220-Dictionary of Pharmaceutical Medicine, 2nd Edition-Gerhard Nahler Annette Mollet-3211898352-S

12audaudit trail → see data trail.authorisation form Form used by the investigator and monitorto document that other persons than the investigator, e.g. a studynurse or a subinvestigator, are authorised to make entries or correctionsin the case record forms, or othercritical trial-relatedprocedures; → see subinvestigator.authorship According to the criteria formulated by the InternationalCommittee of Medical Journal Editors “authorship credit shouldbe based only on substantial contributions to (a) conception anddesign, or analysis and interpretation of data; and to (b) draftingthe article or revising it critically for important intellectual content;and on (c) final approval of the version to be published. Conditionsa, b, c must all be met” (International Committee of Medical JournalEditors. Uniform requirements for manuscripts submitted tobiomedical journals. N Engl J Med 1991, 324: 1415–1417).autoimmune disease A disease in which the body produces antibodiesagainst its own tissues.autoimmunity Condition in which the body mounts an immune responseagainst one of its own organs or tissues.average → see weighted average.