Data management

Based on the protocol, the researcher should ensure that the data can be recorded either on paper or preferably electronically in a data capture system, see SOP Case Report Form (CRF) and Patient Reported Outcome Form Management. See also some CRF examples.  

Also the data management should be planned, see SOP Data Management, point 4.1.

Before the first subject can be enrolled in the trial, the following should be in place: