Group Remit
Our Quality Assurance group discusses aspects relating to the complex research environment in which CTUs operate to help ensure that trials are undertaken in an ethical and regulatory compliant way. They foster relationships with regulatory bodies, sites, and industry partners to facilitate a collaborative approach to managing regulatory changes and promoting best practice,
As part of our activities they:
- Hold an annual meeting for CTU representatives with invited speakers, networking opportunities, and poster sessions.
- Host webinars to enable the sharing of best practice throughout the Network.
- Have ongoing conversations with stakeholders such as the MHRA and HRA, particularly in relation to changes to the regulatory environment.
- Provide an email forum though which data management and IS representatives can access peer support.
Ongoing Work
They have a number of active workstreams looking at areas of interest to QA professionals. The most recent is developing guidance for units setting up new trials in non-secondary care settings
Outputs
The Group’s guidance on preparing for an MHRA inspection, the QA oversight of laboratories, and more can be found here.
Registered CTU staff members can also access an extensive library of recordings and materials from past meetings and webinars through the Secretariat.
Group Membership
- Will Cragg (Chair) – Leeds Clinical Trials Research Unit
- Gail Holland (Joint Deputy Chair) – Swansea Clinical Trials Unit
- Sara Yeats (Joint Deputy Chair) – Southampton Clinical Trials Unit
- Eloise Britten – Imperial Clinical Trials Unit
- Jill Fleming – CaCTUS
- Conor McKee – Northern Ireland Clinical Trials Unit
- Emily Swinburne – Newcastle Clinical Trials Unit
