The AEMPS has updated Annexes II, V and VIIIC for the conduct of clinical trials in Spain.
- Annex II. Security documentation that the sponsor must send to the Health Authorities of the Autonomous Communities
- Annex V. Model of insurance certificate
- Annex VIIIC. Instructions for updating the section of Protection of personal data in the patient information sheet regarding the General Data Protection Regulation (EU) No. 2016/679
Clicking here you can access the annexes.