SOCRA - Society of Clinical Research Associates Audits, Monitoring, and Inspections Questions and Answers 2

Question 1

What is the difference between a clinical trial audit and an inspection?

Accepted Answer

An audit is by the sponsor; an inspection is by a regulatory authority

Answer

Per ICH-GCP, an audit is conducted by or on behalf of the sponsor; an inspection is by regulatory authorities.

Question 2

What triggers an FDA for-cause inspection?

Accepted Answer

Concerns about data integrity, safety issues, high enrollment, or unusual data patterns

Answer

For-cause inspections are triggered by specific concerns such as suspected data fabrication, safety issues, or data inconsistencies.

Question 3

What are key responsibilities during a routine monitoring visit?

Accepted Answer

Verifying consent, source data, protocol compliance, drug accountability, AE reporting, and document maintenance

Answer

CRAs verify informed consent, perform SDV, assess compliance, check drug accountability, review AE reporting, and ensure documents are maintained.

Question 4

What is a Corrective and Preventive Action (CAPA) plan?

Accepted Answer

A systematic approach to identify, correct problems, and prevent recurrence

Answer

A CAPA identifies root causes, implements corrective actions, and establishes preventive measures.

Question 5

What is risk-based monitoring (RBM) per ICH E6(R2)?

Accepted Answer

A monitoring approach focusing resources on critical data and processes based on risks

Answer

RBM directs monitoring toward the most important aspects based on risk assessment, combining on-site and centralized techniques.

(SOCRA) Society of Clinical Research Associates Practice Test