " in Section 5 when stating clinical trials should be
designed and conducted by qualified individuals. It also includes Section 3.11.2.1 for Selection and Qualification
of Auditors. Qualification includes education, training, and experience to perform the respective tasks; however,
guidance documents do not state explicit requirements for the education, training, and experience for auditors.
Auditors, both employees of the sponsor and external consultants/contractors, should be reviewed on a caseby-case
basis to ensure the person is qualified through education, training, and experience. An auditor should
be an individual independent of the clinical trial being audited. There should be procedures in place to support
the conduct of the audit. If the sponsor does not have procedures in place, then the selected auditor should have
procedures that are leveraged for the audit. If neither organization has audit SOPs in place, then at a minimum
there should be a detailed audit plan that describes how the audit will be conducted.
9.8
Q. Do all clinical investigator sites require a sponsor audit?
A. No, not necessarily. ICH GCP E6 (R3) Draft states that processes, measures, and approaches should be
implemented in a way that is proportionate to the risks to participants and to the importance of the data collected.
Section 3. 11. 2, Audit, states that " when performed, audits should be conducted in a manner that is proportionate
to the risks associated with the conduct of the trial. " Therefore, clinical investigator sites chosen for a sponsor audit
should be based on the highest risk to participants and the data collected. The number of clinical investigator sites
chosen for a sponsor audit will vary from sponsor to sponsor and from study to study; however, the selection of
sites should be determined based on the risk.
9.9
Q. Do all service providers working on a clinical study require a sponsor audit?
A. ICH GCP E6 (R3) Draft defines the ultimate responsibility for sponsor's trial related activities to reside with the
sponsor, even if a service provider is used for activities. It states that the sponsor is responsible for assessing the
suitability of and selecting the service provider to ensure they can adequately undertake the activities transferred to
them. Lastly, it states the sponsor should ensure appropriate oversight of important trial-related activities that are
transferred to service providers.
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Good Clinical Practice: A Question and Answer Guide2024/2025 Edition

Table of Contents for the Digital Edition of Good Clinical Practice: A Question and Answer Guide2024/2025 Edition