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The Clinical Quality Assurance Professional 发布时间:2014-04-01

Lizanne C. Noble,MPH

 

The quality assurance (QA) professional performs “a systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirements.”(1)


These “auditor” roles can be critical in determining a company’s adherence to the quality of clinical trial conduct and identifying areas of needed improvement.

 

Today, clinical QA auditors review most aspects of clinical research and development (CR&D) trial activities, from protocol conception to final study reports. Audit departments may also assist in site selection and vendor qualification.

 

Often, QA personnel provide GCP training for monitors and investigators, consulting services, and those handling management of SOPs. QA units can support regulatory inspections at a company, vendor, or investigator site.

The harmonization of trial regulatory requirements and GCP has expanded the QA role to require audit expertise in domestic and international environments.

 

QA in the Contract Research Organization (CRO)


The CRO can provide the audit professional with a extensive selection of audits to conduct, including internal (CRO) and external (sponsor), domestic and foreign, and pre- and post-regulatory inspections. The scope of sponsor obligations that are transferred to the CRO often includes an audit component, which is beneficial to the advancement of a QA career. The CRO also has an established internal audit program to support the provision of quality products and services.


QA service providers’ adherence to timelines and sponsor instructions is crucial. In addition, a quality product (audit report) is mandated, not only from a contract sense but to secure a continued working relationship. Although CROs are fast-paced environments and not a good fit for everyone, following a set of provided instructions does have its benefits, as long as all parties adhere to the contract. Also, CRO auditors generally conclude their responsibilities once the audit report is finalized and accepted by the biotechnology or pharmaceutical company. In this setting,CRO audits may be considered the clos critical in determining a company’s adherence to the quality of clinical trial conduct and identifying areas of needed improvement.


Today, clinical QA auditors review most aspects of clinical research and development (CR&D) trial activities,from protocol conception to final study reports. Audit departments may also assist in site selection and vendor qualification.

 

Often, QA personnel provide GCP training for monitors and investigators, consulting services, and those handling management of SOPs. QA units can support regulatory inspections at a company, vendor, or investigator site. The harmonization of trial regulatory

requirements and GCP has expanded the QA role to require audit expertise in domestic and international environments.

 

QA in the Contract Research Organization (CRO)


The CRO can provide the audit professional with a extensive selection of audits to conduct, including internal (CRO) and external (sponsor), domestic and foreign, and pre- and post-regulatory inspections. The scope of sponsor obligations that are transferred to the CRO often includes an audit component, which is beneficial to the advancement of a QA career. The CRO also has an established internal audit program to support

the provision of quality products and services.


QA service providers’ adherence to timelines and sponsor instructions is crucial. In addition, a quality product (audit report) is mandated, not only from a contract sense but to secure a continued working relationship.


Although CROs are fast-paced environments and not a good fit for everyone, following a set of provided instructions does have its benefits, as long as all parties adhere to the contract. Also, CRO auditors generally conclude their responsibilities once the audit report is finalized and accepted by the biotechnology or pharmaceutical company.

In this setting, CRO audits may be considered the closest to an “independent” assessment of systems and processes as defined by GCP.

 

QA in the Biotech/Pharma Industry


As with CROs, all types of audits are conducted at biotechnology and pharmaceutical “sponsor” companies; however,the QA role may be narrowed to a therapeutic area, such as oncology or cardiovascular research. The camaraderie of a team developing a marketable product is a career highlight.

 

Resources are vast at biotechnology and pharmaceutical companies; many have extensive QA departments and diversely qualified auditors.


 Clinical QA auditors review most aspects of clinical research and development trial activities, from protocol conception to final study reports.

 

Although audit departments now tend to be independent of the CR&D reporting structure, QA personnel are still direct employees of the companies they audit. A key difference between contract auditing (CRO) and auditing your own organization is that the latter usually sees the process recommendations through to completion.


 Therefore, audit reports must be concise, and significant observations/trends must be clearly delineated, with understandable impact recommendations.

 

QA at the Academic Institution

 

The academic environment of today often includes SOPs, a quality management plan (QA/QC), and a host of systems supporting positive outcomes. Documented processes are essential at the investigator site, as it is the hub of trial conduct and data capture.

 

Institutions may also have an internal quality improvement (QI) department, which serves as the organization’s oversight body and plays an independent audit support role to the investigators.

 

An audit career in this setting can be at a single investigator site, an entire department, or possibly a position within the institution’s QI unit.


 Characteristics of the QA Professional

 

If you possess the analytical skills of a detective, then a QA career might be for you. Minimum requirements include a bachelor’s degree in a relevant field, such as life sciences. However, many QA departments are looking for experienced individuals, such as one who has worked in good laboratory/manufacturing practice QA or in a previous clinical research position. Good practical knowledge of GCP is vital. Individuals must be detailoriented, but able to see the overall picture.


The ability to communicate effectively is a key requirement for this profession, as well as the ability to convey potentially sensitive information.

 

The demand for QA professionals is dramatic, and the venues are continually expanding, especially over the last five years. This challenging career requires individuals with stamina, enthusiasm, and a real interest in world travel.

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Reference


 

1. ICH Guideline For Good Clinical Practice,

9 May 1997, sec. 1 Glossary, 1.6 Audit.


 

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