Chapter 10 Serious Adverse Event Sae
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Standard Operating Procedures - Tata Memorial Centre
tmc.gov.inAX1 V1SOP09/V2 Review Report for SAE Serious Adverse Event 160 AX2 V1SOP09/V2 Off site SAE Classification Form 163 AX3 V1SOP09/V2 Off Site SAE Log Report 164 Flow charts 165-166 Chapter 10 Maintenance of Active Project Files, Archival of Closed Files 167 and Retrieval of documents 10.1 Purpose 169 10.2 Scope 169 10.3 Responsibility 169
NATIONAL TUBERCULOSIS CONTROL PROGRAM MANUAL …
doh.gov.phSerious adverse events (SAE) and adverse events of special interest (AESI) 59 Table 26. Treatment outcome definitions for SSOR5, 16 61 Table 27. Treatment outcome definitions for SLOR and ITR34 62 Table 28. Checking eligibility of different risk groups for TPT using TST 68 Table 29. Treatment regimens for latent tuberculosis infection (LTBI) 72
Medical Device White Paper Series Medical device clinical ...
www.medical-device-regulation.euMEDDEV 2.7/3 Rev. 3 on serious adverse event (SAE) reporting New requirements under the MDR The MDR introduces new requirements, which need to be carefully reviewed and addressed in applicable procedures for the conduct of clinical investigations under the MDR. The new MDR requirements presented