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1. PowerPoint Presentation
... 2 review forms development concepts of> 100 patients have a target timeline of 240 days ... registration trial, FDA days review in 30 days Concept Concept revision/ Protocol Protocol Protocol ...
Terms matched: 2  -  Score: 54  -  10 Nov 2009  -  URL: https://ctep.cancer.gov/SpotlightOn/docs/The_OEWG_Report.pdf
2. 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
3. OEWG_Timelines_for_Studies_Received_After_4-5-2012.pdf
... 2, including Cooperative Group mass-solicitation LOIs 100 patients Cooperative Group phase 1, 1/2, ... received April 5th, 2012 to August 30, 2019: • Phase 1 and 2 ...
Terms matched: 2  -  Score: 49  -  30 Aug 2019  -  URL: https://ctep.cancer.gov/SpotlightOn/docs/OEWG_Timelines_for_Studies_Received_After_4-5-2012.pdf
4. NCI_Informed_Consent_Template_Readability_Assessments.pdf
... word) contained in a sample of 30 sentences. Like the Flesch-Kincaid, it assigns ... Optional Resource: Using Online and Manual Readability Tools to Assess the Reading Level of ...
Terms matched: 2  -  Score: 48  -  6 Oct 2017  -  URL: https://ctep.cancer.gov/protocolDevelopment/docs/NCI_Informed_Consent_Template_Readability_Assessments.pdf
5. H:\newsletterNOV2005.wpd
... it affects the tablets expire on November 30, 2005. After that, the 250 ... to nature – how it affects the tablets expire on November 30, 2005. After ...
Terms matched: 2  -  Score: 39  -  31 Oct 2005  -  URL: https://ctep.cancer.gov/branches/pmb/inside_pmb/nov2005.pdf
6. Development of the Slow Accrual Guidelines
... projected YES 3 82 85 Total 24 100 124 quarter5-6 accrual over 50% of projected ... Total 6 109 115 quarter5-6 accrual over 30% of projected NO YES Total Total accrual ...
Terms matched: 2  -  Score: 38  -  25 Jul 2007  -  URL: https://ctep.cancer.gov/protocolDevelopment/docs/slow_accrual_guidelines_dev.pdf
7. Agent_Dispensing_Handout.pdf
... for an agent that is dosed at 100 mg daily for 28 days. Slide 13 ... Dispensed Dispensing by bottle Dispensing by tablet The quantity dispensed should be recorded in units supported ...
Terms matched: 2  -  Score: 37  -  2 Dec 2015  -  URL: https://ctep.cancer.gov/branches/pmb/drug_training_videos/Agent_Dispensing_Handout.pdf
8. H:\Newsletter August 2005.wpd
... . system does not capture partials. 100 mg per 10 mL vial (10 mg/mL ... alemtuzumab vials in a include Coordinator at 30 mg/mL concentration, 1 mL vial. This ...
Terms matched: 2  -  Score: 37  -  3 Aug 2005  -  URL: https://ctep.cancer.gov/branches/pmb/inside_pmb/aug2005.pdf
9. H:\Newsletter May 2005.wpd
... E discusses nonresearch use of investigational agents 100 mg in 5 mL, but they have ... expiration date for the DARF is Nov 30, 2007. Clever readers went to our ...
Terms matched: 2  -  Score: 36  -  29 Apr 2005  -  URL: https://ctep.cancer.gov/branches/pmb/inside_pmb/may2005.pdf
10. CTMB_Auditor_Monitor_Training_Modules.pdf
... is no mandate from CTMB to verify 100% of data points for each audited patient ... • Delay of protocol re-approval of< 30 days (lesser deficiency) • Delay of ...
Terms matched: 2  -  Score: 32  -  14 Mar 2019  -  URL: https://ctep.cancer.gov/content/docs/CTMB_Auditor_Monitor_Training_Modules.pdf
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