Categories

Core concepts of clinical data management, lifecycle, roles, and deliverables.

MedDRA / WHODrug coding workflow, dictionaries, reviews, and coding quality checks.

GCP concepts, Part 11 principles, privacy expectations, and inspection readiness.

CRF design principles, annotations, completion guidelines, and user experience in EDC.

Listings review, trend checks, data review plans, and escalation of critical issues.

Freeze/lock readiness, approvals, unlock governance, and final data delivery.

Data entry, roles, audit trail, freezes, user management, and workflow states.

Hard/soft checks, cross-form checks, derivations, and validation strategy.

KPIs, dashboards, risk-based oversight, and operational performance management.

Helpful supporting concepts that commonly arise in CDM interviews and operations.

Data exports, transfer specs, derivations, and collaboration with programming/statistics.

Query lifecycle, site communication, discrepancy logs, and closure quality.

Cross-system checks (e.g., SAE, labs, IXRS), mismatch handling, and documentation.

CDISC SDTM/ADaM awareness, controlled terminology, mapping considerations.

DMP, timelines, specifications, UAT, change control, and study start-up essentials.