TASC Quality Assurance
The TASC QA team provides independent assessment of clinical research studies, facilities and processes to Sponsor through a programme of audits.
The TASC QA team provides independent assessment of clinical research studies, facilities and processes to Sponsor through a programme of audits. Under The Medicines for Human Use (Clinical Trials) Regulations 2004, there is a requirement to provide assurance to Sponsor that TASC’s clinical research activities are conducted in accordance with approved study documentation and that any deficiencies in processes are identified and rectified.
TASC QA team have developed and planned routine audit schedules that cover all aspects of clinical research including Study Specific Audits, Process Audits, Facility Audits and Third Party Supplier (Vendor) Audits. The scope and frequency of each audit is risk based and schedules may be modified once implemented if risks and priorities change.
In addition to scheduled audits, unscheduled or ‘for cause’ audits may be required in the event of serious non-compliance or other triggers.
TASC QA team will contact auditees in advance to organise the audit.
The standard used for audit is Good Clinical Practice (GCP). As well as to ensure participant safety and integrity of data, another purpose of internal audit is to assure the Sponsor that researchers and TASC maintain a level of MHRA Inspection readiness at all times.
- TASC SOP20 on QA Audits
- TASC SOP17 on Preparing for MHRA Inspection
The TASC Quality Management System includes availability of TASC policies and SOPs on the TASC website. These documents are designed to provide clear written instructions and guidance to help researchers run their studies while ensuring compliance with GCP and applicable regulations refer to TASC Quality Policy 03.
Monitoring of Clinical Trials
The TASC Clinical Trials Monitoring team provides monitoring of Clinical Trials of Investigational Medicinal Products (CTIMPs) and other types of studies upon request from Sponsor and following the principles of Good Clinical Practice (GCP).
The Sponsor must determine the appropriate extent and nature of monitoring. This is identified during Sponsor risk assessment and documented in a Monitoring Plan. Monitoring is one of the key mechanisms whereby the Sponsor can be assured that a trial is complying with the legislation and the study protocol.
There are different types of Monitoring visits, the first being a Site Initiation Visit (SIV) which takes place before any recruitment begins, Routine Visits which take place during the study and a Close Out Monitoring Visit at the end of recruitment.
The TASC Clinical Trials Monitor will contact the study team in advance to let them know what documents are required and how to plan for the Monitoring Visit.
Monitors act as a point of contact for the investigator site and have a key role to play in the communication between Sponsor and site.
- TASC SOP03 on Monitoring CTIMPs