Clinical Data Management (CDM) Training Course

Lesson 1 • The CDM Lifecycle

Maps all CDM activities from protocol review through database lock. Shows how each phase depends on outputs from the previous one.

Lesson 2 • Regulatory and Ethical Framework

Covers good clinical data practice principles, informed consent data requirements, and audit readiness. Grounds CDM work in compliance obligations.

Lesson 3 • Overview of Clinical Trials

Introduces trial phases, stakeholders, and the role of data in evidence generation. Provides the clinical context that frames all subsequent CDM activities.

Lesson 4 • CDM Role and Responsibilities

Defines the CDM function within a trial team and its deliverables. Clarifies how CDM interfaces with biostatistics, clinical operations, and regulatory affairs.

Lesson 1 • Data Element Standardisation

Addresses variable naming, format conventions, and unit standardisation across sites. Ensures consistent data representation before database build.

Lesson 2 • Submission Data Models

Covers the structure of study data tabulation and analysis dataset models used in regulatory submissions. Learners map trial data elements to standard domains.

Lesson 3 • Standards Compliance Validation

Introduces automated conformance checks and validation rules applied to standardised datasets. Learners interpret validation reports and resolve flagged issues.

Lesson 4 • Controlled Medical Terminologies

Explains the purpose and structure of medical coding dictionaries for adverse events and medications. Learners practise assigning preferred terms and hierarchy navigation.

Lesson 1 • Protocol-to-CRF Translation

Translates protocol endpoints and assessments into data collection requirements. Establishes the traceability between protocol objectives and CRF fields.

Lesson 2 • Electronic CRF Configuration

Addresses building eCRF screens, field properties, and validation rules within electronic data capture systems. Links design decisions to downstream data quality.

Lesson 3 • Annotated CRF Production

Teaches annotation of CRF fields with dataset domain, variable name, and coding references. Annotated CRFs serve as the primary mapping document for database build.

Lesson 4 • CRF Design Principles

Covers layout, question wording, response format, and flow logic for effective data capture. Applies human factors principles to minimise site entry errors.

Lesson 1 • EDC System Validation

Introduces computer system validation principles, user acceptance testing, and change control for EDC systems. Ensures the system is fit for regulated data collection.

Lesson 2 • Study Build and Configuration

Covers creating study structures, visit schedules, and form assignments within an EDC system. Learners apply CRF design outputs to configure a functional study environment.

Lesson 3 • Data Entry and Subject Management

Walks through subject enrolment, visit completion, and data entry workflows from a site perspective. Builds understanding of the site experience that CDM must support.

Lesson 4 • EDC System Architecture

Explains client-server and cloud-based EDC architectures, data flow, and integration points. Provides the technical context needed for system configuration decisions.

Lesson 1 • Manual Data Review

Addresses targeted manual review of listings, patient profiles, and safety data beyond automated checks. Complements programmatic cleaning with clinical judgment.

Lesson 2 • Edit Check Programming

Covers logic-based and range-based edit check design for automated data validation. Learners write check specifications that balance sensitivity with query burden.

Lesson 3 • Data Cleaning Metrics and Reporting

Establishes key performance indicators for cleaning progress and site performance. Learners build cleaning status reports used in team and sponsor communications.

Lesson 4 • Targeted and Risk-Based Cleaning

Applies risk-based monitoring principles to focus cleaning effort on critical data and high-risk sites. Reduces resource waste while protecting data integrity.

Lesson 1 • Safety Signal Support Activities

Explains how CDM supports pharmacovigilance through timely data availability and coding accuracy. Learners prepare safety data extracts for signal detection reviews.

Lesson 2 • Medical Coding Workflow

Describes the end-to-end process from verbatim term receipt to coded term approval. Establishes quality checkpoints that prevent miscoding from entering the database.

Lesson 3 • Coding Conventions and Guidelines

Establishes study-level coding conventions, exception handling, and sponsor approval workflows. Consistent conventions ensure reproducible coding decisions across coders.

Lesson 4 • Concomitant Medication Coding

Addresses collection and coding of prior and concomitant medications using standard drug dictionaries. Accurate medication data supports exposure analysis and safety review.

Lesson 1 • Database Lock Procedures

Defines the formal lock sequence, authorisation requirements, and system access restrictions post-lock. Learners execute a mock lock using a standardised lock checklist.

Lesson 2 • Pre-Lock Data Reconciliation

Covers final reconciliation of external data sources, outstanding queries, and protocol deviations before lock. Ensures all data issues are resolved prior to lock execution.

Lesson 3 • Post-Lock Data Management

Covers unblinding procedures, post-lock amendments, and data archival requirements. Prepares learners to manage the rare but critical post-lock change process.

Lesson 4 • Data Export and Transfer Formats

Addresses export formats, transfer specifications, and encryption requirements for data delivery to biostatistics. Ensures data integrity from export through receipt.

Lesson 1 • CDM Plan Development

Builds a comprehensive CDM plan covering scope, timelines, responsibilities, and quality standards. The plan serves as the governing document for all CDM activities.

Lesson 2 • Continuous Improvement in CDM

Applies lessons-learned processes, process metrics, and quality management frameworks to improve CDM operations. Builds a culture of measurable, sustained improvement.

Lesson 3 • Vendor and CRO Oversight

Covers qualification, contracting, and ongoing oversight of CDM vendors and contract research organisations. Ensures delegated activities meet sponsor quality standards.

Lesson 4 • Stakeholder Communication

Develops communication plans, status reporting formats, and meeting management skills for CDM leads. Effective communication aligns cross-functional teams on data status.