The clinical auditor

The Clinical Auditor†

Patricia Fitzgerald*

ADAMAS Consulting Limited, Surrey, UK

Summary

The skills required of a ClinicalQuality Assurance (CQA) auditor aresimilar to those required for a GoodLaboratory Practice (GLP) or GoodManufacturing Practice (GMP) audi-tor, with perhaps more emphasis oninterpersonal skills and a require-ment for more international travel.However, the role of the CQA and theGood Clinical Practice (GCP) func-tion is still evolving. In general, thetasks required of the CQA auditorinvolve the reviewing and complianceverification of quality systemsthroughout the clinical developmentprocess, from the design of the proto-col to the final clinical study report.Other desirable qualities of the CQAauditor are described. Published in2000 by John Wiley & Sons, Ltd.

Key Words

clinical auditor; GCP

Do you want to be sought after, havecompanies falling over each other to

offer you a job, have the pick of the topcompanies? Do you enjoy internationaltravel, meeting people and problem-solving?

If so, then clinical auditing is just the jobyou have been looking for!

Many of you reading this paper are prob-ably experienced auditors in one of the GXPfields (where X stands for the relevantfield). Have you thought about extendingyour GXP expertise into clinical develop-ment? The skills required as a clinical audi-tor are similar to those required for a GoodLaboratory Practice (GLP) or a Good Man-ufacturing Practice (GMP) auditor, al-though there may be more emphasis oninterpersonal skills and a requirement formore international travel.

Clinical Quality Assurance (CQA) was in-troduced to the industry many years afterGMP QA and GLP QA had been well estab-lished. Therefore, the role of the clinicalauditor, and the Good Clinical Practice(GCP) QA function as a whole, is still evolv-ing and establishing its niche. CQA is gradu-ally taking on a different form within largerorganizations, moving from simple datacompliance audits to process reviews andquality consultancy. Senior management inmany large organizations is becoming moreenlightened as to the value that CQA canadd to the overall development process.

In general, the role of the clinical auditorinvolves the review and compliance verifica-tion of quality systems throughout the clini-cal development process, from the design ofthe protocol to the final clinical study re-port. The clinical auditor conducts a varietyof different types of audits, which wouldusually include:

� audit of essential documents for aspecific study (Trial Master Files);

* Correspondence to: ADAMAS Consulting Limited, AbbeyHouse, Grenville Place, Bracknell, Berks RG12 1BP, UK.E-mail: [email protected]† This article was previously published in a slightly differentform in Clinical Research Focus and reproduced with kindpermission of Clinical Research Focus. Copyright © 1999ACRPI.

Published in 2000 by John Wiley & Sons, Ltd. Qual Assur J 2000; 4, 79–82.

P. Fitzgerald80

� audit of a selected sample of investigatorsites (including site-specific essentialdocuments);

� audit of contract research organizations(CROs), central laboratories and otherspecialist facilities;

� computer systems validation audits;� audit of software vendors;� database audits;� clinical study report audits; and� regulatory submission audits.

Barnett [1] conducted a poll of CQA unitsand their activities in 1995 and found thatalmost 56% of audit time was spent onauditing investigator sites. Therefore, to de-scribe the clinical auditor’s role in moredetail, I will use the process involved inconducting such an audit.

An investigator site audit usually startswith an Audit Plan. This is a document thatoutlines the objectives of the audit and de-scribes how the auditor will achieve these.For a routine study audit, the Plan shouldspecify details of the sites selected for auditand the criteria used for selection (such asrecruitment figures, discontinuations, Seri-ous Adverse Events [SAEs], location). Inmost organizations, the Audit Plan is dis-cussed with the individuals in the companyresponsible for the study. Good auditorsshould ensure that the audit process istransparent and that all parties are fullyaware of what is going to happen.

After reviewing the essential documentsin-house, an audit of the investigator sitewill be conducted. The auditor will have apre-audit meeting with the investigator andstudy staff to explain the reason for theaudit and what will take place during theday. Following this, the auditor will inter-view the investigator and the staff to obtaininformation on how they are recruiting sub-jects, obtaining informed consent, imple-menting the protocol and documenting theresults. The investigator’s site files will bereviewed and a sample of subjects will beselected for source data verification. The

storage, documentation and management ofthe investigational products would be re-viewed routinely. The auditor will conduct atour of the facilities and check documenta-tion for equipment being used in the study.At the end of the audit, a post-audit meet-ing will be held to provide feedback onfindings to the investigator, the study staffand the monitor. Any misunderstandingsare usually resolved at this point in theaudit.

The next task of the auditor is the prepa-ration of the audit report. In most organiza-tions, auditors have a time limit in which togenerate the report. (In our company, weallow 10 working days.) The audit report isusually sent to the auditees (excluding theinvestigator and the site staff) to solicitresponses to the audit observations and toallow preparation of a corrective action plan(policies and procedures vary between com-panies) by the recipients of the audit report.

The final audit report, incorporating theauditees’ responses and actions, is then dis-tributed to clinical management. The levelof management receiving the audit reportsvaries between companies. In some compa-nies, senior management does not want toread individual audit reports, but are moreinterested in the issues concerning the studyas a whole. The auditor may be required togenerate an overview or management reportspecifically for senior clinical management.When all of the tasks have been completed,an Audit Certificate is generated and for-warded to the clinical team for incorpora-tion into the clinical study report. In somecompanies, the Audit Certificate is not pre-pared until all corrective actions have beencompleted. However, the Audit Certificateonly states that an audit has been con-ducted; it does not declare an investigatorsite to be compliant!

As is mentioned previously, the role ofthe clinical auditor is still evolving and inmany organizations, because of limited re-sources, CQA is beginning to focus moreon the systems and processes involved in


The Clinical Auditor 81

clinical development, i.e. developing a qual-ity management role. The auditors reviewwhat is actually carried out and how itcompares with the standard operating pro-cedures (SOPs); they then advise on changesthat would make the process more compli-ant with the guidelines/regulations as wellas more efficient. Auditors believe in mak-ing processes as simple as possible, as thisreduces the potential number of errors.

In addition to their auditing function,most auditors offer many other services toclinical development. The types of addi-tional services that the CQA function mightoffer are:

� GCP training for monitors and investi-gators;

� feedback on audit findings;� GCP advice; and� GCP problem-solving.

The CQA function has an overall view ofthe clinical development process as well aslinks with other good practice functionssuch as GLP and GMP. Many auditors arealso trained in ISO 9000 and would be ableto apply the principles to clinical develop-ment. A background in one or more of theseareas would be an asset when working in theclinical field.

It is generally agreed that the clinicalauditor should remain independent of theprocess in order to be objective. However,this does not necessarily mean that the au-ditors are completely outside the process. Inmany enlightened organizations, QA is inte-grated into clinical development and has aconsultancy/advisory role as well as an au-diting function. The two functions work to-wards a common goal, and CQA should beconsidered as a valuable resource to achiev-ing that goal.

In most companies, clinical auditors re-port at a high level; thus, they are highlyvisible and what they do and say can havea significant impact on the overall qualityof clinical research. Therefore, auditors haveto be both confident and competent; other-

wise, they will lose their credibility. As wellas the obvious attention to detail, theyshould possess excellent interpersonal andcommunication skills, pragmatic problem-solving abilities and have a sense of hu-mour. A good auditor’s first task shouldalways be to put the auditees at ease. Thisis an important skill and not everyone hasthe ability to achieve it.

It is important that auditors are capableof seeing the big picture. Sometimes, smallissues can have major repercussions and theauditor must be able to quickly assesswhether a non-compliance problem is im-portant or not. A good auditor must be ableto put the problem into context and suggestpragmatic and practical solutions.

Auditors need to have a good knowledgeof the regulations and guidelines, but thenso do all clinical researchers. I doubt if anyauditors could recite the International Con-ference on Harmonization (ICH) GCP guide-lines if asked; however, they know where toobtain the information they need. Most au-ditors are good resource investigators, i.e.they know how to find relevant informationand ensure that they maintain an up-to-date knowledge of what is happening in theregulatory world. The Internet has becomean extremely important source of in-formation.

Clinical auditors usually operate interna-tionally, either in Europe or worldwide. Thejob requires a reasonable amount of travel.In a British Association of Research QualityAssurance (BARQA) survey conducted in1998 [2], the majority of auditors travelled25% of the time.

The entry qualifications are similar tothose for other GXPs. The majority of clini-cal auditors in the pharmaceutical industry(87%) have a life sciences degree, with ap-proximately 20% having a MSc or PhD(data from BARQA survey). In order tohave the necessary credibility as an auditor,experience and maturity are essential. It canbe an advantage to have worked in clinicalresearch, either as a clinical research associ-ate (CRA) or in data management.


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In terms of career progression, clinicalauditing can present new opportunities. Forexample, some auditors return to or transferinto clinical research, but the majority seemto remain in CQA and continue to developnew skills. Many CQA departments havefairly flat structures; however, as auditing isbecoming a more established part of theclinical development process, departmentsare getting larger and different levels ofauditors and various specialist functions arebeing introduced.

The GCP Committee of BARQA conductsan annual Salary and Benefits Surveyamongst clinical auditors. The latest surveywas published in Quasar [2]. This surveyindicated that 68% of clinical auditorswithin pharmaceutical companies earned be-tween £26 000 and £40 000 (26% of thesewere in the £31 000–£35 000 group) and78% earned between £20 000 and £40 000 inCROs (28% in the £26 000–£30 000 group).Forty-one per cent of auditors in the phar-maceutical companies had a company car

compared with 22% in CROs. Future sur-veys will include all members of BARQAand thus will compare the situation for allGXPs.

If you want to know more about becom-ing a clinical auditor, you can contact medirectly or other members of the GCP com-mittee of BARQA. The BARQA web site,which will provide you with informationabout the organization, is located at http://www.barqa.com. If you want to gain sometraining as a clinical auditor, BARQA offersan introductory course ‘GCP Auditing—APractical Approach!’. Contact the BARQAoffice for details on Tel.: +44 1473 221411.

References

1. Barnett ST. Assessing clinical quality assurance units.

Applied Clinical Trials 1997; June: 40–50.

2. Fitzgerald P, Black S. BARQA summary survey of clini-

cal auditor salaries and benefits 1998. Quasar 1999; April:

22–26.


Documents

The clinical auditor