21 CFR Part 312 Flashcards
Grounds for imposition of a clinical hold include the following:
a) the investigator brochure is misleading
b) the investigator brochure is complete
c) the IND does not contain sufficient information to assess risks
d) a and c
d) a and c
312. 42
The immediate package of an investigational new drug intended for human use shall bear a label with the statement:
a) “Caution: for FDA research purposes only”
b) “Caution: New drug - limited known side effects”
c) “Caution: New drug - Limited by Federal (or United States) law to investigational use”
d) none of the above
c) “Caution: New drug - Limited by Federal (or United States) law to investigational use”
312. 6(a)
Subject means a human who participates in an investigation, as a recipient of the investigational new drug. A subject may be a healthy human or a patient with a disease.
true
false
false
Subjects means a human who participates in an investigation, either as a recipient of the investigational new drug or as a control. A subject may be a healthy human or a patient with a disease.
312.3
________ studies usually include from several hundred to several thousand subjects.
a) Phase 1
b) Phase 2
c) Phase 3
d) all of the above
c) Phase 3
312. 21(c)
The FDA may propose to terminate an IND during Phase 1 if it finds:
a) human subjects would be exposed to an unreasonable and significant risk of illness or injury
b) the clinical investigations are being conducted in a manner substantially different than that described in the protocol submitted in the IND
c) the sponsor fails to submit an accurate report of the investigations
d) all of the above
d) all of the above
312. 44(b)
What is an organization contracted by the sponsor of a clinical trial to perform one or more trial-related obligations?
a) Clinical Research Organization
b) Contract Research Organization
c) Center for Research Operations
d) Contracted Research Operations
b) Contract Research Organization
312. 3
Prior to permitting an investigator to begin participation in an investigation, the sponsor shall obtain:
a) signed FDA 1572
b) curriculum vitae
c) protocol
d) financial disclosure information
e) all of the above
e) all of the above
312. 53
If a sponsor discovers an investigator is not compliant with FDA Form 1572, the sponsor can either secure compliance or discontinue shipments of the investigational new drug.
true
false
true
312.56(b)
21 CFR 312 subpart D pertains to:
a) record keeping and record retention
b) disqualification of a clinical investigator
c) responsibilities of Sponsors and Investigators
d) none of the above
c) responsibilities of Sponsors and Investigators
A sponsor who determines its investigational drug presents an unreasonable and significant risk to subjects shall discontinue the investigation:
a) as soon as possible
b) as soon as possible, and in no event later than 5 working days
c) as soon as possible, and in no event later than 10 working days
d) none of the above
b) as soon as possible, and in no event later than 5 working days
312. 56(d)
Under 21 CFR 312, this form is the statement of the investigator of a clinical trial:
a) 1571
b) 483
c) 1572
d) 3454
c) 1572
312. 53(c)
An expanded access submission must include Form FDA 1571.
true
false
true
312.305(b)(2)
21 CFR 312 Subpart G deals with:
a) Guidance documents
b) Drugs for investigational Use in Laboratory Research Animals
c) Drugs for investigational Use in Laboratory Research Animals or Invitro Tests
d) Drugs for investigational Use in Invitro Tests
e) Expanded Access to Investigational Drugs for Treatment Use
c) Drugs for investigational Use in Laboratory Research Animals or Invitro Tests
An investigator’s responsibilities under an expanded access includes the following:
a) reporting adverse drug events to the sponsor
b) informed consent requirements are met
c) IRB review is obtained
d) accurate case histories and drug disposition records are maintained
e) all of the above
e) all of the above
312. 305(c)(3)
An expanded access IND goes into effect _____ days after FDA receives the protocol or upon earlier notification by the FDA.
a) 90
b) 60
c) 30
d) 14
c) 30
312. 305(d)(2)(ii)
Emergency expanded access use may be requested by phone, fax, or other electronic means.
true
false
true
312.310(d)
The Term “life-threatening” means:
a) diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted
b) diseases or conditions with potentially fatal outcomes, where the end point of clinical trial analysis is survival
c) a and b
d) none of the above
c) a and b
312. 81(a)
A sponsor or applicant must retain the records for a foreign clinical study not conducted under an IND if the study is submitted in support of an application for marketing approval for ____ year(s) after an agency decision on that application.
a) 1
b) 2
c) 5
d) indefinitely
b) 2
312. 120(d)
FDA may terminate authorization to ship a drug if it finds that:
a) the sponsor of the investigation has failed to comply with any of the conditions for shipment
b) the continuance of the investigation is unsafe or otherwise contrary to the public interest
c) none of the above
d) a and b
d) a and b
312. 160(b)
A licensed physician under whose immediate direction an investigational drug is administered or dispensed, and who submits an IND for expanded access use under 21 CFR part 312 subpart (E/F) is considered:
a) an investigator
b) a sponsor-investigator
c) a principal investigator
d) a sponsor
b) a sponsor-investigator
FDA may permit an investigational drug to be used for the treatment of an individual patient by a licensed physician under the following criteria:
a) the physician must determine that the probable risk the person from the investigational drug is not greater than the probable risk from the disease or condition
b) the patient cannot obtain the drug under another IND or protocol
c) a and b
d) none of the above
c) a and b
312. 310(a)
A sponsor shall retain the records and reports required by 21 CFR Part 312 for ____ year(s) after a marketing application is approved for the drug.
a) 1
b) 2
c) 5
d) indefinitely
b) 2
312. 57(c)
When scientific or medical disputes arise during the drug investigation process, sponsors should discuss the matter directly with the responsible reviewing officials.
true
false
true
312.48(c)(1)
Sponsors are responsible for:
a) selecting qualified investigators
b) providing them with the information they need to conduct an investigation properly
c) ensure proper monitoring of the investigation
d) ensure that FDA and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug
e) all of the above
e) all of the above
312. 50