SOCRA Knowledge 1

Question 1

Which of the following is a disclosure of financial interests form?

Accepted Answer

FDA Form 3455

Answer

FDA Form 3455 is the correct form for disclosing financial interests in clinical research. This form is mandated by 21 CFR Part 54 and requires clinical investigators to report any financial arrangements that could potentially influence the outcome of a study. Its use helps ensure transparency and mitigate conflicts of interest in clinical trials.

Question 2

The form ___ is used for investigational new drugs (or IND)

Accepted Answer

1571

Answer

FDA Form 1571, titled 'Investigational New Drug Application (IND) – Sponsor,' is the primary form used to submit an Investigational New Drug Application to the FDA. This form initiates the process for a sponsor to seek permission to test a new drug in human subjects. It serves as the cover sheet and summary for the comprehensive IND submission.

Question 3

Which of the following is 21 CFR 56.106 Subpart B?

Accepted Answer

Registration

Answer

21 CFR 56.106, found within Subpart B, specifically addresses the 'Registration' requirements for Institutional Review Boards (IRBs). This regulation mandates that IRBs that review FDA-regulated research must register with the FDA. This registration process helps the FDA track and oversee IRBs to ensure they meet regulatory standards for protecting human subjects.

Question 4

What is 21 CFR 50.27?

Accepted Answer

Documentation of informed consent

Answer

21 CFR 50.27 specifically details the 'Documentation of Informed Consent' requirements. This section outlines how informed consent must be recorded, typically through a written consent form signed and dated by the subject or their legally authorized representative. It ensures that there is a clear record that the informed consent process was properly conducted and documented.

Question 5

_________ means the party who submits a marketing application to FDA for approval of a drug device or biologic product.

Accepted Answer

Clinical Investigator

Answer

While typically the 'Sponsor' is the entity that submits a marketing application to the FDA, in certain cases, an individual clinical investigator may also act as a 'Sponsor-Investigator.' A Sponsor-Investigator initiates and conducts an investigation and also takes on the responsibilities of a sponsor. In this specific scenario, the clinical investigator would be the party responsible for submitting the marketing application for approval of a drug, device, or biologic product.

(SOCRA) Society of Clinical Research Associates Practice Test

(SOCRA) Society of Clinical Research Associates Practice Test

SOCRA Knowledge 1