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Updated Guidance for Managing Externally Monitored Studies

Published on December 22, 2020 in Announcements · Last updated 4 months 2 weeks ago
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Updated Guidance for Managing Externally Monitored Studies

The Office of Research Compliance has provided updated guidance for managing externally monitored studies during the pandemic.

The guidance clarifies available CHOP-supported file sharing options if remote visits are required for source data verification.

  • CHOP-supported videoconference applications (e.g., Skype, WebEx, and Bluejeans) may be used with remote monitors to facilitate review of limited records by screen sharing.
  • Epic access may be provided to monitors. A new and improved tool will soon be available. 
  • Define critical source data verification requirements with PDF Epic records, fully redact names, and add subject ID to each page of every document shared. Limited redacted records may be shared via email if using [send secure].
  • OneDrive or Citrix Sharefile may be used to share source documents with PHI or PII.

NOTE: Review expectations with the monitor to secure any PHI or PII that is shared (e.g., the monitor should avoid printing, sharing, and saving the documents).

Contact the Office of Research Compliance with questions.