Data Management and Source Document Verification Flashcards

The 'data lock' in a clinical trial refers to:

Answer: The point at which the database is closed to further changes in preparation for statistical analysis

Database lock is the formal process of freezing the clinical database after all data queries are resolved, confirming the dataset is complete and ready for unblinded statistical analysis.

What percentage of SDV is typically used in a traditional 100% SDV monitoring approach?

Answer: 100% of all CRF data compared to source documents

Traditional monitoring required 100% SDV of all CRF data against source documents, though modern risk-based approaches allow reduced SDV targeting critical data only.

Which regulatory guidance specifically supports a reduced and risk-adapted approach to source data verification?

Answer: FDA Guidance for Industry: Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring (2013)

The FDA's 2013 RBM guidance explicitly endorses a risk-based approach to monitoring including targeted SDV focused on critical data rather than 100% verification of all data.

In clinical data management, 'edit checks' are used to:

Answer: Validate data entries against predefined rules to detect out-of-range values, missing data, or logical inconsistencies

Edit checks (or validation rules) are programmed into EDC systems to flag data that is missing, illogical, or outside expected ranges, prompting review or generating queries.

A 'data management plan' (DMP) in a clinical trial typically includes:

Answer: Database design, data collection procedures, validation rules, and quality control processes for the trial's data

The DMP outlines how data will be collected, validated, cleaned, and managed throughout the trial, covering EDC configuration, query management, coding, and database lock procedures.

Subject diaries used to collect patient-reported outcomes (PROs) are considered:

Answer: Source documents, as they represent the original record of subject-reported information

Subject diaries are source documents because they capture data directly from the subject as the original record, and must be retained according to the same archiving requirements as other source documents.