CCRA Data Management and Source Document Verification 3

Question 1

When a laboratory value is flagged outside the reference range, the investigator must:

Accepted Answer

Clinically evaluate the result, document their assessment, and determine whether it is clinically significant

Answer

Out-of-range lab values require the investigator to make a clinical significance determination; if clinically significant, appropriate action (including possible AE reporting) must follow and be documented.

Question 2

The ALCOA+ principles add which additional attributes beyond ALCOA?

Accepted Answer

Complete, Consistent, Enduring, and Available

Answer

ALCOA+ expands the original five attributes with Complete (all data present), Consistent (coherent dates/sequences), Enduring (recorded on durable media), and Available (accessible for review and audit).

Question 3

A 'data reconciliation' process between the safety database and the clinical database is performed to:

Accepted Answer

Ensure all adverse events captured in the safety system are accurately reflected in the clinical database and vice versa

Answer

Safety-to-clinical database reconciliation ensures that all adverse events, medications, and safety data are consistently recorded in both the safety reporting system and the clinical EDC.

Question 4

What is the minimum required retention period for clinical trial essential documents under FDA regulations?

Accepted Answer

2 years after a marketing application is approved, or 2 years after the IND is terminated if no application is filed

Answer

Under 21 CFR 312.62, investigational records must be retained for 2 years following the date a marketing application is approved, or 2 years after IND discontinuation if no application is submitted.

Question 5

Which practice best ensures blinding integrity during data management activities?

Accepted Answer

Limiting access to randomization codes to only those who need them for safety monitoring, with all others remaining blinded

Answer

Maintaining blinding integrity requires strict access controls to randomization codes, ensuring that only authorized personnel (e.g., DSMB members, emergency unblinding team) can access treatment assignments.

CCRA - Certified Clinical Research Associate Practice Test

CCRA - Certified Clinical Research Associate Practice Test

CCRA Data Management and Source Document Verification 3