Russian translation: увеличение и уменьшение степени тяжести НЯ
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08:25 Mar 8, 2018
English to Russian translations [PRO] Medical - Medical: Pharmaceuticals
English term or phrase:ensure both step up and step down grades
To update and enhance safety precautions for patients with potential hematologic or nonhematologic toxicities in Sections 6.5.1 and 6.5.2.
To modify Section 188.8.131.52 to ensure both step up and step down grades for AEs are recorded in eCRF.
To clarify reporting of non-treatment emergent AEs and SAEs in Section 8.4.1.
To delete text regarding the recording of diagnosis vs signs and symptoms; AEs occurring secondary to other events; and persistent or recurring AEs in Sections 8.5.1, 8.5.2 and 8.5.3.