📚 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 Pharmacy / Investigational Medicinal Product manual — how the study drug is received, stored, prepared, and dispensed at sites.

Why it exists. The blind depends on correct drug handling, especially with a double-dummy IV+oral design. This manual instructs site pharmacists on storage, preparation, accountability, and maintaining the blind.

How it is produced here. It is an operational trial document — a plan, charter, or template of the kind kept in the Trial Master File. It describes how the trial is run, rather than reporting the trial's results.

Format & governing standard. ICH E6(R3); GMP; double-dummy blinding

Pharmacy / IMP Manual — GLPI103-301

Field	Value
Document ID	TMF-PHARM
Version	1.0
Study No.	GLPI103-301
Standard	ICH E6(R3); GMP; double-dummy blinding
Confidentiality	Confidential — TMF

Instructions for handling the investigational medicinal products at site. [MOCK] specifics.

Change History

Version	Date	Author	Summary
1.0	2026-06-29	Clinical Supply / Pharmacy	Initial IMP manual

1. Products & Double-Dummy

Kit	Contents
Arm A	GLPI-103 IV (active) + oral placebo
Arm B	GLPI-103 Oral (active) + IV placebo
Arm C	Oral semaglutide (active) + IV placebo

All subjects receive one IV product + one oral product of identical appearance to maintain the blind. Kit assignment via IWRS (TMF-RAND).

2. Storage & Stability

Store per label (e.g., refrigerated 2–8 °C for IV; controlled room temperature for tablets); protect from light/moisture; restricted-access, temperature-monitored. Temperature excursions quarantined and reported to the sponsor for disposition (do not use until released).

3. Preparation & Administration

IV: prepared by unblinded pharmacist per instructions; administered/observed at site weekly; infusion/injection details and in-use stability specified.
Oral: dispensed for daily self-administration with dosing instructions (titration schedule per PROT-301 §6).

4. Dose Titration & Modification

Dispense the scheduled titration step (1→2→4 mg QW IV; 2→4→8 mg QD oral; 3→7→14 mg QD semaglutide). Dose delay/down-titration for intolerance per PROT-301 §6.2 (blinding maintained via IWRS kit changes).

5. Accountability, Returns & Destruction

Drug accountability logs maintained (received/dispensed/returned/destroyed); reconciled at monitoring visits; unused/expired IMP returned or destroyed per procedure with documentation. Compliance computed (pill count + IWRS); <80% / >120% flagged (PPS-relevant).

6. Blinding & Unblinding

Unblinded pharmacist prepares IV; blinded staff administer where required by design. Emergency unblinding via IWRS only, documented and reported (TMF-RAND §2).