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 Xxx 0000. 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 Xxx 0000 (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.
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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.
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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. 1.3. „ISO 14155“ znamená s ohledem na přístrojové a diagnostické studie mezinárodní normu 14155 Mezinárodní organizace pro normalizaci společně s dalšími požadavky správné klinické praxe, jak je uvedeno v místních vnitrostátních právních předpisech v místě provádění studie.
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Examples of ISO 14155 in a sentence

  • The study will be performed in accordance with the relevant parts of the Code of Federal Regulations, ICH Guidelines for Good Clinical Practices, the European Standard ISO 14155, the Declaration of Helsinki, and any regional and/or national regulations.

  • This study will be conducted in accordance with this protocol and the ethical principles that have their origin in the Declaration of Helsinki, ISO 14155: 2011 and :2020.

  • A device deficiency is defined in accordance with ISO 14155 as “inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance.” Device deficiencies include malfunctions, use errors, and inadequate labeling.

  • The Investigator is responsible for ensuring that Informed Consent is obtained prior to the use of any investigational devices, study-required procedures and/or testing, or data collection.The obtaining and documentation of Informed Consent must be in accordance with the principles of the Declaration of Helsinki, ISO 14155, any applicable national regulations, and local Ethics Committee and/or Regulatory authority body, as applicable.

  • This includes every step in the clinical investigation from first consideration of the need and justification of the study to publication of the results.” As a general principle, “the rights, safety and wellbeing of clinical investigation subjects shall be protected consistent with the ethical principles laid down in the Declaration of Helsinki” (EN ISO 14155).

  • Any deviations should be documented on the appropriate Protocol Deviation Case Report Form.If a Clinical Monitor becomes aware that an Investigator is not complying with the signed Investigator’s Agreement, the Investigational Plan, the requirements of ISO 14155, or FDA or other applicable regulations, or any conditions of approval imposed by the reviewing IRB and Ethics Committee, Corvia Medical, Inc.

  • It is NOT intended that it will reproduce EN ISO 14155 or ICH GCP, but it will summarise for the benefit of staff of all parties administering the investigation site, issues over which the NHS body will liaise with the CRO.

  • These studies must follow ISO 14155, which requires study monitoring.

  • The investigator/co-investigators must obtain the sponsor’s approval for all protocol deviations, except for cases in which the safety and well-being of a patient will be affected, as stated in section 4.5.4 b of the ISO 14155 (2011).

  • Ultimately, under EN ISO 14155 or ICH GCP, the sponsor is accountable for the execution of sponsor duties, even if they are delegated to a CRO.


More Definitions of ISO 14155

ISO 14155 means the guideline for clinical trials of medical devices which is valid as harmonized standard in the European Union.
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