e-DESIGN - electronic CRF Design

    The e-DESIGN interface enables the design of e-CRFs and the development of online queries, detailed instructions and guidance for data collection and capture.

One objective of any well designed clinical research project is to ensure that only accurate data relevant to the research question is collected within the planned project timelines. A properly designed and logically constructed e-CRF is critical to achieving this goal. If met, the time required to train site personnel is reduced significantly and the likelihood of accurate completion of the e-CRF is maximised.

Using e-DESIGN, e-CRFs can be effortlessly tailored to specific research project requirements by using a large library of pre-defined customisable and validated data items. The e-CRF design capability is enhanced by the use of available templates. Detailed instructions for the completion of the e-CRF and data acquisition procedures as defined in a relevant study protocol are concurrently developed. Customised online queries can also be developed and implemented in order to check for data completeness and basic plausibility during data capture.

The structure of e-SOCDAT™ is compatible with industry standards such as the Clinical Data Interchange Standards Consortium (CDISC) and Operational Data Model (ODM).

Key features and benefits of e-DESIGN are: Configurable for any study design (i.e. phase I to IV, observational studies, epidemiological studies, registries) Flexible and easily customisable e-CRFs Time for study set-up and deployment minimised Pre-validated data items Definition of tailored online queries Specific and unambiguous guidance for investigators CDISC/ODM compliant

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