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Security

Security and integrity of data is a number one priority for all CoAcS systems. Here are some of the measures that have been put in place to ensure your data remains safe and secure:

  • The servers are physically and electronically guarded at a remote data centre
  • Servers operate in tandem and are backed up every hour. Data copies are stored off-site
  • The CtDatabank website uses SSL certification from VeriSign
  • The website is secure and data encrypted at the time of transfer
  • The software is protected behind a firewall; users will require strong passwords
  • Escrow agreements are in place

User security

CtDatabank supports role-based access levels which ensures that administrators, managers, dispensers and trial monitors (CRAs) are given appropriate read / write access to the functions required for their role.

CtDatabank is compliant with 21CFR Part 11 guidelines on electronic signatures. Both username and password must be re-entered to complete all key transactions in the sytem. To maintain security, user passwords expire after 90 days. Screen time-outs are applied throughout CtDatabank which automatically requires a user to log in again after a specified period.

Audit trail

Whenever a record is entered, modified or deleted from CtDatabank, the audit log takes a 'snapshot' of the data fields changed at that time together with the user identifier, type of transaction, date and time stamp.  

Clinical trial and audit trail data is never removed from the data server, being permanently accessible to users with appropriate permissions. 

Software validation

CtDatabank has been validated to provide assurance in its design and performance and to minimise perceived risk. The system has been tested against numerous written test scripts and performance criteria. Further documentation can be supplied as an optional deliverable.

An audit trail contains all the necessary safety features to track changes in the status of any field. This means all changes are recorded thereby reducing the risk of transcription errors and deliberate misuse.