RESEARCH PROJECTS | POST-AUTHORISATION STUDIES
Principal Investigator Documentation Financial Report Form Patient Information Sheet template and Informed Consent Form (PIS-ICF) for research projects Guide to providing the CEIm with the necessary information on personal data protection Research project protocol template CLINICAL TRIALS WITH MEDICINAL PRODUCTS / MEDICAL DEVICES
Suitability of the site's facilities Annex III. Suitability of the Investigator (AEMPS template) Anex V. Insurance certificate Model ( AEMPS template) Anex VIIIA. Guideline for correct preparation of a model Patient Information Sheet and Informed Consent Form (AEMPS template) AGREEMENT MANAGEMENT Clinical trial agreement template (Spanish) Clinical trial agreement template (English) Observational Study with Medicinal Products agreement template (Spanish) Observational Study with Medicinal Products agreement template (English) Research Projects agreement template (Spanish) Research Projects agreement template (English) Agreement addendum template (Spanish) Agreement addendum tempalte (English) Collaboration agreement with the Pharmacy Department (Spanish) Collaboration agreement with the Pharmacy Department (English) Principal Investigator and collaborators (Clinical trials with medicinal products or medical devices) Collaboration agreement with departaments involved (clinical trials with medicinal products or medical devices) PAYMENT OF FEES (New studides, relevant amendments, administrative management of the agreement) Invoice request form Temporary waiver of fees (if you have applied for a grant that is pending approval)
