We are exceptionally pleased to announce that Prof Rustam Al-Shahi Salman has accepted the offer of a part-time secondment to the UKCRC CTU Network as Clinical Director, after an open application process in 2022.

Drawing on his experiences as both a clinician and a clinical trial chief investigator, he will define the scale and scope of what better relationships between clinical trials units and clinical communities look like, plan and carry out some activities to improve this relationship, and what metrics could be used for light touch evaluation of this activity across the UK.

We very much look forward to working with him over the next two years.

The collection and management of robust, reliable, and statistically sound data has long been recognised as a vitally important part of a successful clinical trial and a core activity within a well-functioning clinical trials unit (CTU).

In CTUs, data managers usually work closely with IS teams, or are embedded within them. For that reason, data management has always been within the remit of the IS Operations Group. However, it deserves further attention as a activity in its own right.

In order to raise the profile of this important part of the Groups remit, a number of changes have been made. Firstly, a permanent working group has been established to take data management activities are taken forward. Four workstreams have been identified and the teams will begin meeting this year. The workstreams are:

1. CRF/eCRF Development
2. Data validation and query process
3. Study database lifecycle
4. Working with external/third party data sets

Secondly, the name of the Group has been changed to Data and Information Systems Operations Group (DaIS for short).

We look forward to sharing updates on the work of the four data management workstreams, as well other DaIS outputs, throughout the year.

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