CRP Regulatory Compliance & Guidelines 3

Question 1

A researcher wants to conduct a retrospective chart review using de-identified patient records at a hospital. Which of the following is most accurate regarding IRB oversight?

Accepted Answer

The research may qualify for exemption if data cannot be linked back to individuals

Answer

Retrospective chart reviews using truly de-identified data may qualify for IRB exemption because de-identified data does not meet the definition of human subjects research under 45 CFR 46.

Question 2

Which of the following best describes a 'minimal risk' study under the Common Rule (45 CFR 46)?

Accepted Answer

The probability and magnitude of harm are not greater than those encountered in daily life or routine physical/psychological examinations

Answer

The Common Rule defines minimal risk as research where the probability and magnitude of harm are not greater than those ordinarily encountered in daily life or routine examinations.

Question 3

Under HIPAA, which of the following is NOT one of the 18 identifiers that must be removed to create a de-identified dataset under the Safe Harbor method?

Accepted Answer

Participant's research ID number assigned by the study team

Answer

Research ID numbers assigned by the study team are not PHI identifiers under HIPAA's Safe Harbor method; the 18 identifiers include account numbers, SSNs, and medical record numbers but not arbitrary study codes.

Question 4

A clinical trial sponsored by a pharmaceutical company is underway. The FDA inspects the site and finds that the investigator failed to follow the protocol. Under 21 CFR Part 312, what action can FDA take?

Accepted Answer

Disqualify the investigator from receiving investigational drugs

Answer

Under 21 CFR Part 312.70, FDA can disqualify a clinical investigator who has repeatedly or deliberately failed to comply with regulatory requirements.

Question 5

Which element of informed consent is required under 45 CFR 46.116 but is often misunderstood as optional?

Accepted Answer

A statement that participation is voluntary and refusal involves no penalty

Answer

45 CFR 46.116 explicitly requires that consent documents state participation is voluntary and that refusal or withdrawal will involve no penalty or loss of benefits.

(CRP) Certified Research Professional Practice Test

(CRP) Certified Research Professional Practice Test

CRP Regulatory Compliance & Guidelines 3