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Specification:

FHIR Core (FHIR)
Raised in Version:

R5
Work Group:

Biomedical Research & Regulation
Related URL:
https://build.fhir.org/substancedefinition.html
Related Artifact(s):

SubstanceDefinition
Grouping:
- FDA-PQ/CMC
- eCTDM3
Resolution Description:

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Approved on BR&R call 24th March

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Approved on BR&R call 24th March
Resolution Vote:
Rik Smithies / Norman Gregory : 13-0-0
Change Category:
Correction
Change Impact:
Non-compatible
Pre Applied:
Yes
Applied for Version:

R5

Request to the change the name of Structure.sourceCoding element to technique.

See proposed definition below:

Definition: The method used to elucidate the structure or characterization of the drug substance.

Examples: x-ray, HPLC, NMR, peptide mapping, ligand binding assay, etc.