CCRA Data Management and Source Document Verification 2

Question 1

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

Accepted Answer

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

Answer

Encrypting the trial database at study startup

Answer

Locking physical CRF binders at the site

Answer

The EDC system going offline for maintenance

Question 2

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

Accepted Answer

100% of all CRF data compared to source documents

Answer

25% of critical data fields

Answer

50% of safety data only

Answer

10% random sampling of all data

Question 3

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

Accepted Answer

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

Answer

FDA Guidance on IND Applications (2012)

Answer

ICH E8 General Considerations for Clinical Studies

Answer

21 CFR Part 50 Informed Consent

Question 4

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

Accepted Answer

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

Answer

Correct CRF data automatically without site input

Answer

Grant data entry permissions to site coordinators

Answer

Send regulatory submissions automatically

Question 5

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

Accepted Answer

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

Answer

The statistical analysis plan for primary endpoints only

Answer

Subject recruitment and retention strategies

Answer

Investigational product manufacturing specifications

Question 6

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

Accepted Answer

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

Answer

CRF data only, not source data

Answer

Secondary data derived from clinical assessments

Answer

Not admissible as evidence in regulatory submissions