Electronic Clinical Record Forms
Having clinical data collected in the field, transferred electronically into a database provides research staff with live data that can be analysed on the fly. The double entry from paper to electronic CRF provides additional integrity checks but the systems Click and Fix develop include form based data validation and work flow that will provide a single point of entry solution via the Internet. This may include conditional questioning or validation ‘stop’ messages if a date field entered is not within the set criteria for example.
For multiple site entry, automated reminder emails can be generated to ensure patient information is collected within the time-frames specified.
Drug Randomisation Engine
Click and Fix have produced innovative systems for patient drug randomisation within a clinical trial framework. Electronic Clinical Record Forms will be completed to obtain the information required to appropriately stratify the drug randomisation criteria. At a push of a button, the system will validate, minimise the patient’s criteria against previously randomised patients, and assign an appropriate drug or randomise if necessary. Email generated reports can be sent to the hospital, pharmacy and trial centre.
Trial Investigators have secure access to administrative reports to ensure data integrity. Double-blind randomisation has also been developed to ensure a drug/placebo allocation remains secret.