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Cortex - Life Sciences Insights

| 1 minute read

The Spanish authorities designate an independent supervisory body to ensure compliance with the clinical trials Code of Conduct.

After the publication of the Code of conduct regulating the processing of personal data in the field of clinical trials and other clinical research and pharmacovigilance (the “Code of Conduct”), the Spanish Data Protection Commissioner (“AEPD”) and Farmaindustria have established an independent supervisory body (“Supervisory Body”) to ensure compliance with the code.

As indicated in our previous entry to this blog, the Code of Conduct is the first sectorial code of conduct on the processing of personal data within the scope of clinical trials, and the first code approved in the EU in this field. Also, the Code of Conduct will have significant impact on the GDPR Code of Conduct on Clinical Trials and Pharmacovigilance which is being drafted by EFPIA.

This Supervisory Body will be formed by experts with proven expertise in data protection in the field of clinical research and pharmacovigilance.

Among other functions, the Supervisory Body will be responsible for the dissemination, interpretation, compliance and control of the application of the Code of Conduct. The Supervisory Boy will actively collaborate with the member entities and will ensure compliance with the Code. It will also be responsible for assisting and answering queries from member entities regarding compliance with the code. Finally, the Supervisory Body will ensure that adequate promotional activities are launched to spread the understanding of the Code of Conduct, and will launch training activities aimed at ensuring that member entities understand their obligations under the Code of Conduct.


europe, data privacy, regulation, gdpr, clinical trials