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.
4. The Trial Protocol Tool has an excellent section on Data Collection and Management:
5. Templates and guidelines on Case Report Forms and database design: http://www.admin.ox.ac.uk/rso/clinical/downloads.shtml#SOPwriting
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