Training and start-up
Before the study can start, it must be ensured that all trial personnel have sufficient training.
SOP Opplæringsplan og kompetansekrav (Training plan and competence requirements)
Training must be documented.
Much of the training can be done in connection with the start-up meeting.
SOP Søknadsprosess, godkjenninger og oppstart (Application process, approvals and start-up)
See the checklist before drawing up the agenda.
To check that everything is ready for the inclusion of patients, the monitor must perform an initiation visit. Significant deviations in the initial report must be resolved before the first patient can be included.
As part of the start-up/initiation, the following templates must be completed:
Template Delegation of Tasks within the Study Team.
Template Prescreening Log can be used to keep track of trial participants who are being considered for participation and who have not yet been asked for consent. This is not a GCP document; it should not be kept for 15 years, but should be shredded after it has done its job.