ADaM Dataset Specification — GLPI103-301
📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.
This is a mock / simulation document, made for a portfolio and for learning. The drug (GLPI-103), the sponsor, the people, and the data are all fictional. It is not a real regulatory submission and has no clinical, legal, or regulatory standing. What is real is the shape of the thing — the document structure, the standards it follows, and the analysis methods; the content inside is illustrative.
What it is. The ADaM dataset specification — the variable-by-variable definition of the analysis datasets (e.g., ADSL, ADLB).
Why it exists. Analyses must run on standardized analysis-ready data. The ADaM spec defines every derived variable and how it is computed, so a reviewer can reproduce the analysis datasets exactly (CDISC ADaMIG).
How it is produced here. It is generated from the standardized study datasets (the SDTM and ADaM data and their define.xml 'data dictionary'), so the guide always describes the exact datasets a regulator would receive.
Format & governing standard. CDISC ADaMIG v1.x; Define-XML 2.1
ADaM Dataset Specification — GLPI103-301
| Field | Value |
|---|---|
| Document ID | ADaM-SPEC-301 |
| Version | 1.0 |
| Study No. | GLPI103-301 |
| Standard | CDISC ADaMIG v1.x; Define-XML 2.1 |
| Confidentiality | Confidential |
Variable-level specification for the analysis datasets, matching
src/cdisc/adam_builder.py,define.xml, and the ADRG (DEF-301).
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Biostatistics / DM | Initial ADaM spec |
ADSL — Subject-Level Analysis Dataset (one record per subject; N=900)
| Variable | Label | Type | Source / Derivation |
|---|---|---|---|
| STUDYID | Study Identifier | Char | GLPI103 |
| USUBJID | Unique Subject ID | Char | STUDYID-SITEID-SUBJID |
| SUBJID, SITEID | Subject/Site ID | Char | DM |
| AGE | Age (yr) | Num | DM |
| AGEGR1 | Age group | Char | <65 / >=65 |
| SEX, RACE, COUNTRY | Demographics | Char | DM |
| TRT01P / TRT01A | Planned / Actual treatment | Char | DM ARM / ACTARM |
| TRT01PN / TRT01AN | Treatment (numeric) | Num | 1=IV, 2=Oral, 3=Sema |
| RANDDT | Randomization date | Char | DM RFSTDTC |
| FASFL / SAFFL | FAS / Safety flags | Char | "Y" (all randomized/dosed) |
| PPSFL | Per-protocol flag | Char | "Y"/"N" — derived from DEVFL (major deviation); PPS=847, FAS=900 |
| STRAT_HBA1C | HbA1c stratum | Char | <8.5/>=8.5 from baseline HbA1c (IRT) |
| STRAT_BMI | BMI stratum | Char | <30/>=30 from baseline BMI |
| STRAT_REGION / REGION | Region stratum | Char | Province→region group |
| EDUCATION / MARITAL / EMPLOYMENT | Baseline covariates | Char | SC domain (English CT) |
ADLB — Laboratory Analysis Dataset (BDS; one record per parameter/visit/subject)
| Variable | Label | Type | Source / Derivation |
|---|---|---|---|
| STUDYID, USUBJID | Identifiers | Char | — |
| TRT01A / TRT01AN | Treatment | Char/Num | ADSL |
| FASFL/PPSFL/SAFFL | Population flags | Char | ADSL |
| PARAMCD / PARAM | Parameter (code/name) | Char | LB (HBA1C, FPG, ALT, AST, EGFR) |
| AVAL / AVALU | Analysis value / unit | Num/Char | LB LBSTRESN |
| BASE | Baseline value | Num | AVAL where ABLFL="Y" |
| CHG / PCHG | Change / % change from baseline | Num | AVAL−BASE / CHG/BASE×100 |
| ABLFL | Baseline flag | Char | "Y" at VISITNUM=1 |
| ANL01FL | Analysis flag | Char | "Y" for non-baseline visits |
| VISITNUM / VISIT | Visit | Num/Char | 1–9 (W0–W56) |
| STRAT_HBA1C/STRAT_BMI, AGE, AGEGR1, SEX | Analysis covariates | — | ADSL |
Additional analysis datasets in a full submission: ADAE (adverse events), ADVS (vital signs), ADTTE (time-to-event, if any). Their specs follow the same conventions.
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