Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 51

A case report, also called an “individual case safety report” (ICSR), is a clinical observation of a patient who received a drug and experienced one or more AEs. The most common paper formats for presentation of a case report are the MedWatch form and the CIOMS I form. The electronic equivalent is the E2B report, which is an electronic file transmitted to a health authority or company or elsewhere with all the elements of the ICSR. Sometimes cases are published as short reports in medical journals, some of which have been previously reported to health authorities and some not. These cases are picked up in the periodic review of the medical literature done by companies.