Quality Assurance is the organized and independent assessment of all clinical trial-associated activities and records. The functions of the quality assurance department in the case of a particular clinical trial are very diverse. QA departments often assist in laying down investigator sites selection standards, identifying service providers to be audited, for instance laboratories, drug packaging and supply vendors. QA departments also identify what internal procedures of the research will be audited from initial study design, site and data supervision, statistical evaluation, and the final CSR. An audit team and auditee for each study phase are defined, along with the specifications against which the audit will be performed, like the protocol, CRF completion guidelines, standard operating procedures, ICH/GCP guidelines, and the applicable regulatory authority regulations.

Auditors should also keep in mind the quality standards of nations other than the United States, such as the recently implemented EU Clinical Trial Directives 2001/20/EC and 2005/28/EC.5.

A comprehensive QA audit strategy also clearly suggests what records are expected of the auditee, along with the location, estimated date, and timeframe of the audits. Preparation for QA audits must consist of evaluation of the accepted protocol and modifications, SOPs, any specific training related with the research, annotated CRFs, and the statistical analysis plan (SAP).

Internal process audits are another important QA responsibility. Internal audits evaluate all the drug development processes applied throughout several studies to identify if there are systemic difficulties. This contains an evaluation of employee training, complying with SOPs and regulatory specifications, and recorded evidence that Quality Control was properly performed in each internal method, along with the final deliverable to a client.

Quality Assurance – Clinical Trial Specific Audits

Job Responsibilities of QA Professionals in Clinical Research Industry

Quality Assurance Professionals usually have the following responsibilities:

• Make sure that all procedures making contributions to the performance of a clinical study are performed appropriately.
• Troubleshoot clinical trials activities.
• Manage and maintain data source for the quality system.
• Prepare and support in organizing yearly reports and quality trending reports.
• Report the status of the quality levels of employees, systems and manufacturing activities.
• Preside over enhancement programs.
• Review quality activities, incidents, concerns, and problems.
• Maintain up to date with all relevant quality regulation and compliance concerns.
• Prepare reports for submission to regulatory authorities.
• Record internal regulatory procedures.
• Make sure regulatory guidelines are communicated via corporate guidelines and processes.
• Make use of guidance documents, global standards, or consensus specifications.
• Make sure that investigator, service supplier, facility and system audits are performed.
• Prepare Standard Operating Procedures.

Qualification Required to become a QA Professional in Clinical Research Industry

Usually, at minimum a Bachelors or Masters degree in life science related area is required. An experience of about 2 years in clinical research or pharmaceutical industry is preferred. Good understanding of ICH GCP guidelines and local regulatory norms is expected. Having undergone a training program such as a PG diploma in quality assurance will be added advantage to become a QA professional.

Pay Scale for QA Associates in Clinical Research Industry