Creating an electronic version of a Case Record Form (CRF) is more challenging than at face value. Forms need to be linked together with an anonymous identity and designed with a work-flow for entering data that provides the best means of ensuring data integrity.
Electronic CRF’s have been designed by Click and Fix that provide the end-user (normally a research nurse) with a simple interface, based on a paper CRF, but with work-flow and validation rules in place to ensure data is entered correctly. There is also a ‘save or submit’ function in place. This enables an end user to save, exit the form and return later. By entering a subject number, the saved details can be recalled and further form fields completed as necessary. Once a form has been submitted, a more rigorous validation process is initiated. Only once the validation has passed, the form will be submitted and ‘locked-down’ to ensure data cannot be subsequently changed.
Various validation techniques have been designed by Click and Fix that include a message interface to clearly describe to the end-user any validation error messages and point to the part of the form that needs to be amended.
Validation rules may include processes such as ensuring a date entered is within the correct range, a field dependency has not been completed (such as a ‘reason’ if ‘no’ was selected), or an invalid selection has been made from a drop-down list. Programmatical validation is also built in where necessary in addition to field based validation, such as ensuring gender specific information has been completed by querying information provided earlier on in the process.