ClinFactory/eCRF template design

ClinFactory/eProtocol facilitate single-sourced, downstream electronic consumption of the protocol content. It means the system generates automatically all eCRFs and Annotated CRFs based on data collected during eProtocol developing process.

An eCRF template (further template) is builded from collection of Observation Mapping Patterns (see BRIDG/DefinedObservation; further pattern) where each pattern defines an arbitrary complex measurement in scope of a specific domain. E.g. we want to design a VS based eCRF template containing Systolic Blood Pressure, Diastolic Blood Pressure, and Pulse Rate measurements. For each measurement we need to find an appropriate pattern. In the pattern catalog there are diverse versions of one type of measurement (e.g SYSBP) which differ merely in the number of qualifiers and according to circumstances have other default values ( e.g. "SUPINE" by VSPOS). Final result is an eCRF template which covers ODM/FormDef level downwardly.

In order to keep the size of a templates repository manageable, a template doesn't deal with multiple time offsets. These are assigned later on as described bellow.

On the level of ODM/ItemDef each element keep "a link" to his pattern to guarantee series of automatic mapping processes (e.g automatic eCRF generation by multiple time offsets, vertical ODM/ClinicalData mapping, and final SDTM tabulation mapping) on backend.

During the clinical trial planning phase a trial planner selects desired templates and assigns each one to the corresponding Visit in the course of a Visit Schedule Matrix generation process. This is the process where pattern and template participating on the formation of Planned Assessment.

To define multiple measurements of the same Planned Assessment within a Visit a Time Offset distribution process is necessary during the Visit Schedule Matrix generation process.

This is the basis for automatic generation of eCRFs (see Figure 1) and Annotated CRFs (see Figure 2).

Figure 1

The Figure 2 shows an automatic generated Anotated CRF (PDF file) where you can see SEQ number assignment and SEQ number span by Qalifiers with mapping scope "Group" (VSPOS) mapping scope "Time Block" (VSTIM).

Figure 2

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