Organisations are selected for GCP and GVP inspections on the basis of a risk-based approach when the annual inspection schedule is drawn up. Furthermore, additional knowledge – for example knowledge that comes to light during the approval process for clinical trials – is channelled into the selection process.
GCP inspections focus primarily on clinical trials that expose participants to a particular risk or where the integrity of the data collected may be at risk. By way of example, these include:
- First-in-human (FIH) trials of a medicinal product.
- Clinical trials involving particularly vulnerable participants (e.g. children) or medical emergency situations.
- Sponsors, CROs, organisations and trial centres with a high level of clinical research activity in Switzerland.
- Sponsors, CROs, organisations and trial centres that have never been involved in arranging or conducting clinical trials, or whose involvement has been limited.
- Observations from earlier GCP inspections.
Authorisation holders, as well as CROs and organisations contracted by authorisation holders to carry out pharmacovigilance activities, are selected for GVP inspections on the basis of the following criteria:
- Quality of individual case safety reports (ICSRs)
- Compliance with the rules of the pharmacovigilance reporting system
- Risk management and mitigation measures
- Products that present specific risks
- Observations from earlier GVP inspections.