Central Laboratory Manual — 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 central laboratory manual — how samples are collected, handled, shipped, and analysed.
Why it exists. Consistent lab results require standardized sample handling across all sites. The manual specifies collection, processing, shipping conditions, and the central lab's methods and reference ranges (GCLP).
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); GCLP
Central Laboratory Manual — GLPI103-301
| Field | Value |
|---|---|
| Document ID | TMF-LAB |
| Study No. | GLPI103-301 |
| Version | 1.0 |
| Standard | ICH E6(R3); GCLP |
| Confidentiality | Confidential — TMF |
Central-laboratory procedures, analytes, reference ranges, and alert values.
[MOCK]ranges are illustrative (Korean adult population).
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Clinical Operations / Central Lab | Initial lab manual |
1. Analytes & Reference Ranges (illustrative)
| Analyte | Unit | Reference range | Alert / panic value |
|---|---|---|---|
| HbA1c (primary) | % | 4.0–5.6 (non-diabetic) | >12.0 → review |
| FPG | mmol/L | 3.9–5.5 | <3.0 (hypo) / >20 |
| ALT | U/L | ≤40 (ULN) | >3× ULN → AESI follow-up (EDC-007) |
| AST | U/L | ≤40 (ULN) | >3× ULN |
| eGFR | mL/min/1.73m² | ≥90 normal | <45 post-baseline → notable (EDC-006) |
| NT-proBNP / hsCRP | — | per assay | per assay [MOCK] |
2. Sample Collection, Handling & Shipment
Collection per the Schedule of Activities (PROT-301 §8); fasting required for FPG; tubes/volumes/processing per kit instructions; centrifugation and storage temperatures specified; barcoded labels link to subject/visit; shipment to the central lab with temperature monitoring and chain-of-custody.
3. Data Flow & Reconciliation
Central-lab results transmitted electronically to the EDC/data warehouse; reconciled against eCRF key analytes (TMF-DMP §7). Plausibility checks EDC-001–002, 006–007 (TMF-DMP §4).
4. Alert / Critical Values
Alert and critical values are flagged to the investigator in real time for participant safety; eGFR <45 and ALT/AST >3× ULN post-baseline trigger medical review and AESI follow-up per the Safety Management Plan (TMF-SMP).
5. Quality
Accredited central laboratory (e.g., CAP/ISO 15189); assay validation, calibration, and external quality assessment maintained; normal ranges versioned and provided to sites.
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