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21 CFR 312 Flashcards

1
Q

IND regulations typically do not apply to investigations with lawfully marketed drugs which are being studied for purposes other than supporting a change in labeling or a change in advertising, so long as the study complies with IRB & consent regulations & does not significantly increase risks or decreaseacceptability of risks. TRUE OR FALSE?

A

true

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2
Q

Some clinical investigations involving an in vitro diagnostic biologic product may be exempt from the IND regulations if it is used only to confirm a diagnosis made by another medically established diagnostic
product or procedure. TRUE OR FALSE?

A

true

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3
Q

Clinical research on blood grouping serum, reagent RBC & anti-human globulin are generally exempt from
the FDA’s IND regulation. TRUE OR FALSE?

A

true

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4
Q

Clinical Investigations involving placebos may be exempted from the IND regulations if the investigation does not otherwise require the submission of an IND application. TRUE OR FALSE?

A

true

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5
Q

Use of a marketed drug or biologic product for an unlabeled indication in practice of medicine is not subject to IND regulations. TRUE OR FALSE?

A

true

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6
Q

Researchers planning an investigation may contact the FDA to obtain guidance on the applicability of the IND regulations to a particular study. TRUE OR FALSE?

A

true

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7
Q

What is the definition of a “contract research organization” according to FDA’s IND regulations?

A

A person working with the sponsor as an independent contractor who assumes one or more of the obligations of the sponsor.

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8
Q

What type of products are generally subject to IND
regulations?

A
  1. Investigational new drugs
  2. Biological products used in vitro for diagnostic
    purposes that are to be used in a clinical
    investigation.
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9
Q

What statement must the label of all investigational
drugs bear?

A

“Caution: New Drug - Limited by Federal (or United States) Law to Investigational Use.”

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10
Q

What are the labeling requirements for investigational drugs with respect to safety or effectiveness of the product?

A

The label can bear no misleading statement & shall not represent that the drug is safe or effective for the
purposes for which it is being investigated.

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11
Q

A promotional claim is acceptable on investigational drug supply labeling, provided the claim was previously
approved by FDA. TRUE OR FALSE?

A

False. Promotional claims may not appear on investigational drug supply label.

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12
Q

Investigational drugs may be commercially distributed or test-marketed by sponsor or investigators. TRUE OR FALSE?

A

false

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13
Q

Sponsors are prohibited from unduly prolonging clinical investigations, once adequate data has been generated
to support a marketing application. TRUE OR FALSE?

A

true

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14
Q

Describe the FDA requirement for charging for Investigational drugs under an IND.

A

Charging for Investigational drugs under an IND is not permitted without prior written approval from FDA. Written explanation of why charges are necessary & not a normal cost of doing business is required.

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15
Q

Charging a reasonable amount for investigational drugs under a treatment IND is permissible provided certain criteria are met & there is no commercialization or promotion involved. TRUE OR FALSE?

A

true

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16
Q

The FDA may withdraw authorization to charge for an investigational drug. TRUE OR FALSE?

A

true

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17
Q

Sponsor may request waivers of the IND requirements from FDA. TRUE OR FALSE?

A

true

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18
Q

Filing an IND application with the FDA is required prior to commencing any clinical investigation with an investigational new drug. TRUE OR FALSE?

A

true

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19
Q

Filing a separate IND with the FDA is required if a sponsor elects to conduct investigations involving waiver of informed consent in emergency research. TRUE OR FALSE?

A

true

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20
Q

A sponsor must receive written approval from the FDA, prior to beginning emergency research being conducted with waiver of consent. TRUE OR FALSE?

A

true

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21
Q

How much time does the FDA have to provide a sponsor with written approval to proceed with an IND that involves waiver from ICF due to emergency conditions?

A

30 days

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22
Q

Name three phases of a clinical investigation for a
previously untested drug?

A

Phase 1
Phase 2
Phase 3

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23
Q

A study of normal volunteers designed to evaluate the metabolic & pharmacologic actions of a drug with increasing doses would be considered as what phase of investigation?

A

Phase 1

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24
Q

When several hundred to several thousand subjects are in a study, what phase is the clinical investigation
typically in?

A

Phase 3

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25
Q

What phase of clinical investigation includes a study that evaluates structure-activity relationships or
mechanism of action in humans?

A

phase 1

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26
Q

Controlled trials evaluating the effectiveness of multiple doses of a drug in patients would be considered as what phase of investigation?

A

phase 2

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27
Q

What phase of a study typically evaluates the pharmacokinetics of a drug in normal volunteers?

A

phase 1

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28
Q

Studies which provide an overall evaluation of a drug & an adequate basis for physician labeling would be
considered as what phase of the investigation?

A

phase 3

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29
Q

What are the FDA’s primary objectives when reviewing an IND regarding the various phases of investigation?

A

Phase 1: focus is on safety assessment.
Phase 2 & 3: Focus is on safety & effectiveness & to help assure scientific evaluation.
All phases: Assure the rights & safety of subjects.

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30
Q

Name at least two factors that determine the amount of information that must be submitted in an IND.

A
  1. Novelty of the drug.
  2. Extent to which the drug has been previously studied.
  3. Known or suspected risks.
  4. Particular developmental phase.
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31
Q

What should be the main focus of an initial IND submission?

A

The general investigational plan & the protocols for specific human studies.

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32
Q

What FDA form specifies the content & order of an IND submission?

A

FDA form 1571

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33
Q

FDA form 1571 requires the names & titles of two persons with specific functions. Who are they?

A
  1. The person responsible for monitoring the conduct & progress of the evaluation
  2. The person responsible for review & evaluation of safety information for the drug.
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34
Q

The FDA form 1571 contains a statement that an IRB that complies with the requirements of 21 CFR 56 will
be responsible for review of all studies conducted under
IND. TRUE OR FALSE?

A

true

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35
Q

Obligations transferred by a sponsor to CROs are always submitted as an information amendment to an IND, rather then being included in the original IND application. TRUE OR FALSE?

A

false

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36
Q

Foreign clinical experience with a drug must be submitted in an original IND application. TRUE OR
FALSE?

A

true

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37
Q

Name at least four elements required in the general investigational plan of an original IND application .

A
  1. Rationale for the drug or study.
  2. Indications.
  3. General evaluation approach.
  4. Types of trials to be conducted in the first year.
  5. Estimated number of patients to be studied in the first year.
  6. Any anticipated risks of particular severity or seriousness.
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38
Q

The Investigator Brochure is a required component of an original IND submission. TRUE OR FALSE?

A

true

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39
Q

Describe the relative level of detail required for Phase 1 protocol vs. Phase 2 & Phase 3 protocols.

A

Phase 1 may be less detailed & more flexible than Phase 2 & 3
Phase 1 should outline the plan, specific number of patients, describe safety measures & include dosing plan

Phase 2-3 should be very detailed & will generally not permit unanticipated protocol changes.

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40
Q

List at least four required sections in a clinical protocol for a study conducted under an IND.

A
  1. Objectives & purpose.
  2. Name, address & qualifications of investigators &
    of the reviewing IRB
  3. Inclusion/exclusion criteria.
  4. Study design
  5. Dosing information.
  6. Planned observations & measurements.
  7. Clinical procedures to evaluate safety.
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41
Q

Name three of the five required content elements in the chemistry, manufacturing, & control section of an original IND application.

A
  1. The drug substance.
  2. The drug product.
  3. Placebo composition if applicable.
  4. Labeling.
  5. Environmental analysis requirements.
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42
Q

The pharmacology & toxicology section of an IND
application requires the names & qualifications of the
individuals who performed what tasks?

A

Those who evaluates the result of the pre-clinical
studies & concluded it was reasonably safe to begin the
proposed clinical investigations

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43
Q

Results of pre-clinical studies on abuse potential & drug
dependence are required in the original IND application
for which classes of drugs?

A

Psychotropic substance or any other drug with abuse
potential.

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44
Q

What are the FDA’s requirements for translation &
inclusion of documents in an IND application which are
not in English?

A

A complete English translation must be included as well
as a copy of the original publication in the foreign
language.

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45
Q

Name three categories of protocol amendments which
require a sponsor to update the original IND
application.

A
  1. New Protocols
  2. Changes in a protocol.
  3. New investigators.
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46
Q

How soon does a sponsor have to submit a new investigator amendment to an IND?

A

30 days following the addition of the investigator.

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47
Q

Give an example of the type of information required to
be filed as an information amendment to an original
IND application.

A
  1. New technical information such as toxicology or
    chemistry.
  2. Reports regarding discontinuation of a clinical
    Investigation.
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48
Q

What is the FDA’s preferred filing frequency for
information amendments by sponsor?

A

At intervals of 30 days.

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49
Q

What is the FDA’s definition of the term “associated
with the use of the drug” with respect to the evaluation
of adverse experience.

A

What is the FDA’s definition of the term “associated
with the use of the drug” with respect to the evaluation
of adverse experience.

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50
Q

What type of experiences does the FDA classify as
serious adverse drug experiences in clinical trials?

A

Serious adverse drug experiences include:
1. Any event that results in death.
2. A life-threatening drug experience,
3. In patient hospitalization or prolongation thereof.
4. A significant or persistent disability
5. Congenital anomaly or birth defect.
6. Important medical events may also be serious
events.

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51
Q

What is the FDA’s definition of disability, as it relates to
serious adverse drug experience?

A

A substantial disruption of a person’s ability to conduct
normal life functions.

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52
Q

What is the FDA criterion which classified an adverse
drug experience as unexpected?

A

Any adverse experience, the specificity or severity of
which is not consistent with the IB, or other designated
document when an IB is not required.

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53
Q

Sponsor are required to maintain an ongoing review of
safety information from which sources?

A
  1. Any foreign or domestic source including clinical,
    epidemiological & animal investigations.
  2. Commercial marketing experience
  3. Scientific literature reports & unpublished scientific papers .
  4. Reports from foreign regulatory authorities not
    previously reported to the FDA.
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54
Q

Who must be notified, via an IND safety report, of
serious, unexpected adverse experiences that are
associated with the use of the drug?

A

FDA & all investigators conducting studies under the
IND.

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55
Q

What is the time requirement for filing IND safety
reports with the FDA?

A

As soon as possible & never later than fifteen calendar
days after the sponsor’s initial receipt of the
information.

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56
Q

How soon must the FDA be notified of a fatal or life-threatening
adverse experience which is associated
with use of a drug?

A

By telephone or facsimile transmission, no later than
seven calendar days after sponsor receipt of the
information, followed by written report no later than 15
calendar days after initial receipt of the information by
the sponsor.

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57
Q

For purposes of filing IND safety reports with FDA,
what is the definition of a “life threatening event?”

A

The patient was at immediate risk of death from the
reaction as it occurred.

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58
Q

Who must approve modifications on the reporting
format or frequency of IND safety reports prior to a
sponsor deviating from the regulations ?

A
  1. The director of the new drug review division of
    either the Center for rug Evaluation & Research
    (CDER)
  2. The Center for Biologics Evaluation & Research
    (CBER).
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59
Q

For marketed drugs, a sponsor is not required to file
IND safety report for events which are from non-clinical
trial sources. TRUE or FALSE?

A

true

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60
Q

When are sponsors required to file follow-up
information for IND safety reports?

A

As soon as the relevant information is available.

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61
Q

If a sponsor evaluates an adverse experience &
determines that it is reportable as an IND safety
report, but it was not originally reported as such, how
long does the sponsor have to report the event as an
IND safety report?

A

As soon as possible ,but in no event later than 15
calendar days after the determination is made.

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62
Q

If a sponsor submits an IND safety report, it is
assumed by FDA that the drug caused or contributed to
the event, unless it is specifically denied by the
sponsor. TRUE OR FALSE?

A

false

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63
Q

What is the time frame in which a sponsor must file an
annual report ?

A

Within 60 days of the anniversary date that the IND
went into effect.

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64
Q

Name at least three elements required to be reported
for each individual study reported in an IND annual report.

A
  1. Study Title, identifier & purpose, description of
    patient population & completion status.
  2. Total number of subjects
    􀁻 initially planned for inclusion,
    􀁻 entered to date
    􀁻 who completed as planned
    􀁻 dropped for any reason.
  3. Brief description of any interim or final analysis
    results, if available.
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65
Q

Name at least two specific clinical adverse experience
summary items required in an IND annual report.

A
  1. Most frequent & most serious adverse experience
    by body system.
  2. IND safety reports submitted within the past year.
  3. List of subjects who died with cause of death.
  4. List of subjects who dropped due to an adverse
    experience.
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66
Q

Summary information for clinical trials activity within
the past year is required in the IND annual report,
while results of pre-clinical studies are not. TRUE OR
FALSE?

A

false

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67
Q

A revised copy of an Investigator Brochure in an IND
annual report must accompanied by what additional
information?

A

A description of revisions.

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68
Q

The IND annual report should include an updated
description of the general investigational plan for the
coming year. TRUE OR FALSE?

A

true

69
Q

The term “Treatment Protocol” & “Treatment IND” are
interchangeable & mean the same thing. TRUE OR
FALSE?

A

false

70
Q

Serious or life threatening diseases in patients for whom no alternative drug or comparable therapies are available may be evaluated outside of sponsor-planned clinical trials in a treatment protocol. TRUE OR FALSE?

A

true

71
Q

“Treatment use” protocols are generally used once a
drug’s initial safety in Phase 2 trials has been demonstrated. TRUE OR FALSE?

A

true

72
Q

The FDA commissioner may deny requests for treatment-use of a drug for serious or life threatening diseases if there is sufficient evidence to support its use. TRUE OR FALSE?

A

true

73
Q

FDA clinical holds apply to all sponsored clinical
investigations under an IND, but do not apply to
treatment INDs. TRUE OR FALSE?

A

false

74
Q

When a licensed medical practitioner files a treatment
IND with the FDA, the investigator becomes a sponsorinvestigator,
even though the sponsor may be supplying the drug. TRUE OR FALSE?

A

true

75
Q

For treatment INDs, the investigator is responsible for
reporting safety information directly to the FDA. TRUE
OR FALSE?

A

true

76
Q

What is the appropriate FDA form for an investigator to
use when filing a treatment IND?

A

FDA form 1571.

77
Q

What does the phrase emergency use of an
investigational drug imply, in the FDA’s IND regulations?

A

Use of a drug in an emergency situation for which an
IND application has not yet been filed.

78
Q

When FDA approves shipment of a drug for emergency
use from a telephone request, what addition requirement typically is made of the sponsor?

A

The sponsor must make an appropriate IND submission
as soon as practicable after receiving the approval.

79
Q

A sponsor may withdraw an effective IND at anytime,
without prejudice. TRUE OR FALSE?

A

true

80
Q

If an effective IND is withdrawn by a sponsor for safety reasons whom must the sponsor notify?

A

The FDA, all clinical investigators & all reviewing IRBs. Notification must also include the reason for such
withdrawal.

81
Q

Unless the FDA notifies a sponsor that Investigations in
an IND are subject to clinical hold, how soon may a
sponsor begin a clinical Investigation after filing the
IND?

A

Thirty days after the FDA receives the IND submission.

82
Q

Generally sponsor may request FDA comment & advice
on which components of an IND submission?

A
  1. Adequacy of technical data to support an
    investigational plan.
  2. Design of a clinical trial.
  3. A determination of whether proposed
    investigations are likely to produce the data &
    information needed for FDA.
83
Q

What is a clinical hold?

A

An order issued by FDA to a sponsor to delay a clinical
study.

84
Q

Clinical holds always apply to all clinical investigations
under an IND. TRUE OR FALSE?

A

false

85
Q

When a clinical hold order is issued by the FDA for an
ongoing study, what actions must the sponsor take?

A

Notify all investigators to stop recruitment of new
subjects & to remove subjects from the investigational
drug, unless specifically permitted to continue the
ongoing patients, in the interest of safety.

86
Q

Name at least two grounds for FDA imposition of a
clinical hold for a Phase 1, 2 or 3 investigation.

A
  1. Subjects would be exposed to unreasonable &
    significant risk of illness or injury.
  2. Unqualified investigators.
  3. Inadequate IB.
  4. IND lacks safety data.
  5. Gender bias on subject eligibility.
87
Q

The FDA may place a Phase 2 or Phase 3 clinical trial
on clinical hold if the study design is deficient in design
to meet the stated objectives. TRUE OR FALSE?

A

true

88
Q

The FDA may place a treatment IND or Treatment
protocol on clinical hold if a comparable or satisfactory
alternative therapy or drug becomes available for
patients with conditions to be treated in the
investigation. TRUE OR FALSE?

A

true

89
Q

The FDA may place a treatment IND on clinical hold if a
sponsor is not pursuing marketing approval with due
diligence. TRUE OR FALSE?

A

true

90
Q

If enrollment in a sponsored, adequate & well
controlled investigation is being impeded by a
treatment IND investigation, what action may the FDA
take?

A

The FDA may place the treatment IND on clinical hold.

91
Q

Only the sponsor may interrupt a treatment IND
investigation if inadequate supplies are available to
support it as well as concurrent controlled trials. TRUE
OR FALSE?

A

FALSE. The FDA may also place the treatment IND on
clinical hold under these circumstances.

92
Q

The FDA may not place any investigator on clinical hold
that employs the exception from informed
consent criteria for emergency research, or that has
not been determined by the President to waive the
prior consent requirement. TRUE OR FALSE?

A

false

93
Q

Unless patients are exposed to immediate & serious
risk the FDA will attempt to satisfactorily resolve
deficiencies with sponsor prior to issuing a clinical hold
order. TRUE OR FALSE?

A

true

94
Q

Who at the FDA is responsible for issuing a clinical hold?

A

The Division Director with responsibility for review of
the IND.

95
Q

If a clinical hold order is issued by telephone, how soon
thereafter must the FDA provide the sponsor with
written explanation of the basis for the clinical hold?

A

Within 30 days of imposing the clinical hold.

96
Q

Resumption of clinical investigations which were
subject to a clinical hold must always be issued in
writing by the FDA to a sponsor. TRUE OR FALSE?

A

false

97
Q

For what length of time must all clinical investigations
under IND remain on hold prior to FDA converting the
IND to inactive status?

A

One year or more.

98
Q

If a sponsor fails to inform the FDA of all serious &
unexpected adverse experiences, what is the most
significant action the FDA may take relative to the IND?

A

Termination of IND.

99
Q

Sponsor failure to comply with any IND requirement of
21 CFR parts 312, 50, or 56 may result in FDA termination of the IND. TRUE OR FALSE?

A

true

100
Q

On what grounds may the FDA terminate an IND immediately, without opportunity for sponsor response?

A

If the FDA concludes that continuation of the
investigation presents a substantial danger to the
health of the individuals.

101
Q

Name the two conditions under which the FDA may
place an IND on inactive status.

A
  1. If no subjects are entered into clinical trials for a
    period of 2 years or more under the IND.
  2. If all investigation under the IND remain on
    clinical hold for a period of more than one year.
102
Q

If an IND is placed on inactive status by the FDA, what
action must the sponsor take with drug supplies?

A

Arrange with all investigators for the return or other
proper methods of disposal of the investigational drug.

103
Q

At what point in the clinical development process of a
drug does the FDA encourage meetings with an IND
sponsor?

A

At the end of Phase 2 & prior to NDA submission.

104
Q

End of Phase 2 meetings b/w the FDA & a sponsor are
generally reserved for what type for IND?

A

INDs involving new molecular entities or major new
uses of marketed drugs.

105
Q

Who may bring consultants to an End of Phase 2 meetings?

A

Both FDA & the sponsor.

106
Q

What clinical items must a sponsor provide to the FDA
at least one month in advance of the end of phase 2
meeting?

A
  1. A summary of Phase 1 & investigations
  2. Specific protocols for Phase 3.
  3. Plans for any pediatric studies.
  4. Requests for waiver or deferral of pediatric
    studies.
  5. Tentative labeling for the drug.
107
Q

Name at least three major purposes for a pre-NDA or
pre-BLA meeting b/w sponsor & the FDA.

A
  1. To uncover major unresolved problems.
  2. To identify studies on which the sponsor will rely
    to establish effectiveness.
  3. To identify the status of ongoing or needed
    studies, to assess pediatric safety & effectiveness.
  4. To acquaint FDA reviewer with the technical
    content.
  5. To discuss statistical analysis methods.
  6. To determine the optimal approach for presenting
    & formatting of NDA data.
108
Q

What is the proper sequence of action a sponsor should
take when attempting to resolve an administrative or
procedural dispute with the FDA?

A
  1. Attempt to resolve the dispute with the reviewing
    division of CDER or CBER, beginning with the
    assigned Consumer Safety office (CSO)
  2. If the dispute is not resolved via the CSO, seek
    resolution via an Ombudsman.
109
Q

What is the proper sequence of action a sponsor should
take when attempting to resolve a scientific or medical
dispute with FDA?

A
  1. Discuss the matter directly with the responsible
    reviewing officials.
  2. If unresolved, request a meeting with the
    reviewing officials & management representatives.
110
Q

List at least three general responsibilities of a sponsor

A
  1. Select qualified investigators, providing them with
    information to properly conduct the trial.
  2. Ensure proper monitoring.
  3. Ensure the study is conducted in compliance with
    the protocol.
  4. Maintain an effective IND
  5. Ensure FDA & investigators are provided fully
    safety information.
111
Q

If a sponsor desires to transfer some obligations to
CRO, what documentation must the sponsor prepare?

A

Sponsors must describe, in writing, the specific
responsibilities being transferred unless all
responsibilities are being transferred in which case a
general statement will suffice. Any obligation not
described in writing is deemed not have been transferred

112
Q

When a sponsor transfers some or all obligations to
CRO, the CRO is required to comply with all regulations
designated as sponsor requirements for the transferred obligations. TRUE OR FALSE?

A

true

113
Q

What is a sponsor’s regulatory responsibility with
respect to selecting investigators?

A

The sponsor must select only investigators qualified by
training & experience to investigate the drug.

114
Q

When a sponsor receives information from an IRB
regarding public disclosure of research being conducted
under exception to informed consent, what action must
the sponsor take?

A

Submit copies of the information disclosure to both the IND file & the Dockets management Branch of the FDA.

115
Q

To whom may a sponsor provide investigational drugs?

A

Only investigators participating in the clinical
investigation under the IND.

116
Q

What FDA document must all investigators sign prior to
participation in an investigation of a drug?

A

FDA form 1572.

117
Q

Who must be specifically named on the FDA form
1572?

A
  1. The Investigators.
  2. The Institution where the Investigation will be
    conducted.
  3. The clinical laboratory to be used in the study.
  4. The IRB responsible for review & approval.
  5. Any sub-Investigators who will assist the
    investigators.
118
Q

According to FDA form 1572, what are the investigator’s obligations for conducting the study & supervising those who assist him/her in the conduct of the study?

A

Personally conduct or supervise the investigation &
ensure that all associates, colleagues, or employees
involved in the investigation are informed of the investigator’s obligations.

119
Q

What information must an investigator provide study
subjects regarding the drug they may receive?

A

That the drug is being used for investigational purposes.

120
Q

Who has responsibility for ensuring that an IRB that
complies with the requirements of 21 CFR 56 will
provide review & approval of an investigation?

A

the investigator

121
Q

What actions must an investigator take to make
changes in a study protocol?

A
  1. Inform the sponsor ,request the change,& obtain a
    protocol amendment, if required.
  2. Inform the IRB as needed, & request review &
    approval of the amendment
  3. Modify the ICF, if required & obtain IRB approval.
  4. Inform study subjects of the pertinent changes &
    obtain new ICF, if applicable.
122
Q

What is a sponsor’s responsibility with respect to
selecting monitors for a study?

A

Select monitors who are qualified by training &
experience to monitor the progress of the Investigation.

123
Q

During the Investigator selection process, sponsors are
required to obtain a commitment from an investigator
to provide financial disclosure statements before,
during & for one year after the completion of a study.
TRUE OR FALSE?

A

true

124
Q

When a sponsor is conducting investigations under 21 CFR 50.20, in emergency research conditions, what information must sponsor promptly file with the FDA, under the IND?

A

Information received from the IRB concerning the public disclosure required by regulations.

125
Q

What information document must a sponsor provide to
an investigator prior to beginning an investigation?

A

An Investigator Brochure.

126
Q

Investigators are responsible for periodically requesting
updates regarding new information gleaned by a
sponsor during the course of a clinical investigation.
TRUE OR FALSE?

A

false

127
Q

Even though the FDA form 1572 is a contract b/w an
investigator & the FDA, a sponsor may discontinue
shipments of drug, or terminate a study if the
investigator fails to comply with the obligations on the
signed for 1572 form. TRUE OR FALSE?

A

true

128
Q

What is a sponsor’s obligation relative to review of patient data in an ongoing investigation?

A

The sponsor must review & evaluate safety & efficacy
data as it is obtain from the investigator.

129
Q

Although a sponsor reserves the right to terminate an
ongoing clinical investigation for reason of Pt safety,
the sponsor is required to confer with the investigator
prior to terminating the Investigation. TRUE OR FALSE?

A

FALSE.

130
Q

What records must a sponsor maintain regarding
investigational drug supplies?

A

Records of Receipt, shipment or other disposition of the
drug, which should include the name of the
investigator, as well as the date, quantity, batch or
code mark of each shipment.

131
Q

What records are sponsors required to retain regarding
financial interests of its investigators?

A
  1. Complete & accurate records showing any
    financial interest paid to investigators by the
    sponsor for the study.
  2. Complete & accurate records concerning all other
    financial interests of the investigator in
    compliance with 21 CFR part 54.
132
Q

How long must a sponsor retain record of clinical
investigations?

A

Two years after a marketing application is approved for
the drug or, if an application is not approved for the
drug, until 2 years after shipment & delivery of the
drug for Investigational use is discontinued & the FDA
has been notified.

133
Q

Sponsors are required to reserve samples of any test
article & reference standards used in bioequivalence or
bioavailability studies, yet are not required to release
these samples to the FDA. TRUE OR FALSE?

A

false

134
Q

What authority does FDA have regarding inspection of
sponsor records?

A

The FDA may have access to, inspect, copy & verify
any records & reports relating to a clinical investigation
at reasonable times.

135
Q

Upon written request fro the FDA, the sponsor is
required to submit records or reports pf clinical
investigations to the FDA. TRUE OR FALSE?

A

true

136
Q

Sponsors should discontinue shipment of drug to any
investigator who has failed to make available, records
or reports of an Investigation covered by the IND
regulations. TRUE OR FALSE?

A

true

137
Q

Who may inspect records of investigational drugs that
are also controlled substances?

A

The FDA & the DEA (Drug Enforcement Administration)
of the US Department of Justice.

138
Q

What precautions must a sponsor take regarding
storage of investigational drugs that are also controlled
substances?

A

Ensure the drug is stored in securely locked or
substantially constructed enclosure, access to which is
limited to prevent theft or diversion of the substance
into illegal channels of distribution.

139
Q

Under what conditions may an investigator dispose of
investigational drug?

A

Only under written authorization by the sponsor; the
sponsor must also ensure that the disposition method
will not expose humans to risks from the drug.

140
Q

Investigators are responsible for ensuring that a clinical
Investigation is conducted in full compliance with the
signed investigator statement & applicable regulations.
TRUE OR FALSE?

A

true

141
Q

To whom may an investigator administer or supply
investigational drug?

A
  1. Drug may be administered only to subjects under
    an investigator’s supervision.
  2. Drug may only be supplied to those under direct
    supervision of the investigator for use in the
    clinical study.
142
Q

What records must be maintained by investigators for
investigational drug supplies?

A

Records of drug disposition including dates, quantities
& use by study subjects.

143
Q

Maintenance of adequate & accurate case histories for
study subjects include documentation that ICF was
obtained prior to a subject’s participation in the study.
TRUE OR FALSE?

A

true

144
Q

An investigator is required to prepare & maintain
adequate records & case histories for all study
subjects. TRUE OR FALSE?

A

true

145
Q

For how many years must an investigator retain
records of investigational drug supplies & study subject
case records?

A
  1. Two years after NDA approval or if an NDA is not
    approved.
  2. Two years after the investigation has been
    discontinued & the FDA has been informed.
146
Q

What types of reports is an investigator obligated to provide to the sponsor of a study ?

A
  1. Progress Reports.
  2. Safety Reports.
  3. A final report.
  4. Financial disclosure reports.
147
Q

What information must an investigator provide to a
sponsor regarding his/her financial interests?

A

Sufficient, accurate information to allow the sponsor to
file required reports with the FDA & any changes to
their financial interests during or for one year after the
closure of the study.

148
Q

Name two types of information which an investigator
must promptly report to the reviewing IRB?

A
  1. All changes in the research.
  2. All unanticipated problems involving risks to
    human subjects or others.
149
Q

In addition to permitting authorized FDA representative
to have access to, copy, & verify study records, what
information is an investigator required to divulge
regarding each study subject?

A

No other information. The Investigator may withhold
subject names unless the records of particular subject
required more detailed study, or if there is reason to
believe the records do not represent the actual cases,
or results.

150
Q

How must an investigator store investigational drug
which are also controlled substances?

A

In a securely locked, substantially constructed cabinet
or other enclosure with limited access to prevent theft
or diversion of the substance into illegal channels of
distribution.

151
Q

If an investigator is disqualified by the FDA, what
impact might this event have for the sponsor?

A

Data from disqualified investigator may be eliminated
from NDA consideration & ultimately result in the FDA’s
failure to approve the NDA. Further, for approved
drugs data from disqualified investigators could result
in withdrawal of the marketing approval by the FDA.

152
Q

Once an investigator has been disqualified by the FDA, he /she may never gain receive investigational drug.
TRUE OR FALSE?

A

false

153
Q

What is the basic premise, relative to risk, of IND
regulations regarding drugs intended to treat life threatening
& severely debilitating disease?

A

Physicians & patients are generally willing to accept
greater risks or side effects from drugs intended to
treat severely debilitating or life-threatening illnesses.

154
Q

What are the criteria for life-threatening diseases or
conditions to which special IND regulations apply for
clinical trials?

A
  1. Where the likelihood of death is high unless the
    disease is interrupted.
  2. With outcomes where the end point of the clinical
    trial analysis is survival.
155
Q

What is the FDA’s definition of a “severely debilitating”
disease?

A

A disease or condition that may cause irreversible
morbidity.

156
Q

What types of early consultation meetings are usually
available for INDs to evaluate life threatening or
severely debilitating illnesses?

A
  1. A pre-IND meeting to review animal data or study
    design, to discuss Phase 1 trial designs or data
    presentation in the IND.
  2. An End of Phase 1 meeting to discuss the design
    of Phase 2 trials.
157
Q

For INDs evaluating drugs for severely debilitating or
life threatening disease, the FDA may request that the
sponsor initiate a treatment protocol, if Phase 2 data
appears promising. TRUE OR FALSE?

A

true

158
Q

Although a full NDA is required for drugs intended to
treat life threatening diseases, special recognition of
the medical risk/ benefit must be given by the FDA.

A

true

159
Q

Concurrent with approval of a drug for a life
threatening or severely debilitating disease, the FDA
may request that the sponsor conduct Phase 4 studies
to further evaluate the drug. TRUE OR FALSE?

A

true

160
Q

For what purpose might the FDA undertake focused
regulatory research?

A

To evaluate critical rate-limiting aspects of the drug
development process in facilitating the development of
therapies to treat life-threatening or severely
debilitating illnesses.

161
Q

For what type of studies do FDA officials intend to
monitor study progress & evaluation to facilitate
appropriate progress of the trial?

A

Drugs intended to treat life-threatening or severely
debilitating illnesses.

162
Q

All of the safeguards incorporated in the FDA
regulations regarding ICF (21 CFR 50, IRB review (21
CFR 56), IND (21 CFR 312), NDA (21 CFR 314) &
Biologics (21CFR 600) also apply to drugs intended to
treat life-threatening or severely debilitating illnesses.
TRUE OR FALSE?

A

true

163
Q

Import of IND into US is permissible provided the
consignee meets one of the three criteria. Name the
three criteria.

A
  1. The US sponsor of the IND
  2. A qualified investigator named in the IND.
  3. The domestic agent of a foreign sponsor, who is
    responsible for the control & distribution of the
    drug & is so identified in the IND.
164
Q

Name one of the two individuals who may submit a
request for authorization to the FDA to export
Investigational drug outside of the US.

A
  1. The person is in the US who seeks to export the
    drug.
  2. Authorized official of the Government of the
    country to which the drug is proposed to be
    shipped.
165
Q

Name the International doctrine of ethical principles
that is the standard requirement for acceptance of
foreign studies in support of an IND or NDA.

A

The Declaration of Helsinki.

166
Q

In general, the FDA accepts foreign studies not
conducted under an IND, provided what conditions are
present?

A
  1. Well designed.
  2. Well conducted.
  3. Performed by qualified investigators.
  4. Conducted in accordance with ethical principles
    acceptable to the world community.
167
Q

The FDA may disclose the existence of an IND, even if
it has not previously been made public. TRUE OR
FALSE?

A

false

168
Q

What additional information is available from the FDA
that applies to & support interpretation of the FDA
regulations?

A

FDA guidance documents which support interpretation
of the regulations are available from both Center for
Drug Evaluation & Research. Also from the Center for
Biologics Evaluation & Research.

Socra (11 decks)

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