Cleveland Family Study

10.17 Data Storage

10.17.1 On-Site Facilities

Videocassette tapes will be kept in a locked metal file cabinet located with limited access only by research personnel. This room is located in one of the main hospital buildings in a locked, limited access corridor protected by standard fire safety measures and sprinkler systems. All other source documents including print outs from the videocassette tape for diameter measurements, core logbooks and correspondence will be kept in a locked, metal file cabinet in the Triangle Building.

10.17.2 Quality Assurance

• All videocassette tapes will be reviewed completely by ______________ personnel to assess quality and complete compliance with the __________ SOP and the study protocol.
• Feedback to the ultrasonographer will be made via fax with specific comments needed.
• Assessment of inter-observer and intra-observer variability has been previously performed and published. Periodic re-assessment will be performed and expressed as mean difference, mean percent difference, and coefficient of variability.
• Review of patient related factors that could influence brachial artery vasoactivity entails review or receipt of confirmation that study protocol-related restrictions and patient preparation will be in compliance with the study protocol and pre-requisites for brachial artery ultrasound procedure.
• The adjudication of differences between the __________________readers has been described.