REFERENCE:-

http://www.mastercontrol.com/audit-management/cro-audit-software-systems.html
http://ec.europa.eu/health/files/eudralex/vol-
10/chap4/annex_iv_to_guidance_for_the_conduct_of_gcp_inspections_-_sponsor_and_cro_en.pdf
http://www.jsqa.com/download/doc/TheGlobalGuidelineForGCPAudit.pdf
INTRODUCTION:
Audit:
A systematic and independent examination of trial-related activities and documents to
Determine whether the evaluated trial-related activities were conducted and whether the data
Were recorded, analyzed and accurately reported according to the protocol sponsors Standard
Operating Procedures (SOPs) Good Clinical Practice (GCP), and the applicable regulatory
Requirement.
A contract research organization (CRO) is a strategic partner hired by pharmaceutical and
biotechnology companies to perform clinical trials and other critical drug development
services on their behalf. Many CROs conduct audits to evaluate their quality, compliance,
and work flow procedures.

Contact research organization (CRO) audit:
The process for a CRO audit follows the same format as for other audits that is
Preparation of the Audit plan
Conduct of the audit
Reporting of the audit

Preparation and Notification:
The CRO should be notified at least before 2 weeks before the audit taking place. Notification of
the audit including the audit date, together with a draft agenda should be sent in writing by the
auditor to the CRO. This will enable the CRO to start preparations for the audit.
The sponsors QA Department should have SOPs and standard worksheets available for the
conduct of CRO audits. The SOP should specify the document that need to be obtained in order
to prepare for the audit. These might include:
Index of SOP
Organisation charts
Promotional material
The contract
Protocol, Informed consent documents, investigator brochure.

The Audit Plan should be reviewed and signed-off by the auditor and also by QA/clinical
management

Conduct:
The format of a CRO audit is usually as follows
Pre-audit meeting with key staff to discuss the scope and agenda
Interview with key staff members
Review of requested documentation that is policies, SOPs, personnel records.
Tour of the facility
Post-audit meeting to feedback the audit findings.

Pre-Audit Meeting: The objective of the Pre-audit meeting is to introduce the auditor and present
the audit agenda to the CRO staff. The following should be ascertained at the meeting
Confirm to access will be granted to all relevant documentation and with the copies. Any
restrictions should be documented.
Request a brief overview of the CRO and services provided.
Request for an organisation chart if not already approved.
Request Quality manual/SOPs where required
Request a contact person for the duration of the audit

Interview with the key personnel: A suitable representative from each of the service departments
that might be contracted by the sponsor should be available for interview by the auditor
Details of the organisation and reporting lines
The quality control system in place
Monitoring of deliverable and sponsor satisfaction.
The individual would be asked to describe the procedures with in their particular function which
would be compared by the auditor
Documentation reviews: The auditor would not be allowed to access to any ongoing study
documentation to confirm compliance with SOP unless there was a project already ongoing for
the sponsor concerned. The documents which would be made available for audit would be:
Policies and SOPs
CV of staff
Training records
Promotional material
Computer system validation
Facility Assessment: A tour of facility can provide information on the quality of the organisation
and the security of the electronic and hard copy data that they will be holding for the client. Some
of the areas which should be closely reviewed include:
IP storage areas
Computer room
Archive facilities on site
Subject facilities
Laboratory areas

Post audit meting and Reporting: The post audit meeting should be takes place with the
managers of the departments audited. Feedback should be brief but constructive. The level of
detail of the feedback will depend on the policy of the sponsor. The audit report may or may not
be provided to the sponsor CRO by the sponsor.

The services to be audited will depend on the on the contractual requirements. For a full
capability audit the following would be included
Project management
Contracts department
Computer system validation
Personnel
SOP management
Quality Assurance
Quality control system
Facility.






Conduct of audit: - The format of CRO audit is usually as follows:

Pre-audit meeting with the key staffs


Interview with the key staff members


Review of requested documentation

Tour of the facility

Post-audit meeting