General principle — maximise benefits and minimise risks/harm
Legal framework:
- Clinical Trial
» Directive 2001/20/EC and Directive2001/83/EC
- Non-intervention Clinical Study
» Directive2005/28/EC (GCP)
Ethics requirements related to the human participants:
- Copies of Ethics Approvals from all participating hospitals/centres/institutions
- Participation Identification details & Recruitment Criteria for all research participants
- Template Informed consent
- Template PILs
Copies of all must be kept on file and submitted upon request following funding.