SOCRA - Society of Clinical Research Associates FDA Regulations and Compliance Questions and Answers 1

Question 1

According to 21 CFR 312, an investigator is required to report a serious adverse event (SAE) to the sponsor:

Accepted Answer

Immediately, regardless of whether it is considered drug-related.

Answer

FDA regulation 21 CFR 312.64(b) requires investigators to immediately report any serious adverse event to the sponsor, whether or not the investigator considers the event to be drug-related. The sponsor then has specific timelines to report to the FDA, but the initial responsibility of the investigator is immediate notification to the sponsor.

Question 2

A clinical investigator conducting a study under an IND is required by 21 CFR 54 to disclose certain financial interests to the study sponsor. This disclosure must be updated:

Accepted Answer

During the study and for one year after completion.

Answer

According to 21 CFR 54.4(b), clinical investigators must provide the sponsor with accurate financial information and update this information if any relevant changes occur during the clinical study and for one year following its completion. This ensures that any potential for bias due to financial interests is monitored throughout the study and for a period after.

Question 3

Which of the following is a primary responsibility of an Institutional Review Board (IRB) as defined by FDA regulations?

Accepted Answer

To approve or disapprove research and ensure the protection of the rights and welfare of human subjects.

Answer

FDA regulations (21 CFR Part 56) establish that the primary purpose and authority of an IRB is to review, approve, require modifications to, or disapprove biomedical research involving human subjects. This role is critical to protect the rights, safety, and welfare of the participants.

Question 4

A site is preparing for a clinical trial involving an investigational new drug. The Principal Investigator (PI) must sign the FDA Form 1572. By signing this form, what is the PI committing to?

Accepted Answer

Complying with FDA regulations for the conduct of a clinical investigation and personally supervising the study.

Answer

The FDA Form 1572 is a legally binding agreement between the investigator and the sponsor. By signing it, the investigator commits to personally conduct or supervise the investigation, follow the protocol, and comply with all pertinent FDA regulations for the conduct of clinical trials, as outlined in 21 CFR 312.

Question 5

Under what circumstances may an FDA-regulated clinical investigation be initiated without a signed informed consent form from the subject?

Accepted Answer

In a life-threatening situation where specific conditions under 21 CFR 50.23 are met.

Answer

FDA regulations under 21 CFR 50.23 allow for an exception from the general requirements of informed consent in life-threatening situations when the subject cannot provide consent, time is not sufficient to obtain consent from a legal representative, and both the investigator and a non-participating physician certify these conditions in writing.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA - Society of Clinical Research Associates FDA Regulations and Compliance Questions and Answers 1