Study Identifier
Unique Subject Identifier
Subject Identifier for the Study
Subject Identifier for the Study (N)
Cohort (N)
Group (N)
Planned Treatment
Planned Treatment (N)
Actual Treatment
Actual Treatment (N)
Sequence Number
Analysis Sequence Number
Parameter
Parameter Code
Parameter (N)
Parameter Category 1
Parameter Category 1 (N)
Parameter Category 2
Parameter Category 2 (N)
Specimen Type
Analysis Value
Analysis Value (C)
Clinically Significant
Clinically Significant (N)
Baseline Record Flag
Baseline Value
Baseline Value (C)
Change from Baseline
Percent Change from Baseline
Analysis Reference Range Indicator
Analysis Reference Range Indicator (N)
Baseline Reference Range Indicator
Baseline Reference Range Indicator (N)
Analysis Normal Range Lower Limit
Analysis Normal Range Lower Limit (C)
Analysis Normal Range Upper Limit
Analysis Normal Range Upper Limit (C)
Normal/Abnormal/CS
Normal/Abnormal/CS (N)
Derivation Type
Worst Post-Baseline Flag
Analysis Flag 01
Analysis Flag 02
Unscheduled Visit Flag
Post-Baseline Flag
Vendor Name
Method of Test or Examination
Fasting Status
Identification for Result
Second Identification for Result
LOINC Code for Identification
LOINC Code for second Identification
Report Blood Count
Report Blood Count 2
Date/Time of Specimen Collection
Analysis Date
Analysis Time
Analysis Datetime
Study Day of Specimen Collection
Analysis Relative Day
Analysis Visit
Analysis Visit (N)
Visit Name
Visit Number
Comments 1
Comments 1 Evaluator
Comments 2
Comments 2 Evaluator
Age Units
Sex (N)
Race (N)
Screened Population Flag
Screened Population Flag (N)
Safety Population Flag
Safety Population Flag (N)
Safety Boost Population Flag
Safety Boost Population Flag (N)
Immunogenicity Population Flag
Immunogenicity Population Flag (N)
Prime + 7 Days Completers Set
Prime + 7 Days Completers Set (N)
Prime to Boost or Prime +28 D. Comp. Set
Pri. to Bo. or Pri. +28 D. Comp. Set (N)
Boost + 7 Days Completers Set
Boost + 7 Days Completers Set (N)
Boost + 28 Days Completers Set
Boost + 28 Days Completers Set (N)
Prime or Boost + 28 Days Completers Set
Prime or Boost + 28 Days Comp. Set (N)
Completers Population Flag
Completers Population Flag (N)
Date of First Exposure to Treatment
Time of First Exposure to Treatment
Datetime of First Exposure to Treatment
Date of Last Exposure to Treatment
Time of Last Exposure to Treatment
Datetime of Last Exposure to Treatment
Date of Allocation
Time of Allocation
Datetime of Allocation
Source Data
Source Variable
Source Sequence Number
Cohort Category 1
Cohort Category 1 (N)
Cohort Category 2
Cohort Category 2 (N)