ACR - Trial Design at Hochschule Bonn-Rhein-Sieg

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Exemplary flashcards for ACR - Trial Design at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

There are 3 different main purposes of clinical trials. Which ones? 

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What are side purposes in clinical trials? 

Exemplary flashcards for ACR - Trial Design at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

What is the difference between an interventional clinical trial and a non international/observational trial? 

Exemplary flashcards for ACR - Trial Design at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

What is the basic outline of trial design? 

Exemplary flashcards for ACR - Trial Design at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

What is a project in context to clinical study?

Exemplary flashcards for ACR - Trial Design at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

What are the attributes of a project? 

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

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What is the Case Report Form?

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What are the roles of the clinical research associate?

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What is a monitoring plan? 

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Who adopted the Declaration of Helsinki and what does it say? 

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Which product classes do exist and what do they mean?

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Exemplary flashcards for ACR - Trial Design at the Hochschule Bonn-Rhein-Sieg on StudySmarter:

ACR - Trial Design

There are 3 different main purposes of clinical trials. Which ones? 
- Treatment of condition, syndrome or disease

- Prevention of development of disease or health condition

- Diagnostic identification of disease or health condition

ACR - Trial Design

What are side purposes in clinical trials? 
- Supportive care
- Screening
- Health Services Research
- Basis Science
- Device Feasibility 

ACR - Trial Design

What is the difference between an interventional clinical trial and a non international/observational trial? 
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 

ACR - Trial Design

What is the basic outline of trial design? 
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) 

ACR - Trial Design

What is a project in context to clinical study?

a temporary endeavor undertaken to accomplish a unique product or service

ACR - Trial Design

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

  • –  temporary

  • –  require resources, often from various areas

  • –  should have a primary sponsor and/or customer

  • –  involve uncertainty

ACR - Trial Design

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

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

ACR - Trial Design

What is the Case Report Form?

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

ACR - Trial Design

What are the roles of the clinical research associate?

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

- Monitoring (validation, review, checking) --> control

ACR - Trial Design

What is a monitoring plan? 

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

ACR - Trial Design

Who adopted the Declaration of Helsinki and what does it say? 
- World Medical Assembly

"Concern for the interest of the subject must always prevail over the interests of science and society"

ACR - Trial Design

Which product classes do exist and what do they mean?
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

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