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Clinical Trial Regulatory Affairs in Spain

Patricio Ledesma

28 May, 2018

Clinical trials involve several regulatory affairs before, during, and after the research.

In Spain, trial sponsors need to interact with the ethics committee (EC) and the competent authority (CA), namely the Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), to fulfil various administrative tasks and reporting requirements.

Communication with these two entities will continue during the course of the study until its end.

This article describes the main regulatory aspects involved in a clinical trial conducted in Spain, specifically in the start-up stage, during the recruitment period, and after the trial has been completed.

The description is not exhaustive but provides a general overview of the main processes involved.

The initiation of a clinical trial in Spain requires two key approvals, one by an authorized EC and another one by the national regulatory authority (AEMPS).

According to Spanish law, only one EC approval is required for a clinical trial (that of the central EC of reference), even in multicenter studies. Usually, the initial trial application is submitted to both the ethics committee and AEMPS at the same time.

The main documentation needed in these two applications is similar: the study protocol, the patient information sheet (PIS) and informed consent (IC), a set of local documents signed by site staff (suitability of facilities, CV of principal investigators), the study XML file generated by the EudraCT website, and documents related to the study drugs (summary of product characteristics, Investigator’s Brochure, medication labels).

The study is then submitted via the AEMPS trials portal.

The average time from study submission to EC and AEMPS approval is around 2 months, depending on the clarifications and/or corrections required during the process.

Once the study has been approved by the EC and AEMPS, sponsors must negotiate trial contracts with local sites.

In Spain, the contract units of each hospital participating in the trial provide contract templates to be completed by the sponsor.

These agreements include the legal, financial and technical conditions of the research, including a detailed breakdown of the study costs.

After site contract signatures, and once the corresponding site initiation visits have been completed, trial sites are ready to recruit patients.

During the enrollment period, sponsors must submit annual safety reports to EC and AEMPS, as well as annual reports describing the progress of the trial.

In case trial amendments are required, these will have to be submitted and approved by the EC and AEMPS before the modifications can be put into practice.

Any urgent safety measures implemented during the development of the study must be reported as well.

Finally, the end of the clinical trial will imply some additional communications. The EC and AEMPS must be informed about the termination of the study, including the final results of the research.

Clinical trials generate extensive paperwork that can be beyond the scope of the sponsor’s focus and capabilities.

Contract research organizations (CROs) play an important role helping sponsors in managing regulatory affairs. Sofpromed is a Spanish CRO specialized in dealing with trial administrative issues in Spain.

Sponsors conducting studies in Spain can benefit from Sofpromed’s local expertise in regulatory processes. Delegating these tasks will allow them to focus on their core business, reduce costs, and ensure the administrative quality of the research.

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