Fundación Investigación Biomédica Hospital Universitario La Paz (FIBHULP) Paseo de La Castellana, 261
Edificio Norte, 4ªPlanta 28046 - Madrid
POST AUTHORIZATION STUDY PROSPECTIVE FOLLOW-UP (PAS-PF)
▪ AGREEMENT model and FINANCIAL REPORT, completed in Spanish. The Agreement may also be signed in English, but the Spanish signature is required
▪ Qualification of the study by AEMPS
▪ Favourable opinion by the MREC.- If the approval is issued by another MREC, we will need ratification by our MREC.
▪ APPROVAL BY THE CENTRE MANAGEMENT.- Issued by our MREC. This document will include the HULP code. You must contact with:
[email protected] [email protected] [email protected]
▪ Authorization by the Autonomous Community Madrid (CAM)
▪ NOTARIZED DOCUMENTATION OR WITH HAGUE APOSTILLE OF:
WHO SIGNS THE AGREEMENT? REQUIRED DOCUMENTATION Only signs the Sponsor Powers of Sponsor’s legal representative
CRO signs on behalf of Sponsor
Powers of legal representative of the CRO Sponsor’s letter of delegation to the CRO
