So you want to be a Clinical Auditor? 发布时间:2014-02-28

This article was originally published in the Clinical Research Focus, Vol 10, No. 5, 22-24, July 1999

What can the industry do to attract more clinical research personnel into Clinical Quality Assurance (CQA)? Having recently conducted a survey amongst CRAs on their experience of audits (to be published), I was quite surprised by the positive attitudes expressed. However, there were a few who still perceive auditors as checking up on their work, nit-picking or time-wasting. If the overall impression is positive, why are more CRAs not moving into CQA? There are plenty of opportunities available, but the perception of the role is often negative.

When people are asked to define the key requirements for a clinical auditor the usual response is 'attention to detail', 'ability to memorise regulations and guidelines' These requirements are not immediately appealing to CRAs! I would like the opportunity to describe, from my own perspective as an ex-clinical researcher having transferred into CQA, what clinical auditing is really like and what makes a good auditor.

The role of the clinical auditor involves the review and compliance verification of quality systems throughout the clinical development process, from the design of the protocol to the final clinical study report. In general, the clinical auditor conducts a variety of different types of audits which would usually include: Audit of essential documents for a specific study (Trial Master Files), audit of a selected sample of investigator sites (including site specific essential documents), audit of contract research organisations, central laboratories and other specialist facilities, computer systems validation audits, audit of software vendors, database audits, clinical study report audits, and regulatory submission audits. Quality assurance should not be confused with quality control (QC). Quality control is the responsibility of the people carrying out the work, such as the monitor, investigator or data manager. SOPs are provided to ensure that QC is built into the process. QA encompasses both QC and audit, however the audit is a check of whether QC has been performed as required, and that the outcome of a process is correct, where a sample of documentation/data is checked.

In most organisations the limited amount of CQA resource is starting to focus more on the systems and processes involved in clinical development. The auditors review what is actually done and how it compares with the SOPs, and advise on changes to make the process more compliant with the guidelines/regulations as well as more efficient. Contrary to popular belief, auditors believe in making processes as simple as possible, as this reduces the potential number of errors occurring.

It would take a long time and a lot of paper to describe all of the different types of audits, but as investigator site audits are the most frequently conducted in most companies, I will outline the process. The audit usually starts with an Audit Plan, this is a document which outlines the objectives of the audit and describes how the auditor will achieve these objectives. For a routine study audit it should detail the sites selected for audit and the criteria used for selection (such as recruitment figures, discontinuations, SAEs, location). In most organisations the Audit Plan is discussed with the individuals in the company responsible for the study. Good auditors should ensure that the audit process is transparent and that all parties are fully aware of what is going to happen.

After reviewing the essential documents in-house, the audit of the investigator site will be conducted. The auditor will have a pre-audit meeting with the investigator and study staff to explain the reason for the audit and what will be done during the day. Following this the auditor will interview the investigator and staff to obtain information on how they are recruiting subjects, obtaining informed consent, implementing the protocol and documenting the results. The investigator's site files will be reviewed and a sample of subjects will be selected for source data verification. The storage, documentation and management of the investigational products would be reviewed routinely. The auditor will conduct a tour of the facilities and check documentation for equipment being used in the study. At the end of the audit, a post-audit meeting will be held to feed-back on findings to the investigator, study staff and monitor. Any misunderstandings are usually resolved at this point in the audit.

The next task of the auditor is the preparation of the audit report. In most organisations auditors have a time limit in which to generate the report, in our company we allow ten working days. The audit report is usually sent to the auditees (excluding the investigator and site staff) for responses to the audit observations and preparation of a corrective action plan (policies and procedures vary between companies).

The final audit report, incorporating the auditees' responses and actions, is then distributed to clinical management. The level of management receiving the audit reports varies between companies. In some companies, senior management do not want to read individual audit reports, but are more interested in the issues concerning the study as a whole. The auditor may be required to generate an overview or management report specifically for senior clinical management. Once all tasks have been completed by the auditor an Audit Certificate would be generated and forwarded to the clinical team for incorporation into the clinical study report. In some companies the Audit Certificate is not prepared until after all corrective actions have been completed. However, the Audit Certificate only states that an audit has been conducted, it does not declare an investigator site compliant.

International clinical auditors have to have the confidence and ability to audit in a variety of languages. In most organisations the CQA department is centralised rather than decentralised (individual auditors in different countries) as a team spirit and support from colleagues is important to the audit group, and therefore may have limited language skills. In order to overcome the language problem, auditors work closely with the local monitor who can provide translations of documents and interpret for the investigator if necessary. Some auditors I have worked with have audited successfully in China, Israel and Russia - which is quite a challenge.

In addition to their auditing function, most auditors offer many other services to clinical development. The types of additional services that the CQA function might offer are: GCP training for monitors and investigators, feedback on audit findings, GCP advice and problem-solving.

It is generally agreed that the clinical auditor should remain independent of the process in order to be objective. However, this does not necessarily mean that they are completely outside the process. In many enlightened organisations, QA is integrated into clinical development and has a consultancy/advisory role as well as an auditing function. The two functions are working towards a common goal, and CQA should be considered as a valuable resource to achieving that goal.

The CQA function has an overall view of the clinical development process as well as links with other good practice functions such as Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP). Many auditors are also trained in ISO 9000 and would be able to apply the principles to clinical development.

If the role sounds interesting to you, what do you need to become a clinical auditor? The majority of clinical auditors in the pharmaceutical industry (87%) have a life sciences degree, with approximately 20% having a MSc or PhD (data from BARQA survey). Therefore, the entry requirements are similar to those for CRAs. However, most organisations are looking for experienced individuals whether they are from GLP/GMP QA or clinical research. In order to have the necessary credibility as an auditor, experience and maturity (not necessarily age, but personality) are essential.

In most companies clinical auditors report at a high level so they are highly visible and what they do and say can have a significant impact. Therefore, auditors have to be confident and competent otherwise they will lose their credibility. As well as the obvious attention to detail they should possess excellent interpersonal and communication skills, pragmatic problem-solving ability and have a sense of humour. Clinical auditors are often the butt of jokes such as 'what is the difference between a shopping trolley and an auditor?' 'A shopping trolley has a mind of its own'! I think we actually make up most of the jokes, but it is essential to have sufficient self-confidence, and a sense of humour, to not be affected by negative attitudes. Auditors also need to understand and fully appreciate how vulnerable and insecure auditees can feel. A good auditor's first task should always be to put the auditees at ease. This is an important skill and not everyone has the ability to achieve it. Many clinical researchers do not appreciate how auditors have to be very sure and confident about their work, as any mistake, however small, will result in criticism. Everyone loves to catch an auditor out! Auditors do make mistakes, after all they are human too.

It is important that auditors are able to see the big picture; sometimes small issues can have major repercussions and the auditor must be able to quickly assess whether a non-compliance problem is important or not. A good auditor must be able to put the problem into context and suggest pragmatic and practical solutions. It is often easier to find a practical solution, and to be able to communicate it effectively to the auditees if the auditor has prior clinical research experience.

Auditors need to have a good knowledge of the regulations and guidelines, but then so do all clinical researchers. I doubt if any auditors could recite the ICH GCP guidelines if asked, but they know where to obtain the information they need. Most auditors are good resource investigators i.e. they know how to find relevant information and ensure that they maintain an up to date knowledge of what is happening in the regulatory world. The Internet has become an extremely important source of information. In addition, professional organisations such as BARQA, Drug Information Association (DIA), and ACRPI help us to keep up to date with developments. It can be quite an onerous task to find out about all of the clinical trial regulations in each of the countries in which we audit, but we have always found our clinical research colleagues helpful in this respect.

Clinical auditors usually operate internationally either in Europe or worldwide. The job requires a reasonable amount of travel, but not as much as many people think. In the BARQA survey the majority of auditors travelled 25% of the time. This is much lower than many CRAs who may be away from home up to 80% of the time.

Clinical researchers sometimes perceive the auditing function as boring, all that checking of data. Well, sometimes it is, I personally have never had a job that didn't have boring aspects to it! However, there are a huge variety of tasks that the auditor becomes involved with. This variety is what keeps most people in the job for many years.

Auditing provides an opportunity to learn about all aspects of clinical development and how each of the parts inter-link. Study audits cover all therapeutic areas and phases, gaining an insight into differences in design and implementation. An auditor's experiences of specific problems can be of great use to clinical teams designing future studies. The disadvantage to some people might be that as an auditor you are not responsible for the studies, are less involved, and do not have the same depth of knowledge as the CRA/Project Manager. However, some individuals see this as an advantage as they can advise on how to correct quality issues, but then don't have to implement the recommendations!

One of the major differences I found on moving from clinical research into CQA was that I could manage my own time. In clinical research there was rarely enough time to do the important, non-urgent tasks, which was extremely frustrating. I also found the lack of autonomy and independence frustrating, but this is a personal view only. Within CQA I found it possible to set my own timelines for activities and to manage myself with a high degree of autonomy although this may not be true in all organisations. Unless an audit is urgently needed, auditors do not experience the same time pressures and dependence on other groups, as they do in clinical research. This is not to say that the job is not demanding! It has other demands such as being able to switch between different protocols and therapeutic areas, from investigator site audits to facility audits or computer system audits etc. It is essential to be able to assimilate information rapidly and to be adaptable to different situations and demands.

In terms of career progression, some auditors return to clinical research at a more senior level such as an International Study Co-ordinator, Project Manager etc, but the majority seem to remain in CQA and continue to develop new skills. Many CQA departments have fairly flat structures, but as auditing is becoming a more established part of the clinical development process departments are getting larger and different levels of auditors and various specialist functions are being introduced.

The GCP Committee of BARQA conducts a Salary and Benefits survey amongst clinical auditors annually. The latest survey was published in Quasar April 1999 (ask one of your QA colleagues for a copy). This survey indicated that 68% of clinical auditors within pharmaceutical companies earned between £26,000 and £40,000 (26% of these were in the £31,000 to £35,000 group) and 78% earned between £20,000 and £40,000 in CROs (28% in the £26,000 to £30,000 group). Forty one percent of auditors in the pharmaceutical companies had a company car compared to 22% in CROs.

I have been working in CQA for seven years and I am still learning and gaining new experiences each day. I doubt if this can be said about many jobs in the pharmaceutical industry. I really believe that CQA adds enormous value to the drug development process and I look forward to playing a highly proactive role in introducing practical and effective quality management systems into clinical development with my clinical colleagues.

Dr Patricia Fitzgerald

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