Data Collection & CRF Management Flashcards

In a clinical trial, 'source document verification' (SDV) refers to:

Answer: The process of comparing data in the CRF against original source documents to confirm accuracy

SDV is the monitoring activity of comparing CRF entries against original source records (lab reports, medical charts, etc.) to confirm that data was accurately transcribed.

A data management plan (DMP) for a Phase III trial TYPICALLY includes which of the following?

Answer: Database design, data collection methods, query management procedures, and data lock criteria

A DMP describes how data will be collected, managed, and cleaned throughout the trial, including database design, edit check logic, query handling, and criteria for data lock.

Which of the following scenarios represents a violation of data integrity principles?

Answer: Pre-dating a CRF entry to match the date a procedure was supposed to have occurred

Pre-dating entries to match a scheduled procedure date rather than the actual date of entry violates the 'contemporaneous' and 'attributable' requirements of ALCOA and constitutes data falsification.

Risk-based monitoring (RBM) approaches in clinical trials often use 'centralized statistical monitoring' (CSM) to:

Answer: Identify data patterns and anomalies across sites that may indicate data integrity issues without on-site presence

CSM analyzes data across all sites for statistical outliers, unusual patterns, or fabrication signals, allowing sponsors to prioritize monitoring resources toward higher-risk sites.

A site uses both paper CRFs and an electronic data capture system for the same study. This hybrid approach requires:

Answer: Clear procedures specifying which system is the source record to avoid duplicate or conflicting data

Hybrid data collection requires unambiguous procedures identifying which record is the source to prevent conflicting data and ensure a clear audit trail.

When a subject withdraws from a clinical trial, the CRF should:

Answer: Document the withdrawal date, reason for withdrawal, and last known data points, then close the subject record appropriately

Withdrawal must be documented with the date, reason, and final data points; previously collected data is retained per the protocol and regulatory requirements unless the subject specifically requests data deletion (where permitted).

In EDC systems, 'edit checks' serve what primary function?

Answer: They automatically flag inconsistent, out-of-range, or logically impossible data entries at the point of data entry

Edit checks (also called validation rules) are programmed into eCRF systems to detect data entry errors — such as impossible dates, out-of-range values, or missing required fields — in real time.