CPEDC study guide
CPEDC · Work through your exam, one topic at a time.
The Certified Professional in Electronic Data Capture (CPEDC) is a vendor-neutral credential for people who build, run, and defend the systems that collect clinical trial data. Candidates are typically clinical data managers, EDC study builders, database programmers, and clinical systems or quality specialists who want their practical EDC knowledge recognized in a form employers and sponsors can evaluate consistently. The CPEDC study guide has 8 sections and about 1,856 words.
01Regulatory Framework and Clinical Trial Standards
Clinical data management sits inside a web of rules. At the top is ICH-GCP E6, which establishes the investigator's responsibility for accuracy and the sponsor's responsibility for oversight and recordkeeping.
293 words, about 1 min02EDC System Requirements and Architecture
An electronic data capture (EDC) system must support protocol-driven data collection, audit trails, role-based access, and export capability. Architecture questions test understanding of tiers: presentation (browser), application (business logic), and database (persistence).
260 words, about 1 min03Study Build and Database Design
Study build translates the protocol into a database. The annotated CRF (aCRF) maps each collected field to a dataset and variable.
238 words, about 1 min04Data Entry, Validation, and Query Management
Data entry moves source data into the EDC. Validation uses edit checks to flag discrepancies.
227 words, about 1 min05Data Quality, Cleaning, and Reconciliation
Data cleaning identifies and resolves errors, inconsistencies, and outliers. Reconciliation compares data across sources (EDC vs.
211 words, about 1 min06Security, Access Control, and Audit Trails
Security protects confidentiality, integrity, and availability of trial data. Access control ensures users see only what their role requires (least privilege).
225 words, about 1 min07System Validation and Change Control
Validation demonstrates that a system consistently produces accurate results. The classic V-model links user requirements to design, build, and testing.
195 words, under 1 min08Data Management Documentation and Closeout
Documentation proves what was done and why. Core documents include the DMP, CRF and aCRF, edit check specifications, data transfer specifications, query logs, and the database lock checklist.
207 words, about 1 min