UPDATED: 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.
Monitoring of clinical trials: a handbook [December 2021]
Considerations for a Participant Data Sharing SOP [March 2021]
Vendor Assessments of IT Systems – Points for Consideration [December 2020]
The UKCRC CTU Network publishes guidance for CTUs on undertaking Internal Audit Prioritisation [November 2020]
Guidance for CTUs undertaking Covid19 contingency planning
The UKCRC Registered CTU Network has been carefully following developments in relation to the Covid-19 pandemic.
Following discussions with a number of stakeholders including regulators (inc. the HRA & MHRA), funders, and CTUs, the Network has issued the following guidance. Its aim is to provide advice on assessing priorities and operating in a risk proportionate way during the Covid19 pandemic whilst ensuring a joined up approach across the system.
As always, patient safety is paramount.
We will continue an open dialogue with all parties as the situation unfolds – Click here to download the guidance
|Version Number||Date Of Issue||Changes Made Since Previous Version|
|1||13 March 2020|
|1.1||17 March 2020||Inclusion of link to NIHR Q&A Guidance|
|1.2||20 March 2020||Inclusion of links to Health & Care Research Wales and FDA Guidance|
|1.3||26 March 2020||Inclusion of updated MHRA Guidance|
Endorsement of UK Standards for Public Involvement in Research – December 2019
The UKCRC Registered CTU Network is pleased to endorse the UK Standards for Public Involvement in Research. The Network believes that this guidance is an important step towards improving the practice of public involvement in clinical trials throughout the UK and supports the adoption of its principles across its Registered CTUs. We are also pleased to note that a number of Registered CTUs were involved in the consultation and testing phases of the project and we are grateful for their efforts. – More information on the UK Standards for Public Involvement in Research can be found here.
Guidelines for the Content of Statistical Analysis Plans in Clinical Trials – December 2017 JAMA. 2017;318(23):2337-2343. doi:10.1001/jama.2017.18556.
UKCRC Registered CTUs Network publishes additional guidance materials on clinical trials research insurance:
UKCRC Registered CTUs Network publishes Guidance on QA oversight of laboratories:
Recognition of ECRIN data standards:
The UKCRC Registered CTUs Network recognise the ECRIN Requirements for Certification of ECRIN Data Centres version 2.2 as a useful standard of good practice in IS and Data Management for its registered CTUs. While we recognise that there may be different approaches to achieving similar standards, we recommend that registered CTUs consider this standard when planning their local IT and data management strategy. These standards are built on the previous work that members of the Network’s IS Operational Group and other members of registered CTUs contributed to within the DIMS Project, published in 2009.