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1. aeguidelines.pdf
... document when requesting information) .... 30 Appendix 5: HIPAA Document .... 31 ... 3500A). Reporting can be conducted online by phone (1-800-FDA-1088) or by submitting ...
Terms matched: 2  -  Score: 53  -  16 Sep 2013  -  URL: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/aeguidelines.pdf
2. Registration Header (Information in this box below may be pre-printed by some groups
... without restriction. (Karnofsky 90- 100) ? 1= Restricted in physically strenuous ... % of waking hours. (K 30- 40) ? 4= Completely disabled ...
Terms matched: 2  -  Score: 19  -  4 Nov 2013  -  URL: https://ctep.cancer.gov/protocolDevelopment/docs/NCI_BOLD_General_CDEs.pdf
3. February 2014 p1
... , ANBL1221, NANT N2011-04, Special Exception Olaparib (AZD2281)- NSC 747856 Tablets are now available for the phase 1-T cohort. Only dispense tablets to new patients ...
Terms matched: 1  -  Score: 19  -  20 Jan 2014  -  URL: https://ctep.cancer.gov/branches/pmb/inside_pmb/feb2014.pdf
4. Training ? <Group/Site> CTEP-AERS Training Site: TBD
... (i.e. one that occurs more than 30 days after treatment) or for commercial agents ... Click to access the CTEP- AERS online help. Training site only, (use ...
Terms matched: 2  -  Score: 24  -  22 Jan 2014  -  URL: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTEP-AERS_vs_AdEERS.pdf
5. Training ? <Group/Site> CTEP-AERS Training Site: TBD
... down to the Concomitant Medications page. 30 Subject Details – Concomitant Medications 1. If ... Click to access the CTEP- AERS online help. Training site only, (use ...
Terms matched: 2  -  Score: 12  -  22 Jan 2014  -  URL: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTEP-AERS_Training_Presentation.pdf
6. A Handbook for Clinical Investigators Conducting Therapeutic Clinical Trials Supported by CTEP, DCTD, NCI
... large phase 2 studies (100 or more patients) and ... an IND, FDA has 30 days to complete its review ... The protocol has been completed prematurely (e.g. due to poor ...
Terms matched: 5  -  Score: 138  -  10 Mar 2014  -  URL: https://ctep.cancer.gov/investigatorResources/docs/InvestigatorHandbook.pdf
7. Common Data Elements for collection from Group preoperative breast cancer trials
... ? 80% ? 90% ? 100% other% Number of Involved Lymph Nodes ... ? 10% ? 20% ? 30% ? 40% ? 50% ? ...
Terms matched: 2  -  Score: 29  -  25 Jul 2014  -  URL: https://ctep.cancer.gov/protocolDevelopment/docs/NCI_BOLD_Preoperative_CDEs.pdf
8. November 2014 p1
... . If 936558; monoclonal 100 mg vial melanoma, solid ... itted from 15 C to 30 C (5 9 F ... mg/mL) AEWS1221 trial Pazopanib tablet 750008 IGF1R IV (AMG ...
Terms matched: 3  -  Score: 62  -  15 Oct 2014  -  URL: https://ctep.cancer.gov/branches/pmb/inside_pmb/nov2014.pdf
9. CTEP-AERS Training Guide_2015-02-18
... Score Description Normal, no 100 complaints, no 100 Fully ... the Adverse Event .... 30 Step 4. Course/Cycle- ... .... 1 Using CTEP-AERS Online Help .... 2 CTEP-AERS ...
Terms matched: 3  -  Score: 76  -  18 Feb 2015  -  URL: https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTEP-AERS_Training_Guide.pdf
10. August 2015.revised. ppp
... patients' tumors to determine 1,000 patients whether they contain actionable Each arm will enroll 30 mutations of interest. Treatment is evaluable patients assigned based on the actionable mutation with ...
Terms matched: 1  -  Score: 11  -  4 Aug 2015  -  URL: https://ctep.cancer.gov/branches/pmb/inside_pmb/aug2015.pdf
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