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PV Section 3 3.1: management of adverse events reports from spontaneous reporting 3.1.1: Single case Processing Activities: SOP 202 defines the responsibilities of LSU For…

Documents CDSCO-GuidanceForIndustry


 Guidance for Industry • Submission of Clinical Trial Application for Evaluating Safety and Efficacy • Requirements for permission of New Drugs Approval • Post approval…

Health & Medicine Clinical Trial Optimization

1. Clinical trial analytics for trial set-up, site selection, monitoring and optimization 2. Confidential. Copyright 2015 Site Investigator Dashboard (1/2) Patient Enrolment…

Documents Structured Data Capture (SDC) Public Health Tiger Team Call will begin 3 min after the hour November...

Slide 1 Structured Data Capture (SDC) Public Health Tiger Team Call will begin 3 min after the hour November 12, 2013 1 1 DRAFT: Not for distribution Public Health Tiger…

Documents Standards and Interoperability Public Health Tiger Team (PHTT) Jim Daniel, MPH John Saindon, DrHSc,....

Slide 1 Standards and Interoperability Public Health Tiger Team (PHTT) Jim Daniel, MPH John Saindon, DrHSc, MT Public Health Lead Health Scientist ONC CDC 1 1 DRAFT: Not…

Documents Standards and Interoperability Public Health Tiger Team (PHTT)

Slide 1 Standards and Interoperability Public Health Tiger Team (PHTT) Jim Daniel, MPH John Saindon, DrHSc, MT Public Health Lead Health Scientist ONC CDC 1 1 DRAFT: Not…

Documents CDSCO-GuidanceForIndustry


 Guidance for Industry • Submission of Clinical Trial Application for Evaluating Safety and Efficacy • Requirements for permission of New Drugs Approval • Post approval…