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... verbatim term exists or is expand the not applicable, then enter Adverse Events the CTCAE term. page. 9 Adverse Events – AE Term and Related Information 1. ...
... CTCAE v3.0 (MedDRA 10.0) to CTCAE v4.0 (MedDRA 12.1) ...
3. CTEP
... Access Login Cancer Therapy Evaluation Program (CTEP) Last Updated: 09/18/20 CTEP Highlights CTCAE v6.0-Change Requests 09/17/2020 — CTCAE v6.0-Change Requests Operational Efficiency Working Group (OEWG) 09/04/2019 ...
... CTCAE v4.0 (MedDRA 12.1) to CTCAE v3.0 (MedDRA 10.0) ...
... loss" ," 10047900" "DEATH" ," Death not associated with CTCAE term" ," Death NOS" ," Death" ," 10011906" ...
... expedited adverse event reporting is 21CFR 312.32. Adverse events should be reported using the CTCAE v4.0 or most recent version available. B. Serious adverse event reporting for all ...
... Adverse events should be reported using the Common Terminology Criteria for Adverse Events v3.0 (CTCAE), which is NCI and CTEP ? s standard language for reporting adverse events ...
... Clinical Research CTEP Highlights 2021 NCTN Audit Guidelines 2021 ETCTN Monitoring Guidelines Career Development Opportunities CTCAE v6.0-Solicitation of Changes Funding Opportunities LOI Submission Form NCI Informed Consent Template NCTN& Updated ...
... Clinical Research CTEP Highlights 2021 NCTN Audit Guidelines 2021 ETCTN Monitoring Guidelines Career Development Opportunities CTCAE v6.0-Solicitation of Changes Funding Opportunities LOI Submission Form NCI Informed Consent Template NCTN& Updated ...
... layer: We've just finished updating all CAEPRs from to the NCI within 90 days CTCAE v3.0 language to CTCAE v4.0 language. of expiration or study closure Some of those ...