Quality Control & Regulatory Compliance Flashcards

Under 21 CFR Part 11, which technical control is required to ensure electronic records cannot be altered without detection?

Answer: Audit trails that capture date, time, and operator identity

21 CFR Part 11 mandates audit trails that record the date, time, and identity of individuals who create, modify, or delete electronic records.

A sponsor receives a critical finding during an FDA inspection that a required source data verification (SDV) step was skipped for 30% of CRF entries. Which CDISC standard directly governs the expectation for SDV documentation?

Answer: ICH E6(R2)

ICH E6(R2) GCP guidelines set expectations for source data verification procedures and documentation as part of monitoring activities.

Which of the following best describes a 'critical data element' in clinical data management?

Answer: Data that directly affects subject safety assessments or primary efficacy endpoints

Critical data elements are those that directly impact subject safety or primary efficacy endpoints and therefore require the highest level of quality control scrutiny.

During a CAPA investigation following a data quality audit, the root cause is identified as inadequate CRF completion guidelines. What is the most appropriate immediate corrective action?

Answer: Revise the completion guidelines and issue updated site training before data collection resumes

Revising the completion guidelines and retraining site staff directly addresses the identified root cause and prevents recurrence of the quality issue.

Which regulatory agency guidance specifically addresses risk-based monitoring (RBM) strategies in clinical trials?

Answer: FDA Guidance on Oversight of Clinical Investigations: A Risk-Based Approach to Monitoring

The FDA's 2013 Guidance on Oversight of Clinical Investigations introduced a risk-based approach to monitoring, encouraging sponsors to focus resources on critical data and processes.

A data manager identifies that a site consistently enters laboratory values in mg/dL when the protocol specifies mmol/L. Which QC process should have caught this earliest?

Answer: Edit check programming during eCRF build

Edit checks programmed during eCRF build can validate units at the point of entry, catching unit inconsistencies before they propagate through the dataset.

Under ICH E6(R2) GCP, the sponsor's obligation to retain essential documents from a clinical trial is:

Answer: As required by applicable regulatory requirements, typically at least 2 years after marketing approval or study discontinuation

ICH E6(R2) requires sponsors to retain essential documents per applicable regulatory requirements, which typically means at least 2 years after the last marketing approval or 2 years after discontinuation.