Mar 8, 2018 08:25
6 yrs ago
1 viewer *
English term
ensure both step up and step down grades
English to Russian
Medical
Medical: Pharmaceuticals
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 8.1.1.3 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.
To modify Section 8.1.1.3 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.
Proposed translations
(Russian)
4 | увеличение и уменьшение степени тяжести НЯ | Margarita Vidkovskaia |
Proposed translations
19 mins
Selected
увеличение и уменьшение степени тяжести НЯ
внесены изменения в раздел 8.1.1.3 о регистрации в CRF как увеличения, так и уменьшения степени тяжести НЯ
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