In the Technical Conformance Guide, the FDA defines baseline flags. And, even though it is in a section that has a heading that includes SDTM, SEND, and ADaM, the sentence itself only calls out SDTM.
1. Baseline flags (e.g., last non-missing value prior to first dose) for Laboratory results, Vital Signs, ECG, Pharmacokinetic Concentrations, and Microbiology results. Currently, for SDTM, baseline flags should be submitted if the data were collected or can be derived.
In the OpenCDISC Validator Tool, selecting SEND, the only rules with baseline in them are below. Notice the one that throws the flag (SD0006) does NOT have an FDA validation rule number attached.
SD1044 |
FDAN051 |
No --BLFL variable in custom Findings domain |
Baseline Flag (–BLFL) should be present in all custom Findings domains |
Presence |
Warning |
|---|---|---|---|---|---|
SD1131 |
FDAN173 |
Missing --STRESC value for Baseline record |
A Standard Result value (–STRESC) is expected to be populated for Baseline records (–BLFL=“Y”) |
Presence |
Warning |
SD0006 |
No baseline result in – for subject |
All subjects should have at least one baseline observation (–BLFL = ‘Y’) in EG, LB, MB, MS, PC and VS domains, except for subjects who failed screening (ARMCD = ‘SCRNFAIL’) or were not fully assigned to an Arm (ARMCD = ‘NOTASSGN’) or were not treated (ACTARMCD = ‘NOTTRT’) |
Presence |
Warning |
The FDA SEND Validation Rules document has the first two rules.
The FDA SDTM Validation Rules document also has the third:
FDAC113 |
No baseline result in Domain for subject |
All subjects should have at least one baseline observation (–BLFL = ‘Y’) in EG, LB, MB, MS, PC and VS domains, except for subjects who failed screening (ARMCD = ‘SCRNFAIL’) or were not fully assigned to an Arm (ARMCD = ‘NOTASSGN’) or were not treated (ACTARMCD = ‘NOTTRT’) |
EG, LB, MB, MS, PC, VS |
Warning |
|---|
Additionally, SEND does not have MB or MS domains, does not use SCRNFAIL, NOTASSGN, or the ACTARMCD.
Please consider removing the warning SD0006 for SEND regarding baseline flags.