Any information relating to an identified or identifiable natural person ('data subject'); an identifiable person is one who can be identified, directly or indirectly, in particular by reference to an identification number or to one or more factors specific to his physical, physiological, mental, economic, cultural or social identity.

A chemically inert substance given in the guise of medicine for its psychologically suggestive effect. Placebos are used in controlled clinical trials to determine whether improvement and side effects may reflect imagination or anticipation rather than actual power of a drug.

1) A document that provides the background, rationale, and objective(s) of a biomedical research project and describes its design, methodology, and organization, including ethical and statistical considerations. Some of these considerations may be provided in other documents referred to in the protocol. 2) A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. 3) A document that describes the objective(s), design, methodology, statistical considerations and organisation of a trial. The term protocol refers to the protocol, successive versions of the protocol and protocol amendments.

1) A written description of a change to, or formal clarification of, a protocol. 2) A written description of a change(s) to or formal clarification of a protocol.