8th Jun 2015, 02:01 PM
Clinical Trial Unit Compliance Reports - June 2015
There have been a number of queries relating to the provision of compliance reports for Clinical Trial Units (CTUs) and this post is intended to clarify the request for these to be submitted in June 2015.
Clinical trial units were originally requested to provide a GCP compliance report in December 2014 following a MHRA request for information by the GCP Inspectorate. The request letter stated ‘After submission of this information you are encouraged to complete a compliance report once every two years. Your next compliance report therefore will be due in May 2015 (with a deadline of 30 June 2015)’. The letter also stated ‘Organisations engaged in clinical trials are encouraged to complete a compliance report once every two years’. This has led to a number of organisations querying whether a compliance is due in June 2015 or January 2016.
So to clarify; CTUs are requested to provide a compliance report covering the period between 01 April 2014 to 31 March 2015 using the template and associated guidance (which can be found here: http://www.gov.uk/good-clinical-prac...pliance-report) by Tuesday 30th June 2015.
Please note that you do not have to submit a compliance report in June 2015 if:
- Your CTU has submitted a compliance report in the last 12 months
- Your CTU has been inspected between 1 July 2014 and 30 June 2015
- Your CTU has a confirmed GCP inspection between July 2015 and September 2015
- Your CTU has not provided support to a clinical trial of an investigational medicinal product between 01 April 2014 to 31 March 2015
Please note that compliance reports for CTUs should be submitted as stand-alone documents and should not include data from other parts of the organisation.
If your unit works as a collaborative and operates the same systems as other units within the group then you may provide one compliance report. Please ensure that this is clearly stated on the submission.
Following a submission in June 2015 your next compliance report will then be due in June 2017.