Clinical Research Quality Assurance (QA)March 28, 2011 2011-03-28 18:48
Clinical Research Quality Assurance (QA)
Quality Assurance (QA) in clinical research is a department which performs compliance check of processes involved in clinical research from the time a clinical trial is assigned to the time the final clinical study report is written. These compliance checks are done through audits which can be investigator site audits or in house company audits to ensure that the studies are carried out as per organizational SOPs, GCP, protocol, and applicable regulatory requirements. Quality Assurance department then reports the observations and findings (if any) which are rectified by the responsible personnel. Though rectifying the identified problem is not the responsibility of the Quality Assurance department itself, however they must follow up with the concerned person to ensure that all identified findings or observations are rectified within agreed upon time lines.
Apart from these activities the Clinical Research Quality Assurance department also handles external inspection or audits by the regulatory authorities and sponsor(s). It prepares reviews and manages the Standard Operating Procedures of the organization and conducts routine trainings as required. This is a department which is responsible for the overall quality of the organization and is independent of other departments and functions within a clinical research organization. The QA team directly reports to the company head. Quality assurance roles are challenging and demand a lot of knowledge about applicable guidelines and regulations. Personnel working in Clinical Quality Assurance need to have good communication and persuasion skills and more then anything else, they need to have an eye for detail to pick up errors that may have been over looked by many.