April 18, 2022
April 18 is European Patients’ Rights Day (EPRD).
The European Charter of Patients’ Rights proclaims 14 rights that aim to guarantee “a high level of protection of human health” and to ensure the provision of high quality of health services in European countries, in particular during the Covid pandemic.
More specifically, this charter proclaims:
- The right to information (“access to all that scientific research and technological innovation makes available”),
- The right to consent for any procedure or treatment, but also for participation in clinical trials,
- The right to innovation (“right of access to innovative procedures, including diagnostic procedures”), which implies the right of access to treatments or medical devices assessed in clinical trials.
The European Clinical Trials Regulation (Regulation (EU) No 536/2014) also aims to guarantee the rights of patients, and all of the medical writers at Synergy Pharm/Santé Active Edition are committed to ensuring that information relating to compliance with ethical standards and good clinical practice is clearly stated in publications reporting the results of clinical trials.
Our regulatory medical writing team also provides other medical writing services for clinical projects, including the information notes and Informed Consent Forms (ICFs) that should be provided to patients before their inclusion in a clinical study, as well as other study-related documents: Clinical Study Protocols (CSPs), Investigator’s Brochures (IBs), Investigational Medicinal Product Dossiers (IMPDs) for Clinical Trial Authorizations (CTAs), Clinical Study Reports (CSRs), etc.