Before revision: Definitions Protection of clinical trial subjects Clinical trials on minors Clinical trials on incapacitated adults not able to give informed legal Ethics Committee Single opinion Detailed guidance Commencement of a clinical trial Conduct of a clinical trial Exchange of information Suspension of the trial or infringements Manufacture and import of investigational medicinal products Labelling Verification of compliance of investigational medicinal products with good clinical and manufacturing practice Notification of adverse events Notification of serious adverse reactions Guidance concerning reports General provisions Adaptation to scientific and technical progress Committee procedure Application Entry into force Addressees The effects of the directive It is considered to have increased the costs of doing clinical trials in the EU, and to have caused the reduction in the number of such trials .
After revision: Definitions Protection of clinical trial subjects Clinical trials on minors Clinical trials on incapacitated adults not able to give informed legal Ethics Committee Single opinion Detailed guidance Commencement of a clinical trial Conduct of a clinical trial Exchange of information Suspension of the trial or infringements Manufacture and import of investigational medicinal products Labelling Verification of compliance of investigational medicinal products with good clinical and manufacturing practice Notification of adverse events Notification of serious adverse reactions Guidance concerning reports General provisions Adaptation to scientific and technical progress Committee procedure Application Entry into force Addressees The effects of the directive It is considered to have increased the costs of doing clinical trials in the EU, and to have caused the reduction in the number of such trials