This example shows findings from an assessment <> with the purpose of determining <>.
Human leukocyte antigen (HLA) typing
This example shows findings from an assessment of genomic variations in drug metabolizing genes with the purpose of determining how variations in those genes affect drug absorption, distribution, metabolism, and excretion (ADME). The method used to summarize nucleotide variation is represented in variable GFANMETH where appropriate. Identifying information for the genomic panel is represented in SPDEVID. Additional information about the genomic panel may be represented in the Medical Device Domains (e.g., DI domain) as needed.
This example shows findings from an assessment of genomic variations in genes associated with HLA typing with the purpose of determining the allele subtypes.
Rows 1-6, 9-14:
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Study Identifier
Domain Abbreviation
Unique Subject Identifier
Sponsor Device Identifier
Non-Host Organism Identifier
Sequence Number
Group ID
Reference ID
Sponsor-Defined Identifier
Link ID
Link Group ID
Short Name of Genomic Measurement
Name of Genomic Measurement
Measurement, Test, or Examination Detail
Result or Finding in Original Units
Genomic Symbol
Genomic Symbol Type
Copy Identifier
Completion Status
Reason Test Not Done
External File Path
Laboratory/Vendor Name
Specimen Material Type
Method of Test or Examination
Run ID
Analysis Method
Baseline Flag
Derived Flag
Lower Limit of Quantitation
Repetition Number
Visit Number
Visit Name
Planned Study Day of Visit
Date/Time of Specimen Collection
Study Day of Specimen Collection
Planned Time Point Name
Planned Time Point Number
Planned Elapsed Time from Time Point Ref
Time Point Reference
Date/Time of Reference Time Point
STUDYID
DOMAIN
USUBJID
SPDEVID
NHOID
GFSEQ
GFGRPID
GFREFID
GFSPID
GFLNKID
GFLNKGRP
GFTESTCD
GFTEST
GFTSTDTL
GFORRES
GFSYM
GFSYMTYP
GFCOPYID
GFSTAT
GFREASND
GFXFN
GFNAM
GFSPEC
GFMETHOD
GFRUNID
GFANMETH
GFBLFL
GFDRVFL
GFLLOQ
GFREPNUM
VISITNUM
VISIT
VISITDY
GFDTC
GFDY
GFTPT
GFTPTNUM
GFELTM
GFTPTREF
GFRFTDTC
Study-123
GF
S123-001
1
HGA4567
An assessment of the unique pattern of sequence variation of one to many loci associated with a normal or abnormal biological process.