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Guidance for CTUs
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NEW: Patient and Public Involvement and Engagement Task and Finish Group Report - May 2018

Click here to access the report.


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

Click here to download the guidance.


Checklist for Chief Investigator Engagement - February 2018

Click here to download the checklist. [NB: A fully editable version of this document may be obtained by emailing]


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

Click here to access the report.


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

Click here to access the report.


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. To access the article please click here.


UKCRC Registered CTUs Network publishes additional guidance materials on clinical trials research insurance:

- Glossary of Insurance Terms

- Advisory Paper on Insurance for International Trials

- ITCC International Clinical Trials Insurance Spreadsheet

- Research Insurance: Frequently Asked Questions

- Clinical Trials' DMCs/DSMBs: appropriate indemnification for committee members


UKCRC Registered CTUs Network publishes Guidance on QA oversight of laboratories:

- 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


Core Activities Survey 2015 Report by the Core Infrastructure & Resource Task Group.
Click here to access the report.

Report of survey of registered CTUs 2013 by the Efficient Trial Conduct Task Group.

To access the report please click here.

 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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