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SOCRA_2015 > FDA Forms > Flashcards

FDA Forms Flashcards

1
Q

For Use by User-Facilities, Distributors, and Manufacturers for Mandatory Reporting:

a) FDA Form 482
b) FDA Form 483
c) FDA Form 1572
d) FDA Form 3454
e) FDA Form 3455
f) FDA Form 3500
g) FDA Form 3500A

A

g) FDA Form 3500A

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2
Q

Inspectional Observations:

a) FDA Form 482
b) FDA Form 483
c) FDA Form 1572
d) FDA Form 3454
e) FDA Form 3455
f) FDA Form 3500
g) FDA Form 3500A

A

b) FDA Form 483

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3
Q

Disclosure - Financial Interests and Arrangements of Clinical Investigators:

a) FDA Form 482
b) FDA Form 483
c) FDA Form 1572
d) FDA Form 3454
e) FDA Form 3455
f) FDA Form 3500
g) FDA Form 3500A

A

e) FDA Form 3455

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4
Q

Statement of Investigator:

a) FDA Form 482
b) FDA Form 483
c) FDA Form 1572
d) FDA Form 3454
e) FDA Form 3455
f) FDA Form 3500
g) FDA Form 3500A

A

c) FDA Form 1572

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5
Q

Certification - Financial Interests and Arrangements of Clinical Investigators:

a) FDA Form 482
b) FDA Form 483
c) FDA Form 1572
d) FDA Form 3454
e) FDA Form 3455
f) FDA Form 3500
g) FDA Form 3500A

A

d) FDA Form 3454

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6
Q

Notice of Inspection:

a) FDA Form 482
b) FDA Form 483
c) FDA Form 1572
d) FDA Form 3454
e) FDA Form 3455
f) FDA Form 3500
g) FDA Form 3500A

A

a) FDA Form 482

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7
Q

For Voluntary Reporting of Adverse Events and Product Problems:

a) FDA Form 482
b) FDA Form 483
c) FDA Form 1572
d) FDA Form 3454
e) FDA Form 3455
f) FDA Form 3500
g) FDA Form 3500A

A

f) FDA Form 3500

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8
Q

Which 2 forms have to do with Adverse Event Reporting?

a) 482 & 483
b) 3500 & 3500A
c) 3454 & 3455
d) 1572 & 1573

A

b) 3500 & 3500A

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9
Q

Which form must be signed by the investigator and provided to the sponsor before participation in a clinical study conducted under IND regulations?

a) 482
b) 483
c) 1572
d) 3454

A

c) 1572

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10
Q

In order to enter any establishment in which drug or devices are manufactured, processed, packed, or held, officers or employees of the FDA must present (select all that apply):

a) 2 forms of ID
b) FDA Form 482
c) FDA Form 483
d) Appropriate credentials
e) A letter signed by the DHHS director

A

b) FDA Form 482

d) Appropriate credentials

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11
Q

A notice is required for each entry made during the time of inspection.

true
false

A

false

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12
Q

Fill in the blanks:

FDA form ______ is used for _______ reporting, whereas FDA form _____ is used for _______ reporting.

3500
3500A
Mandatory
Voluntary

A

3500
Voluntary
3500A
Mandatory

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13
Q

Certification of Compliance:

a) FDA Form 482
b) FDA Form 1572
c) FDA Form 3454
d) FDA Form 3674

A

d) FDA Form 3674

http: //www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM354618.pdf

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14
Q

Officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice … are authorized to:

a) enter establishments, vehicles
b) inspect factories, equipment, containers
c) inspect records, files, papers
d) inspect financial, pricing, personnel data

A

a, b, c

No inspection …shall extend to financial data, sales data…

Form FDA 482
704(a)(1)

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15
Q

A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection.

true
false

A

true

Form FDA 482
704(a)(1)

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16
Q

Any officer, agent, or employee of the Department of Health and Human Services, authorized by the Secretary for the purpose, may during all hours enter and inspect any establishment for the propagation or manufacture and preparation of any virus, toxin, antitoxin, vaccine…

true
false

A

false

…during all reasonable hours…

Form FDA 482
351(c)

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17
Q

The Secretary may by regulation require dealers and distributors of electronic products, to which there are applicable standards prescribed under this subpart and the retail prices of which is not less than ____, to furnish manufacturers or such products …

a) $10
b) $50
c) $100
d) $500

A

b) $50

Form FDA 482
360 A (f)
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18
Q

Form FDA 483 (Inspectional Observations) are required under Section:

a) 351(c)
b) 361(a)
c) 512(l)
d) 704(b)

A

d) 704(b)

Form FDA 483
704(b)

19
Q

As an Investigator, a completed Form FDA 1572 should be forwarded to:

a) Sponsor
b) FDA
c) both a & b

A

a) Sponsor

Investigators should not send this form directly to the Food and Drug Administration.

Form FDA 1572, pg 2, instructions

20
Q

Form 3454…for purposes of this statement, a clinical investigator includes the spouse and each dependent child of the investigator…and subinvestigator

true
false

A

true

Form FDA 3454
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf

21
Q

Form FDA 3500 may be used by health professionals or consumers.

true
false

A

true

http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/ucm149236.htm

22
Q

Form FDA 3500 may be used to report adverse events involving vaccines.

true
false

A

false

Adverse events involving vaccines should be reported to theVaccine Adverse Event Reporting System (VAERS), http://vaers.hhs.gov/index.

http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/ucm149236.htm

23
Q

FDA is now providing a voluntary reporting form, Form FDA 3500B, that is customized to make the completion of the form by non-health professionals or consumers easier.

true
false

A

true

http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/ucm149236.htm

24
Q

Submission of a report constitutes an admission that medical personnel, user facility, importer, distributor, manufacturer or product caused or contributed to the event.

true
false

A

false
…does not…

Form FDA 3500A
footer

25
Q

The voluntary version of the form FDA 3500 is used to submit most adverse event, product problem, medication errors, dietary supplement and cosmetic reports not mandated by federal law or regulation.

true
false

A

true

http://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=3&ved=0CC0QFjAC&url=http%3A%2F%2Fwww.fda.gov%2FOHRMS%2FDOCKETS%2F98fr%2F03n-0016-ss00001.doc.doc&ei=VTtnVYPqCdDEogSU94FI&usg=AFQjCNG5Ags7eECmXYKw9dkQy7F4UAu6LQ&sig2=was6EfCWlqPuHUCyF98TTw&bvm=bv.93990622,d.cGU

26
Q

In clinical studies, sponsors are required to report serious, unexpected, related events that are fatal or life threatening to the FDA by telephone or fax within seven calendar days of the date the sponsor first becomes aware of the event.

The first person may be a secretary or any other person who happens to answer the telephone or receive the fax.

true
false

A

true

The CRC’s Guide to Coordinating Clinical Research
p 149

27
Q

Events collected after a product is marketed are called spontaneous adverse events.

true
false

A

true

The CRC’s Guide to Coordinating Clinical Research
p 150

28
Q

Which are threatened by a conflict of interest?

a) subject safety
b) scientific integrity
c) academic mission

A

a, b, and c

Protecting Study Volunteers in Research
p 94

29
Q

In addition to financial incentives, personal fame and ambition can be sources of conflict of interest.

true
false

A

true

Protecting Study Volunteers in Research
p 94

30
Q

Under 21 CFR § 54.4(b), each clinical investigator who is
not a full-time or part-time employee of the sponsor of the covered clinical study is required to provide the sponsor with sufficient accurate financial information to allow for complete disclosure or certification and to
update this information if any relevant changes occur during the study and for one year following its completion.

true
false

A

true

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf

31
Q

Re: form FDA 3454
A covered clinical study may have more than one sponsor for whom financial information will need to be collected. For example, if one party designed and
conducted the covered clinical study, a second party provided funding, and a third party provided the test product, there would be three sponsors of the covered clinical study. However, if the third party in this example was reimbursed for the test product, it would not be considered a sponsor of the covered clinical study and the study would be considered to have two sponsors.

true
false

A

true

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf

32
Q

Re: form FDA 3454
“Applicant” means the party who submits a marketing application to FDA for approval of a drug, device or biologic product or who submits a reclassification petition. The applicant is responsible for submitting the required certification and disclosure statements. (See
21 CFR § 54.2(g).)

true
false

A

true

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf

33
Q

Re: form FDA 3454
The dollar amounts that trigger reporting are the combined financial interests of the investigator, spouse, and dependent children.

true
false

A

true

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf

34
Q

Disclosable Financial Interests and Arrangements
(form FDA 3454)

Any equity interest in any sponsor of the covered study if the sponsor is a publicly held company and the interest exceeds _______ in value.

Significant payments of other sorts (SPOOS) are payments that have a cumulative monetary
value of _______ or more and are made by any sponsor of a covered study to the investigator or the investigator’s institution during the time the clinical investigator is carrying out the study and for one year following completion of the study.

a) $10,000, $25,000
b) $25,000, $50,000
c) $50,000, $25,000
d) $25,000, $10,000

A

c) $50,000, $25,000

http: //www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf

35
Q

RE: form FDA 3454
Applicants should provide the total number of investigators in the study and a table indicating, for each clinical investigator listed who is not identified as
an employee, whether they are providing a Certification (FORM FDA 3454), a Disclosure Statement (FORM FDA 3455) or certification that they acted with due diligence but were unable to obtain the information
(option 3 on FORM FDA 3454).

true
false

A

true

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf

36
Q

Who, specifically, is responsible for signing the financial certification/disclosure forms (3454, 3455)?

a) Applicant
b) Investigator
c) Sponsor

A

a) Applicant

The forms are to be signed and dated by the chief financial officer or other responsible corporate official
or representative of the applicant. FDA recommends that the “other responsible corporate official or representative” be a senior official who has the authority to ensure the information is collected and reported accurately. Depending on company structure, such an individual could be the person in charge of regulatory or clinical affairs.

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf

37
Q

Is clinical investigator financial disclosure information required in IND or IDE applications?

yes
no

A

no

IND/IDE sponsors are not required to submit information regarding clinical investigator financial interests or arrangements in IND or IDE applications.

They are, however, required to collect this information before a clinical investigator participates in a clinical study (see 21 CFR §§ 312.53(c)(4), 812.20(b)(5),
and 812.43(c)(5)), and clinical investigators are required to disclose financial information to sponsors (see 21
CFR §§ 312.64(d) and 812.110(d)). The information need not be submitted to FDA until a marketing application is submitted containing the results of the covered clinical study (21 CFR § 54.4).

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf

38
Q

What information about a financial interest or arrangement should be disclosed to the agency? For example, if an investigator owns more than $50,000 of stock in a publicly held company, can the applicant just disclose that there is an interest that exceeds the $50,000 threshold or is it necessary to disclose in written detail the interest or arrangement in question?

a) just disclose that there is an interest that exceeds the $50,000 threshold
b) disclose in written detail the interest or arrangement in question

A

b) disclose in written detail the interest or arrangement in question

The applicant must make a complete and accurate disclosure (21 CFR § 54.4(a)(3)). The specific details of the financial interest or arrangement, including its size and nature, should be disclosed as should any steps take
n to minimize the potential for study bias resulting from the interest or arrangement. In describing financial interests, for example, the applicant might list:
stock valued at $77,000, speaking fees of $7,500, consulting fees of $22,000, and a grant of $125,000 and
include a discussion of the specific steps taken to
minimize potential bias. Sponsors should request that clinical investigators provide sufficient detail about their
financial disclosure information to allow the appropriate
disclosures to be made.

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf

39
Q

Should a clinical investigator report all fluctuations above and below the $50,000 level during the course of the investigation and one year after completion of
the study?

a) yes
b) only if above $50,000 level
c) only if below $50,000 level
d) no, initial disclosure is sufficient

A

b) only if above $50,000 level

In light of the potential volatility of stock prices, FDA recognizes that the dollar value of an investigator’s equity holding in a sponsoring company is likely to fluctuate during the course of a study. Clinical investigators should report an equity interest when the
investigator becomes aware that the holding has exceeded the threshold and the investigator should use judgment in updating and reporting on fluctuations in equity interests exceeding $50,000. FDA does not expect the investigator to report when an equity interest fluctuates below that threshold.

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf

40
Q

FORM FDA 3455 was designed for applicants to use to report financial information they collected from clinical investigators to FDA.

true
false

A

true

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf

41
Q

RE: form FDA 3454

Hospital staff, including nurses, residents, fellows, and office staff who provide ancillary or intermittent care
but who do not make direct and significant contribution to the data are not meant to be included under the definition of clinical investigator.

true
false

A

true

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf

42
Q

RE: form FDA 3454

Who may be considered a “dependent child”?
(mark all that apply)

a) child by blood or adoption
b) stepchild or foster child
c) under the age of 24 if a full-time student
d) child permanently and totally disabled

A

a, b, c, and d

For purposes of clinical investigator financial disclosure under part 54, a dependent child is the investigator’s ch
ild (whether by blood or adoption), stepchild or foster child who is unmarried, and for whom the investigator provides more than one-half of the child’s support. This would include a child who, at any time during the course of the study and for one year following completion of the study, is under the age of 19, under the age of 24 if a full-time student, or who is permanently and totally disabled. Such a child would generally have the same principal residence as the investigator.

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf

43
Q

RE: form FDA 3454

The IND/IDE sponsor, the part 54 sponsor, and the applicant are rarely the same party.

true
false

A

false

In many cases, the IND/IDE sponsor, the part 54 sponsor, and the applicant will be the same party.

However, there may be times when they are not. For example, consider the case when an academic institution serves as the IND/IDE sponsor and a drug company serves as the part 54 sponsor by providing funding or the investigational drug for the study. When a marketing application is submitted, the drug company is likely to
be the applicant. If, however, the drug company was sold to another company, the applicant may be neither the IND/IDE sponsor nor a part 54 sponsor.

http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM341008.pdf

SOCRA_2015 (15 decks)

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