User-friendly eCRF-design: the key for successful data collection

eCRF-design and user friendliness of an eCRF are the keys for successful data collection.

eCRF-design

To ensure a perfectly suited eCRF design many different aspects have to be taken into account. The quality and smooth running of the eCRF design is dependent on:

the quality of the study protocol
the time for eCRF set-up
the experience of the team responsible for the process of eCRF set-up
the definition and clear communication of timelines
the process of eCRF set-up itself with the most important process steps as there are:
-> definition, set-up and validation of the eCRF contents and online edit checks
-> definition, set-up and validation of the roles and rights within the EDC System
the willingness and motivation of all persons involved within the eCRF set-up to review the respective documents thoroughly

User-friendly eCRF

During the eCRF set-up process the following aspects should be taken into account with regard to user-friendliness:

Clearly placed help texts for guidance of users which are unambiguous, comprehensible and as short as possible
Clear and comprehensibly navigation
Less is more: only data that are really needed should be collected
Minimal free text entries
Clear and unambiguous error messages
Clear layout and structure: static text, not too many colors, no blinking text/symbols
Clear workflow with clearly defined rights (e.g. only one role is granted the access right to sign the eCRF)
Multilingual eCRF set-ups for multi-country and multi-centric studies

… last but not least…

The design and user-friendliness of the eCRF is dependent on:

a thorough user acceptance testing
the EDC System itself: there are many EDC systems on the market – none does perfectly fit all needs, but all of them have their own specific features regarding design and user-friendliness.

… good is not good enough…

The best designed and the most user-friendly eCRF is not sufficient enough – involved study personnel needs to be trained on the specific eCRF. In addition to the training user manuals with clear instructions should be available.