CT-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 CT SOP Case Report Form and Patient Reported Outcome.

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

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

• A description of the systems that will be used for data management, how required data quality will be ensured etc., see Data Management Plan.
• A log listing who have which roles in data management, see Data Management Personnel Log.
• Testing documentation of the data entry application, see User Acceptance Testing (UAT) and approval of the application, see DEA Approval Form.