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UID:2140535:Event:78682
DTSTAMP:20260523T054217Z
SUMMARY:Investigator Reporting Responsibilities - OHRP
DESCRIPTION:Overview:The webinar will also discuss how to make determi
 nations of whether an adverse event is probably related, possibly rela
 ted, or possibly/probably not related to a drug or device.\nWhy should
  you Attend:Are you being cited for failure to report safety informati
 on, changes to the research plan, or protocol deviations/violations or
  noncompliance to the sponsor or the IRB?\nAreas Covered in the Sessio
 n:FDA RegulationsOverview of recent changes in regulatory frameworkGCP
  R2 GuidelinesFDA guidance on electronic source documentationFDA BIMO 
 ProgramQuality Management of DataEnhancing Excellence in conduct of Cl
 inical Trials\nWho Will Benefit:Clinical Research InvestigatorsResearc
 h NursesResearch ManagersClinical Research Associates (CRAs)Clinical R
 esearch CoordinatorsCompliance Officers\nSpeaker Profile:George Gaspar
 is has over 35 years of experience in the administration or conduct of
  human subjects research.He worked at the Office for Human Research Pr
 otections (OHRP) for seven years and served as the Director, Division 
 of Assurances and Quality Improvement from 2000-03, where he led the d
 evelopment of the OHRP QI Program and electronic submission of the Fed
 eralwide Assurance (FWA).\nEvent Fee: One Dial-in One Attendee Price: 
 US$150.00\nContact Detail:Compliance4All DBA NetZealous,Phone: +1-800-
 447-9407Email: support@compliance4All.com\n\nFor more information visi
 t https://medtechiq.ning.com/events/investigator-reporting-responsibil
 ities-ohrp
DTSTART;TZID=America/New_York:20180518T100000
DTEND;TZID=America/New_York:20180518T110000
CATEGORIES:webinar
LOCATION:Online
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 1856LIVE?channel=medtechiq_May_2018_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=501856
 LIVE?channel=medtechiq_May_2018_SEO
CONTACT:18004479407
ORGANIZER:Event Manager
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562017035?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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