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
The investigator shall monitor the progress of all clinical investigations being conducted under its IND.
true
false
false
312.56
The SPONSOR shall monitor…
If the investigation is terminated, suspended, discontinued, or completed, the investigator shall keep the unused supplies of the drug.
true
false
false
The investigator shall return the unused supplies of the drug to the sponsor.
312.62
If the drug is the subject of an existing IND, the expanded access submission may be made by the sponsor or by a licensed physician.
true
false
true
312.310(b)(1)
Individual patients, including for emergency use
FDA may permit an investigational drug to be used for widespread treatment use if the following criteria are met:
a) the drug is being investigated in a controlled clinical trial under an IND designed to support a marketing application for the expanded access use
b) all clinical trial of the drug have been completed
c) the sponsor is actively pursuing marketing approval of the drug for expanded access use with due diligence
d) all of the above
d) all of the above
312.320(a)
Treatment IND or treatment protocol
The investigator is responsible for monitoring the treatment protocol to ensure that licensed physicians comply with the protocol and the regulations applicable to investigators.
true
false
false
the sponsor is responsible
- 315(d)(2)
- 320(c)
New insulin and antibiotic drug products may be exported for investigational use without complying with the import and export requirements of 21 CFR part 312.
true
false
true
312.110(d)
The FDA will accept as support for an IND or application for marketing approval, a well-designed and well-conducted foreign clinical study not conducted under an IND, if the following conditions are met:
a) the FDA is able to validate the data from the study through an onsite inspection if the agency deems it necessary
b) the study was approved by the foreign agency
c) the study was conducted in accordance with good clinical practice (GCP)
d) a and c
e) all of the above
d) a and c
312. 120(a)(1)(i)
A sponsor or applicant must retain the records for a foreign clinical study not conducted under an IND for how many years after either an agency decision OR the submission of an IND?
a) 1 year
b) 2 years
c) 5 years
d) 7 years
b) 2 years
312. 120(d)
A sponsor must send an initial IND submission to which agency?
a) Center for Drug Evaluation and Research (CDER) for drug products
b) Center for Biologics Evaluations and Research (CBER) for biological products
c) appropriate center depends on the center responsible for regulating the product
d) a and b
c) appropriate center depends on the center responsible for regulating the product
312. 140(a)
CDER: drug products regulated by CDER
(responsible for the safety of chemically synthesized
drugs)
CDER Office of Generic Drugs: in vivo
CDER Therapeutic Biological Products: biological
products regulated by CDER
CBER for biologological products regulated by CBER
(responsiblity for vaccines, blood and tissue products,
and cellular or gene therapies)
___________________ is a review panel that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately constituted to provide assurance of that protection.
a) External Committee
b) Ethicists Panel
c) Independent Ethics Committee
d) Peer Reviewed Medical Research Program
c) Independent Ethics Committee
312. 3
If granted by the FDA, charging for expanded access to an investigational drug may continue for how long?
a) duration of the clinical trial
b) 3 years
c) FDA would never grant ability to charge for expanded access to an investigational new drug
d) 1 year - unless the FDA specifies a shorter length of time
d) 1 year - unless the FDA specifies a shorter length of time
312. 8(c)(4)
Practitioners can commercially distribute an investigational new drug as long as they have verifiable evidence that the drug is working, they have a patient population who have no alternate medical option, and they communicate their intent to distribute through FDA form 1040A
true
false
false
312.7
The FDA’s primary objective in reviewing an IND in all phases of the investigation is:
a) to assure the safety and rights of subjects
b) to help assure that the quality of the scientific evaluation of drugs is adequate to permit an evaluation of the drug’s effectiveness and safety capable of meeting statutory standards for marketing approval
c) to make sure that investigational new drugs are not being used commercially
d) both a and b
a) to assure the safety and rights of subjects
312.22(a)
in Phases 2 and 3, b is also true
A change in protocol regarding an IND application has to be submitted to the FDA in the following instances:
a) any increase in drug dosage or duration of exposure of individual subjects to the drug beyond that in the current protocol
b) significant increase in the number of subjects under study
c) significant change in the design of the protocol
d) the addition of a new test or procedure that is intended to improve monitoring for or reduce the risk of a side effect or adverse event
e) the dropping of a test intended to monitor safety
f) all of the above
f) all of the above
312. 30(b)
For the purposes of 21 CFR 312 subpart E, “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 that have severely limited one’s ability to carry out activities of daily living and further decline in imminent
c) diseases or conditions with potentially fatal outcomes, where the end point of clincial trial analysis is survival
d) both a and c
d) both a and c
312. 81(a)
Sponsors may request to meet with FDA-reviewing officials early in the drug development process. Match the meeting with the correct purpose of the meeting.
Meeting:
a) End of Phase 1 Meeting
b) Pre-investigational New Drug (IND) meeting
Purpose:
1) review and reach agreement on the design of
further controlled clinical trials, including trials in
the pediatric population
2) review and reach agreement on the design of
animal studies needed to initiate human testing
a) 1
b) 2
312.82
For products intended to treat life-threatening or severely-debilitating illnesses, sponsors may request to meet with FDA-reviewing officials early in the drug development process…
The FDA’s application to the statutory standards for marketing approval shall recognize the need for a medical risk-benefit judgment in making the final decision on approvability. As part of this evaluation, the FDA will consider the following:
a) whether the benefits of the drug outweigh the known and potential risks of the drug and the need to answer remaining questions about risks and benefits of the drug, taking into consideration the severity of the disease and the absence of satisfactory alternative therapy
b) whether the benefits of the drug outweigh the known and potential risks of the drug
c) whether the benefits of the drug outweigh the known and potential risks of the drug AND demonstrated increased survival rates of those participants in early phase trials
d) the need to answer remaining questions about risks and benefits of the drug
e) all of the above
a) whether the benefits of the drug outweigh the known and potential risks of the drug and the need to answer remaining questions about risks and benefits of the drug, taking into consideration the severity of the disease and the absence of satisfactory alternative therapy
312.84
Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses.
An investigational new drug can never be imported into the US or exported from the US.
true
false
false
312.110
If it is mandatory that a person exporting an investigational new drug sends a written certification to the Office of International Programs at the FDA, the certification must include (select all that apply):
a) description of drug being exported and the country/countries it is being exported to
b) the drug is intended for export and intended for investigational use in a foreign country
c) the drug does not present an imminent hazard to public health either in the US or in the foreign country
d) the drug is not sold or offered for sale in the US
e) the drug meets the foreign purchaser’s or consignee’s specifications and the drug is manufactured, processed, packaged, and held in substantial conformity with current good manufacturing practices
a) description of drug being exported and the country/countries it is being exported to
b) the drug is intended for export and intended for investigational use in a foreign country
c) the drug does not present an imminent hazard to public health either in the US or in the foreign country
e) the drug meets the foreign purchaser’s or consignee’s specifications and the drug is manufactured, processed, packaged, and held in substantial conformity with current good manufacturing practices
312. 110(b)(4)
The aim of 21 CFR 312 Subpart G is to:
a) provide guidance on investigational devices
b) provide guidance on drugs intended for investigational use in laboratory research animals or in vitro tests
c) facilitate the availability of investigational new drugs or drugs with limited availability to patients with serious diseases or conditions that have no comparable or satisfactory alternative therapy
d) facilitate investigational drug shipment
b) provide guidance on drugs intended for investigational use in laboratory research animals or in vitro tests
Under 21 CFR Part 312 subpart G:
Termination of authorization to ship. The FDA may terminate authorization to ship a drug if (check all that apply):
a) the drug is used for purposes other than the scientific investigation
b) the sponsor has failed to comply with any of the conditions for shipment
c) the sponsor fails to include the FDA’s approval of authorization with each shipment
d) the continuance of the investigation is unsafe or contrary to public interest
e) an agent submits a whistleblower report
a) the drug is used for purposes other than the scientific investigation
b) the sponsor has failed to comply with any of the conditions for shipment
d) the continuance of the investigation is unsafe or contrary to public interest
312.160
Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
Unused drug has to be returned to the shipper.
true
false
false
- 59
- 160(c)
Expanded access submission must include (check all that apply):
a) FDA form 1571
b) rational for the intended use of the drug and criteria for patient selection
c) description of the facility where the drug is manufactured and description of clinical procedures, lab tests, or other monitoring that will be necessary
d) reason for why the researcher thinks this is optimal treatment for the patient
e) method of administration for the drug, dose, and duration
a) FDA form 1571
b) rational for the intended use of the drug and criteria for patient selection
c) description of the facility where the drug is manufactured and description of clinical procedures, lab tests, or other monitoring that will be necessary
e) method of administration for the drug, dose, and duration
312. 305
Expanded access allows a drug to be administered in the case that an investigator believes that it will be more beneficial than current treatment.
true
false
false
312.305
A sponsor may recover both the direct and indirect costs of making its investigational drug available.
true
false
false
312.8(d)
A sponsor may recover only the direct costs…
When does an IND go into effect?
a) 15 days after the FDA receives the IND
b) 30 days after the FDA receives the IND
c) on earlier notification by the FDA that the clinical investigations in the IND may begin
d) both b and c
d) both b and c
312. 40(b)
What happens when a clinical hold is issued by the FDA to the sponsor?
a) subjects may not be given the investigational drug
b) no new subjects may be recruited to the study
c) patients already on the study should be taken off therapy
d) a and b
e) a, b, and c
e) a, b, and c
312.42 (a)
patients should be taken off therapy…unless specifically permitted by FDA in the interest of patient safety
Please match the following statements to their corresponding timeframes.
Statements:
a) no subjects enrolled for _____ = inactive
b) clinical hold for _____ = inactive
c) IND that remains inactive for _____ may be terminated
Timeframes:
1) 5 years
2) 2 years
3) 1 year
a) 2 years 312.45(a)
b) 1 year 312.42(g)
c) 5 years 312.44(b)(x)
A sponsor or investigator may represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation.
true
false
false
312.7
Clinical studies conducted to evaluate the effectiveness of the drug for a particular indication(s) in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug are called:
a) Phase 1 studies
b) Phase 2 studies
c) Phase 3 studies
d) Pilot studies
b) Phase 2 studies
312. 21
Please match the following type of study to the typical subject enrollment number.
Type of study:
a) Phase 1
b) Phase 2
c) Phase 3
Typical enrollment number:
1) several hundred to several thousand
2) 20 to 80
3) no more than several hundred
a) 2
b) 3
c) 1
312.21
How long should a sponsor and/or investigator retain records following the date a marketing application is approved for the drug for the indication for which it is being investigated (or if no application is to be filed/the application is not approved for such an indication) after the investigation is discontinued and FDA notified?
a) 1 year
b) 2 years
c) 3 years
d) 5 years
b) 2 years
312. 57(c)
Whose responsibility is it to prepare and maintain adequate and accurate case histories that record all observations and other data pertinent to the investigation on each individual administered the investigational drug or employed as a control in the investigation?
a) Sponsor
b) FDA
c) Investigator
d) CTEP
c) Investigator
312. 62(b)
How much in advance of an end-of-Phase 2 meeting should a sponsor submit to the FDA background information on the sponsor’s plan for Phase 3?
a) 1 month
b) 2 months
c) 3 months
d) 6 months
a) 1 month
312.47(b)(iv)
…at least 1 month in advance…
If a dispute resolution cannot be reached between the sponsor and the consumer safety officer assigned to the application, who should the sponsor raise the matter with next?
a) FDA’s CDER/CBER which is responsible for review of the IND
b) the sponsor’s IEC
c) the person designated as ombudsman
d) the NCI
c) the person designated as ombudsman
Notes:
CDER = Center for Drug Eval & Research
CBER = Center for Biologics Eval & Research
IEC = Independent Ethics Committee
312.48(b)
A sponsor of any IND may request and obtain an end-of-Phase 2 meeting.
true
false
true
312.47
According to 21 CFR Part 312 subpart E, these procedures recognize that physicians and patients are generally willing to accept greater risks or side effects from products that treat life-threatening and severely-debilitating illnesses than they would accept from products that treat less serious illnesses.
true
false
true
312.80
What are Phase 4 studies?
a) studies that are conducted to evaluate the effectiveness of the drug for a particular indication in patients with the disease or condition under study and to determine the common short-term side effects and risk associated with the drug
b) studies that include the initial introduction of an investigational new drug in humans designed to determine the metabolosm and pharmacologic actions of teh drug in humans, the side effects associated with increasing doses, and if possible, to gain early evidence on effectiveness
c) studies to delineate additional information about the drug’s risks, benefits, and optimal use
d) studies performed after preliminary evidence suggesting effectiveness of the drug has been obtained intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefits-risk relationship of the drug and to provide an adequate basis for physician labeling
c) studies to delineate additional information about the drug’s risks, benefits, and optimal use
312. 85
How long must a sponsor or applicant retain the records required by 21 CFR Part 312 for a foreign clinical study not conducted under an IND?
a) 1 year
b) 2 years
c) 3 years
d) 5 years
b) 2 years
312. 120(d)
If there is an emergency that requires the patient to be treated before a written submission can be made, FDA may authorize the expanded access use to begin without a written submission.
true
false
true
312.310(d)
How many days after the FDA receives the IND does an expanded access IND go into effect?
a) 15 days
b) 30 days
c) on earlier notification by FDA that expanded access use may begin
d) both b and c
d) both b and c
312. 305(d)
In order for a patient to qualify for expanded access use, which of the following criteria must be met?
a) the patient to be treated must have a serious or immediately life-threatening disease or condition
b) there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the disease or condition
c) the potential patient benefit outweighs the potential risks
d) providing the investigational drug for the requested use will not interfere with the initiation, conduct, or completion of clinical investigations that could support the marketing approval of the expanded access use
e) all of the above
e) all of the above
312. 305(a)
Please match the following titles with their roles/responsbilities.
Titles:
a) Sponsor
b) Investigator
Roles/Responsbilities:
1) a licensed physician under whose immediate direction
an investigational drug is administered or dispensed
2) ensures that the informed consent requirements of
21 CFR Part 50 are met
3) responsible for submitting IND safety reports and
annual reports to the FDA
4) maintains an effective IND for the expanded access
use
5) maintains accurate case histories and drug
disposition records
6) monitors the expanded access protocol to ensure
that licensed physicians comply with the protocol
and regulations
a) 3, 4, 6
b) 1, 2, 5
- 50 General responsibilities of sponsors
- 60 General responsibilities of investigators
- 305 …expanded access…responsibilities…
What does REMS stand for?
risk evaluation and mitigation strategy
312.300(a)
The sponsor may submit foreign suspected adverse reactions on a Council for International Organizations of Medical Sciences (CIOMS) I Form instead of a FDA Form 3500A.
true
false
true
312.32(c)(1)(v)
A clinical investigation involving an in vitro diagnostic biological product (blood grouping serum, reagent red blood cells, anti-human globulin) is exempt from the requirements of CFR 21 Part 312 if (a) it is intended to be used in a diagnostic procedure that confirms diagnosis made by another medically established, diagnostic product or procedure and (b) it is shipped in compliance with 312.160.
true
false
true
312.2(b)
A clinical investigation involving an exception from informed consent under 50.24 is not exempt from the requirements of Part 312.
true
false
true
312.2(b)(6)
What is required for submitting an “Investigational New Drug Application”? (n=10)
in the following order:
1) cover sheet (form FDA-1571)
2) table of contents
3) introductory statement and general investigational plan
4) investigator’s brochure
5) protocols
6) chemistry, manufacturing, and control information
7) pharmacology and toxicology information
8) previous human experience with the investigational drug
9) additional information (i.e., drug dependence, radioactive drugs, pediatric studies, etc.)
10) relevant information, if requestd by FDA
312.23(a)
What should an investigator’s brochure contain? (n=5)
1) description of drug substance and formulation, including structural formula
2) summary of pharacological and toxicological effects of the drug in animals, and, if known, in humans
3) summary of pharmacokinetics and biological disposition of drug in animals, and, if known, in humans
4) summary of information relating to safety and effectiveness in humans obtained from prior clinical studies
5) description of possible risks and side effects to be anticipated on basis of prior experience with drug under investigation or with related drugs, and of precautions or special monitoring to be done as part of the investigational use of drug
Which of the following are Protocol Amendments and which are Information Amendments?
a) changes in protocol
b) content and format
c) new investigator
d) new protocol
e) new technical information
f) new toxicology or chemistry
g) report regarding discontinuance of clinical investigation
Protocol Amendments 312.30
a, b, c, d
Information Amendments 312.31
e, f, g
Any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related is a(n):
a) adverse event
b) life-threatening adverse event or life-threatening suspected adverse event
c) serious adverse event or serious suspected adverse reaction
d) suspected adverse reaction
e) unexpected adverse event or unexpected suspected adverse reaction
a) adverse event
312. 32(a)
If, in the view of either the investigator or sponsor, its occurrence places the patient or subject at immediate risk of death is a(n):
a) adverse event
b) life-threatening adverse event or life-threatening suspected adverse event
c) serious adverse event or serious suspected adverse reaction
d) suspected adverse reaction
e) unexpected adverse event or unexpected suspected adverse reaction
b) life-threatening adverse event or life-threatening suspected adverse event
312. 32(a)
When there is a reasonable possibility that the drug caused the event, it is considered a(n):
a) adverse event
b) life-threatening adverse event or life-threatening suspected adverse event
c) serious adverse event or serious suspected adverse reaction
d) suspected adverse reaction
e) unexpected adverse event or unexpected suspected adverse reaction
d) suspected adverse reaction
312. 32(a)
If, in the view of either the investigator or sponsor, it results in any of the following outcomes: death, …, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant incapacity disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect, it is considered a(n):
a) adverse event
b) life-threatening adverse event or life-threatening suspected adverse event
c) serious adverse event or serious suspected adverse reaction
d) suspected adverse reaction
e) unexpected adverse event or unexpected suspected adverse reaction
c) serious adverse event or serious suspected adverse reaction
312. 32(a)
If it is not listed in the investigator brochure or is not listed at the specificity or severity that has been observed; …or is not consistent with the risk information described in the general investigational plan elsewhere in the current application, as amended is considered a(n):
a) adverse event
b) life-threatening adverse event or life-threatening suspected adverse event
c) serious adverse event or serious suspected adverse reaction
d) suspected adverse reaction
e) unexpected adverse event or unexpected suspected adverse reaction
e) unexpected adverse event or unexpected suspected adverse reaction
312. 32(a)
What should be included in an Annual Report? (n=7)
1) individual study information…status
2) summary information
3) description of general investigational plan for coming year
4) if investigator brochure revised, description of revision and copy of new brochure
5) description of any significant Phase 1 protocol modifications not previously reported to IND in protocol amendment
6) brief summary of significant foreign marketing developments with drug during past year
7) (optional) log of any outstanding business with respect to IND for which sponsor requests or expects a reply, comment, or meeting
312.33
At any time, a sponsor may withdraw an effective IND without prejudice.
true
false
true
312.38
An ombudsman is utilized in which type of dispute resolution?
a) general
b) administrative and procedural issues
c) scientific and medical disputes
b) administrative and procedural issues
312. 48(b)
For which reports are investigators responsible? (n=4)
1) progress reports
2) safety reports
3) final report
4) financial disclosure reports
An investigator is never required to divulge subject names?
true
false
false
312.68
…unless records of particular individuals require a more details study of the cases, or unless there is reason to believe that the records do not represent actual case studies, or do not represent actual results obtained
At the discretion of the agency, FDA may undertake focused regulatory research on critical rate-limiting aspects of the preclinical, chemical/manufacturing, and clinical phases of drug development and evaluation.
true
false
true
312.86
…as a means for meeting a public health need in facilitating the development of therapies to treat life-threatening or severely debilitating illnesses
An investigational new drug may be exported from the U.S. for use in a clinical investigation to which countries?
1) Australia
2) Canada
3) Israel
4) Japan
5) New Zealand
6) Switzerland
7) South Africa
8) any country in the European Union or European Economic Area
312.110(b)(3)
…and complies with the laws of the country to which it is being exported…
There may be instances where exportation of an investigational new drug is needed so that the drug may be used in a sudden and immediate national emergency that has developed or is developing. In such cases…exportation may proceed without prior FDA authorization.
true
false
true
312.110(b)(5)(ii)
The existence of an investigational new drug application will not be disclosed by FDA unless it has previously been publicly disclosed or acknowledged.
true
false
true
312.130(a)
A person may ship a drug intended solely for tests in vitro or in animals used only for laboratory research purposed if it is labeled as follows:
a) CAUTION: Contains a drug for investigational use. Not for use in humans.
b) CAUTION: Contains a drug for investigational use only in laboratory animals, or for tests in vitro.
c) CAUTION: Contains a new drug for investigational use only in laboratory animals, or for tests in vitro. Not for use in humans.
d) CAUTION: Contains a new drug for investigational use. Not for use in humans.
c) CAUTION: Contains a new drug for investigational use only in laboratory animals, or for tests in vitro. Not for use in humans.
312. 160(a)
A disease or condition associated with morbidity that has substantial impact on day-to-day functioning. Short-lived and self-limiting morbidity will usually not be sufficient, but the morbidity need not be irreversible, provided it is persistent or recurrent is considered a(n):
a) immediately life-threatening disease or condition
b) serious disease or condition
b) serious disease or condition
312.300(b)
as compared to…a stage of disease in which there is reasonable likelihood that death will occur within a matter of months or in which premature death is likely without early treatment
FDA may permit an investigational drug to be used for the treatment of an individual patient by a licensed physician. Treatment is generally limited to:
a) a single course of therapy for a specified duration unless FDA expressly authorizes multiple courses or chronic therapy
b) multiple courses of therapy for disease under study only
c) therapy for duration of clinical trial period only
d) a specified duration with an unspecified number of courses or therapy
a) a single course of therapy for a specified duration unless FDA expressly authorizes multiple courses or chronic therapy
312. 310(c)
If the FDA has received a significant number of requests for individual patient expanded access, they may ask a sponsor to consolodate individuals into a patient population smaller than that typical of a treatment IND or treatment protocol.
true
false
true
312.315
When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of which one of the following to FDA?
a) Adverse Event Summary Report, but only from unblinded portions of studies (“open-label IND safety report”)
b) Marketing plan (i.e. annual updated projection of sales and profits)
c) IND report
d) IND renewal application
c) IND report
The sponsor shall obtain a commitment from the clinical investigator to promptly update financial disclosure information if any relevant changes occur during the course of the investigation and for _______ following the completion of the study.
a) 30 days
b) 1 year
c) 2 years
d) 5 years
b) 1 year
312. 53(c)(4)
