The quality management and control system provides processes and procedures for the planning and execution of all activities related to the design and implementation of the clinical study. All processes supporting the management of clinical trials are described in standard operating procedures (SOPs) or more detailed work instructions. This is to ensure that activities are carried out in a uniform and consistent manner and are in line with GCP and regulatory requirements.
Quality assurance is a process that involves planned and systematic activities to ensure that the conduct of a clinical trial and the data it generates are of the highest possible quality. It is a systematic and independent audit carried out by personnel not directly involved in the research. Quality assurance includes activities such as data collection, analysis and reporting to determine study compliance and the effectiveness of quality control processes.
Quality control, on the other hand, refers to the set of procedures and activities that are carried out to ensure that the data collected during the study are complete, accurate and consistent with the study protocol. This process involves various steps, including DMP, DVP.
In other words, quality assurance is about preventing problems, while quality control is about identifying and correcting problems that do occur.
Key and sub-services include:
- Documented procedures developed, implemented and updated
- A documentation system that allows any records or documentation to be retrieved to show actions taken, decisions made and results. All approved documents and records are version controlled
- Defined organization charts and responsibilities, roles and accountabilities
- Appropriate documented staff training to meet the defined competencies of their role and familiarity with GCP
- Documented evidence to demonstrate that computer systems are fit for purpose (validation)
- Quality control (QC) activities, (inspection and control). For example, on-site monitoring of test sites or through centralised or remote monitoring techniques
- Quality Assurance (QA), including independent auditing of ICTU processes and studies by the QA team
- A risk-based approach used to determine the scope of experiment, process and trial monitoring activities through to audit and computer validation activities
- Continuous improvement including corrective and preventive action (CAPA)
- Established quality objectives
