Training and start-up

The trial cannot start before study personnel has received appropriate training, see SOP Opplæringsplan og kompetansekrav (Norwegian).

Training can be undertaken during a national/international start-up meeting or during local meeting(s), or both. Use Sjekkliste oppstartmøte (Norwegian) in order to keep an overview of what needs to be done, and set up an agenda for the start-up meeting(s), Agenda oppstartmøte (Norwegian).

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:

Mal delegeringslogg (Norwegian) / Template delegation of tasks within the study team

Mal kildedataliste (Norwegian) / Template Source Data List