After approval of the RD 957/2020 which regulates observational studies with medicinal products for human use it is mandatory the publication of results of observational studies with medicinal products for human use in the spanish clinical trials registry, as we mentioned in a previous post. Thus, the AEMPS with the aim to facilitate this process…
Last week, the Royal Decree 957/2020 which regulates the observational studies with medicines for human use was published in the BOE. This regulation will come into force on January 2, 2021 aims to simplify the procedures regulated by the Order SAS/3470/2009 taking into account the observational nature of these type of studies with drugs that…
AECIC (Asociación Española de Compañías de Investigación Clínica/Spanish association of CROs) is aware of the continuous development and innovation in clinical research. Thus, it is necessary to include improvements and changes in daily processes in order to enhance working results and follow the evolution of clinical research. For this reason, on November 12th 2019, AECIC…
The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies(HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT). Transparency and public access to clinical trial results, whether positive or negative, are fundamental…
On April 24th 2019, AEMPS updated the contents of GCP section. Two points were updated: New version of serious protocol breaches notification form. Prohibition of FDA 1572 form in clinical trials carried out in Spain. Those clinical trials must follow Spanish laws 2001/20/EC, 2001/83/EC y 2005/28/EC and Regulation (EU) No. 536/2014 (when come into force).…
The participation of a human being in a clinical trial generates a potential situation of vulnerability in which his/her rights must keep clearly protected. It is necessary that any medical investigation, which involves the human persons study, complies with several ethics requirements stablished in The Helsinki Declaration. All clinical trial protocol should be evaluated by…
The AEMPS has updated Annexes II, V and VIIIC for the conduct of clinical trials in Spain. Annex II. Security documentation that the sponsor must send to the Health Authorities of the Autonomous Communities Annex V. Model of insurance certificate Annex VIIIC. Instructions for updating the section of Protection of personal data in the patient…
Desde el pasado día 22 de noviembre de 2017 está disponible la nueva versión de EudraVigilance y comenzó un nuevo flujo de envío de sospechas de reacciones adversas a medicamentos en la Unión Europea. Esto implica que según lo que establece el Real Decreto 577/2013, por el que se regula la farmacovigilancia de medicamentos de…
El Reglamento General de Protección de Datos (RGPD), que regula el tratamiento que realizan las personas, empresas u organizaciones de los datos personales relacionados con personas en la Unión Europea, fue aprobado por el Parlamento Europeo en abril de 2016, su ámbito de aplicación se extiende a todos los países miembros de la Unión Europea…
Desde la finalización de las Normas de Buena Práctica Clínica (GCP) de la ICH en 1996, la escala, la complejidad y el coste de los ensayos clínicos han aumentado. Cuando se preparó el texto original de ICH E6 (R1), los ensayos clínicos se realizaban en un proceso básicamente basado en papel. Los avances en el…