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.