Investigators are required to have documented knowledge of ICH GCP guidelines. This course is normally a one day course but the duration and content can be customised to meet client’s needs or requirements.
Description
History of GCP
Declaration of Helsinki
Principles of GCP
Ethics Committee
Investigator’s responsibilities
Sponsor’s responsibilities
Safety reporting (AE, SAE, SUSAR)
Informed Consent
Protocol and Amendments
Investigator’s brochure
Essential documents
EU Directives & guidance documents
Target group
Investigators and other research personnel working with clinical trials in hospital.
Course leader
- Alistair Bone, Director of Quality Assurance and Training
- Sheelagh Corcoran, Global Training Manager
- Staff from local TFS office
Date/location
As requested by customer or at TFS Trial Form Support office.
Language
Swedish or English, as agreed with customer.
Cost
To be decided.
For more information please contact us!