Data Management Plan (DMP) — GLPI103-301
| Field | Value |
|---|---|
| Document ID | TMF-DMP |
| Version | 2.0 (full) |
| Study No. | GLPI103-301 |
| Standard | ICH E6(R3); CDISC (CDASH/SDTM/ADaM); SCDM GCDMP |
| Confidentiality | Confidential — TMF |
Change History
| Version | Date | Author | Summary |
|---|---|---|---|
| 1.0 | 2026-06-29 | Data Management | Initial DMP |
| 2.0 | 2026-06-29 | Data Management | Full DMP — edit-check spec, data flow, coding, reconciliation, lock |
1. Scope, Roles & Responsibilities
Governs data capture → cleaning → coding → standardization → lock for GLPI103-301.
| Role | Responsibility |
|---|---|
| Lead Data Manager | DMP, edit checks, query oversight, lock |
| DB Programmer | EDC build, edit-check programming, exports |
| Medical Coder | MedDRA/WHO-DD coding |
| Biostatistician | SAP alignment, derived data review |
| PV | SAE reconciliation |
| QA | Audit, lock approval |
2. Systems
EDC (eCRF, CDASH-aligned), IWRS (randomization/IMP — TMF-RAND), central laboratory data feed (TMF-LAB), safety database. Access controlled, audit-trailed, 21 CFR Part 11 compliant.
3. Data Flow
Site eCRF entry → automated/manual edit checks → query issuance/resolution → external-data reconciliation (lab, IWRS, SAE) → medical coding → SDTM → ADaM → define.xml (DEF-301) → analysis (SAP-301). Soft/hard locks per visit cohort.
4. Data Validation Specification (Edit Checks)
Programmatic checks implemented by the Data Quality Engine (src/validation/dqe.py); outputs the DVS report and query log (outputs/validation/). Active rules:
| Rule | Description | Domain | Severity |
|---|---|---|---|
| EDC-001 | HbA1c plausibility (4.0–15.0%) | LB | Query |
| EDC-002 | FPG plausibility (2.0–25.0 mmol/L) | LB | Query |
| EDC-003 | Weight plausibility (30–200 kg) | VS | Query |
| EDC-004 | Blood pressure plausibility (SBP 70–250, DBP 40–140) | VS | Query |
| EDC-005 | Visit-window deviation (>7 days from scheduled) | Visit | Query |
| EDC-006 | Post-baseline eGFR < 45 mL/min/1.73m² | LB | Notable |
| EDC-007 | ALT/AST > 3× ULN (ULN 40 U/L) | LB | Notable |
Realized query volume (this dataset): EDC-005 visit-window 1,240; EDC-006 eGFR 27; EDC-007 hepatic 2; EDC-002 FPG 1 (outputs/validation/dvs_report.csv). "Notable" findings (EDC-006/007) trigger medical review and AESI follow-up.
5. Query Management
Queries are auto- or manually generated, routed to sites, tracked to closure with audit trail; aging/overdue queries are escalated (KRI in TMF-CMP). Target: critical queries resolved before each interim/lock.
6. Medical Coding
Adverse events → MedDRA (version fixed at study start; PT/SOC); concomitant medications → WHO-DD. Coding reviewed by medical monitor; auto-encoder + manual reconciliation; coding report approved before lock.
7. External Data Reconciliation
Central lab vs eCRF (key analytes), IWRS (treatment/strata) vs database, and SAE reconciliation between clinical and safety databases (PV) — all reconciled and documented before lock.
8. CDISC Standardization
Raw → SDTM (DM/SC/VS/LB/AE) → ADaM (ADSL/ADLB; ADaM-SPEC-301) with define.xml/SDRG/ADRG (DEF-301). Controlled terminology in English. Conformance via validate_cdisc.py.
9. Database Lock
Lock checklist: all data entered/cleaned; queries closed; coding approved; external data reconciled; SAE reconciliation complete; QC sign-off. Post-lock changes are controlled and documented. Unblinding follows lock per SAP-301.
10. Quality & Metrics
Double-programming/QC of derivations; data-quality metrics (entry timeliness, query rate/aging, error rate). The reproducible build (build.py) and gates (verify_pipeline, validate_cdisc, reconcile_csr) provide automated, repeatable QC evidence (QC-001).