Regulated clinical trial
A study begins as a protocol, gathers observations from people and systems, and ends as a traceable package that a regulator can review. Different standards carry different parts of that journey.
- Starts with
- A protocol, source observations, and product definitions
- People steering it
- Study standards, data management, statistical programming
- Release outcome
- Traceable acquisition-to-submission data with regulator-specific outputs.
How the data becomes ready
Read each step as the information moving first and the standards supporting that job second.
- 01
Design + concepts
What moves Study objectives, visits, activities, and concepts become reusable structured definitions.
Standards in play USDM where adopted · CDISC Biomedical Concepts
- 02
Acquire
What moves Measurements and source observations move from sites, devices, images, and health records into study collection.
Standards in play CDASH · named FHIR IG for eSource · DICOM for imaging
- 03
Product identity
What moves Medicinal-product identifiers and jurisdictional master data travel with the study data.
Standards in play IDMP + jurisdictional master data
- 04
Tabulate + analyze
What moves Collected observations become reviewable tabulations and traceable analysis datasets.
Standards in play SDTM / SEND → ADaM
- 05
Exchange + validate
What moves Datasets, metadata, terminology, and validation results become the regulator-specific submission package.
Standards in play Define-XML · pinned terminology · regulator rules
Release gates
Pause the release until each of these checks has passed.
- 1
Pin every standard, IG, terminology, and validator version.
- 2
Preserve source identifiers, timestamps, units, mappings, and reconciliations.
- 3
Generate the regulator-required package; a successful mapping is not submission conformance.