SOCRA CCRP Regulatory Compliance 3

Question 1

What is the key distinction between a 'sponsor' and an 'investigator' under FDA regulations?

Accepted Answer

The sponsor initiates and oversees the trial; the investigator conducts it at the site

Answer

Under 21 CFR Part 312, the sponsor initiates and takes responsibility for the investigation, while the investigator conducts it at a specific site.

Question 2

What must a site do when a protocol deviation occurs that increases risk to participants?

Accepted Answer

Report it to the IRB and sponsor promptly

Answer

Protocol deviations that increase risk to participants must be reported promptly to both the IRB and the sponsor per GCP requirements.

Question 3

Under HIPAA, what does 'minimum necessary' mean in the context of clinical research?

Accepted Answer

Only protected health information needed for the specific research purpose should be accessed

Answer

The HIPAA 'minimum necessary' standard requires that only the PHI needed to accomplish the intended research purpose is used or disclosed.

Question 4

What is the role of an IRB in the context of an expedited review?

Accepted Answer

Review minimal-risk studies or minor changes to approved research without full board convening

Answer

Expedited IRB review allows a designated reviewer to approve minimal-risk studies or minor protocol changes without convening the full board.

Question 5

According to FDA regulations, which of the following is NOT required on a Form FDA 1572?

Accepted Answer

The investigator's financial disclosure information

Answer

Financial disclosure is collected on Form FDA 3455/3454, not on Form FDA 1572, which covers investigator commitments and site information.

SOCRA CCRP - SOCRA Certified Clinical Research Professional Practice Test