Data Management Plan (DMP) — 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 Data Management Plan — how trial data are collected, cleaned, coded, and locked.
Why it exists. Trustworthy results require disciplined data handling. The DMP defines the database, edit checks, query process, medical coding, and database-lock criteria that turn raw entries into an analysis-ready dataset.
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); CDISC (CDASH/SDTM/ADaM); SCDM GCDMP
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).
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