Today (12th October) Prof. R. Holman (Director) & Steven Richards (Software Validation Manager), Diabetes Trials Unit hosted the second Oxford CRC IT Group meeting.
For the First Oxford CRC IT Group meeting see http://blog.octru.ox.ac.uk/content/oxford-ukcrc-it-meeting
Talks presented included:
- “Overview of the General Data Protection Regulation (GDPR)” – Max Todd. Assistant Registrar (Compliance), Council Secretariat, University of Oxford.
- “Trial Closure and Archiving of Trial Data” – Patrick Julier/Tim Cranston. OCTRU, Botnar Research Centre.
- A Data Warehousing Proposal for Oxford CTUs – Jim Davis, BDI / Ian Kennedy, DTU.
- “Clinical Data Standards” – Michael Lay/Karl Wallendzsus/Hazel Ashurst/Will Stevens /Ligia Adamska/Gisela Aguilar. Nuffield Department of Population Health
- “Data Integrity and Computer System Validation in the updated GCP regulations” –Steve Richards, Diabetes Trials Unit.
Points of note:
- GDPR - 25th May 2018 is not long away now, yet It seems there is still little knowledge about the new General Data Protection Regulations (GDPR), so Max Todd’s presentation on this was welcome and great to hear information on this from the central University. Although more questions were raised than answered - further information is coming. The University is to provide information and guidance on GDPR so ‘watch this space’ (the ICO also have information on this too). However there is a lot to look out for and not much time now, and great uncertainty about who will be ready come May 25th 2018.
(see OCTRU’s blog dated 2nd August for more info on GDPR http://blog.octru.ox.ac.uk/node/233)
- Data Warehouse MSD Clinical trials committee is looking at a centralised data warehouse for the archiving and sharing (where applicable) of data. LabKey was presented as an idea of a possible solution. Although many questions were raised and points to be addressed, there was general approval and support of the idea. This approval will be relayed to the CT committee, so further planning and investigating of a centralised Data Warehouse can start.
- Clinical Data Standards. A provoking talk, looking at the CDISC standards and what we can do to ensure the way we data handle conforms to a global clinical data standard(s). This is something for us to look into and what we can do to confirm to this good practice.
Overall the meeting was well organised with interesting and thought provoking talks. Many thanks to Steven Richards and Professor Holman for organising.
Initial plans are to meet again in the first part of the new year.