CT-Training and start-up 

The trial cannot start before study personnel has received appropriate training, see CT SOP Training and Qualification.

Training can be undertaken during a national/international start-up meeting or during local meeting(s), or both. Use Start-up Meeting Cheklist in order to keep an overview of what needs to be done, and set up an agenda for the start-up meeting(s), Start-up Meeting Agenda. Participants can be documented on Meeting Participants List.

Training should be documented in a Training Log.

To ensure that everything is ready for inclusion of subjects, the monitor needs to perform an initiation visit. If feasible, the initiation visit and the start-up meeting can be combined. As part of the initiation visit the following template should be filled in:

Delegation Log.

Source Data List

Clinical Trial Protocol Site Signature Form