Minimum Documentation For Clinical Trial Contracts Between Sponsor And Research Sites.pdf

The Spanish Agency for Medicinal Products and Medical Devices (AEMPS) has established the minimum documentation necessary for requesting management of the contract to conduct clinical trials between the sponsor and the research sites. This documentation is required after the entry into force of Royal Decree 1090/2015, which separates the authorisation of a clinical trial from its conduct in a specific site.

The sponsor is responsible for accrediting the suitability of the facilities chosen for the clinical trial before the Ethics Committee for Investigation with medicinal products (CEIm) evaluating the trial. The document on suitability of facilities submitted by the sponsor should be signed by the "director or designee of the healthcare site or institution where the clinical trial site is located".

The minimum documentation required for signing the clinical trial contract includes:

1. Protocol in English or Spanish and protocol summary in Spanish to allow the sites to know the objectives, design, methods, and organisation of the trial.
2. Status of application for trial authorisation (in preparation phase prior to submission of application, under evaluation, authorised).
3. Insurance certificate which should be contracted by the sponsor for all clinical trials, except those classified low-intervention clinical trials.
4. Financial schedule of the site which forms part of the contract and which should include the indirect costs that will be applied by the site and the extraordinary direct costs.
5. Identification of the principal investigator and staff of the site and department to which they belong.
6. Pertinent documentation of sponsor delegation, if appropriate.

It is recommended that each site have an established, agile, and public procedure for requesting the document on suitability of facilities, and that the documentation submitted by the sponsor be limited to the protocol summary in Spanish or the protocol in Spanish and English. The contract can be formalised at any time, but it will only be effective when the clinical trial is authorised by the AEMPS and has the favourable opinion of the CEIm.