At the moment, everyone is talking about the GDPR (Spanish abbreviation RGPD). It has led to many changes, especially for clinical trials, where special emphasis is placed on data protection. Especially patient information sheets and informed consent forms must be revised thoroughly.
On 9 July 2018 the responsible Spanish authority Agencia Española de Medicamentos y Productos Sanitarios published recommendations on how to update study documents that shall be used in Spain. This information was updated on 17 October 2018.
The authority’s recommendations primarily concern the adaptations that must be made in the patient information sheet (hoja de información al sujeto – HIP) and informed consent form (consentimiento informado – CI).
According to the Spanish data protection authority Agencia Española de Protección de Datos, patients that consented to participating in a clinical trial before 25 May 2018 do not need to receive additional information concerning the changes brought about by the GDPR.
For ongoing trials that were approved before 25 May 2018, patients who provide their consent to participate after 25 May 2018 must receive and sign an annex containing information about the GDPR in addition to the existing informed consent form. You can find the Spanish template for this annex published by the responsible authority here.
If this template is left unchanged, a submission to the Spanish ethics committee (Comité de Ética de la Investigación con Medicamentos) is not necessary. In case the template is modified this is considered a substantial amendment. Do not forget to update the information on data protection in the HIP/CI if you are submitting another substantial amendment unrelated to data protection.
Apart from that the GDPR as current legal basis must be mentioned in the data protection section of the HIP. The information concerning data protection must be adapted to the authority’s template. At the moment the Agencia Española de Medicamentos y Productos Sanitarios is also revising its patient information sheet template.
Our experienced medical writers will gladly adapt your patient information sheets in accordance with the new requirements.