eTMF

A Trial Master File (TMF) plays a key role in the successful management of a trial by the investigator/institutions and sponsors. The essential documents and data records stored in the TMF enable the operational staff as well as monitors, auditors, and inspectors to evaluate compliance with the protocol, the trial's safe conduct and the quality of the data obtained.

CIMS eSystems is an easy yet powerful system that will handle all your clinical trial documentation.

CIMS eSystems provides the appropriate security and reliability, ensuring that no loss, alteration or corruption of data and documents occur. The system contains the controls listed below:

  • user accounts
  • secure passwords for users
  • a system in place locking/protecting individual documents or the entire eTMF (e.g., at time of archiving) to prevent changes to documents
  • regular backup
  • periodic test retrieval or restores to confirm the on-going availability and integrity of the data
  • an audit trail in place to identify date/time/user details for creation and/or uploading deletion of and changes to a document (explanation of the deletion or modification, if necessary)
  • role-based permissions for activities being undertaken, such as restricted access to files (e.g., randomization codes, unblinded adverse event data)

CIMS eSystems is built upon the DIA reference model, which allows organizations to effectively compile the minimum list of essential documents that will serve to demonstrate the compliance of the investigator, sponsor, and monitor with the standards of good clinical practice (GCP) and with all applicable regulatory requirements.

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