Trials should follow the ethical principles that derive from the Declaration of Helsinki, GCP and applicable regulation and be designed and run to protect participants. Participants' rights, safety and well-being come first and outweigh scientific and societal interests. New safety information that could affect participants, their willingness to remain, or how the trial runs should be reviewed promptly. A trial should start and continue only while expected benefits to individuals and society justify the known and foreseeable risks and inconveniences. Design should not exclude populations unnecessarily, so that those enrolled reflect the groups the product is meant to help (early phase, proof of concept and bioequivalence studies may not need this). A qualified physician or dentist, or other qualified professional allowed locally, should carry overall responsibility for medical care and decisions arising from the trial, though suitably qualified professionals can deliver care. Anything that could identify a participant should stay confidential under privacy and data protection law.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.