Ensuring clinical data is ready for regulatory submission
This eBook is a must-read that will enable clinical professionals to better understand the Clinical Data Management (CDM) processes involved in a clinical trial to ensure clinical data is ready for submission.
This informative eBook covers:
- The role of IDDI’s CDM team
- The regulations, guidelines and standards to be considered
- Understanding the EDC set-up process
- The need for a SAS database and cleaning tools
- The SDTM activities
- How to successfully lock your database and maintain data integrity
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