PharmStatus.com - Regulatory Document Preparation

Database locks the existing data in the database. Data can be locked by DCM (specific data capture modules such as Medical History, Demography, Adverse Events, etc), by subject, by center, or a full lock of existing data. Data cannot be added or modified in the locked modules, but new data can be entered in the database. Once the data is locked it cannot be unlocked. If a modification to the locked data is needed, such as an update per a query, the change can be made via 'privileged update' access.

Database freeze prevents updates to existing data and prevents addition of any new data. Data can be frozen at any level (DCM, patient, center, or full database). Data frozen at a higher level freezes all underlying data. Freezing can be undone, but the data remains locked. Freezing the database is the final step in the database release process.

DCM

glossary

online medical dictionary

another online medical dictionary