https://www.idival.org/wp-content/uploads/2022/10/encab_ensay_contratos.jpg

CLINICAL TRIALS CONTRACT TEMPLATE

DOCUMENTS NEEDED FOR THE SIGNING OF THE CONTRACT (ART. 32, R.D 1090/2015)

This contract only will be effective after AEMPs and CEIm approval:

  1. Brief of the protocol in Spanish and English
  2. Clinical trial status (authorization, evaluation, approved)
  3. Insurance certification
  4. Economical Report (as part of the contract)
  5. Main research identification and research collaborators
  6. Delegation report if apply
  7. Chief of the Clinical Service authorization
  8. XML file (Anex IA)