Clinical Data Management System

Clinical data management system

Setting up an appropriate Clinical Data Management System is essential for the smooth running of the trial and for compliance with ICH-GCP. This should have been outlined in the Trial Protocol. This may take some time to develop so this step should be started early.

Useful resources:
1. http://www.globalhealthtrials.org/articles/approach-centralized-clinical-data-management-system-story-vietnam/
2. http://www.globalhealthtrials.org/articles/data-management/
3. http://www.globalhealthtrials.org/community/groups/group/data-management-statistics/
4. The Trial Protocol Tool has an excellent section on Data Collection and Management:
http://www.globalhealthtrials.org/site_media/media/articles/trialprotocoltool/TrialProtocolTool.html
5. Templates and guidelines on Case Report Forms and database design: http://www.admin.ox.ac.uk/rso/clinical/downloads.shtml#SOPwriting
6. http://www.globalhealthtrials.org/community/blog/post/romollo/2010/07/missing-data/
7. http://www.globalhealthtrials.org/community/blog/post/gogetii/2010/07/does-delayed-documentation-amount-to-fraud/

To return to the Global Health Research Process Map click the following link:
https://processmap.tghn.org/

Please use the comment box to explain any problems that you have with this process step or any solutions that you have found to make this step easier for others. If you have any suggestions for additional resources or guidance, please provide these below.

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