SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates FDA Regulations and Compliance 1 — Questions and Answers
Question 1: What is the primary purpose of FDA Form 1572 (Statement of Investigator)?
- To authorize payment to clinical trial participants
- To document an investigator's commitments and qualifications to conduct an IND study (Correct answer)
- To report serious adverse events directly to the FDA
- To request emergency use authorization for an investigational drug
Correct answer: To document an investigator's commitments and qualifications to conduct an IND study
FDA Form 1572 is a legally binding agreement in which the investigator commits to following applicable FDA regulations, GCP, and the study protocol. By signing it, the investigator becomes a legal subject of FDA oversight and inspection.
Question 2: Under 21 CFR Part 50, which of the following is a basic required element of informed consent?
- The sponsor's projected revenue from the investigational product
- A description of reasonably foreseeable risks or discomforts to the subject (Correct answer)
- The investigator's curriculum vitae and training history
- The IRB's internal vote tally on study approval
Correct answer: A description of reasonably foreseeable risks or discomforts to the subject
21 CFR 50.25(a)(2) explicitly requires that informed consent documents include a description of any reasonably foreseeable risks or discomforts so that subjects can make a truly informed decision about participation.
Question 3: Under 21 CFR Part 312.32, within how many calendar days must a sponsor report an unexpected fatal or life-threatening serious adverse event to the FDA?
- 7 calendar days (Correct answer)
- 15 calendar days
- 30 calendar days
- 45 calendar days
Correct answer: 7 calendar days
21 CFR 312.32(c)(2) requires sponsors to notify the FDA within 7 calendar days of receiving information about an unexpected serious adverse event that is fatal or life-threatening, reflecting the urgency of protecting trial participants.
Question 4: What is an FDA Form 483?
- A formal application to begin human clinical trials
- A written list of inspectional observations issued to a facility at the close of an FDA inspection (Correct answer)
- A certification confirming GCP training for clinical investigators
- An authorization granting expanded access to an unapproved drug
Correct answer: A written list of inspectional observations issued to a facility at the close of an FDA inspection
FDA Form 483 is issued by an FDA investigator at the conclusion of a facility inspection and documents conditions or practices observed that may constitute violations of applicable regulations. The recipient is expected to respond with a corrective action plan.
Question 5: Which FDA application must a sponsor submit to request approval to commercially market a new small-molecule drug in the United States after completing clinical development?
- IND (Investigational New Drug Application)
- NDA (New Drug Application) (Correct answer)
- BLA (Biologics License Application)
- ANDA (Abbreviated New Drug Application)
Correct answer: NDA (New Drug Application)
An NDA is submitted under 21 CFR Part 314 to formally ask the FDA to approve a new pharmaceutical compound for sale and marketing in the U.S., compiling all preclinical and clinical data generated during development.
Question 6: Under 21 CFR Part 56, what is the minimum number of members required for an Institutional Review Board (IRB)?
- Three members
- Five members (Correct answer)
- Seven members
- Ten members
Correct answer: Five members
21 CFR 56.107(a) specifies that each IRB must have at least five members with sufficiently diverse backgrounds, including at least one member with primarily scientific expertise and one with primarily nonscientific expertise, to allow adequate review.
SOCRA - Society of Clinical Research Associates Society of Clinical Research Associates FDA Regulations and Compliance 1
What is the primary purpose of FDA Form 1572 (Statement of Investigator)?