Data Management requirements

Data management requirements

Once you have decided on your study design and data to be captured you will need to consider how the data will be captured, stored and managed. This will involve designing CRFs and setting up a data management system to process and store the data. The way data is validated and stored may be governed by regulatory requirements and is an important part of GCP. Setting up a Data Management system can take time and may also require investment so you need to start planning this early and may have to incorporate it into your budget.

Useful resources:
1. http://www.globalhealthtrials.org/articles/data-management/
2. The Trial Protocol Tool has an excellent section on Data Collection and Management:
http://www.globalhealthtrials.org/site_media/media/articles/trialprotocoltool/TrialProtocolTool.html
3. A great resource for research data management: http://www.admin.ox.ac.uk/rdm/
4. http://www.globalhealthtrials.org/articles/approach-centralized-clinical-data-management-system-story-vietnam/
5. http://www.globalhealthtrials.org/community/groups/group/data-management-statistics/
6. Templates and guidelines on Case Report Forms and database design: http://www.admin.ox.ac.uk/rso/clinical/downloads.shtml#SOPwriting
7. CRF Design SOP: http://workspace.imperial.ac.uk/clinicalresearchgovernanceoffice/public/JRO%20SOP%20007%20CRF%20Design%20Controlled%202010.pdf
8. http://www.globalhealthtrials.org/community/blog/post/romollo/2010/07/missing-data/
9. http://www.globalhealthtrials.org/community/blog/post/gogetii/2010/07/does-delayed-documentation-amount-to-fraud/

To return to the Trial Initiation Participatory 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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