ICTU Quality Assurance
All clinical trials within ICTU are conducted to UK and international clinical trials regulations and guidelines. Quality Assurance ensures that clinical trials are performed to meet the requirements of Good Clinical Practice, (GCP). This is an international ethical and scientific quality standard for the design, conduct, recording and reporting of clinical studies that involve human participants. Under GCP, systems with procedures that assure the quality of every aspect of the trial need to be implemented.
ICTU has implemented a Quality Management System (QMS) to provide assurance that all its clinical study activities are conducted in accordance with approved clinical trial documentation. Everyone in the ICTU is responsible for the “quality” of their work, and so the QMS provides a way by which working practices within the unit are continuously reviewed and improved, and can learn from instances which didn’t go as planned.
The Quality Management System helps provide a framework for assuring quality in all clinical study activities conducted by ICTU. Procedures and records are maintained by the ICTU Quality Assurance Manager and Administrator, who are independent of the study teams, but have over-arching ICTU QA oversight.
What does the ICTU Quality Management System (QMS) include?
The QMS provides processes and procedures for planning and execution of all activities in ICTU. All processes supporting the management of clinical trials are described in Standard Operating Procedures (SOPs), or more detailed Work Instructions (WIs). This is to ensure that the activities are conducted in a uniform and consistent manner, and are compliant with GCP and regulatory requirements. The key elements of the ICTU Quality System include:
1) Documented procedures developed, implemented and kept up-to-date
2) A documentation system that allows for the retrieval of any records or documentation to show actions taken, decisions made and results. All approved documents and records are version-controlled
3) Defined organisational and accountability charts, roles and responsibilities
4) Appropriate documented training of personnel to meet the defined competencies of their role, and familiarisation with GCP
5) Documented evidence to demonstrate that computerised systems are fit for purpose (validation)
6) Quality Control (QC) activities, (review and checking). For example, monitoring of trial sites either on-site or through centralised or remote monitoring techniques
7) Quality Assurance (QA), including independent audit of ICTU processes and studies by the QA team
8) A risk-based approach used to determine the extent of trial monitoring activities, processes and trials to audit, and computer validation activities
9) Continuous improvement incorporating Corrective and Preventive Actions (CAPA)
10) Established Quality Objectives
11) Strategic direction and management through ICTU Co-Directors and the senior management team (SMT)
ICTU Quality objectives
Activities within the ICTU Quality System will follow a continuous improvement cycle of Plan, Do, Check, Act, as shown in the diagram below:
1) To ensure that clinical trials conducted by ICTU are supported by a Quality Management System that meets the needs of patients, researchers, regulatory authorities and Sponsors.
2) To develop and use effective monitoring and quality assurance systems which provide assurance that the trial management service provided by ICTU is efficient, reliable and fit for purpose.
3) To follow a risk-based approach to quality activities, decision making, and the monitoring of clinical studies. Decisions taken under the risk-based approach should be documented.
4) To ensure that ongoing collaboration between ICTU staff and researchers on clinical studies have documented terms of reference and details are reviewed on a regular basis.
5) To ensure that ICTU staff have received appropriate training for the activities they perform.
6) To ensure that the organisational structure of ICTU is documented, demonstrating lines of responsibility and accountability.
7) To identify and implement a continuous improvement process.
8) To provide ICTU senior management team with regular updates and metrics to demonstrate operation of the Quality System.
9) To ensure ICTU staff are aware of recent developments and changes to regulatory requirements from UK, European or other regulatory bodies, appropriate to ICTU trial(s).