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

No difference

Answer

An audit is more serious

Answer

Inspections are voluntary

Question 2

What triggers an FDA for-cause inspection?

Accepted Answer

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

Answer

Random selection only

Answer

Every site is for-cause inspected

Answer

Only participant complaints

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

Only checking drug supply

Answer

Just collecting CRFs

Answer

Only meeting the PI

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 plan to increase enrollment

Answer

A financial strategy

Answer

A manufacturing process

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

Monitoring only high-enrollment sites

Answer

Eliminating on-site visits

Answer

Only for Phase III

Question 6

What essential documents must be in the investigator site file?

Accepted Answer

All documents permitting evaluation of trial conduct and data quality

Answer

Only the protocol

Answer

Only consent forms

Answer

Only the drug log