A crucial criterion for electronic data capture (EDC) personnel is accuracy and consistence of collected data. This needs a precise observation type definition, an ergonomic user interface with a rigorous validation process.

ClinFactory electronic data capture (eDC) can immediately work with automatic generated eCRFs after eProtocol was released. The absence of the classical eCRF design phase substantially speeds-up the whole Clinical Trial planning and preparation process. With ClinFactory/EDC you will:

  • capture complete and accurate data that answer study questions (e.g. by checking completeness, by avoiding duplication of data, easing transcription of data onto the CRF, and complying with the study protocol)
  • force accurate data entry e.g. by giving visual cues to the person recording the data, clear guidance, clean layout (unify look-and-feel, see Figure 1 and other)
  • force accurate date/time format (ISO 8601) using ergonomic date/time picker (see Figure 1)
  • organize data in a format that facilitates data analysis (e.g. by grouping related data that will be analyzed together on the same form)
  • load and link LAB data in an extremely fast thread
  • view LAB data using several "perspectives". E.g. from the corresponding eCRF by clicking "View data" push button, automatically triggered if data already exist
  • establish traceable relationships between data collected on eCRFs

Figure 1

Distribution of Time Offsets is the cause for growing diversification of eCRFs which deliver same portion(s) of data, merely differentiate in CDASH --TIM (time-offset) variable value. The eProtocol releasing step generates automatically all final eCRF variants from specific  Form Template depend on number of different time-offsets. The Figure 2 shows a final eCRF automatically generated from template "as is" for visit "Baseline".

Figure 2

The Figure 3 shows a final eCRF automatically generated from template for the Visit "Day 1" having an intervention ("Compound X with A") where series of time-offsets was defined in eProtocol.

Figure 3

The Figure 4 shows an automatic generated Anotated CRF where you can see SEQ number assignment and SEQ number span by Qalifiers with mapping scope "Group" (VSPOS) mapping scope "Time Block" (VSTIM).

Figure 4

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