Annotated Case Report Form (aCRF) — 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 annotated Case Report Form (aCRF) — the CRF marked up to show which SDTM dataset and variable each field maps to.
Why it exists. The aCRF is the Rosetta Stone linking collected data to the standardized SDTM datasets and define.xml. It lets a reviewer trace any value from the form to the dataset.
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 SDTM annotation (define.xml companion)
Annotated Case Report Form (aCRF) — GLPI103-301
| Field | Value |
|---|---|
| Document ID | ACRF-301 |
| Version | 1.0 |
| Study No. | GLPI103-301 |
| Standard | CDISC SDTM annotation (define.xml companion) |
| Confidentiality | Confidential — portfolio use |
Maps CRF data collection fields to the SDTM domains/variables, supporting the define.xml and reviewer traceability. Domains correspond to the generated datasets (
data/sdtm/).
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Data Management | Initial annotated CRF |
CRF Forms → SDTM Annotation
The annotated CRF is the Rosetta Stone of the data package: each field on the paper/electronic form is marked with the exact dataset and variable it flows into. It lets a reviewer trace any value back from the standardized data to the question that was actually asked.
| CRF Form / Field | Collected at | SDTM Domain.Variable |
|---|---|---|
| Demographics (DOB→age, sex, race, ethnicity, country, site) | Screening | DM.AGE, DM.SEX, DM.RACE, DM.ETHNIC, DM.COUNTRY, DM.SITEID |
| Subject Characteristics (education, marital status, employment) | Screening | SC.SCTESTCD (EDLEVEL/MARISTAT/EMPLST), SC.SCORRES |
| Eligibility (I/E criteria checklist) | Screening | IE (derived); supports randomization |
| Vital Signs (height, weight, BMI, SBP, DBP) | All visits | VS.VSTESTCD (HEIGHT/WEIGHT/BMI/SYSBP/DIABP), VS.VSSTRESN, VS.VISITNUM |
| Laboratory (HbA1c, FPG, ALT, AST, eGFR) | Per schedule | LB.LBTESTCD, LB.LBSTRESN, LB.LBNRIND, LB.VISITNUM |
| Randomization (arm, strata) | Week 0 | DM.ARM/ARMCD/ACTARM; strata → ADSL.STRAT_* |
| Study Drug Administration / Compliance | Treatment visits | EX (exposure; not in scope of generated data) |
| Adverse Events (term, onset/end, severity, causality, seriousness, outcome) | Continuous | AE.AETERM, AE.AEDECOD, AE.AEBODSYS, AE.AESEV, AE.AEREL, AE.AESER, AE.AEOUT, AE.AESTDTC, AE.AEENDTC |
| Concomitant Medications | Continuous | CM (not in scope of generated data) |
| Disposition / Completion | End/early term | DS (derived; CONSORT) |
Notes
- Visit structure (Screening, W0–W56) per the Schedule of Activities (PROT-301 §7).
- Controlled terminology in English (CDISC CT); see SDRG (DEF-301).
- Forms marked "not in scope" (EX, CM, IE, DS) are described for completeness; the simulated dataset implements DM, SC, VS, LB, AE and derives disposition.
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