21 CFR 312 Flashcards
What is 21 CFR Part 312?
A federal regulation that establishes the requirements for the submission of Investigational New Drug (IND) applications for clinical trials involving human subjects.
Who is responsible for submitting an Investigational New Drug (IND) application according to 21 CFR Part 312?
The sponsor is responsible for submitting an IND application.
What information must be included in an Investigational New Drug (IND) application according to 21 CFR Part 312?
1) Form 1571 (Cover Sheet)
2) A table of contents
3) Introductory statement and general investigational plan
4) Investigator’s Brochure
5) Protocol for each planned study
6) Chemistry, manufacturing, and control information
7) Pharmacology and toxicology information
8) Previous human experience with the Drug
9) Other additional or relevant information
Describe the IND safety reporting requirements under 21 CFR Part 312.32.
The Sponsor must notify FDA and all participating investigators in an IND safety report of potential serious risks from clinical trials or any other source as soon as possible (no later than 15 calendar days) if the information includes any suspected Serious and Unexpected Adverse Reaction, Findings from other studies or from animal or in-vitro testing that suggest a significant risk to humans, or an increased rate of Serious Expected Adverse Reactions.
The Sponsor must notify FDA of any unexpected fatal or life-threatening suspected adverse reactions as soon as possible (no later than 7 calendar days).
The sponsor uses Form 3500A (Mandatory AE/AR reporting) to report these instances.
When is an IND application required before conducting clinical trials with an investigational drug?
An IND application is required when testing a new drug that has not been approved for commercial marketing or when studying a previously approved drug for a new indication, dosage, or patient population.
Explain the role of the Institutional Review Board (IRB) in the context of 21 CFR Part 312.
The IRB reviews and approves the clinical trial protocol, and informed consent form, and ensures the protection of the rights and welfare of human subjects. FDA requires IRB approval before an IND application can be submitted.
What is the purpose of the IND review process by the FDA under 21 CFR Part 312?
The FDA reviews the IND to ensure the safety and rights of human subjects, the scientific integrity of the study, and that the benefits outweigh the risks.
What are the phases of clinical trials mentioned in 21 CFR Part 312, and what distinguishes them?
Phases are I, II, III, and IV.
Phase 1 (Safety): Assess safety and dosage.
Phase 2 (Efficacy): Evaluate effectiveness and side effects.
Phase 3 (Confirmation): Confirm efficacy and monitor adverse reactions.
Phase 4: Post-marketing surveillance for additional risk/benefit data.
What should be included in the Investigator’s Brochure according to 21 CFR Part 312?
-A brief description of the drug and it’s formulation
-A summary of pharmacological/toxicological effects of the drug in animals/humans
-A summary of pharmacokinetics/biological disposition of the drug in animals/humans
-A summary of safety/effectiveness in human from prior clinical studies
-A description of anticipated risks/side effects based on prior studies
-A description of precautions or special monitoring to be done when using the drug
What additional info might be applicable to include in an IND submission?
1) Drug dependence and abuse potential
2) Radioactive Drug info
3) Pediatric Study plan
How does 21 CFR Part 312 define a clinical hold?
A clinical hold is an order issued by the FDA to the Spomsor to delay a proposed clinical investigation or suspend an ongoing clinical trial due to concerns about participant safety.
How does 21 CFR Part 312 address the expedited review process for certain IND applications?
The expedited review process allows for faster evaluation of drugs intended to treat serious or life-threatening conditions.
Explain the concept of “sponsor-investigator” in 21 CFR Part 312.
A sponsor-investigator is an individual who both initiates and conducts an investigation and is responsible for ensuring compliance with regulatory requirements.
What is the purpose of the IND Annual Report according to 21 CFR Part 312? (When is it due and from who?)
Within 60 days of the anniversary date that the IND went into effect, the sponsor must submit a brief process report to the FDA to inform them of enrollment, study disposition, safety data, and changes to the protocol or any other study documents.
Define “Investigational New Drug (IND)” according to 21 CFR Part 312.
An IND is a submission to the FDA that contains information on a new drug’s safety and efficacy, allowing the initiation of clinical trials in humans.
