FDA New Electronic Data Capture Guidance- Inspectional Record 2015

  • 03 Nov 2015
  • Online Event

Description

FDA New Electronic Data Capture Guidance- Inspectional Record 2015 covers topics such as:

  • FDA definitions for data elements
  • FDA definitions of E records, and E CRF
  • The requirement for original source data to support every data element
  • FDA definitions of Source data and types of electronic source data systems
  • What types of electronic data elements pose noncompliance challenges
  • The requirements for electronic data - origination, authorization, signatures, and data tracking
  • Participant input and questions
  • Preventing non compliance by sponsor due diligence at the investigator site

FDA New Electronic Data Capture Guidance- Inspectional Record 2015 brings together attendees from:

  • Medical Record Personnel
  • Clinical Research Coordinators and Investigators
  • Clinical Program Managers
  • Clinical CRA Monitors
  • Clinical Quality Assurance Auditors

Past Events

Important

Please, check "FDA New Electronic Data Capture Guidance- Inspectional Record" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Healthcare

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