Guidance
QA oversight of laboratories [May 2024] NB: This guidance supersedes all previous versions.
~ Guidance for CTUs assessing the suitability of Labs processing research samples
~ Guidance on training requirements for labs processing research samples
~ Flowchart for oversight of laboratories by CTUs
~ Self-assessment Questionnaire
Good Clinical Practice (GCP) Inspection Preparation and Conduct: Guidance for Clinical Trials Units [December 2021] NB: This guidance supersedes the version issued in May 2018.
Considerations for a Participant Data Sharing SOP [March 2021]
Internal Audit Prioritisation [November 2020]
~ Guidance on internal audit prioritisation
~ Internal audit prioritisation tool
~ Short presentation on using the internal audit prioritisation tool
Reports & Publications
e-Consent in UK academic-led clinical trials: current practice, challenges and the need for more evidence Trials 24, 657 (2023). https://doi.org/10.1186/s13063-023-07656-8 [October 2023] – As part of the e-Consent collaborative group
Collaborate
The CTU Network QA Operations Group is currently undertaking a project around shared auditing activities.
If you work within a registered CTU and would like to find out more about how to get involved please contact regctus@leeds.ac.uk.
Membership
For a list of current Quality Assurance Operations Group members please click here.
