46 results found.
Instructions for Building “Possible Side Effects” Tables for Informed Consent Forms - Investigational Agents (Single Agents)
... Consent, Investigational, Single Agents, NCI, National Cancer Institute, CAEPR, CTCAE, Terms, Symptoms ...
Terms matched: 1 - Score: 10 - 9 Nov 2015 - URL: https://ctep.cancer.gov/protocolDevelopment/docs/Instructions-Tables-Investigational.doc
... CTCAE v3.0 (MedDRA 10.0) to CTCAE v4.0 (MedDRA 12.1) ...
Terms matched: 1 - Score: 21 - 9 Nov 2015 - URL: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_3_to_CTCAE_4_Mapping.xls
Terms matched: 1 - Score: 31 - 9 Nov 2015 - URL: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTEP_Guidance_Quant_Grade.doc
... CTC v2.0 to CTCAE v3.0 with Short Names ...
Terms matched: 1 - Score: 10 - 9 Nov 2015 - URL: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/MappingShort2-3.xls
... CTC v2.0 (MedDRA 10.0) to CTCAE v3.0 (MedDRA 10.0) ...
Terms matched: 1 - Score: 10 - 9 Nov 2015 - URL: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/Mapping_CTC2_CTCAE3_MEDDRA10.xls
... CTCAE v4.0 (MedDRA 12.1) to CTCAE v3.0 (MedDRA 10.0) ...
Terms matched: 1 - Score: 21 - 9 Nov 2015 - URL: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/Reverse_Mapping_CTCAE_4_to_CTCAE_3.xls
... 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 ...
Terms matched: 1 - Score: 16 - 5 Jul 2016 - URL: https://ctep.cancer.gov/initiativesPrograms/docs/ETCTN_Program_Guidelines.pdf
... Informatics Branch, NCI, DCTD, CTEP Subject: Conversion of CDUS Data from CTCAE v4.0 to CTCAE v5.0 To all CDUS Submitters, The new CTCAE version 5.0 is ...
Terms matched: 1 - Score: 216 - 12 Jan 2018 - URL: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/Conversion_of_CDUS_Data_from_CTC_v4_to_CTCAE_v5.pdf
... Date: 1/25/2018 From: Shanda Finnigan, MPH, RN Subject: CTEP CTCAE v4.0 to CTCAE v5.0 Conversion Amendment Request – UPDATE page 3 On March 31, ...
Terms matched: 1 - Score: 277 - 25 Jan 2018 - URL: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Conversion_Amendment_Request.pdf
Adverse Event Reporting
... Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 Published: November 27, 2017 U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National ...
Terms matched: 1 - Score: 612 - 23 Feb 2018 - URL: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_8.5x11.pdf
