2.1.10 Plausibility check

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​​​​​​​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


  • ​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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Next item: 2.1.11 Preregistration