SCDM Data Collection and EDC Systems 3

Question 1

What is a 'blind data review' (BDR) in clinical data management?

Accepted Answer

A review of cleaned, blinded data by the study team before unblinding to confirm readiness for analysis

Answer

A review of adverse events conducted without site identification

Answer

An audit of edit check logic before database go-live

Answer

A review of SAE narratives before regulatory submission

Question 2

What is the role of a 'data transfer specification' in EDC implementations involving external data feeds?

Accepted Answer

To define the format, structure, frequency, and validation rules for data imported from external sources such as labs

Answer

To authorize third-party vendors to access the EDC system

Answer

To document the statistical mapping rules for external laboratory data

Answer

To specify the firewall configuration for external data connections

Question 3

In the context of EDC systems, what is 'role-based access control'?

Accepted Answer

A security mechanism that grants users access only to data and functions permitted by their assigned role

Answer

A system that routes queries to the appropriate team member automatically

Answer

A feature that controls which subjects a site can enroll based on quotas

Answer

A mechanism for restricting EDC access during database lock

Question 4

What is a 'screen failure' in clinical trial data collection?

Accepted Answer

A subject who consents and undergoes screening assessments but does not meet eligibility criteria to enroll

Answer

An EDC system error that prevents a site from submitting a form

Answer

A monitoring finding indicating incomplete source documentation

Answer

A database validation test that identifies a design flaw

Question 5

What is the purpose of a 'data listing review' prior to database lock?

Accepted Answer

To manually review tabular data listings to identify any remaining errors or inconsistencies before locking the database

Answer

To generate the final statistical analysis tables from the clean database

Answer

To archive all CRF images to the TMF before lock

Answer

To audit the EDC system's user activity logs for the full study period

Question 6

In EDC data management, what is the significance of a 'query aging report'?

Accepted Answer

It tracks how long outstanding queries have been open, helping management identify and escalate unresolved issues

Answer

It monitors the age of subjects enrolled in the trial

Answer

It reports how frequently edit checks have been triggered over time

Answer

It measures the time elapsed since each site's last monitoring visit