edc-cdisc

CDISC ODM export for the clinicedc clinical-trial data-collection framework.

edc-cdisc reads the visit schedule, CRF definitions, and submitted data from a clinicedc installation and produces standards-compliant XML in CDISC ODM 1.3.1 format.

It provides three serializers, all built on the same class hierarchy (Serializer → VisitScheduleSerializer → the concrete serializers):

Serializer	Produces
MetadataSerializer	<Study> — the study definition (visit schedule, forms, items, code lists)
ClinicalDataSerializer	<ClinicalData> — submitted CRF values
SnapshotSerializer	a combined <Study> + <ClinicalData> document

Transactional (incremental) export is planned but not yet implemented; it will be driven by the audit trail.

Contents:

• Installation
  • Requirements
  • Install
• Quickstart
  • Minimal example
  • Writing to a file
  • Validating the output
  • Common options
• Metadata Export
  • Usage
  • Output structure
• Clinical Data Export
  • Usage
  • Output structure
• Combined Snapshot Export
  • Usage
  • Output structure
  • Validation
• Validation
  • Which documents to validate
  • What XSD validation does not catch
  • Bundled schema
• ODM Mapping Reference
  • OID conventions
  • Study events
  • Fieldset mapping
  • Excluded fields
  • Django field type mapping
  • Code lists
• SDTM Export — Design Notes
  • Why SDTM is a different kind of problem from ODM
  • SDTM observation classes
  • What clinicedc can supply (mostly) for free
  • What existing code is directly reusable
  • Output format: Dataset-JSON
  • Proposed phased plan
  • Open questions
• API Reference
  • Serializers
  • Validation
  • Exceptions