The ClinFactory/eProtocol is a web based, data-centric Clinical Trial protocol planning solution that significantly increases the speed and efficiency of entire trial planning and set-up phases (allowing high degree of automation for key downstream activities like eCRF and annotated CRF generation).

Here are nine major highlights:

  1. Clinical Trial/Study Registry - dynamically configurable (xml-driven) structured attributes related to the background information of a study (e.g. Study Type, Registration ID, Number of Sites, Date of First Enrollment, ...).
  2. Rich template repository - rich catalog of complex observations and their groups (eg. DefinedObservation, DefinedObservationGroup) which guarantee well defined, well structured, complete and consistent definitions with CDISC standards (see Research Concept metaphor).
  3. Arm->TreatmentPeriod->PlannedVisit/PlannedObservation Matrix - easy (point-and-click) generation of a Visit Schedule. A "metamorphose" of DefinedObservation to PlannedObservation. A real nightmare for protocol writer by doing it manually.
  4. ScheduledObservation generation process - easy (point-and-click) process within the Visit Scheduler to assign Time offset attribute(s) on selected PlannedObservation to generate one or more ScheduledObservations.
  5. Blood log table - automatic generation of the Blood log table. An another nightmare for protocol writer by doing it manually.
  6. eProtocol Authoring Tool - easy management of eProtocol hierarchical topic structure and narrative segments. The resulting xml-driven structure of generated document(s) follows OASIS/DITA standards which are fundamental for fully fledged authoring tool. To utilize legacy protocol documents we offer a WinWord parsing process to initialize eProtocol structure and content with data originating in a similar, older study.
  7. Calculated chapters - some pretty complex chapters in the protocol could be tagged as calculated to triger corresponding Chapter Agent which uses current Study Registry and Visit Scheduler context to create desired narrative text.
  8. Study Registry referencing mechanism - a link mechanism between study registry data and their appearance in the narrative segment.
  9. eCTD - easy (point-and-click) interface to recognize/align narrative document segments to the eCTD node structure. It allows fully automated eCTD submission process (see ClinFactory/eProtocol Short Tutorial).

ClinFactory/eProtocol's functionality spectrum is role driven. An user in the Clinical Trial Leader role has overall access and is in the position to assign other study members in subsidiary roles (writer, reviewer ...). A Clinical Trial Leader has access to all "crucial" commands (like create new protocol version, select document template, parse legacy WinWord document ...) and maintains restricted access to particular sections/chapters of the document to users in the Protocol Writer role.

A Document Template repository allows Clinical Trial Leader to choose an optimal document structure and initial narrative content based on the TA.

Above mentioned DefinedObservation/DefinedObservationGroup entities represent a mapping patterns (which resolve Research Concept) and guarantee end-to-end traceability of clinical data definition and captured value later on. This is the real reason for overall automation.

For more information please visit ClinFactory/eProtocol Short Tutorial.

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John P.2012-08-05 03:08 PMI have read it with gender!