CPCD study plan
CPCD · Give each week a clear focus.
8 weeks · About 6 hours per week
Clinical Data Management Fundamentals and Regulatory Environment
Define the purpose and scope of clinical data management and list the core documents it produces
Map each major regulatory source (ICH GCP, 21 CFR Part 11, GDPR-like privacy rules) to the data management activity it governs
Differentiate the roles of sponsor, CRO, investigator site, and data manager in the data lifecycle
Outline the sequence of a study from protocol to database lock using a one-page flow diagram
Your checkpoint
A one-page annotated data lifecycle diagram with each stage labeled by the regulation or guidance that governs it
Clinical Data Management Fundamentals and Regulatory Environment & Study Start-Up and Data Management Planning
Identify the components of a Data Management Plan and explain the purpose of each section
Draft study start-up activities in order, from protocol review through first-patient-in readiness
Describe how protocol objectives translate into data collection requirements
List the contents of a CRF completion guideline and an investigator site file relevant to data
Your checkpoint
A skeleton Data Management Plan for a hypothetical Phase II study covering at least eight standard sections
CRF Design and Database Build
Distinguish required, optional, and derived data fields and justify each choice
Design CRF pages that avoid ambiguous questions, leading prompts, and redundant entries
Apply database build concepts: edit checks, field types, code lists, and visit schedules
Explain the purpose of user acceptance testing and write sample test scripts
Your checkpoint
Three redesigned CRF pages plus five UAT test scripts with expected results for a sample form
Data Entry, Validation, and Discrepancy Management
Compare manual and electronic data entry workflows and their error profiles
Classify edit checks as range, consistency, format, and cross-form and give an example of each
Write a query that is specific, neutral in tone, and actionable for a site coordinator
Trace a discrepancy from detection through resolution and closure, including audit trail entries
Your checkpoint
A discrepancy log with ten realistic queries, each showing detection method, query text, response, and resolution status
Data Entry, Validation, and Discrepancy Management & Data Cleaning and Quality Control
Apply a risk-based approach to prioritizing cleaning activities across visit types and endpoints
Execute a mock data review: list outliers, missing values, and protocol deviations from a sample dataset
Describe source data verification, its sampling rationale, and how its findings feed query generation
Explain how medical coding findings and lab ranges trigger data cleaning actions
Your checkpoint
A written data review report on a sample dataset identifying at least fifteen issues with recommended actions
Data Cleaning and Quality Control & Coding and Data Standardization
Distinguish data cleaning from quality control and describe the QC steps performed before lock
Outline the coding workflow for adverse events and concomitant medications using standard dictionaries
Explain how dictionary versions, coding conventions, and auto-encoding affect consistency
Identify common coding pitfalls such as partial matches and verbatim-to-term mismatches
Your checkpoint
A coding worksheet of twenty verbatim terms coded to preferred terms with a note on each ambiguous case
Safety Data Handling and Reconciliation & Database Lock, Study Close-Out, and Archival
Describe the safety data flow from site entry to sponsor safety database and the reconciliation touchpoints
Draft a reconciliation procedure for serious adverse events and pregnancies between clinical and safety databases
List the prerequisites, participants, and outputs of a database lock meeting
Explain archival requirements, retention periods, and the role of the audit trail in reconstruction
Your checkpoint
A reconciliation checklist and a database lock readiness checklist, each with at least ten line items
Data Management Systems, Technology, and Data Integrity & Data Entry, Validation, and Discrepancy Management & Database Lock, Study Close-Out, and Archival
Explain the data integrity principles behind audit trails, e-signatures, and access controls
Evaluate system validation and change control requirements for a clinical data system
Complete a timed mixed-domain practice set and analyze errors by domain
Build a personal weak-area remediation list with specific next actions
Your checkpoint
A scored practice exam summary with a prioritized remediation plan listing three weak domains and a study action for each
Milestones
Week 2: Can explain the Data Management Plan sections and study start-up sequence without notes
Week 4: Scores at least 80% on a self-made quiz covering domains 1 through 4
Week 6: Completes the data review and coding deliverables with defensible justifications for each decision
Week 8: Scores at least 80% overall on a timed mixed-domain practice set, with no domain below 70%