Brainscape's Knowledge GenomeTM

Browse over 1 million classes created by top students, professors, publishers, and experts.


See full index

CCRP > Cards to study > Flashcards

Cards to study Flashcards

1
Q

What is premarket approval? (PMA)

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
2
Q

What is WNL?

A

within normal limits

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
3
Q

What are phase 2 studies?

A

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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
4
Q

How many patients are generally in a phase 2 study?

A

several hundred

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
9
Q

What is ICH 57A?

A

safety pharmacology studies for human pharmaceuticals

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
10
Q

what is 21 CFR 314?

A

new drug application

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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)``
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
13
Q

What are the 3 principles of the belmont report?

A
  1. respect for persons
  2. beneficence
  3. justice
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
16
Q

3 parts for beneficence

A
  1. respecting decisions
  2. protecting from harm
  3. securing wellbeing
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
17
Q

what is justice in research?

A

fairness of distribution (potential participants should be treated equally)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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
How well did you know this?
1
Not at all
2
3
4
5
Perfectly
19
Q

What is form 3455?

A

financial disclosure form

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
20
Q

what is form 3454?

A

certification of financial interests

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
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)

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
22
Q

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

A

3500A

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
23
Q

what is the voluntary form for adverse event reporting?

A

3500

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
24
Q

What is 21 CFR 312?

A

investigational new drug application

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
25
Q

what label needs to be on an investigational new drug intended for a huamn?

A

caution: new drug - limited by federal/united states law to investigational use

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
26
Q

is an approved informed consent document listed on form 1571?

A

no

How well did you know this?
1
Not at all
2
3
4
5
Perfectly
27
Q

what is an adverse drug experience that places the subject at immediate risk of death?

A

life-threatening

28
Q

What are the 3 applications of the belmont report?

A
  1. informed consent
  2. assessment of risk and benefits
  3. selection of subjects
29
Q

how many subjects does a phase 3 study usually include?

A

thousands

30
Q

how does the FDA define a drug?

A

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
Q

what is a phase I study and how many subjects are typically enrolled?

A

Is it safe? 20-80 generally healthy subjects

32
Q

what is the goal of a phase 3 study?

A

gathering more info about safety and efficacy, studying different populations or dosages, using drug in combination

33
Q

what is a phase 4 trial?

A

post marketing study: continued safety monitoring post FDA approval

34
Q

What is 21 CFR 50?

A

protection of human subjects

35
Q

What is 21 CFR 50 subpart D?

A

additional safeguards for children

36
Q

can the FDA restrict, suspend or terminate an institution or IRB’s use of expedited review to protect rights or welfare of subjects?

A

yes

37
Q

what phase protocol is more flexible and less detailed than others?

A

phase 1

38
Q

T/F: a source document is any document found that is associated with a trial

A

false. a source doc is any doc where the date are first recorded

39
Q

what 3 sets of documents are needed prior to a sponsor shipping an investigational drug?

A
  1. IRB approved documents (letter, ICF, protocol)
  2. investigator documents (1572, CV, FDFs)
  3. current lab certifications and normal ranges
40
Q

what is the minimum number of IRB members?

A

5

41
Q

what is the purpose of monitoring clinical trials?

A

verify rights, safety and well-being of subjects are protected

42
Q

what is a CRO?

A

contract research organization

43
Q

Can the CRO be responsible for selecting investigators?

A

Yes, if the Sponsor contracts them to do so

44
Q

how long after a study’s completion does the investigator have to update the financial disclosure information?

A

1 year

45
Q

What does a sponsor need to give an investigator before the trial can begin?

A

an investigator brochure

46
Q

what does 21 CFR 56 contain?

A

IRB regulations

47
Q

what is 21 CFR 56 subpart B?

A

IRB documentation

48
Q

what is 21 CFR 50 subpart B?

A

elements of informed consent

49
Q

what document did the doctor’s trial prompt?

A

nuremberg code

50
Q

who does the ICH GCP guideline provide a unified standard for?

A

US, Japan, EU

51
Q

___ is permission to examine, analyze, verify and reproduce any records and reports important to evaluation of a trial

A

direct access

52
Q

What is the Declaration of Helsinki?

A

World Medical Association ethical principles for research involving human subjects

53
Q

What is 45 CFR 46?

A

HHS- protection of human health subjects

54
Q

which subpart of 45CFR46 covers additional protections for pregnant women, fetuses, and neonates?

A

subpart B

55
Q

If using a short form, what does the witness sign?

A

both the short form and the summary

56
Q

what does 21 CFR 11 cover?

A

electronic signatures and records

57
Q

if using a short form, what does the patient sign?

A

patient signs the short form only and receives a copy of both the summary and short form

58
Q

what is 45 CFR 46 subpart A?

A

basic HHS policy for protection of human subjects

59
Q

what does 21 CFR 54 deal with?

A

financial disclosure of investigators

60
Q

what is an investigation or marked product, or placebo, used as a reference in a trial?

A

comparator

61
Q

what does 21 CFR 50 subpart D deal with?

A

children (all sections of subpart D)

62
Q

what is FDA form 483?

A

inspectional observations

63
Q

what is FDA form 482?

A

notice of inspections

64
Q

When can an IRB waive written informed consent requirements?

A

when the research presents NO MORE than minimal risk

65
Q

what is 21 CFR 56 subpart B?

A

IRB registration and membership

66
Q

which regulation covers additional protections pertaining to research involving prisoners as subjects?

A

45 CFR 46 subpart C

67
Q

what is 21 CFR 56 subpart C?

A

IRB functions and regulations

CCRP (24 decks)

Brainscape helps you reach your goals faster, through stronger study habits.
© 2025 Bold Learning Solutions. Terms and Conditions