TENALEA services for electronic case report forms
TENALEA eCRF provides a comprehensive, rich electronic case report forms system supporting the use of electronic case report forms by the coordination centres for healthcare trials. It can be used with a standard browser running on any computer connected to the internet. The system has been validated, and has been certified by registered auditors, as being in compliance with relevant regulations, such as the FDA’s CFR 21 Part 11.
The eCRF service is based on an industry grade enterprise electronic forms system: Microsoft Infopath 2007 for form design and Microsoft Forms Server 2007 for data entry. The components make use of a common standard representation of data and metadata: the Operational Data Model of CDISC. Within TENALEA eCRF, the components share a database for storing and retrieving information about the trial, and a separate database for storing and retrieving patient data. More details on the components of TENALEA eCRF are available from the links on the left.