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SOP Reference Number:

Version no. and date:

Standard operating procedure title:

Management of INSTITUTION Internal Audit

SOP Reference number:
Version Number and Date:
Supersedes version:

Effective date:
Review date:

Author
Name

Position
N/A

N/A

Signature

Date

Signature

Date

Approved by
Name

Position

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Table of contents

Glossary of acronyms and abbreviations to be provided in a separate

document for all SOPs ................................. Error! Bookmark not defined.
1.
Purpose ...................................................................................... 3
2.
Responsibility ............................................................................ 3
2.1.
2.2.
2.3.

Quality Management Committee (QMC) .................................................. 3

Trial Management Team and Audit Lead.................................................. 3
Trial Team Members (TMT and Site staff) ................................................ 3

3.

Procedures ................................................................................. 4

4.
5.
A.
B.

Other related procedures ........................................................... 6

Appendices................................................................................. 6
Minimum requirements for Audit Reports .................................. 6
Minimum requirements for Audit Certificate .............................. 6

3.1.
3.2.
3.3.
3.4.
3.5.

Assignment of Auditor .......................................................................... 4

Audit Preparation ................................................................................. 4
Audit Conduct ...................................................................................... 4
Audit report......................................................................................... 5
Audit follow-up Actions .......................................................................... 5

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1. Purpose
The purpose of this SOP is:
To describe the INSTITUTION process used for assessment of compliance of clinical
activities against relevant GCP, regulatory and SOP requirements through the
conduct of internal audits. These audits will be commissioned by the INSTITUTION
Quality Management Function and may be performed by externally contracted
auditors or suitably qualified and experienced INSTITUTION staff.
To describe the flow of activity and the allocation of responsibilities required to
manage an internal audit at INSTITUTION, at an investigator site or at a service
provider involved in a clinical trial managed or sponsored by INSTITUTION.
To ensure adequate preparation, facilitation and closure of internal audits.

2. Responsibility
2.1.

Quality Management Committee (QMC)

Identify the need for an audit and appoint an Audit Lead. The Audit Lead will be the
member of the Trial Management Team (TMT) who will ensure coordination of the
audit and the follow up of actions.
The following are some of the criteria which may result in the decision to perform an
internal audit:
1. Quality issues which are brought to the attention of the QMC. Quality
issues identified by the TMT during the course of the trial. This includes the
identification of any potential issues which may result in a serious breach
at investigational sites.
2. Implementation of a new process or new SOP.
3. Type of trial (e.g. trial whose results will be filed for registration of a
product in a new indication).
4. A new service provider with whom the INSTITUTION have not had prior
experience and who are taking on a key trial responsibility.
5. Pre-inspection audit on internal or external trial related systems.

2.2.

Trial Management Team and Audit Lead

Inform the QMC of any quality concerns which may arise during the performance of
the trial quality control procedures.
The Audit Lead - ensures that internal audit requirements are fulfilled, that all trial
team members (TMT plus site staff) and sites have the expertise and preparation
required for the audit, and that all activities are performed to meet the requirements
of the audit and its closure.
2.3.

Trial Team Members (TMT and Site staff)

Provide the expertise necessary to meet the audit/inspection requirements under the
guidance of the Audit Lead.

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3. Procedures
3.1.

Assignment of Auditor

Once the decision to perform an audit has been made by the QMC and the Principal
Investigator/Trial Manager of the trial, the QMC will assign Auditors who are of
sufficient experience to conduct the audit. If an internal INSTITUTION Auditor is
assigned, they will not be a member of the Trial Management Team for the trial
being audited.
3.2.

Audit Preparation

The Trial Management Team responsible for the trial will be notified of the audit plan.
A Pre-audit meeting with appropriate representative of the TMT may take place if
deemed necessary.
The auditor is responsible for requesting and reviewing the necessary documentation
prior to the audit and creating the agenda. The agenda will be approved by the
Chairperson of the QMC prior to sending to the Principal Investigator and Trial
Manager. The agenda of the audit must include the following items:

Nature of audit

Date of audit

Objective

Scope

Auditor name

References to which function/process is audited against: SOPs, regulations,

guidelines, GCP, etc.

The auditor will review all relevant documentation prior to conducting the audit
including but not limited to:
a. SOPs, working practices, other trial reference documentation as
requested
b. Past audits and preventive and corrective actions
c. Contracts

In the case of a site audit, the Principal Investigator will be notified of the audit
agenda and expectations and the Trial Manager (at a minimum) will attend the site
audit.
3.3.

Audit Conduct

During the introduction meeting, the scope and objective of the audit will be further
discussed with the appropriate TMT/Site staff who will be assisting the audit.
Schedule for interviews will be arranged and any other logistics of the audit agreed.
If during the audit a critical issue arises, the Chairperson of the QMC, the Trial
Manager and Principal Investigator for the trial which is being audited must be
notified without delay. In the case of a site audit, the site Principal Investigator
must have similar notification.
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The Auditor will copy documents needed to support the report writing.
Upon completion of the audit, a closure meeting must be held with the Principal
Investigator, Trial Manager and other appropriate members of the TMT or site staff.
In the case of a site audit, the closure meeting must include the Principal
Investigator and any other site representatives nominated by the Principal
Investigator. The aim of this meeting is to:
a. Communicate positive aspects of the audit
b. Clarify and confirm the audit observations
3.4.

Audit report

A written report must be issued including the audit observations and summary of
discussions held during the closure meeting.
Minimum requirements for audit report are described in Appendix 1.
The audit observations must be documented with their risk impact and related
quality systems. The risks are categorised by the IMB as:
1.

Critical observation: Conditions, practices or processes that

adversely affect the rights, safety or well being of subjects and/or the
quality and integrity of the data Major observation: Conditions,
practices or processes that might adversely affect the rights, safety or
well being of subjects and/or the quality and integrity of data. Major
observations are serious deficiencies and are violations of GCP
principles

2.

Minor observation: Conditions, practices or processes that would not

be expected to adversely affect the rights, safety or well being of
subjects and/or the quality and integrity of data. The audit report will

be distributed as hardcopy as follows:

3.5.

1.

For internal audits: the Chairperson of the (Qality Management

Committee) QMC, the Principal Investigator and Trial Manager (if
applicable) of the trial.

2.

For partner/collaborator/external supplier audits: the Chairperson of the

QMC, the appropriate QA Representative at the partner/external
supplier, the Principal Investigator and the assigned Trial Manager.

3.

For Site Audits: the Chairperson of the QMC, the Principal Investigator
at the site, any other site or institution representative (as applicable),
the Trial Manager for the trial.

Audit follow-up Actions

An appropriate action plan must be received by the Chairperson of the QMC from the
person assigned as Audit Lead within 1 month of issuance of the audit report. The
auditor must review the proposed actions for compliance with regulatory
requirements, guidelines or commitments, completeness and adequacy. Comments
to the action plan will be sent to the Audit Lead for implementation.
The action plan must be distributed to the same individuals as the audit report.
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The action plan will be followed up until completion of all actions by the auditor, the
Audit Lead and the QMC.
Upon completion of all actions, the QMC Administrator will issue an audit certificate:
the original will be filed within the QMC files and a copy sent to the auditee.
Minimum requirements for Audit Certificate are described in Appendix 2.

4. Other related procedures

5. Appendices
A.
B.

Minimum requirements for Audit Reports

Minimum requirements for Audit Certificate

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Appendix 1: Minimum requirements for Audit Reports

1.

Cover
a.
b.
c.
d.
e.

page including:
Audit Lead
Document Reference Number
Date of audit
Distribution list
Confidential

2.

Objective and scope of the audit

3.

References of regulatory requirements, guidelines, SOPs against which

process/function is audited

4.

Name of auditor and individuals involved in audit

5.

Name of Sponsor if applicable

6.

Study name and number if applicable

7.

Summary including:
a. assessment of compliance level
b. summary of observations and their associated risks
c. summary of closure discussions
d. recommendations regarding the audited function, if applicable

8.

Description of systems and processes covered during the audit

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Appendix 2: Minimum requirements for Audit Certificate

1.

Study name and number if applicable

2.

Auditee

3.

Date of audit

4.

List of audited items

5.

Name and Signature of auditor

6.

Date of signature

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