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Raising the profile of data management

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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