Quality Assurance
All clinical trials within NCTU are conducted to UK and international clinical trials regulations and guidelines.
As quality is integral to clinical research NCTU has a comprehensive Quality Management System (QMS) in place which includes detailed Standard Operating Procedures (SOPs). Everyone in NCTU is responsible for the quality of work delivered therefore, the QMS provides a way by which working practices within the unit are continuously reviewed and improved.
The QMS ensures that trials are conducted in compliance with the protocol, Good Clinical Practice (GCP), any applicable regulatory requirements, that data integrity is maintained and the safety of all participants is protected.
The NCTU Quality Assurance (QA) Team are responsible for control and maintenance of the QMS including oversight of safety reporting and implementation of the annual Internal Audit Programme. The NCTU QA Team perform scheduled audits on studies (regulated and non-regulated), systems, process and third party suppliers (vendors) where required.
In addition to scheduled audits the NCTU QA Team perform “for cause” audits in the event a serious non-compliance is identified or another trigger. The NCTU QA Team remain independent of trials and operational delivery, in order to perform auditing activities and are responsible for monitoring the progress and completion of all Corrective and Preventative Actions (CAPAs) arising from audit findings.
What does the NCTU Quality Management System include?
The QMS provided details systems and procedures for all trial stages from trial set-up through to trial closedown and analysis. All processes supporting the management of clinical trials are detailed in Standard Operating Procedures (SOPs) or Work Instructions (WIs). The QMS documents ensure that the activities are conducted in a uniform and consistent manner, and are compliant with GCP and regulatory requirements.
A list of NCTU SOPs can be found here.
Quality Assurance Manager: Emily Swinburne
Deputy Quality Assurance Manager: Joan Farrington
For further information about Quality Assurance please contact the Quality Assurance Team at clinicaltrials.qa@ncl.ac.uk