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.
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
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.
… you never walk alone…
And beyond all that, qualified and friendly support and assistance by email or phone should be offered in any case.
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