An open clinical trial (CT) may have two different meanings based on the possibility of modifying the characteristics described in the study protocol or on the level of masking of the treatment or intervention administered.
A clinical trial cannot be started until it has been approved by the competent agencies designated by law. In Spain, approvals are granted by the Spanish Agency of Medicinal Products and Medical Devices(AEMPS) and an accreditedMedical Research and Ethics Committee(MREC).
The International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guideline,is an international ethics and scientific standard for the design, conduct, documentation, and reporting of clinical trials conducted in human beings.
Recently, there has been a lot of talk about probiotic food products, but what are probiotics? How do they affect our bodies? Read our article to find the answers to these and other questions on the subject.
Several issues of the new legislation regulating clinical trials and studies started by investigators have been explored from a practical approach during the ‘Conference on Clinical Trials’ organized by the European University and BioClever.