CPEDC study plan
CPEDC · Give each week a clear focus.
8 weeks · About 7 hours per week
Regulatory Framework and Clinical Trial Standards
Map the ICH E6(R2/R3) GCP principles to concrete data management activities and write a one-line justification for each mapping
Outline the regulatory submission expectations for clinical data (FDA 21 CFR Part 11 scope, EU CTR/CTIS obligations) and flag where they intersect with EDC operations
Distinguish the roles and required documentation for sponsor, CRO, site, and vendor in a trial data flow
Build a glossary of 25 core regulatory and GCP terms with source citations
Your checkpoint
A 2-page regulatory crosswalk table linking 10 GCP/Part 11 requirements to specific data management tasks, with citations
EDC System Requirements and Architecture
Diagram the architecture of an EDC system (presentation, application, database, integration layers) and annotate data flow from entry to export
Compare EDC deployment models and identify which requirements (e.g., Part 11, GDPR, data residency) drive each choice
Specify the functional requirements for core EDC modules: form engine, edit checks, query workflow, audit trail, and reporting
Explain how CDISC ODM and CDASH/SDTM standards constrain EDC design decisions
Your checkpoint
A one-page EDC architecture diagram with a 10-item annotated requirements list covering audit trail, edit checks, and export
Study Build and Database Design
Draft an annotated CRF for a mock Phase II study covering demographics, dosing, and one AE form
Translate CRF fields into a database specification: variable names, types, codelists, and derivations
Write 15 edit-check specifications (range, cross-field, date logic) with severity and query text
Design the visit schedule and form-to-visit matrix for the mock study
Your checkpoint
A study build package: annotated CRF excerpt, data dictionary (20+ variables), and edit-check specification table
Data Entry, Validation, and Query Management
Trace a mock patient's data from entry through validation, query generation, site response, and closure
Classify query types (edit-check, manual, reconciliation) and write site-ready query text for 10 scenarios
Apply a query management SOP: define response timelines, escalation, and closure criteria
Practice entering data with intentional errors and resolve each query per the workflow
Your checkpoint
A completed query log for the mock study showing 10 queries from open to closed with resolution rationale
Data Quality, Cleaning, and Reconciliation
Define data quality dimensions (completeness, accuracy, consistency, timeliness) and map each to a measurable metric
Perform a mock SAE reconciliation between EDC and safety database extracts and document discrepancies
Reconcile external lab data against EDC entries and record resolution steps
Draft a data cleaning plan covering edit checks, medical coding review, and outlier handling
Your checkpoint
A reconciliation report for the mock study listing at least 8 discrepancies with disposition and a data cleaning plan outline
Security, Access Control, and Audit Trails
Specify role-based access control for a study: define roles, permissions, and least-privilege assignments
Explain the required content and immutability of an audit trail and identify what must never be editable
Outline security controls for authentication, password policy, session management, and data encryption at rest and in transit
Map GDPR and Part 11 privacy/security obligations to specific system controls
Your checkpoint
An access control matrix (roles x permissions) plus a 1-page audit trail and security controls specification
System Validation and Change Control
Write a validation plan for the mock EDC build covering risk assessment, IQ/OQ/PQ scope, and acceptance criteria
Draft 10 test scripts (positive and negative) for edit checks and audit trail behavior with expected results
Describe the change control process: impact assessment, testing, approval, and documentation for a mid-study edit-check change
Identify what constitutes a validated state and how to document deviations
Your checkpoint
A validation package: validation plan outline, 10 executed test scripts with pass/fail results, and a change control request form
Data Management Documentation and Closeout & Regulatory Framework and Clinical Trial Standards & Data Quality, Cleaning, and Reconciliation
Assemble the data management documentation set for closeout: DMP, DVP, database lock checklist, and transfer specification
Draft a database lock checklist and define lock criteria and sign-off roles
Review the full 8-week package for gaps against the exam domain weights and revise weak areas
Complete a timed 60-question self-assessment across all domains and score by domain
Your checkpoint
A closeout documentation binder (DMP outline, lock checklist, data transfer spec) plus a scored self-assessment with a targeted remediation list
Milestones
Week 2: Can explain EDC architecture and cite the regulatory drivers for each design choice without notes
Week 4: Can run the full query lifecycle end-to-end and produce site-ready query text for any scenario
Week 6: Can justify every access control and audit trail requirement with a regulatory or security rationale
Week 7: Can write and execute a test script for an edit check and document a change control decision
Week 8: Score 80%+ on the timed self-assessment and have a written remediation list for any domain below 75%