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SOCRA 2024 Flashcards

1
Q

What is 21 CFR 11?

A

Electronic Records; Electronic Signatures

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2
Q

What is 21 CFR 50?

A

Informed Consent

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3
Q

What is 21 CFR 54?

A

Financial Disclosure

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4
Q

What is 21 CFR 56?

A

Institutional Review Boards

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5
Q

What is 21 CFR 312?

A

Investigational New Drug Application

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6
Q

What is 21 CFR 314?

A

New Drug Application

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7
Q

What is 21 CFR 812?

A

Investigational Device Exemption

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8
Q

What is 21 CFR 814?

A

Premarket Approval of Medical Devices

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9
Q

What is 45 CFR 46?

A

Federal Research
“The Common Rule”

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10
Q

What countries adhere to ICH E6 GCP?

A
  1. European Union
  2. Japan
  3. Unites States
  4. Australia
  5. Canada
  6. Nordic Countries
  7. World Health Organization
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11
Q

What does ALCOA-C stand for?

A

Attributable, Legible, Contemporaneous, Original, Accurate, Complete

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12
Q

What year did the Nuremberg Code come out?

A

1947

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13
Q

What foundation of ethical research come out during WWII?

A

The Nuremberg Code

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14
Q

What is the core principle of the Nuremberg Code?

A

Informed Consent - Voluntary consent of the human subject is absolutely essential.

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15
Q

Who wrote the World Medical Association (WMA)?

A

The Declaration of Helsinki

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16
Q

What year did The Belmont Report come out?

A

1974

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17
Q

What are the three basic ethical principles of The Belmont Report?

A
  1. Respect for Persons
  2. Beneficence
  3. Justice
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18
Q

What is Respect for Persons (Belmont Report)?

A

Individuals should be treated as autonomous agents capable of deliberation about personal goals. This is all about respect for autonomy of the person.

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19
Q

What is Beneficence (Belmont Report)?

A

Persons are treated in an ethical manner not only for respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being.

Example: do not harm, maximize possible benefits and minimize possible harms.

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20
Q

What is Justice (Belmont Report)?

A

Fairness in distribution of burdens and benefits.

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21
Q

who’s responsibility is it to obtain the signed 1572 (pharmaceutical investigation) or Investigator Agreement (device investigation)?

A

a. sponsor
b. monitor
c. investigator
d. IRB

Correct answer: a. sponsor

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22
Q

What does the Investigator’s Agreement contain?

A
  1. CV
  2. Statement of Investigator’s relevant experience
  3. Explanation of termination circumstances
  4. Statement of the Investigator Commitment
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23
Q

Who can the Sponsor transfer any or all of their responsibilities to?

A

Contract Research Organization (CRO)

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24
Q

Who is responsible for proper monitoring and providing a monitoring plan?

A

a. sponsor
b. monitor
c. investigator
d. IRB

Correct answer: a. sponsor

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25
What is the DSMB and what do they do?
DSMB: Data Safety Monitoring Board Independent group who conducts periodic review and evaluates study data for patient safety, study conduct and progress - will have initiated "event triggers" prior to study start.
26
Who is responsible for manufacturing, packaging, labeling and coding of the investigational product?
a. sponsor b. monitor c. investigator d. IRB Correct answer: a. sponsor
27
Who is responsible for providing the investigational product only to investigators participating in an investigation?
a. sponsor b. monitor c. investigator d. IRB Correct answer: a. sponsor
28
Who is responsible for maintaining drug and device accountability records from manufacturing through use, return and destruction?
a. sponsor b. monitor c. investigator d. IRB Correct answer: a. sponsor
29
Who is responsible for promptly reporting information about significant new adverse events, new information or risks with respect to the investigational product or investigations to the FDA and investigators?
a. sponsor b. monitor c. investigator d. IRB Correct answer: a. sponsor
30
If the sponsor determines that the investigational product presents an unreasonable and significant risk to study subjects, the sponsor must do the following (3 things)?
1. Discontinue all studies that present the risk 2. Notify FDA, all investigators involved in the study(ies) and their IRBs 3. Assure return and accounting for all investigational product, its return to the sponsor (or on-site destruction)
31
Who is responsible to submit Safety Reports (Expedited Reporting), if appropriate?
a. sponsor b. monitor c. investigator d. IRB Correct answer: a. sponsor
32
Who is responsible for providing pre-clinical and clinical study reports in information amendments to the IND/IDE?
a. sponsor b. monitor c. investigator d. IRB Correct answer: a. sponsor
33
Who is responsible for submitting an annual report to the IND/IDE?
a. sponsor b. monitor c. investigator d. IRB Correct answer: a. sponsor
34
Who does the Clinical Investigator include?
1. Investigator 2. Any sub-investigators 3. Spouse of investigator or sub-investigators 4. Each dependent child of investigator or sub-investigator
35
What is Form FDA 3454?
Certification: Financial Interests and Arrangements of Clinical Investigators
36
What is Form FDA 3455?
Disclosure: Financial Interests and Arrangements of Clinical Investigators
37
Who is responsible for registering an Applicable Clinical Trial (ACT)?
a. sponsor b. monitor c. investigator d. IRB Correct answer: a. sponsor Explanation: A Principle Investigator (PI) can be responsible, however, this needs to be delegated by the sponsor.
38
Who verifies the rights and well-being of human subjects are protected?
a. sponsor b. monitor c. investigator d. IRB Correct answer: b. monitor
39
Who verifies reported trial data is accurate, complete and verifiable from source documents?
a. sponsor b. monitor c. investigator d. IRB Correct answer: b. monitor
40
Who verifies the study is conducted in compliance with the study protocol, the GCP guidelines, and applicable regulations?
a. sponsor b. monitor c. investigator d. IRB Correct answer: b. monitor
41
Who appoints a monitor for a clinical trial study?
a. sponsor b. clerical staff c. investigator d. IRB Correct answer: a. sponsor
42
Who is properly trained and has the scientific and/or clinical knowledge needed to observe the trail adequately?
a. sponsor b. monitor c. investigator d. IRB Correct answer: b. monitor
43
Who is the main line of communication between the sponsor and the investigator?
The monitor
44
Who selects sites and/or processes for targeted for MVs?
The monitor
45
What does the Statement of Investigator (1572) contain?
1. The name and address of the investigational site(s) 2. The name and address of the responsible IRB 3. The name and address of clinical laboratories, if any 4. For devices, the corresponding requirements are contained in an investigator's agreement (no form comparable to Form FDA 1572)
46
Who personally conducts or supervises the investigation?
a. sponsor b. monitor c. investigator d. IRB Correct answer: c. investigator
47
Does the investigator need IRB approval prior to starting any study related activities?
Yes
48
Who ensures that an IRB complies with requirements of 21 CFR 56 will be responsible for initial and continuing review?
a. sponsor b. monitor c. investigator d. IRB Correct answer: c. investigator
49
Who promptly reports to the IRB all changes in the research activity and unanticipated problems?
a. sponsor b. monitor c. investigator d. IRB Correct answer: c. investigator
50
Who does not may any changes in the research without the sponsor and IRB approval, except to eliminate hazards to human subjects?
a. sponsor b. monitor c. investigator d. IRB Correct answer: c. investigator
51
Who conducts the study in accordance with the relevant, current protocol?
a. sponsor b. monitor c. investigator d. IRB Correct answer: c. investigator
52
Who ensures requirements relating to obtaining informed consent (21 CFR 50) the IRB review and approval (21 CFR 56) are met?
a. sponsor b. monitor c. investigator d. IRB Correct answer: c. investigator
53
Who obtains informed consent from each subject before entry into the study (ex. before any study related procedures)?
a. sponsor b. monitor c. investigator d. IRB Correct answer: c. investigator
54
Who explains the proper use of the investigational product to subjects?
a. sponsor b. monitor c. investigator d. IRB Correct answer: c. investigator
55
Who ensures proper storage and handling of study drug/device; accountability, return or destruction of unused study drug(s)?
a. sponsor b. monitor c. investigator d. IRB Correct answer: c. investigator
56
Who informs subjects that study drugs are being used for investigational purposes?
a. sponsor b. monitor c. investigator d. IRB Correct answer: c. investigator
57
Who ensures investigational product is used only by individuals who have agree to participate in clinical trials as evidenced by signed written informed consent?
a. sponsor b. monitor c. investigator d. IRB Correct answer: c. investigator
58
Who assures the investigational product is used only by the investigator or qualified subinvestigators?
a. sponsor b. monitor c. investigator d. IRB Correct answer: c. investigator
59
Who assures provisions of medical care be given to study patients for study related adverse events?
a. sponsor b. monitor c. investigator d. IRB Correct answer: c. investigator
60
Per 21 CFR 312.64, who reports adverse events during the study?
a. sponsor b. monitor c. investigator d. IRB Correct answer: c. investigator
61
Per 21 CFR 312.62, who maintains adequate and accurate records and make study records available for inspection?
a. sponsor b. monitor c. investigator d. IRB Correct answer: c. investigator
62
How do you correct a mistake per GCP/ALCOA-C?
Single line through the error, enter correct information, initial and date change, provide explanation if needed; do not obliterate the the error, no erasures, no white-out.
63
How do investigator's verify the accountability records?
1. Doses specified in the protocol were provided to subjects 2. Drug/device was provided only to study subjects 3. Use by study subjects reconciles the amounts received and returned to the sponsor 4. Product was stored as specified by the sponsor and in compliance with applicable regulations 5. Device was used for its intended purpose
64
How often does the investigator needs to provide the IRB/IEC?
Annually or more frequent if required by the IRB/IEC
65
Who does the final written summary to the IRB/IEC?
a. sponsor b. monitor c. investigator d. IRB Correct answer: c. investigator
66
What does "clinical investigators" mean per 21 CFR 54?
Listed or identified investigator or sub-investigator who is directly involved in the treatment or evaluation of research subjects", including the spouse and each dependent child of the investigator or subinvestigator.
67
How long is the investigator's financial disclosure for compensation of >$25,000 or >$50,000 valid for?
a. 7 calendar days b. 5 days c. 1 year after completion of the study d. year Correct answer: c. 1 year after completion of the study
68
How long is the investigator's financial disclosure for compensation of any amount <$25,000 valid for?
a. 7 calendar days b. 5 days c. while the study is being conducted d. year Correct answer: c. while the study is being conducted
69
What phase identifies potential new compounds?
a. pre-clinical/non-clinical b. Phase I c. Phase II d. Post Market Correct answer: a. pre-clinical/non-clinical
70
What phase tests in appropriate laboratory and animal models to assess potential activity in humans?
a. pre-clinical/non-clinical b. Phase I c. Phase II d. Post Market Correct answer: a. pre-clinical/non-clinical
71
What phase involves thousands of molecules?
a. pre-clinical/non-clinical b. Phase I c. Phase II d. Post Market Correct answer: a. pre-clinical/non-clinical
72
What phase develops the dosage forms?
a. pre-clinical/non-clinical b. Phase I c. Phase II d. Post Market Correct answer: a. pre-clinical/non-clinical
73
What phase includes animal models?
a. pre-clinical/non-clinical b. Phase I c. Phase II d. Post Market Correct answer: a. pre-clinical/non-clinical
74
What needs to occur prior to a clinical trial beginning? 3 things.
1. summaries of all acute toxicity studies 2. 28-day studies in one rodent and one non-rodent species, usually rats and dogs 3. regulatory authorities can require more information 4. non-clinical studies have to support the conclusion that the drug can be administered safely to human subjects
75
What phase helps to assure the quality of the scientific evaluation is adequate to permit evaluation of the drug's safety and effectiveness?
a. pre-clinical/non-clinical b. Phase I c. Phase II d. Post Market Correct answer: b. Phase II
76

SOCRA 2024 (1 decks)

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