HRA RECORDKEEPING AND RECORD RETENTION REQUIREMENTS
COURSE REGISTRATION

Registration for both the live webinar and the pre-recorded on-demand courses is available in HealthStream.  Search for “HRA Recordkeeping and Record Retention Requirements”

COURSE DESCRIPTION

This course is for investigators and all members of the study staff and covers essential information regarding recordkeeping, documentation, and record retention requirements.  Course content is based on the ethical conduct of human research, Good Clinical Practice Guidelines, federal and state research regulations, and institutional research policies.  Although many research teams require this comprehensive course as part of onboarding, it is also a great refresher for experienced members of the study team to ensure they are aware of the most current research regulations, institutional policies, and best practices for conducting clinical research. The course includes information on:

  • Basic recordkeeping requirements
  • Paper versus electronic records
  • Access to source documents and study files
  • Regulatory binder and essential documents
  • Subject files
  • Regulations and policies
COURSE FORMAT OPTIONS
  • In-person, instructor led live webinar training – Eligible for RCR Credit!
  • Pre-recorded course available on-demand
COURSE LENGTH

The course takes 1 ½ hours to complete

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