Difference between revisions of "2.1.10 Plausibility check"

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== ​​​​​​​A. Background​​ & Definitions ==
 
== ​​​​​​​A. Background​​ & Definitions ==
  
There are instances when experiments are very well designed and the research team has an intention to do the study according to the design but there are often "unforeseen" situations and factors that force changes in the study plan.
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There are instances when experiments are very well designed and the research team has an intention to do the study according to the design but there are often "unforeseen" situations and factors that force changes in the study protocol.
 
 
 
Such "unforeseen" factors can in many cases be predicted and appropriate mitigation strategies discussed and implemented.
 
Such "unforeseen" factors can in many cases be predicted and appropriate mitigation strategies discussed and implemented.
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Analysis of such "unforeseen" factors is the essence of the plausibility check that aims to avoid negative impact on the research rigor (e.g. not being able to enrol a required number of subjects, study becomes underpowered).
 
Analysis of such "unforeseen" factors is the essence of the plausibility check that aims to avoid negative impact on the research rigor (e.g. not being able to enrol a required number of subjects, study becomes underpowered).
 
 
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== B. Guidan​​ce & Expectations ==
 
== B. Guidan​​ce & Expectations ==
  
Development of a study plan should be concluded by a formal or informal plausibility check in order to:
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Development of a study protocol should be concluded by a formal or informal plausibility check in order to:
  
 
Identify ​obstacles for performing the experiment (e.g. sufficient amount and quality of materials and reagents; fit-for-purpose status of key hardware and software; availability of trained and properly informed colleagues to support execution of the study)
 
Identify ​obstacles for performing the experiment (e.g. sufficient amount and quality of materials and reagents; fit-for-purpose status of key hardware and software; availability of trained and properly informed colleagues to support execution of the study)
 
Confirm that the experiment can be performed within expected timelines
 
Confirm that the experiment can be performed within expected timelines
 
​PLEASE DO NOT FORGET
 
  
​To consider adding this subject to a training program for new employees or refresher training (if appropriate)
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To check whether there are feedback channels installed so that your colleagues can identify, record and report errors and critical incidents related to this subject​ (if appropriate)​
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'''​PLEASE DO NOT FORGET'''
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* ​To consider adding this subject to a training program for new employees or refresher training (if appropriate)
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* To check whether there are feedback channels installed so that your colleagues can identify, record and report errors and critical incidents related to this subject​ (if appropriate)​
  
  
 
== C. Resources ==
 
== C. Resources ==
 
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to be added
tba
 
 
 
 
   
 
   
  

Latest revision as of 19:43, 23 March 2021

​​​​​​​A. Background​​ & Definitions

There are instances when experiments are very well designed and the research team has an intention to do the study according to the design but there are often "unforeseen" situations and factors that force changes in the study protocol. ​ Such "unforeseen" factors can in many cases be predicted and appropriate mitigation strategies discussed and implemented.

Analysis of such "unforeseen" factors is the essence of the plausibility check that aims to avoid negative impact on the research rigor (e.g. not being able to enrol a required number of subjects, study becomes underpowered). ​


B. Guidan​​ce & Expectations

Development of a study protocol should be concluded by a formal or informal plausibility check in order to:

Identify ​obstacles for performing the experiment (e.g. sufficient amount and quality of materials and reagents; fit-for-purpose status of key hardware and software; availability of trained and properly informed colleagues to support execution of the study) Confirm that the experiment can be performed within expected timelines


​PLEASE DO NOT FORGET

  • ​To consider adding this subject to a training program for new employees or refresher training (if appropriate)
  • To check whether there are feedback channels installed so that your colleagues can identify, record and report errors and critical incidents related to this subject​ (if appropriate)​


C. Resources

to be added



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