Site Initiation Visit at Karolinska Institutet children’s hospital (Stockholm)
On June 14th2017, the Site Initiation Visit (SIV) was held at the new building of Karolinska Institutet children’s hospital (KI) in Stockholm.
The study monitor Louise Rawcliffe from Therakind Ltd. and the Sponsor (represented by Irmgard Toni) met the KI study team around the principal investigator Jonas Berner and the executive investigator Peter Larsson and other people from the team: two medical doctors, the hospital pharmacist and two study nurses.
During the SIV, all site documentation/approvals have been reviewed and approvals from the Ethics Committee and Competent Authority confirmed.
Specific training sessions were held for the team on the patient population, the Investigational Medicinal Products (IMP), the study protocol’s main features and the Pharmacokinetics (PK) and Pharmacogenomics (PCGx) sampling as well as on electronic Case Report Form (eCRF) and on Good Clinical Practice (GCP) guidelines.
After visiting the site facilities, the SIV was concluded successfully. The highly motivated team at KI is now awaiting the IMP to be shipped to the site, before recruitment can start.