eCRF Database

KCTU uses the web-based  MACRO EDC system for clinical trials. The system has a full audit trail, query functionality, a powerful search function to enable data cleaning and is used extensively by UKCRC registered CTU.

The data center 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 the MACRO EDC system 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.