Introduction to a routine GCP Audit

1 Introduction

A sponsor audit is not a standardised audit. It can be a specific type of audit, such as a Trial Master File audit, but it can also be a variety of audits, which is customised to meet the needs of an organisation. Examples are clinical quality systems audits (such as pre-contract CRO audits) and computerised systems audit.
Investigator site audit are more standardised audits, which will focus on compliance with the protocol, the Helsinki declaration and regulatory requirements and the quality of the data.

GCP Consult has Standard Operating Procedures (SOPs) for the conduct and reporting of audits. The procedures are summarised in the following:

2 Audit Principles

The audit will be conducted according to the ICH Guideline for Good Clinical Practice (GCP).

An audit is a systematic and independent examination of trial related activities and documents to determine whether:

• Activities have been conducted in compliance with the protocol, Standard Operating Procedures (SOPs), ICH GCP guidelines and relevant regulatory requirements.
• Reliable, verifiable and retrievable data have been obtained.
• An appropriate quality system is in place, which will ensure that corrective and pre-ventive actions are taken.

3 Audit Plan

As part of the planning of an audit the auditor will prepare an audit plan in co-operation with the client. The audit plan should address:
• Audit objectives
• The scope of the audit
• List the guidelines and regulations against which the audit will be conducted. The most common standards for the conduct of clinical trials are ICH GCP and other ICH Guidelines, European Directives and guidelines, FDA regulations and guidelines, rele-vant local regulations and the Helsinki declaration.
• Date, time and place of the audit.
• Specify which language will be used during the audit
• The preliminary agenda for the audit
• The documents, facilities, departments to be inspected
• Confidentiality issues, if relevant
• Preparation of an audit report and distribution of the report
• Responsibility and timelines for responding to the audit observations

4 Audit Methods

4.1 Preparation for the audit

a) Auditor
Before the audit the auditor will review the relevant documentation for the audit, exam-ples are:
• SOPs and/or other written instructions
• Protocol
• Study specific instructions or manuals
• Organisation chart and an overview of staff involved in the trial/task and their re-sponsibilities/functions
• Agreements. E.g. regarding transfer of obligations to Contract Research Organisa-tions or similar

b) Sponsor/auditee/investigator
The sponsor/auditee/Investigator should:

1. Determine together with the auditor who should be present during the audit. At least one person should be available to answer questions that may arise and to facilitate the audit.

2. Make a working space available for the auditor. It should be possible to have photo-copies taken, if needed.

3. Make appointments with other departments that will be visited during the audit, if applicable

4. Ensure that facilities and equipment are available for inspection, if relevant

5. Further the auditee should ensure that relevant documentation is available for the audit. Examples are:

• Documentation on education, experience, training and delegation of responsibili-ties for the personnel involved in the conduct of the study/task
• SOPs, other written instructions and manuals
• The Trial Master File and other documentation to be inspected by the auditor.
• Documentation on maintenance and calibration of equipment
• CRFs and queries
• Source documentation, including electronic records

4.2 Conduct of the Audit

a) Introductory meeting

The purpose of the introductory meeting is:
• To introduce the auditor and the auditees to be present during the audit
• For the auditor to explain about the audit and answer questions concerning the audit
• To finalise the preliminary agenda for the audit
• For the auditees to explain about procedures, routines or documentation relevant for the audit

b) Audit

The GCP audit will be conducted according to the audit plan and GCP Consult’s SOPs. The facilities, equipment, and documents will be inspected as described in the audit plan.
In general, however, most of the time of the audit will be spend by the auditor reviewing the relevant documentation.

c) End of audit meeting

At the end of the audit a meeting will be held in which the auditor and sponsor staff will be present. At this meeting:
• The auditor will review the relevant audit observations with the sponsor staff
• The auditees will have the opportunity to ask questions about the audit, to comment on audit observations, and to clarify any misunderstandings that may have arisen during the audit

5 Audit Report

After the audit an audit report will be prepared. The audit report will contain a description of each audit observation and a short description of and/or reference to the requirements for each audit observation, unless otherwise agreed.
The final draft of the audit report will usually be send to a representative for the sponsor, who will be given the opportunity to comment on the audit observations. The comments will be reviewed and taken into consideration by the auditor before the audit report is finalised.
The final audit report will be distributed according to the agreement with the sponsor.

6 Corrective Action and Follow-up

It is the responsibility of the sponsor staff to respond to the audit observations and to suggest appropriate corrective and preventive actions to be taken on the audit observa-tions. GCP Consult will review the action plan, if agreed with the sponsor.
Further it is the responsibility of the sponsor to ensure that corrective and preventive ac-tion has been taken.

7 Audit Certificate

After the audit is finalised an audit certificate will be issued. It will be agreed with the sponsor when the audit is finalised. This may be immediately after the issuing of the final audit report, or after the corrective and preventive actions has been reviewed and ac-cepted by GCP Consult.