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

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

Within 24 hours of becoming aware of the event.

Answer

Within 7 calendar days if it is unexpected and life-threatening.

Answer

Only after confirming the event is directly caused by the investigational product.

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

Only at the beginning of the study.

Answer

Annually at the time of the continuing review.

Answer

Only if the financial interest exceeds $50,000.

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

To ensure the scientific validity and design of the research protocol.

Answer

To monitor the investigational product's manufacturing process for quality control.

Answer

To negotiate the clinical trial agreement and budget with the sponsor.

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

Guaranteeing a minimum number of subjects will be enrolled at the site.

Answer

Personally conducting every study-related procedure for all enrolled subjects.

Answer

Assuming full financial responsibility for any subject injuries.

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

When the study involves no more than minimal risk.

Answer

When the subject is a minor and a parent has provided verbal permission.

Answer

If the Institutional Review Board (IRB) provides a blanket waiver for all subjects in the study.

Question 6

Which of the following must be submitted to the FDA to obtain an exemption to ship an unapproved drug across state lines for a clinical investigation?

Accepted Answer

An Investigational New Drug Application (IND).

Answer

A marketing application (NDA or BLA).

Answer

An Institutional Review Board (IRB) approval letter.

Answer

A signed Form FDA 483.