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CRA > Clinical Trials > Flashcards

Clinical Trials Flashcards

1
Q

First agency to conduct a clinical trial

A

Navy

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2
Q

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes

A

Clinical Trial

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3
Q

A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge

A

Fundamental research

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4
Q

The study of health and illness in people

A

Clinical research

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5
Q

3 main types of clinical research

A
  • patient oriented research
  • epidemiological and behavioral studies
  • outcomes and health services research
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6
Q

A research project to test the safety or efficacy of a drug, device or other treatment; must develop or contribute to generalizable knowledge

Administering the intervention

A

Clinical trial

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7
Q

4 phases of clinical trial

A

1) tests the safety of medication and treatment on a small group of people
2) continues safety and effectiveness testing with a slightly larger group; participants are afflicted with disease/condition they are trying to treat
3) studies safety, effectiveness and dosing of treatment on hundreds to thousands of people; double-blinded study (patients and providers)
4) intervention is already approved. studies long term effectiveness, comparing new treatment to standard treatment

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8
Q

Recipe for the study

Establishes the primary outcome; determines feasibility and budget; establishes patient inclusion/exclusion; verifies how data will be collected and managed

A

Protocol

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9
Q

ICF

A

Informed Consent Form

Discussion …review…concerns…time…signatures obtained

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10
Q

Essential elements of informed consent (x8)

A

1) research description
2) risks
3) benefits
4) alternatives
5) confidentiality
6) compensation
7) contacts
8) voluntary participation and withdrawal

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11
Q

IND

A

Investigational New Drug

Experimental drug intervention in clinical trial

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12
Q

Investigational New Drug (IND) types (x3)

A

new intervention (drug usually) tested in a clinical trial. Must have IND FDA approval before phase 1 CT begins. 3 types:

  • investigator IND: submitted by physician who initiates and conducts study
  • Emergency IND: allows FDA to authorize use of experimental drug in emergency situation
  • Treatment IND: submitted for experimental drugs showing promise in clinical testing for serious if immediately life threatening conditions
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13
Q

IDE

A

Investigational Device Exemption

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14
Q

AE

A

Adverse Event

Any type of health issue that occurs in a clinical trial participant

Very common in clinical trials; may or may not be related to intervention

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15
Q

SAE

A

Serious Adverse Event

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16
Q

5 types of Serious Adverse Reaction (SAE)

A

1) death
2) a life threatening adverse event
3) inpatient hospitalization or extension of existing hospitalization
4) persistent significant incapacity or substantial disruption
5) birth defects

17
Q

Nuremburg Code

A

Applies to all human subs research; first intl standard for protection of human subs

10 points to this code - introduces concepts of informed consent, voluntary withdrawal, researcher needing to stop study if he/she felt was dangerous

18
Q

ICH GCP

A

International conference on Harmonisation-good clinical practice

19
Q

Belmont Report

A

Commissioned in 1974 by the National Research Act after the news of the Tuskegee study came out

20
Q

3 parts of Belmont Report

A

1) respect for persons
2) beneficence
3) justice

21
Q

45 CFR Part 46

A

1991 Common Rule

Established 4 major subparts

15 fed departments and agencies adopted the common rule

22
Q

Common Rule major subparts (x4)

A

Subpart A - federal policy

Subpart B - additional protections for pregnant women, human fetuses, neonates

Subpart C - additional protection for prisoners

Subpart D - additional protections for children

23
Q

OHRP

A

Office for Human Research Protections

24
Q

IRB

A

Institutional Review Board

Main job is to protect human subjects; also assess whether a group of individuals is a vulnerable population

25
Q

RCT

A

Randomized Control Trial

Designed to isolate and confirm

26
Q

OSHA

A

Housed in the Department of Labor

The Occupational Safety and Health Administration (OSHA /ˈoʊʃə/) is a large regulatory agency of the United States Department of Labor that originally had federal visitorial powers to inspect and examine workplaces.[2]: 12, 16  Congress established the agency under the Occupational Safety and Health Act (OSH Act)

OSHA’s mission is to “assure safe and healthy working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education and assistance”.

27
Q

Employees are to be provided with place of employment free from recognized hazards

A

Occupational Safety and Health Act (OSHA) of 1970

28
Q

Occupational Safety and Health Administration (OSHA) requirements (x3)

A
  • employees should be ensured work environments free of known hazards; or at least alerted of hazards
  • employers must provide PPE
  • employer must provide a respiratory protection program
29
Q
  • includes participants afflicted w disease
  • 100-300 participants
  • subjects are randomized
  • adds blinded control group (placebo)
  • focus = efficacy
A

Phase 2 clinical trial

Most trials end here bc determined intervention is not effective enough to continue

30
Q

mechanism by which patient data is collected and submitted to sponsor

A

case report form (CRF)

31
Q

PII

A

personally identifiable information

can be used to distinguish or trace individual’s identity

protected by HIPAA

CRA (21 decks)

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