The Clinical Trial Management System is the essential set of tools to effectively plan, manage and track your clinical study portfolio. It is a specialized, comprehensive project management application that takes the study team from startup, through enrollment and monitoring, to study close.
Here are some important considerations for Compliance with a CTMS, including support for 21 CFR Part 11:
Archival Policy
Sometimes it is appropriate to remove records from the CTMS; however, the CTMS should be archiving data rather than deleting the data. The main difference is that archived data can be easily restored, and deleted data cannot. Archival adds protection for unintended or malicious attempts to remove data from the system.
Audit Trail
The CTMS should create a complete audit trail for all data changes made in the system, including who made the change, when, and the old and new values.
Electronic Signatures
The CTMS should support electronic signatures for records that are relevant to the regulatory requirements of your study. For the CTMS, much of the planning and tracking is intended for the efficient and effective execution of the study, but may not be relevant to regulatory agencies (e.g. the study project plan with target vs. actual milestone dates). However, eTMF and document management as well as electronic visit reports are relevant, and should support electronic signatures.
Account Controls
The CTMS should require that users be authorized and authenticated to the system, with controls around password expiration, idle session expiration, and locking of inactive accounts.