2. CLINICAL RESEARCH WITH HEALTHCARE PRODUCTS REGULATED BY RD192/2023 AND REGULATION (EU) 2017/745
- Data updated as of November 2024
- EU Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on healthcare products (hereinafter ‘Regulation’) sets out the general requirements in relation to clinical research involving healthcare products in Chapter VI and Annexes XIV and XV thereof.
- In clinical research with healthcare products, there are different situations that must be clearly differentiated in order to know the requirements applicable to each of them. For more information, please consult: https://www.aemps.gob.es/productos-sanitarios/investigacionclinica-productossanitarios/
The sponsor (or the representative CRO) shall send to the following documentation to the CEIm FJD Secretarial Office via email (ceic@fjd.es): - 2.1. Request for initial evaluation:
- Request for Evaluation
- Summary of the Protocol (in Spanish)
- Study Protocol
- Data collection book
- Information on the healthcare product:
- Specify whether it has CE marking and whether it is used under the authorised conditions of use or not (modifies the usual clinical practice or not). If this is not the case, the study also requires authorisation by the AEMPS.
- Researcher's Manual (if authorised, product data sheet)
- List of proposed Researchers and Centers
- Proposed financial report or financial compensation for the researchers and the center, if any
- Patient information sheet and informed consent form.
- Proof of insurance coverage or financial guarantee, if any
- Suitability of the researcher, with corresponding summarised CV's
- Adequacy of facilities (to be managed by sponsor/LR)
- Request for Invoice of Processing Fees : Specifying the test data and the fiscal data for invoicing and shipping. * Exemption from payment of fees will be assessed on a case-by-case basis.
- For contract management, models are available in ‘Contract Management ’.
- Evaluation Fees
- 2.2. Request for evaluation of relevant amendments:
- Letter of request for amendment evaluation
- Summary of changes, proposed modification and justification thereof.
- Documents showing all changes made, highlighted with change control and cleaned up.
- Request for Invoice of Processing Fees : Specifying the test data and tax data for invoicing and shipping. * Exemption from payment of fees will be assessed on an individual basis.
- Evaluation Fees
