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1
Q

What is premarket approval? (PMA)

A

required process of scientific review to ensure safety and efficacy of class III devices

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2
Q

What is WNL?

A

within normal limits

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3
Q

What are phase 2 studies?

A

is the drug effective for a particular indication?, determine short-term side effects and risks

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4
Q

How many patients are generally in a phase 2 study?

A

several hundred

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5
Q

Can a Sponsor charge for it’s investigational drug?

A

Yes, but must provide evidence the drug has potential benefit, data obtained from the trial would be essential to proving safety, and show the trial couldn’t be conducted without charging

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6
Q

What are 3 primary sections of a protocol?

A
  1. trial objectives and purpose
  2. assessment of efficacy
  3. data handling and record keeping
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7
Q

What are 5 examples of general controls for devices?

A
  1. prohibition against misbranding
  2. premarket notification requirements
  3. GMPs
  4. registration of manufacturing facilities
  5. listing of device types
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8
Q

what are 7 criteria for IRB approval?

A
  1. minimal risk
  2. reasonable risks compared to benefits
  3. equitable subject selection
  4. informed consent
  5. informed consent documentation
  6. safety monitoring plan
  7. subject privacy protection
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9
Q

What is ICH 57A?

A

safety pharmacology studies for human pharmaceuticals

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10
Q

what is 21 CFR 314?

A

new drug application

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11
Q

what are 3 exemptions from IRB requirements?

A
  1. trials started before 7/27/81 that were/were nt subject to FDA requirements for IRB review at the time
  2. emergency use of a test article
  3. taste and food evaluations, if there are no additives
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12
Q

what are 5 reasons for a clinical hold?

A
  1. subjects exposed to unreasonable or significant risk
  2. investigators not qualified
  3. IB is misleading or inaccurate
  4. IND is not sufficient
  5. protocol is deficient in design (phase 2 and 3)``
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13
Q

What are the 3 principles of the belmont report?

A
  1. respect for persons
  2. beneficence
  3. justice
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14
Q

how does the belmont report defined research?

A

interventions actively designed to test a hypothesis, draw a conclusion to develop or contribute to generalized knowledge

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15
Q

3 parts for respect for persons

A
  1. treated as independent agents
  2. those with diminished autonomy are entitled to protection
  3. entry into research is voluntary, with adequate information
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16
Q

3 parts for beneficence

A
  1. respecting decisions
  2. protecting from harm
  3. securing wellbeing
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17
Q

what is justice in research?

A

fairness of distribution (potential participants should be treated equally)

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18
Q

what are 8 required parts of informed consent?

A
  1. statement that this involves research
  2. potential risks
  3. potential benefits
  4. alternative treatment
  5. confidentiality statement
  6. compensation or treatment if injury occurs
  7. who to direct questions to
  8. statement that participation is voluntary and withdrawal can occur at any time
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19
Q

What is form 3455?

A

financial disclosure form

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20
Q

what is form 3454?

A

certification of financial interests

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21
Q

what form does the sponsor submit to the FDA prior to beginning a drug trial?

A

form 1571 (investigational new drug application, cover sheet)

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22
Q

what is the mandatory form for adverse event reporting to the FDA?

A

3500A

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23
Q

what is the voluntary form for adverse event reporting?

A

3500

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24
Q

What is 21 CFR 312?

A

investigational new drug application

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25
what label needs to be on an investigational new drug intended for a huamn?
caution: new drug - limited by federal/united states law to investigational use
26
is an approved informed consent document listed on form 1571?
no
27
what is an adverse drug experience that places the subject at immediate risk of death?
life-threatening
28
What are the 3 applications of the belmont report?
1. informed consent 2. assessment of risk and benefits 3. selection of subjects
29
how many subjects does a phase 3 study usually include?
thousands
30
how does the FDA define a drug?
product intended for use in diagnosis, cure, treatment, or prevention of a disease, and that is intended to affect the structure or any function of the body
31
what is a phase I study and how many subjects are typically enrolled?
Is it safe? 20-80 generally healthy subjects
32
what is the goal of a phase 3 study?
gathering more info about safety and efficacy, studying different populations or dosages, using drug in combination
33
what is a phase 4 trial?
post marketing study: continued safety monitoring post FDA approval
34
What is 21 CFR 50?
protection of human subjects
35
What is 21 CFR 50 subpart D?
additional safeguards for children
36
can the FDA restrict, suspend or terminate an institution or IRB's use of expedited review to protect rights or welfare of subjects?
yes
37
what phase protocol is more flexible and less detailed than others?
phase 1
38
T/F: a source document is any document found that is associated with a trial
false. a source doc is any doc where the date are first recorded
39
what 3 sets of documents are needed prior to a sponsor shipping an investigational drug?
1. IRB approved documents (letter, ICF, protocol) 2. investigator documents (1572, CV, FDFs) 3. current lab certifications and normal ranges
40
what is the minimum number of IRB members?
5
41
what is the purpose of monitoring clinical trials?
verify rights, safety and well-being of subjects are protected
42
what is a CRO?
contract research organization
43
Can the CRO be responsible for selecting investigators?
Yes, if the Sponsor contracts them to do so
44
how long after a study's completion does the investigator have to update the financial disclosure information?
1 year
45
What does a sponsor need to give an investigator before the trial can begin?
an investigator brochure
46
what does 21 CFR 56 contain?
IRB regulations
47
what is 21 CFR 56 subpart B?
IRB documentation
48
what is 21 CFR 50 subpart B?
elements of informed consent
49
what document did the doctor's trial prompt?
nuremberg code
50
who does the ICH GCP guideline provide a unified standard for?
US, Japan, EU
51
___ is permission to examine, analyze, verify and reproduce any records and reports important to evaluation of a trial
direct access
52
What is the Declaration of Helsinki?
World Medical Association ethical principles for research involving human subjects
53
What is 45 CFR 46?
HHS- protection of human health subjects
54
which subpart of 45CFR46 covers additional protections for pregnant women, fetuses, and neonates?
subpart B
55
If using a short form, what does the witness sign?
both the short form and the summary
56
what does 21 CFR 11 cover?
electronic signatures and records
57
if using a short form, what does the patient sign?
patient signs the short form only and receives a copy of both the summary and short form
58
what is 45 CFR 46 subpart A?
basic HHS policy for protection of human subjects
59
what does 21 CFR 54 deal with?
financial disclosure of investigators
60
what is an investigation or marked product, or placebo, used as a reference in a trial?
comparator
61
what does 21 CFR 50 subpart D deal with?
children (all sections of subpart D)
62
what is FDA form 483?
inspectional observations
63
what is FDA form 482?
notice of inspections
64
When can an IRB waive written informed consent requirements?
when the research presents NO MORE than minimal risk
65
what is 21 CFR 56 subpart B?
IRB registration and membership
66
which regulation covers additional protections pertaining to research involving prisoners as subjects?
45 CFR 46 subpart C
67
what is 21 CFR 56 subpart C?
IRB functions and regulations
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