Data Management and Source Document Verification Flashcards

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

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

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.

The ALCOA+ principles add which additional attributes beyond ALCOA?

Answer: Complete, Consistent, Enduring, and Available

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).

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

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

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.

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

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

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.

Which practice best ensures blinding integrity during data management activities?

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

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.

In electronic clinical trials, 21 CFR Part 11 governs:

Answer: The use of electronic records and electronic signatures, ensuring they are trustworthy and equivalent to paper records

21 CFR Part 11 establishes FDA requirements for electronic records and signatures to be considered reliable, trustworthy, and equivalent to their paper counterparts, covering audit trails, access controls, and validation.