(MIABIS 2.0 Core, https://doi.org/10.1089/bio.2015.0070)

Study represents a set of samples brought together in the context of a research study. 


REGULATION (EU) No 536/2014

https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-1/reg_2014_536/reg_2014_536_en.pdf

“(1)‘Clinical study’ means any investigation in relation to humans intended:
  (a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products;
  (b) to identify any adverse reactions to one or more medicinal products; or
  (c) to study the absorption, distribution, metabolism and excretion of one or more medicinal products;
  with the objective of ascertaining the safety and/or efficacy of those medicinal products;

(2)‘Clinical trial’ means a clinical study which fulfils any of the following conditions:
  (a)  the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned;
  (b)  the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or
  (c)  diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects.

[…]

(4) ‘Non-interventional study’ means a clinical study other than a clinical trial; ”

2 Comments

  1. Anonymous

    Hey Carsten,

    I've added the definition from the EU regulation for ‘Clinical study'. IMHO MIABIS's defining is not that good, as a term is defined with itself: "A study is a set... of a study."

    1. Yes Miabis is not that good but this is about defining the general term of "study" not specific study types, therefore removed the EU definitions to the separate terms "clinical study" and "clinical trial". Such specific definitions should not appear here.

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