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. 
2. 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.
3. Conduction phase:
   • The study is initiated, subjects are recruited, human samples are collected, and experiments are conducted. The generated data is documented and monitored.
4. Closing phase:
   • The monitoring is completed, the sites and the database are closed, the data is analyzed, and the report is created. 

Contact TRIGA-S if you want to know more..