Data Collection and Source Documentation

Define and apply each element of the ICH E6(R3) data integrity criteria with specific CRC-relevant examples, and distinguish the E6(R3) framework from the industry ALCOA-CCEA mnemonic.

Explain the data governance framework introduced in ICH E6(R3) Annex 1, Section 4, including data lifecycle elements, computerized systems requirements, and the CRC's role in implementing governance at the site level.

Examine real-world categories of data integrity failure, trace the cascade of consequences for all stakeholders, and distinguish intentional from unintentional failures.

Understand the CRC's unique position in the data chain, identify systemic threats to data quality, and develop strategies for protecting data integrity at the point of creation.

Parse the ICH E6(R3) definitions of source data and source documents, identify source for each data category, and understand certified copies and prospective source determination.

Identify CRF structural elements, apply completion guidelines for dates, units, and missing data, recognize common pitfalls, and understand the CRF as an investigator attestation.

Navigate EDC systems, execute the data entry workflow, manage operational challenges, and leverage quality-supporting features.

Differentiate hard, soft, and cross-form edit checks, respond appropriately to each type, recognize edit check fatigue, and understand the clinical logic behind validation rules.

Differentiate three query types, identify triggers and response pathways, read query content effectively, and interpret query metrics as quality indicators.

Execute systematic query resolution, write effective responses, route queries to investigators when needed, and handle queries that reveal actual data errors.

Understand the SDV process, what monitors verify, how risk-based monitoring shapes SDV practices, and how centralized statistical monitoring detects data patterns.

Organize source documents for monitoring visits, achieve pre-monitoring data readiness, support SDV efficiently, and self-discover issues before the monitor arrives.

Define ePRO and eCOA, describe CRC responsibilities for electronic outcome assessments, apply source documentation principles to ePRO data, and address common challenges.

Understand wearable devices in clinical trials, distinguish passive from active data collection, fulfill CRC responsibilities for device management, and apply source documentation principles to sensor data.