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. The time required to train site personnel is significantly reduced and the probability of accurate e-CRF completion is maximised.

Using e-DESIGN, e-CRFs can be tailored to specific research project requirements by using a global library of pre-defined customisable and validated data items. 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 with the purpose to check for data completeness and basic plausibility during data capture, thus reducing the number of e-DCFs requiring creation.

The structure of e-SOCDAT™ is compatible with industry standards such as the Clinical Data Interchange Standards Consortium (CDISC) standard, 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, SDTM, ASCII and SAS compatible (data exports)

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