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46 results found.

5 pages of results.
... CTCAE 6.0 Solicitation of Changes September 2020 General Timeline/Activities Review of Change Solicitation of Change Review Draft 1 requests/Draft 1 Draft 1 for Review Requests Comments creation All who ...
Terms matched: 1  -  Score: 98  -  11 Sep 2020  -  URL: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v6_Solicitation_Brief_Overview.pdf
... : The unique CTEP group code where the patient was originally registered on study. CTCAE Adverse Event Codes& Descriptions: Theradex will be able to convert from older versions ...
Terms matched: 1  -  Score: 62  -  14 May 2020  -  URL: https://ctep.cancer.gov/protocolDevelopment/docs/DMU_Complete_Data_Submission_Requirements.pdf
... : The unique CTEP group code where the patient was originally registered on study. CTCAE Adverse Event Codes& Descriptions: Theradex will be able to convert from older versions ...
Terms matched: 1  -  Score: 25  -  14 May 2020  -  URL: https://ctep.cancer.gov/protocolDevelopment/docs/DMU_Light_Data_Submission_Requirements.pdf
... as required in the protocol and defined by Common Terminology Criteria for Adverse Events (CTCAE). 5.5. Imaging Procedures. 5.5.1. The use of imaging to facilitate ...
Terms matched: 1  -  Score: 11  -  21 Feb 2019  -  URL: https://ctep.cancer.gov/initiativesprograms/docs/ETCTN_IR_Research_Biopsy_SOP.pdf
... as required in the protocol and defined by Common Terminology Criteria for Adverse Events (CTCAE). 5.5. Imaging Procedures. 5.5.1. The use of imaging to facilitate ...
Terms matched: 1  -  Score: 11  -  21 Feb 2019  -  URL: https://ctep.cancer.gov/initiativesPrograms/docs/ETCTN_IR_Research_Biopsy_SOP.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 Common Terminology Criteria for Adverse ...
Terms matched: 1  -  Score: 612  -  28 Feb 2018  -  URL: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_5x7.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
... 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
... 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
... 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
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