📚 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 blank Case Report Form — the data-collection form used at each visit to record trial data.
Why it exists. The CRF defines exactly what data are collected and how. A blank CRF in the submission lets a reviewer see the questions behind the data (CDASH-aligned to ease standardization).
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. CDASH-aligned data collection
| Field | Value |
|---|---|
| Document ID | CRF-301 |
| Version | 1.0 |
| Study No. | GLPI103-301 |
| Standard | CDASH-aligned data collection |
| Confidentiality | Confidential — portfolio use |
Representative blank CRF (data collection template). Annotated mapping to SDTM is in ACRF-301.
| Version | Date | Author | Summary |
|---|
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| 1.0 | 2026-06-29 | Data Management | Initial blank CRF |
| AE term | Onset | End | Severity (Mild/Mod/Severe) | Related (Y/N) | Serious (Y/N) | Outcome |
|---|---|---|---|---|---|---|
| Medication | Indication | Start | Stop/Ongoing |
|---|---|---|---|