📚 Part of the GLPI-103 Regulatory Dossier — Reader's Guide. This article shows the live document; edits to the source appear here automatically.

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Mock / simulation document

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.

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About this document — a plain-language guide

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

Blank Case Report Form (CRF) — GLPI103-301

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.

Change History

Version	Date	Author	Summary
1.0	2026-06-29	Data Management	Initial blank CRF

Screening Visit

Informed consent date: ____ · Subject ID: ____ · Site: ____
Date of birth / Age: ____ · Sex: ☐ M ☐ F · Race: ____ · Ethnicity: ____ · Country: KOR
Subject characteristics: Education ____ · Marital status ____ · Employment ____
Eligibility (I/E checklist): Age 18–75 ☐ · HbA1c 7.0–10.5% ☐ · BMI ≥25 ☐ · Metformin ≥3 mo ☐ · eGFR ≥45 ☐ · ALT/AST ≤3×ULN ☐ · Exclusions reviewed ☐
Labs: HbA1c ____ % · FPG ____ · ALT ____ · AST ____ · eGFR ____
Vitals: Height ____ cm · Weight ____ kg · BMI ____ · SBP ____ · DBP ____

Randomization (Week 0)

Randomization date: ____ · Arm (IRT-assigned): ☐ A IV ☐ B Oral ☐ C Semaglutide
Strata: HbA1c (☐ <8.5 ☐ ≥8.5) · BMI (☐ <30 ☐ ≥30) · Region ____

Treatment Visits (W4, W8, W12, W16, W24, W36, W52, W56)

Visit date: ____ · Study drug administered ☐ · Compliance ____ %
HbA1c ____ · FPG ____ · Weight ____ · BMI ____ · SBP/DBP ____ / ____
(per schedule) NT-proBNP ____ · hsCRP ____ · ALT/AST/eGFR ____

Adverse Events (continuous)

AE term	Onset	End	Severity (Mild/Mod/Severe)	Related (Y/N)	Serious (Y/N)	Outcome

Concomitant Medications (continuous)

Medication	Indication	Start	Stop/Ongoing

Disposition

Completed Week 52 ☐ · Early discontinuation ☐ → Reason: ____