Study phases

IVD studies can be subdivided into four main phases: 

  1. Conceptualization and design phase: The IVD-product specific requirements are collected and the individual concept for the study is drafted.  
  1. Preparation phase: Essential documents are prepared, sites are selected, the ethics committee and the competent authority are contacted, and the study team prepares the conduction phase. 
  1. Conduction phase: The study is initiated, subjects are recruited, human samples are collected, and experiments are conducted. The generated data is documented and monitored. 
  1. Closing phase: The monitoring is completed, the sites and the database are closed, the data is analyzed, and the report is created. 

 

Get in touch with TRIGA-S, if you want to learn more about the tasks and responsibilities of each study phase.