ACR - Trial Design an der Hochschule Bonn-Rhein-Sieg | Karteikarten & Zusammenfassungen

Lernmaterialien für ACR - Trial Design an der Hochschule Bonn-Rhein-Sieg

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TESTE DEIN WISSEN
What are side purposes in clinical trials? 
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TESTE DEIN WISSEN
- Supportive care
- Screening
- Health Services Research
- Basis Science
- Device Feasibility 
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TESTE DEIN WISSEN
What is the difference between an interventional clinical trial and a non international/observational trial? 
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TESTE DEIN WISSEN
interventional trial:
a
treatment/drug/intervention is part of the study plan which does not reflect daily clinical practice

observational trial:
no intervention is done 
Lösung ausblenden
TESTE DEIN WISSEN
There are 3 different main purposes of clinical trials. Which ones? 
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TESTE DEIN WISSEN
- Treatment of condition, syndrome or disease

- Prevention of development of disease or health condition

- Diagnostic identification of disease or health condition
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TESTE DEIN WISSEN
What is the basic outline of trial design? 
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TESTE DEIN WISSEN
1. Allocation/Randomization

2. Intervention Model & control (Arm type, number of arms)

3. Masking/Blinding (open label, single blind, double blind, double dummy)

4. Outcome Measures/Endpoints (primary, secondary, exploratory endpoints)

5. Study Population (who is enrolled) 
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TESTE DEIN WISSEN
What is a monitoring plan? 
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TESTE DEIN WISSEN

A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial

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TESTE DEIN WISSEN
What are the attributes of a project? 
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TESTE DEIN WISSEN
  • –  unique purpose

  • –  temporary

  • –  require resources, often from various areas

  • –  should have a primary sponsor and/or customer

  • –  involve uncertainty

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TESTE DEIN WISSEN
What is the Case Report Form?
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TESTE DEIN WISSEN

A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject

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TESTE DEIN WISSEN
What is a critical path (e.g. in Gantt chart)? 
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TESTE DEIN WISSEN

Longest sequence of activities in a project plan which must be completed on time for the project to complete on due date

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TESTE DEIN WISSEN
What is a project in context to clinical study?
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TESTE DEIN WISSEN

a temporary endeavor undertaken to accomplish a unique product or service

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TESTE DEIN WISSEN
What are the roles of the clinical research associate?

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TESTE DEIN WISSEN
- Managing (information, advise, training) --> support

- Monitoring (validation, review, checking) --> control
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TESTE DEIN WISSEN
Who adopted the Declaration of Helsinki and what does it say? 
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TESTE DEIN WISSEN
- World Medical Assembly

"Concern for the interest of the subject must always prevail over the interests of science and society"
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TESTE DEIN WISSEN
Which product classes do exist and what do they mean?
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TESTE DEIN WISSEN
1. Pharmacological

- interaction between the

molecules of the substance

- dose- response correlation is indicative


2. Immunological
- action in or on the body by stimulation and/or mobilisation of cells and/or products involved in a specific immune reaction

3. Metabolic
- action which involves analteration, including stopping, starting or changing the speed of thenormal chemical processes participating in, and available for, normal body function
Lösung ausblenden
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  • 818 Studierende
  • 32 Lernmaterialien

Beispielhafte Karteikarten für deinen ACR - Trial Design Kurs an der Hochschule Bonn-Rhein-Sieg - von Kommilitonen auf StudySmarter erstellt!

Q:
What are side purposes in clinical trials? 
A:
- Supportive care
- Screening
- Health Services Research
- Basis Science
- Device Feasibility 
Q:
What is the difference between an interventional clinical trial and a non international/observational trial? 
A:
interventional trial:
a
treatment/drug/intervention is part of the study plan which does not reflect daily clinical practice

observational trial:
no intervention is done 
Q:
There are 3 different main purposes of clinical trials. Which ones? 
A:
- Treatment of condition, syndrome or disease

- Prevention of development of disease or health condition

- Diagnostic identification of disease or health condition
Q:
What is the basic outline of trial design? 
A:
1. Allocation/Randomization

2. Intervention Model & control (Arm type, number of arms)

3. Masking/Blinding (open label, single blind, double blind, double dummy)

4. Outcome Measures/Endpoints (primary, secondary, exploratory endpoints)

5. Study Population (who is enrolled) 
Q:
What is a monitoring plan? 
A:

A document that describes the strategy, methods, responsibilities, and requirements for monitoring the trial

Mehr Karteikarten anzeigen
Q:
What are the attributes of a project? 
A:
  • –  unique purpose

  • –  temporary

  • –  require resources, often from various areas

  • –  should have a primary sponsor and/or customer

  • –  involve uncertainty

Q:
What is the Case Report Form?
A:

A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject

Q:
What is a critical path (e.g. in Gantt chart)? 
A:

Longest sequence of activities in a project plan which must be completed on time for the project to complete on due date

Q:
What is a project in context to clinical study?
A:

a temporary endeavor undertaken to accomplish a unique product or service

Q:
What are the roles of the clinical research associate?

A:
- Managing (information, advise, training) --> support

- Monitoring (validation, review, checking) --> control
Q:
Who adopted the Declaration of Helsinki and what does it say? 
A:
- World Medical Assembly

"Concern for the interest of the subject must always prevail over the interests of science and society"
Q:
Which product classes do exist and what do they mean?
A:
1. Pharmacological

- interaction between the

molecules of the substance

- dose- response correlation is indicative


2. Immunological
- action in or on the body by stimulation and/or mobilisation of cells and/or products involved in a specific immune reaction

3. Metabolic
- action which involves analteration, including stopping, starting or changing the speed of thenormal chemical processes participating in, and available for, normal body function
ACR - Trial Design

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