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X-LIC-LOCATION:America/New_York
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TZOFFSETFROM:-0500
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TZNAME:EDT
DTSTART:19700308T020000
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UID:2140535:Event:77616
DTSTAMP:20260521T224718Z
SUMMARY:Ensuring Data Integrity and Safety in Clinical Research
DESCRIPTION:Overview: Electronic medical records and electronic handli
 ng of study data is increasingly common. To involve computer systems i
 n clinical research implies knowledge of 21 CFR Part 11.\nWhy should y
 ou Attend: The increasing use of computers and increasing complexity, 
 all persons who have any data input requirements to know the set-up an
 d function of the systems they are using. Forewarned is forearmed.\nAr
 eas Covered in the Session:The CFR definitions of Electronic Record, E
 lectronic Signature, Closed System, Open System, Data Trails, and assu
 re that your data is secure and valid?What needs to happen to make dat
 a trails secure and realWhat questions should you internal QA departme
 nt ask to be sure your system is functioning correctly?What controls n
 eed to be in operation for an open system?What are the controls needed
  for a valid electronic signature?\nWho Will Benefit:Principal Investi
 gators and Sub InvestigatorsClinical Research Scientists (PKs, Biostat
 isticians)Safety NursesClinicl Research Associates (CRAs) and Cordinat
 ors (CRCs)Recruiting Staff\nSpeaker Profile:Charles H. Pierce MD, PhD,
  FCP, CPI is a consultant in the Clinical Research / Drug-Device Devel
 opment arena specializing in bringing the message of GCP Regulations a
 nd Investigator Responsibility to the entire investigative team to hel
 p them understand the regulations as well as the ethics of research in
 volving human subjects.\nEvent Fee: One Dial-in One Attendee Price: US
 $150.00\nContact Detail:Compliance4All DBA NetZealous,Phone: +1-800-44
 7-9407Email: support@compliance4All.com\n\nFor more information visit 
 https://medtechiq.ning.com/events/ensuring-data-integrity-and-safety-i
 n-clinical-research
DTSTART;TZID=America/New_York:20180109T100000
DTEND;TZID=America/New_York:20180109T110000
CATEGORIES:online
LOCATION:Fremont
WEBSITE:http://www.compliance4all.com/control/w_product/~product_id=50
 1592LIVE?channel=medtechiq_Jan_2018_SEO
URL:http://www.compliance4all.com/control/w_product/~product_id=501592
 LIVE?channel=medtechiq_Jan_2018_SEO
CONTACT:18004479407
ORGANIZER:Event Manager
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562016468?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="Adam Fle
 ming":https://medtechiq.ning.com/profile/Compliance4all
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