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Accès direct-- Direkter ZugangPermission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any party (e.g., domestic and foreign regulatory authorities, sponsor's monitors and auditors) with direct access should take all reasonable precautions within the constraints of the applicable regulatory requirement(s) to maintain the confidentiality of subjects' identities and sponsor’s proprietary information.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.21
Bénéfice direct -- Unmittelbarer NutzenA direct benefit to a person’s health signifies not only treatment to cure the patient but also treatment that may alleviate his/her suffering thus improving his/her quality of life.
Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research, explanatory report, Article 6 (risks and benefits)
Documentation -- DokumentationAll records, in any form (including, but not limited to, written, electronic, magnetic, and optical records, and scans, x-rays, and electrocardiograms) that describe or record the methods, conduct, and/or results of a trial, the factors affecting a trial, and the actions taken.
International Conference on Harmonisation (ICH) – Guideline for Good Clinical Practice (GCP) E6 (R1), Glossary art. 1.22