21 CFR Part 812

Question 1

In 21 CFR Part 812, to what does “Act” refer?

a) clinical investigation or research involving one or more subjects
b) Federal Food, Drug, and Cosmetic Act
c) discontinuance, by sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion

Answer 1

b) Federal Food, Drug, and Cosmetic Act

812. 3

Question 2

In 21 CFR Part 812, to what does “Implant” refer?

a) device, including a transitional device, that is the object of an investigation
b) device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more
c) device FDA considered to be a new drug or an antibiotic drug before May 28, 1976

Answer 2

b) device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more
812. 3

Question 3

In 21 CFR Part 812, to what does “Investigational Device” refer?

a) device, including a transitional device, that is the object of an investigation
b) device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 3 days or more
c) device FDA considered to be a new drug or an antibiotic drug before May 28, 1976

Answer 3

a) device, including a transitional device, that is the object of an investigation
812. 3

Question 4

In 21 CFR Part 812, to what does “Transitional Device” refer?

a) device, including a transitional device, that is the object of an investigation
b) device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 3 days or more
c) device FDA considered to be a new drug or an antibiotic drug before May 28, 1976

Answer 4

c) device FDA considered to be a new drug or an antibiotic drug before May 28, 1976
812. 3

Question 5

In 21 CFR Part 812, to what does “Termination” refer?

a) clinical investigation or research involving one or more subjects
b) serious adverse effect resulting in death or other permanently altered physical or mental state
c) discontinuance, by sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion

Answer 5

c) discontinuance, by sponsor or by withdrawal of IRB or FDA approval, of an investigation before completion
812. 3

Question 6

In 21 CFR Part 812, an investigation refers to a clinical investigation or research involving how many subjects to determine the safety or effectiveness of a device?

a) one or more
b) 20-80
c) 100 or more
d) hundreds to thousands

Answer 6

a) one or more

Question 7

In 21 CFR Part 812, to what does “Person” refer?

a) person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an adjunct to providing residential or custodial care to humans
b) individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. Does not include any person other than an individual.
c) human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. Many be in normal health or may have a medical condition or disease.
d) any individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit of a government agency, and any other legal entity

Answer 7

d) any individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit of a government agency, and any other legal entity
812. 3

Question 8

In 21 CFR Part 812, to what does “Monitor” refer?

a) person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an adjunct to providing residential or custodial care to humans
b) individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. Does not include any person other than an individual.
c) one who initiates, but who does not actually conduct, the investigation, that is, the investigational device is administered, dispensed, or used under the immediate direction of another individual
d) individual designated by a sponsor or contract research organization to oversee the progress of an investigation
e) any individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit of a government agency, and any other legal entity

Answer 8

d) individual designated by a sponsor or contract research organization to oversee the progress of an investigation
812. 3

Question 9

In 21 CFR Part 812, to what does “Institution” refer?

a) person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an adjunct to providing residential or custodial care to humans
b) individual designated by a sponsor or contract research organization to oversee the progress of an investigation
c) any individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit of a government agency, and any other legal entity

Answer 9

a) person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an adjunct to providing residential or custodial care to humans
812. 3

Question 10

In 21 CFR Part 812, to what does “Investigator” refer?

a) person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an adjunct to providing residential or custodial care to humans
b) individual designated by a sponsor or contract research organization to oversee the progress of an investigation
c) individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible team leader
d) any individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit of a government agency, and any other legal entity

Answer 10

c) individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible team leader
812. 3

Question 11

In 21 CFR Part 812, to what does “Subject” refer?

a) individual designated by a sponsor or contract research organization to oversee the progress of an investigation
b) human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. Many be in normal health or may have a medical condition or disease.
c) any individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit of a government agency, and any other legal entity

Answer 11

b) human who participates in an investigation, either as an individual on whom or on whose specimen an investigational device is used or as a control. Many be in normal health or may have a medical condition or disease.
812. 3

Question 12

In 21 CFR Part 812, to what does “Sponsor” refer?

a) person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an adjunct to providing residential or custodial care to humans
b) individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. Does not include any person other than an individual.
c) one who initiates, but who does not actually conduct, the investigation, that is, the investigational device is administered, dispensed, or used under the immediate direction of another individual
d) individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible team leader

Answer 12

c) one who initiates, but who does not actually conduct, the investigation, that is, the investigational device is administered, dispensed, or used under the immediate direction of another individual
812. 3

Question 13

In 21 CFR Part 812, to what does “Sponsor-Investigator” refer?

a) person, other than an individual, who engages in the conduct of research on subjects or in the delivery of medical services to individuals as a primary activity or as an adjunct to providing residential or custodial care to humans
b) individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. Does not include any person other than an individual.
c) one who initiates, but who does not actually conduct, the investigation, that is, the investigational device is administered, dispensed, or used under the immediate direction of another individual
d) individual who actually conducts a clinical investigation, i.e., under whose immediate direction the test article is administered or dispensed to, or used involving, a subject, or, in the event of an investigation conducted by a team of individuals, is the responsible team leader

Answer 13

b) individual who both initiates and actually conducts, alone or with others, an investigation, that is, under whose immediate direction the investigational device is administered, dispensed, or used. Does not include any person other than an individual.
812. 3

Question 14

A sponsor that, on July 16, 1980, has an effective IND application for an investigation of a device shall continue to comply with the requirements of 21 CFR Part 312 until ____ days after that date.

a) 30
b) 60
c) 90
d) 120

Answer 14

c) 90

812. 2(e)

Question 15

Custom device means a device that:

a) necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement
b) is not generally available to, or generally used by, other physicians
c) is not generally available in finished form for purchase or prescription
d) is not offered for commercial distribution through labeling or advertising
e) all of the above

Answer 15

e) all of the above

812. 3

Question 16

A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not promote or test market an investigational device until after FDA has approved the device for commercial distribution.

true
false

Answer 16

true

812.7

Question 17

_________ means an individual who actually conducts a clinical investigation.

a) monitor
b) sponsor
c) sponsor-investigator
d) investigator

Answer 17

d) investigator

812. 3

Question 18

Implant means a device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of ____ days or more.

a) 5
b) 10
c) 30
d) 60

Answer 18

c) 30

812. 3

Question 19

21 CFR Part 812:

a) encourages the discovery and development of useful devices intended for human use
b) applies to all clinical investigations of devices to determine safety and effectiveness
c) provides procedures for the conduct of clinical investigations of devices
d) all of the above

Answer 19

d) all of the above

812. 1

Question 20

Which of the following is the definition of an unanticipated adverse device effect?

a) any serious adverse effect on health or safety or any live-threatening problem or death caused by, or associated with, a device if that effect, problem or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application
b) a device that is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject
c) any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects
d) both a and c

Answer 20

d) both a and c

812. 3

Question 21

A person exporting an investigational device subject to 21 CFR Part 812 shall obtain FDA’s prior approval.

true
false

Answer 21

true

812.18

Question 22

A person who imports or offers for importation an investigational device subject to this part shall be the agent of the foreign exporter with respect to investigations of the device and shall act as the _________ of the clinical investigation.

a) investigator
b) monitor
c) sponsor
d) subject

Answer 22

c) sponsor

812. 3

Question 23

A sponsor shall submit an application to the FDA if the sponsor intends to use a(n) _________ in an investigation, intends to conduct an investigation that involves an exception from informed consent under 21 CFR 812 part 50.24, or if FDA notifies the sponsor than an application is required for an investigation.

a) investigational device
b) significant risk device
c) implant
d) non-invasive device

Answer 23

b) significant risk device

812. 20(a)(1)

Question 24

21 CFR Part 812 does not apply to a diagnostic device if the device (select all that apply):

a) does not require an invasive sampling procedure that presents significant risk
b) is invasive
c) introduces energy into a subject
d) is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure

Answer 24

a) does not require an invasive sampling procedure that presents significant risk
d) is not sued as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure
812. 2(c)(3)

Question 25

According to 21 CFR Part 812, a monitor may be:

a) an employee of the sponsor
b) employee of or consultant to a CRO
c) an employee of the investigator
d) a consultant to the sponsor
e) a, b, and d

Answer 25

e) a, b, and d

812. 3

Question 26

To be considered an implant, a device that is placed into a surgically or naturally formed cavity of the human body has to remain within the cavity for 30 days.

true
false

Answer 26

false

812.3
intended to remain 30 days or more

Question 27

There is a common theme regarding an investigational device that is defined as a “significant risk device.” What is that common theme?

a) intended as an implant and presents a potential for serious risk
b) purported or represented to be for a use in supporting or sustaining human life
c) serious risk to the health, safety, or welfare of a subject
d) for use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health

Answer 27

c) serious risk to the health, safety, or welfare of a subject

???
812.3(m) would indicate a, b, c, and d

Question 28

Copies of all forms and informational materials to be provided to subjects to obtain informed consent must be included within the contents of the IDE application.

true
false

Answer 28

true

812.20(b)(11)

Question 29

21 CFR Part 812 Investigational Device Exemptions applies to all clinical investigations of devices to determine safety and effectiveness.

true
false

Answer 29

false

812.2(a)
…except as provided in paragraph (c), exempted investigations, of this section.

Question 30

Report of prior investigations shall include which of the following information (mark all that apply):

a) prior clinical, animal and laboratory testing of the device
b) IRB information
c) summary of all other unpublished information
d) bibliography of all publications
e) description of the device

Answer 30

a) prior clinical, animal and laboratory testing of the device

c) summary of all other unpublished information
d) bibliography of all publications

812.27

Question 31

Labeling of investigational devices shall include which of the following information (mark all that apply):

a) description of all relevant contradictions, hazards, adverse effects, interfering substances or devices, warnings, and precautions
b) name and place of business of the manufacturer, packer or distributor
c) device is safe or effective for the investigational use
d) quantity of contents
e) “Caution-investigational device. Limited by Federal law to investigational use.”

Answer 31

a) description of all relevant contradictions, hazards, adverse effects, interfering substances or devices, warnings, and precautions
b) name and place of business of the manufacturer, packer or distributor

d) quantity of contents
e) “Caution-investigational device. Limited by Federal law to investigational use.”

812.5

Question 32

Which of the following pertains to a significant risk device?

a) device made in a specific form for a specific patient or to meet the special needs of a physician or dentist
b) use of substantial importance in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of the subject
c) placed into a naturally or surgically formed cavity of the human body
d) intended as an implant and presents a potential for serious risk to the health, safety, or welfare of the subject
e) considered to be a new drug or antibiotic drug before May 28, 1976
f) for use in supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of the subject
g) deviates from devices generally available

Answer 32

b) use of importance in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of the subject
d) intended as an implant and presents a potential for serious risk to the health, safety, or welfare of the subject
f) for use in supporting or sustaining human life - presents a potential for serious risk to the health, safety, or welfare of the subject
812. 3(m)

Question 33

Which of the following pertains to a transitional device?

a) device made in a specific form for a specific patient or to meet the special needs of a physician or dentist
b) placed into a naturally or surgically formed cavity of the human body
c) intended as an implant and presents a potential for serious risk to the health, safety, or welfare of the subject
d) considered to be a new drug or antibiotic drug before May 28, 1976
e) deviates from devices generally available

Answer 33

d) considered to be a new drug or antibiotic drug before May 28, 1976
812. 3(r)

Question 34

Which of the following pertains to a custom device?

a) device made in a specific form for a specific patient or to meet the special needs of a physician or dentist
b) use of importance in diagnosing, curing, mitigating or treating disease or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of the subject
c) placed into a naturally or surgically formed cavity of the human body
d) intended as an implant and presents a potential for serious risk to the health, safety, or welfare of the subject
e) considered to be a new drug or antibiotic drug before May 28, 1976
f) for use in supporting or sustaining human life - presents a potential for serious risk to the health, safety, or welfare of the subject
g) deviates from devices generally available

Answer 34

a) device made in a specific form for a specific patient or to meet the special needs of a physician or dentist
g) deviates from devices generally available
812. 3(b)

Question 35

Which of the following pertains to a implantable device?

a) device made in a specific form for a specific patient or to meet the special needs of a physician or dentist
b) placed into a naturally or surgically formed cavity of the human body
c) intended as an implant and presents a potential for serious risk to the health, safety, or welfare of the subject
e) used in supporting or sustaining human life - presents a potential for serious risk to the health, safety, or welfare of the subject
e) deviates from devices generally available

Answer 35

b) placed into a naturally or surgically formed cavity of the human body
c) intended as an implant and presents a potential for serious risk to the health, safety, or welfare of the subject

812.3(d) and 812.3(m)(1)
Note: (c) pertains to a significant risk device

Question 36

FDA approval of a supplemental application is not required if changes are made to clinical protocols that do not affect:

a) the validity of the data or information resulting from the completion of the approved protocol, or the relationship of likely patient risk-to-benefit relied upon to approve the protocol
b) the scientific soundness of the investigational plan
c) the rights, safety, or welfare of the human subjects involved in the investigation
d) all of the above

Answer 36

d) all of the above

812.35(a)(3)(ii)
…and the sponsor provides notice to FDA within 5-working days of making these changes.

Question 37

What is the purpose of the section regarding treatment use of an investigational device?

a) to facilitate the availability of promising new devices to desperately ill patients as early in the device development process as possible, before general marketing begins
b) to obtain additional data on the device’s safety and effectiveness
c) to outline procedures if changes are made to the investigational plan
d) both a and b

Answer 37

d) both a and b

812. 36 (a)

Question 38

Which of the following pertain to a Sponsor?

a) a licensed practitioner who receives an investigational device for treatment use under a treatment IDE
b) in the case of a significant risk device, notifies the FDA within 30 working days of the completion or termination of the investigation
c) keeps records that document evidencing informed consent, relevant observations, record of exposure of each subject to the investigational device, and dates/reasons for deviations from protocol
d) ensures proper monitoring of the investigation, submits an IDE application to the FDA and ensures that any reviewing IRB and FDA are promptly informed or significant new information about an investigation
e) keeps records of shipment and disposition

Answer 38

b) in the case of a significant risk device, notifies the FDA within 30 working days of the completion or termination of the investigation
812. 150(b)(7)

d) ensures proper monitoring of the investigation, submits an IDE application to the FDA and ensures that any reviewing IRB and FDA are promptly informed or significant new information about an investigation
812. 40

e) keeps records of shipment and disposition
812. 140(b)

Question 39

Which of the following pertain an Investigator?

a) a licensed practioner who receives an investigational device for treatment use under a treatment IDE
b) in the case of a significant risk device, notifies the FDA within 30 working days of the completion or termination of the investigation
c) keeps records that document evidencing informed consent, relevant observations, record of exposure of each subject to the investigational device, and dates/reasons for deviations from protocol
d) ensures proper monitoring of the investigation, submits an IDE application to the FDA and ensures that any reviewing IRB and FDA are promptly informed or significant new information about an investigation
e) keeps records of shipment and disposition

Answer 39

a) a licensed practitioner who receives an investigational device for treatment use under a treatment IDE
812. 36(c)(2)

c) keeps records that document evidencing informed consent, relevant observations, record of exposure of each subject to the investigational device, and dates/reasons for deviations from protocol
812. 140(a)

Question 40

How long should an investigator or sponsor maintain the records required by 21 CFR Part 812 after the investigation is terminated or completed or after the records are no longer required for purposes of supporting a premarket approval application?

a) 1 year
b) 2 years
c) 3 years
d) 5 years

Answer 40

b) 2 years

812. 140(d)

Question 41

A sponsor may not begin a part of an investigation until what has happened (mark all that apply)?

a) the IRB at the facility has approved the investigation
b) the FDA has approved the supplemental application
c) the FDA has received certification of IRB approval at the facility where the investigation is being conducted
d) upon filing a marketing application

Answer 41

a) the IRB at the facility has approved the investigation
b) the FDA has approved the supplemental application
c) the FDA has received certification of IRB approval at the facility where the investigation is being conducted

812.42

Question 42

If a clinical investigator is disqualified, the FDA Commissioner notifies the sponsor of any investigation in which the investigator has been named a participant.

true
false

Answer 42

true

812.119(b)

Question 43

An investigator that has been disqualified by the FDA can be reinstated as an eligible investigator?

true
false

Answer 43

true

812.119(f)
…when the Commissioner determines that the investigator has presented adequate assurances that the investigator will employ all test articles, and will conduct any clinical investigation … solely in compliance with the applicable provisions of 21 CFR Part 812.

Question 44

An investigator shall submit unanticipated adverse device effects to the sponsor and their IRB within ____ of first learning of the effect.

a) 5 working days
b) no less often than yearly
c) 10 working days
d) within 3 months after termination
e) 6 months
f) 30 working days

Answer 44

c) 10 working days

812.150(a)(1)
…as soon as possible, but in no event later than 10 working days after the investigator first learns of the effect…

Question 45

The sponsor will submit a current investigator list every ________.

a) 5 working days
b) no less often than yearly
c) 10 working days
d) 3 months after termination
e) 6 months
f) 30 working days

Answer 45

e) 6 months

812. 150(b)(4)

Question 46

The sponsor will notify the FDA within _____ of the completion or termination of the investigation.

a) 5 working days
b) no less often than yearly
c) 10 working days
d) 3 months after termination
e) 6 months
f) 30 working days

Answer 46

f) 30 working days

812.150(b)(7)
In the case of a significant risk device…

In the case of a device that is not a significant risk device, the sponsor shall submit a final report to all reviewing IRB’s within 6 months after termination or completion.

Question 47

An investigator will report to the sponsor withdrawal or approval by the reviewing IRB within ______.

a) 5 working days
b) no less often than yearly
c) 10 working days
d) 3 months after termination
e) 6 months
f) 30 working days

Answer 47

a) 5 working days

812. 150(a)(2)

Question 48

An investigator will submit progress reports how frequently?

a) 5 working days
b) no less often than yearly
c) 10 working days
d) 3 months after termination
e) 6 months
f) 30 working days

Answer 48

b) no less often than yearly

812. 150(a)(3)

Question 49

An investigator shall submit a final report to the sponsor and reviewing IRB within _____.

a) 5 working days
b) no less often than yearly
c) 10 working days
d) 3 months after termination
e) 6 months
f) 30 working days

Answer 49

d) 3 months after termination

812. 150(a)(6)

Question 50

FDA may, in order to protect public health, determine that devices placed in subjects for shorter periods (less than 30 days) are also “implants” for purposes of this part.

true
false

Answer 50

true

812.3(d)

Question 51

An IDE approved under 812.30 or considered approved under 812.2(b) exempts a device from which requirements? (mark all that apply)

a) performance standards
b) premarket approval
c) color additive requirements
d) good clinical practice
e) good manufacturing practice

Answer 51

a, b, c, e

812.1
…also misbranding, banned device regulation, restricted device requirements…

Question 52

What is the cut-off date used to qualify a device as transitional?

a) May 28, 1976
b) July 16, 1980
c) January 19, 1981

Answer 52

a) May 28, 1976
812. 3(r)

812.2(b)
The following investigations are considered to have approved application for IDEs…
An investigation of a device other than one subject to 812.2(e), if the investigation was begun on or before July 16, 1980, and to be completed, and is completed, on or before January 19, 1981.

Question 53

An investigation of a device other than a significant risk device, if the device is not a banned device, is considered to have approved applications for IDEs.

true
false

Answer 53

true

812.2(b)
…unless FDA has notified sponsor that approval of an application is required.

Question 54

Labeling of investigational devices should include all except which information?

a) name/place of business of manufacturer, packer, or distributor
b) sponsor name/address
c) relevant contraindictions, hazards, adverse effects, warnings, precautions
d) CAUTION statement
e) specifications about lots, batches, or other units
f) quantity of contents
g) quality of contents

Answer 54

b, e, g

812.5

Question 55

A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not commercialize an investigational device by charging the subjects or investigators for a device a price larger than that necessary to recover costs of:

a) manufacture and handling
b) research and development
c) a and b
d) none, no costs are recoverable

Answer 55

c) a and b

812. 7(b)

Question 56

If data developed by the investigation indicate in the case of a class III device that premarket approval cannot be justified, the sponsor shall promptly terminate the investigation.

true
false

Answer 56

true

812.7(c)
also true in the case of a class II device that it will not comply with an applicable performance standard or an amendment to that standard

Question 57

A sponsor shall submit an application to FDA in what 3 scenarios?

Answer 57

1) if the sponsor intends to use a significant risk device in an investigation
2) intends to conduct an investigation that involves an exception from informed consent (for emergency research)
3) if the FDA notifies the sponsor than an application is required for an investigation

812.20(a)

Question 58

An IDE application shall include, in the following order:

n=12

Answer 58

1) name and address of sponsor
2) complete report of prior investigations of the device and an accurate summary or the complete investigational plan
3) description of methods, facilities, and controls…
4) example of agreements to be entered into by all investigators…and list of names and addresses…
5) certification that all investigators who will participate have signed the agreement…
6) list of name, address, and chairperson of each IRB…
7) name & address of any institution at which a part of the investigation may be conducted…
8) if device is to be sold, amount to be charged…
9) claim for categorical exclusion under 25.30 or 25.34 or environmental assessment under 25.40
10) copies of all labeling for the device
11) copies of all forms and informational materials to be provided to subjects to obtain informed consent
12) any other relevant information FDA requests for review of the application

812.20 (b)

Question 59

Investigational plan shall include, in the following order:

n=10

Answer 59

1) purpose
2) protocol
3) risk analysis
4) description of device
5) monitoring procedures
6) labeling
7) consent materials
8) IRB information
9) other institutions
10) additional records and reports

812.25

Question 60

The report of prior investigations shall include reports of all prior: (mark all that apply)

a) clinical testing
b) animal testing
c) laboratory testing

Answer 60

a, b, and c

812.27(a)

Question 61

Treatment use of an investigational device

A device may be made available for treatment use under this section prior to the completion of all clinical trials in the case of a serious disease or in the case of an immediately life-threatening disease.

true
false

Answer 61

false

serious disease - after all clinical trials have been completed

812.36(a)

Question 62

FDA shall consider the use of an investigational device under a treatment IDE if: (mark all that apply)

a) device is intended to treat or diagnose a serious or immediately life-threatening disease or condition
b) there is no comparable or satisfactory alternative device or other therapy available to treat or diagnose that stage of disease or condition in the intended patient population
c) device is under investigation in a controlled clinical trial for the same use under an approved IDE, or such clinical trials have been completed
d) sponsor of investigation is actively pursuing marketing approval/clearance of the investigational device with due diligence

Answer 62

a, b, c, and d

812.36(b)

Question 63

A treatment IDE application shall include, in the following order: (n=10)

Answer 63

1) name, address, & phone number of sponsor
2) intended use, criteria for patient selection, written protocol
3) explanation of rationale for use…
4) description of clinical procedures, lab tests, or other measures used to evaluate effects of devise and minimize risk
5) written procedures for monitoring treatment; name & address of monitor
6) instructions for use and all other labeling
7) information relevant to safety and effectiveness…
8) statement of sponsor’s commitment…
9) example of agreement to be signed by all investigators…
10) if sold, price to be charged and statement indicating that the price is based on manufacturing and handling costs only

812.36(c)

Question 64

FDA may disapprove or withdraw approval of a treatment IDE if there is reasonable evidence that the treatment use is impeding enrollment in, or otherwise interfering with the conduct or completion of, a controlled investigation of the same or another investigational device.

true
false

Answer 64

true

812.36(d)(2)(v)

Question 65

The sponsor of a treatment IDE shall submit progress reports on a semi-annual basis to all reviewing IRBs and FDA until the filing of a marketing application. Upon filing of a marketing application, progress reports shall be submitted annually.

true
false

Answer 65

true

812.36(f)

Question 66

If no IRB exists or if FDA finds that an IRB’s review is inadequate, a sponsor may not submit an application to FDA.

true
false

Answer 66

false

812.62(b)
…a sponsor may submit…

Question 67

If an IRB determines that an investigation involves a significant risk device, it shall so notify: (mark all that apply)

a) FDA
b) sponsor
c) investigator

Answer 67

b and c

812.66
it shall notify the investigator, and, where appropriate, the sponsor

Question 68

General responsibilities of sponsors include: (n=5)

Answer 68

1) selecting qualified investigators and providing them with information needed to conduct investigation properly
2) ensuring proper monitoring of the investigation
3) ensuring that IRB review and approval are obtained
4) submitting an IDE application to FDA
5) ensuring that any reviewing IRB and FDA are promptly informed of significant new information about an investigation

812.40

Question 69

General responsibilities of investigators include: (n=4)

Answer 69

1) ensuring that an investigation is conducted according to the signed agreement, the investigational plan and applicable FDA regulations
2) protecting the rights, safety, and welfare of subjects under the investigator’s care
3) control of devices under investigation
4) ensuring that informed consent is obtained

812.100

Question 70

While awaiting approval, an investigator may determine whether potential subjects would be interested in participating in an investigation.

true
false

Answer 70

true

812.110(a)

Question 71

Disqualification of a clinical investigator involves the following process:

a) informal conference, regulatory hearing, then written notice
b) informal conference, written notiice, then regulatory hearing
c) written notice, informal conference, then regulatory hearing
d) regulatory hearing, informal conference, then written notice

Answer 71

c) written notice, informal conference, then regulatory hearing
812. 119

Question 72

A participating investigator shall maintain the following records: (n=5)

Answer 72

1) all correspondence with another investigator, an IRB, the sponsor, a monitor, or FDA
2) records of receipt, use or disposition of a device…
3) each subject’s case history and exposure to the device…
4) protocol and each deviation…
5) any other records that FDA requires to be maintained…

812.140(a)

Question 73

A sponsor shall maintain the following records: (n=6)

Answer 73

1) all correspondence with another sponsor, a monitor, an investigator, an IRB, or FDA
2) records of shipment and disposition
3) signed investigator agreements including financial disclosure
4) abbreviated requirements…records…(device other than significant risk device)…
5) records concerning adverse device effects and complaints
6) any other records that FDA requires…

812.140(b)

Question 74

An investigator or sponsor may withdraw from the responsibility to maintain records for the period required and transfer custody to any other person who will accept responsibility for them.

true
false

Answer 74

true

812.140(e)

Question 75

Notice of a transfer of records custody shall be given to the FDA:

a) at least 10 working days prior to transfer
b) at least 30 working days prior to transfer
c) not later than 10 working days after transfer occurs
d) not later than 30 working days after transfer occurs

Answer 75

c) not later than 10 working days after transfer occurs

812. 140(e)

Question 76

How many copies of a signed “Application for an Investigational Device Exemption (IDE)” does the sponsor need to submit to the FDA?

a) 0
b) 1
c) 2
d) 3
e) 5

Answer 76

d) 3

812. 20

Question 77

The FDA may disapprove or withdraw an IDE submission for which of the following reasons:

a) there has been a failure to comply with any requirement
b) the application contains an untrue statement
c) the sponsor fails to respond to a request for additional information
d) the FDA believes it is unreasonable to begin or continue the investigation
e) all of the above

Answer 77

e) all of the above

812. 30

Question 78

The FDA must disclose to all individuals whom an IDE has been used a copy of a report of adverse devise effects relating to that use.

true
false

Answer 78

false

The FDA is not required to disclose this information, unless the individual requests the report or they decide on their own initiative.

812.38(c)

Question 79

Noninvasive, when applied to a diagnostic device or procedure, means one that, by design or intention: (mark all that apply)

a) does not penetrate or pierce the skin or mucous membranes of the body, the ocular cavity, or the urethra
b) does not enter the ear beyond the external auditory canal, the nose beyond the nares, the mouth beyond the pharynx, the anal canal beyond the rectum, or the vagina beyond the cervical os
c) blood sampling that involves simple venipuncture
d) use of surplus samples of body fluids or tissues that are left over from samples taken for noninvestigational purposes

Answer 79

all

812.3(k)

Question 80

The Center for Devices and Radiological Health (CDRH) oversees products such as intravenous (IV) catheters, pacemakers, implantable pumps for insulin or other medications, synthetic grafts, and breast implants.

true
false

Answer 80

true

Conducting Clinical Research
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