⦁ Basic principles & concepts

GCP in clinical trial work – before trial start

⦁ A request arrives

⦁ Contact with the sponsor

⦁ Contracts and applications

⦁ Delegation and training within the team

⦁ Investigator site file

⦁ Source data

⦁ Planning of the initiation meeting

GCP during the trial

⦁ Deviations

⦁ Trial start

⦁ Recruitment of subjects

⦁ Informed consent

⦁ Screening and enrollment

⦁ Follow-up visits and adverse events

Monitoring

⦁ The monitor´s role

⦁ The monitor’s work during the visit

⦁ Audits and inspections

The investigational treatment continues

⦁ The investigational treatment continues according to the protocol

⦁ Changes during the course of the trial

⦁ Trial close-out, signing and archiving