Guidance For CTUs

NEW: High-level principles around the restart of on-site monitoring [June 2021]

How to move to remote monitoring with least burden to site staff – hints and tips [May 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 on internal audit prioritisation

Internal audit prioritisation tool

Short presentation on using the internal audit prioritisation tool

Guidance for Trial Management teams involved in trial restart

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 NumberDate Of IssueChanges Made Since Previous Version
113 March 2020
1.117 March 2020Inclusion of link to NIHR Q&A Guidance
1.220 March 2020Inclusion of links to Health & Care Research Wales and FDA Guidance
1.326 March 2020Inclusion 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.

Patient and Public Involvement and Engagement Task and Finish Group Report – May 2018

Good Clinical Practice (GCP) Inspection Preparation and Conduct: Guidance for Clinical Trials Units – May 2018

Checklist for Chief Investigator Engagement – February 2018 [NB: A fully editable version of this document may be obtained by emailing regctus@leeds.ac.uk.]

Recruitment Report and Survey Findings published by the Information Systems Operational Group – January 2018

Abstract Writing for Future Conferences Report published by the Information Systems Operational Group – January 2018

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.

Core Activities Survey 2015 Report by the Core Infrastructure & Resource Task Group

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.

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