Update of Annexes II, V and VIIIC of the AEMPS for the conduct of clinical trials in Spain
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…