ISO 14155 definition
ISO 14155. 2011 means the version in force from time to time, or its replacement, of the International Standard ISO14155:2011 'Clinical investigation of medical devices for human subjects -Good clinical practice’ developed by the International Organisation for Standardisation. Medical Device means the same as in the Therapeutic Goods ▇▇▇ ▇▇▇▇. Multi-centre Study is a Study conducted by several investigators according to a single Clinical Investigation Plan at more than one study site. NHMRC means the National Health and Medical Research Council of the Commonwealth of Australia. Personal Information has the same meaning as in the Privacy ▇▇▇ ▇▇▇▇ (Cth) Personnel means employees, agents and/or authorised representatives, and includes in the case of the Institution, the Principal Investigator. Principal Investigator is the person responsible for the conduct of the Study at the Study Site as described in Schedule 1.
ISO 14155. 2020 means the version in force from time to time, or its replacement, of the International Standard ISO14155:2020 'Clinical investigation of medical devices for human subjects -Good clinical practice’ developed by the International Organisation for Standardisation.
ISO 14155. 2020 means the version in force from time to time, or its replacement, of the International Standard ISO14155:2020 'Clinical investigation of medical devices for human subjects -Good clinical practice’ developed by the International Organisation for Standardisation. Medical Device means the same as in the Therapeutic Goods Act 1989. Multi-centre Study is a Study conducted by several investigators according to a single Clinical Investigation Plan at more than one study site. NHMRC means the National Health and Medical Research Council of the Commonwealth of Australia. Personal Information has the same meaning as in the Privacy Act 1988 (Cth) Personnel means employees, agents and/or authorised representatives, and includes in the case of the Institution, the Principal Investigator. Principal Investigator is the person responsible for the conduct of the Study at the Study Site as described in Schedule 1.
Examples of ISO 14155 in a sentence
The Subject Information Leaflet (SIL) and Informed Consent Form (ICF) SIL and ICF will be prepared in accordance with ISO 14155 Good Clinical Practice Subjects will be invited to participate in the study and will be given the SIL to review.
More Definitions of ISO 14155
ISO 14155 means, with regard to device and diagnostic studies, the international standard 14155 of the International Organization for Standardization together with such other good clinical practice requirements as are specified in local national law where the Study is being performed.
ISO 14155 si intende, per quanto riguarda i dispositivi e gli studi diagnostici, lo standard internazionale 14155 dell’Organizzazione internazionale per la standardizzazione, unitamente ad altri requisiti di buona pratica clinica specificati nella legge nazionale locale in cui viene condotto lo Studio.
ISO 14155 means the guideline for clinical trials of medical devices which is valid as harmonized standard in the European Union.