Glossary


TRREE Glossary
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P

Personal data (Personal information)

Données personnelles -- Personenbezogene Daten
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.
Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data

Placebo

Placebo -- Placebo
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.
NEBRA: Networking for Ethics on Biomedical Research in Africa, Presentation of the NEBRA Project - nebra-booklet (english) p. 15

Protocol

Protocole -- Protokoll/Prüfplan
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.
WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22
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.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.44
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.
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, art. 2h

Protocol Amendment

Amendement / modification au protocole -- Protokoll-Amendment / Prüfplanänderung
1) A written description of a change to, or formal clarification of, a protocol.
WHO, Operational Guidelines for Ethics Committees That Review Biomedical Research, Geneva 2000, TDR/PRD/ETHICS/ 2000, p. 22
2) A written description of a change(s) to or formal clarification of a protocol.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), art. 1.45

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