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Study Start Up > Study Start Up > Flashcards

Study Start Up Flashcards

1
Q

The voluntary consent of human subjects is essential

A

Nuremberg Code

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2
Q

The duty and responsibility for ascertaining the quality of consents rests upon each individual who initiates, directs or engages in the experiment

A

Nuremberg Code

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3
Q

The experiment should be conducted only by scientifically qualified persons with highest degree of skill and care

A

Nuremberg Code

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4
Q

Protection of subjects human rights

A

The core of the Nuremberg Code

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5
Q

The primary purpose of medical research is to generate new knowledge, this goal can never take precedence over the rights and interest of individuals research subjects

A

Declaration of Helsinki

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6
Q

The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects

A

Declaration of Helsinki

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7
Q

The 3 basic principles in ethics of research involving human subjects.
2
1. Respect for Persons
2. Beneficence
3. Justice

A

Belmont Report

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8
Q

Informed Consent

-Subject enter into research voluntarily and with adequate info
-Individual treated as autonomous agent

A

Respect for Persons

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9
Q

Do not harm

Maximize possible benefits and minimize possible harms

Assess risk and benefits

A

Beneficence

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10
Q

Selection of subjects

Fairness in distribution of burdens and benefits

A

Justice

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11
Q

Informed consent

A

FDA- 21 CFR 50 Subpart B

                   &

HHS- 45 CFR 46 Subpart B

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12
Q

Institutional Review Board

A

FDA- 21 CFR 56

 &

HHS- 45 CFR 46.107-46.115 Subpart E (IRB Registration)

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13
Q

Protection pregnant women, fetuses

A

Only HHS- 45 CFR 46 Subpart B

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14
Q

Research with prisoners

A

Only- 45 CFR 46 Subpart C

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15
Q

Research with children

A

FDA- 21 CFR 50 Subpart C

          & HHS- 45 CFR 46 Subpart D
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16
Q

Exception from general requirement for Emergency Research

A

Only- FDA 50.23(a)-(c)

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17
Q

Exempt Research

A

Only -HHS- 45 CFR 46.104

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18
Q

Waiver of IRB requirement

A

Only- FDA 45 CFR 46.104

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19
Q

Process that must happen before clinical research begins

A

IND- Investigational New Drug Process

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20
Q
  1. Animal study data and toxicity
  2. Manufacturing info
  3. Clinical protocols for studies to be conducted
  4. Data from prior human research
  5. Information about investigator and other experts involved in study
A

Investigational New Drug (IND) application to FDA before beginning a clinical trial

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21
Q

Tightly controlled in-patient setting. Usually single center studies. Range from 20-80 participants

A

Phase 1

22
Q

Obtain short-term data, multicenter, well-controlled studies. A relatively small number of subjects.

A

Phase 2

23
Q

Researchers confirm its effectiveness, monitor side effects, compare commonly used treatments, and collect information that will allow the experimental drug or treatment to be used safely.

A

Phase 3

24
Q

Delineate additional information about the drug’s risk, benefits, and optimal use; continue assessing overall therapeutic value. Surveillance for less common adverse events. May be similar to the phase 2 and phase 3 study design.

A

Phase 4

25
Q

To avoid subconscious bias in assigning subjects to treatment. Subjects are assigned by chance to a treatment group. Sponsor assigned schedules and balanced to assure even assignments across groups.

A

Randomization

26
Q

Minimize potential subconscious bias in evaluating treatment response-efficacy and safety outcomes. Blinding conceals randomization assignment from one or more participants (subjects and investigators). Procedure for blinding is determined by sponsors

A

Blinding

27
Q

What does a control group tell us?

A

What would have happened to patients if they had not received the test treatment or if they had received a different treatment known to be effective.

28
Q

What should a investigational New Drug Application need to include?

A

•Cover sheet (Form FDA 1571)
•Table of contents
•Introductory statement and general investigational plan
•Protocol(s) for clinical trials
•Chemistry and manufacturing information
•Pharmacology and toxicology information
•Previous human experience with investigational drug
•Additional information e.g- drug dependence and abuse potential, exposure to radiation plans for pediatric studies.

29
Q

How does an IND determination occur?

A

•Upon FDA notification
•OR 30 days after the FDA acknowledges receipt if no notification is received
•OR after clinical hold is resolved

30
Q

What is a Clinical Hold?

A

An order issued by the FDA to the Sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation.

31
Q

What happens during a Clinical Hold?

A

•subjects may not be given the investigational drug
•No new subjects may be given the investigational drug and subjects already taking the drug should discontinued unless continuation is specifically permitted by FDA.

32
Q

What is Expanded Access

A

Aka… “compassionate use” is a pathway for a patient with an immediately life-threatening condition or serious disease to gain access to an investigational medical product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

33
Q

What are categories for expanded Access?

A
  1. Emergency Use
  2. Compassionate Use
  3. Treatment Use
  4. Continued Access
34
Q

What are the requirements for Emergency Use?

A

•Informed consent
•Report to IRB within 5 days of use
•Report to Sponsor
>before or after initiation of a clinical trial

35
Q

What are the requirements for Compassionate Use?

A

•Prior FDA approval of IND supplement

> During a clinical trial

36
Q

What are the requirements for Treatment Use?

A

•Prior FDA approval of treatment IND

> During a clinical trial

37
Q

What are the requirement for continued Access

A

•Prior FDA approval of IND supplement

> After completion of clinical trial

38
Q

FDA Regulatory Submission Path for pharmaceuticals?

A
  1. Preclinical
  2. IND
  3. Phase 1,2,3
  4. NDA
39
Q

FDA Regulatory Submission Path for Medical Device

A
  1. If needed Pre-IDE
  2. If clinical trials are needed; IDE via IRB Approval or FDA approval
  3. Pilot, Pivotal
  4. Letter to file 510 (k), PMA
40
Q

What is the development timeline for drugs/biologics?

A

*10-12 years and thousands of subjects.
*Phase 1,2,3

41
Q

What is the development timeline for medical devices?

A

*hundreds of subjects
*1+ years

42
Q

Lowest risk, clinical trials generally not required

A

Class I

43
Q

Moderate risk usually requires 510 (k) and might require PMA. Generally requires clinical trials

A

Class II

44
Q

Highest Risk; PMA is usually required, and clinical trials absolutely necessary

A

Class III

45
Q

An approved IDE Permits a device to be shipped lawfully for the purpose of conducting investigations of the device without complying with other requirements for the food, Drug, and Cosmetic Act that would apply to devices in commercial distribution

A

Investigational Device Exemption.

46
Q

Are there special labeling requirements for investigational devices?

A

Yes, 21 CFR 812.5 the label must include:
- Name and place of business of the manufacturer, packer, or distributor;
-the quantity of contents, if appropriate; and
-the statement, “CAUTION Investigational device. Limited by Federal (or United States) law to investigational use”

47
Q

IDE reports

A

*Sponsor must report the results of an evaluation of an unanticipated adverse device effect to FDA and all reviewing IRBS and investigators within 10 working days after the sponsor first received notice of the adverse effect.
-Withdrawal of IRB approval (5 working days)
-Withdrawal of FDA approval (5 working days)
-Current list of investigators (every 6 months)
-Progress reports (at least yearly to IRB and SR to FDA

48
Q

What is a closed system

A

An environment in which access is controlled by persons who are responsible for the content of the electronic records that are on the system.

49
Q

Children who are wards of the State or any other agency, institution, or entity can be included in clinical investigations
approved under §50.53 or §50.54 only if such clinical investigations are:

A

(1) Related to their status as wards; or
(2) Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as
subjects are not wards.
(b) If the clinical investigation is approved under paragraph (a) of this section, the IRB must require the appointment of an
advocate for each child who is a ward.
(1) The advocate will serve in addition to any other individual acting on behalf of the child as guardian or in loco parentis.
(2) One individual may serve as an advocate for more than one child.
(3) The advocate must be an individual who has the background and experience to act and agrees to act in, the best
interest of the child for the duration of the child’s participation in the clinical investigation.
(4) The advocate must not be associated in any way (except in the role of advocate or member of the IRB) with the clinical
investigation, the investigator(s), or the guardian organization.

49
Q

Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement for children if it finds and documents that:

A

(1) The clinical investigation involves no more than minimal risk to the subjects;
(2) The waiver will not adversely affect the rights and welfare of the subjects;
(3) The clinical investigation could not practicably be carried out without the waiver; and
(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

50
Q

According to FDA guidelines, the financial disclosure form should be completed by all study personnel who have a significant role in the study.

A

True:
Principal investigator and Sub-investigator

50
Q

What does the content of a protocol need to contain?

A
  1. Trial Objectives & Purpose
  2. Assessment of Efficacy
  3. Data Handling & Record Keeping

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