Clinical Data Management is the process of collection, cleaning, and management of subject data in compliance with regulatory standards. The primary objective of CDM processes is to provide high-quality data. Over the course of the trial the monitor and data manager will support ongoing data management by reviewing data and following up on queries.
As the protocol changes or modified, the corresponding data collection forms may need to change. If you are participating as a site in a clinical trial then revised forms and data capture tools will be provided to you.
If you are the sponsor investigator of the study, then during each modification you should be determined with the team if a modification to the database is needed. If it is, additional time will be needed for testing and validation of new forms and data collection. Additional training may be required for the sites as well.