SOCRA - Society of Clinical Research Associates Audits, Monitoring, and Inspections Questions and Answers 2 — Questions and Answers
Question 1: What is the difference between a clinical trial audit and an inspection?
- No difference
- An audit is by the sponsor; an inspection is by a regulatory authority (Correct answer)
- An audit is more serious
- Inspections are voluntary
Correct answer: An audit is by the sponsor; an inspection is by a regulatory authority
Per ICH-GCP, an audit is conducted by or on behalf of the sponsor; an inspection is by regulatory authorities.
An audit is a systematic examination by the sponsor or third party. An inspection is by regulatory authorities (FDA, EMA, MHRA). Audits are planned by the sponsor; inspections can be routine, submission-triggered, or for-cause.
Question 2: What triggers an FDA for-cause inspection?
- Random selection only
- Concerns about data integrity, safety issues, high enrollment, or unusual data patterns (Correct answer)
- Every site is for-cause inspected
- Only participant complaints
Correct answer: Concerns about data integrity, safety issues, high enrollment, or unusual data patterns
For-cause inspections are triggered by specific concerns such as suspected data fabrication, safety issues, or data inconsistencies.
Common triggers include suspected fraud, unusual data patterns, high enrollment rates, participant complaints, whistleblower reports, discrepancies during routine inspections, and issues during NDA/BLA review.
Question 3: What are key responsibilities during a routine monitoring visit?
- Only checking drug supply
- Verifying consent, source data, protocol compliance, drug accountability, AE reporting, and document maintenance (Correct answer)
- Just collecting CRFs
- Only meeting the PI
Correct answer: Verifying consent, source data, protocol compliance, drug accountability, AE reporting, and document maintenance
CRAs verify informed consent, perform SDV, assess compliance, check drug accountability, review AE reporting, and ensure documents are maintained.
ICH E6(R2) Section 5.18.4 outlines verifying consent, source data verification, protocol compliance, IP storage and accountability, AE documentation, and essential document completeness.
Question 4: What is a Corrective and Preventive Action (CAPA) plan?
- A plan to increase enrollment
- A systematic approach to identify, correct problems, and prevent recurrence (Correct answer)
- A financial strategy
- A manufacturing process
Correct answer: A systematic approach to identify, correct problems, and prevent recurrence
A CAPA identifies root causes, implements corrective actions, and establishes preventive measures.
An effective CAPA includes problem identification, root cause analysis, action plan with responsibilities and timelines, implementation tracking, effectiveness verification, and documentation. CAPAs demonstrate commitment to quality.
Question 5: What is risk-based monitoring (RBM) per ICH E6(R2)?
- Monitoring only high-enrollment sites
- A monitoring approach focusing resources on critical data and processes based on risks (Correct answer)
- Eliminating on-site visits
- Only for Phase III
Correct answer: A monitoring approach focusing resources on critical data and processes based on risks
RBM directs monitoring toward the most important aspects based on risk assessment, combining on-site and centralized techniques.
RBM involves risk identification, risk assessment, centralized monitoring (statistical analyses, data trends), targeted on-site visits, and adaptive monitoring frequency based on site performance.
Question 6: What essential documents must be in the investigator site file?
- Only the protocol
- All documents permitting evaluation of trial conduct and data quality (Correct answer)
- Only consent forms
- Only the drug log
Correct answer: All documents permitting evaluation of trial conduct and data quality
Essential documents include all records that permit evaluation of the trial and the quality of data produced.
ICH E6 Section 8 lists documents by trial phase including signed protocol, IRB approvals, IB, consent forms, source documents, CRFs, drug accountability records, monitoring reports, lab certifications, and delegation log.
SOCRA - Society of Clinical Research Associates Audits, Monitoring, and Inspections Questions and Answers 2
What is the difference between a clinical trial audit and an inspection?