eCRF Database

KCTU uses a web-based EDC system for clinical trials. The EDC system has a full audit trail, query functionality and a powerful search function to enable data cleaning.

The Data Centre at KCTU has a team of highly skilled data managers who bring a wealth of experience alongside robust methodological knowledge to ensure systems are designed in an optimal manner to meet the needs of the trial, the recruiting site staff and the study analysts.

An EDC system may be provided for a trial in the absence of any other KCTU involvement; the study analyst must be available to attend database development meetings with the Chief Investigator and the protocol must be SPIRIT compliant https://www.spirit-statement.org/.

More than 130 clinical trials have benefited from using EDC systems via KCTU, which ensures that the CI and trial analysts can rely on consistent robust standards both in system design and in control of user access, data extracts and system changes, all essential components of a well conducted clinical trial.