Subject Specific Documentation

You should keep separate files with information on each of your study subjects. Source documents should be kept in subject files and contain source data, which are the first time data were recorded.

For subject files, you should ensure:

  • The most recent, watermarked version of the consent form was used (printed from the "Study Documents" tab in eIRB immediately preceding the consent process)
  • The consent forms are signed and dated (by both the subject and the person giving consent) and contain subject initials on every page
  • The consent forms have 2 participant identifiers; such as name and date of birth, on every page in the top right corner
  • Signed forms of acknowledgement of receipt of the Notice of Privacy Practices (NOPP) (for non-Duke patients only)
  • Subject documents should be stored in secure location (locked file cabinets or secure database)
  • While SSNs should be collected for payment purposes, remember that these should be kept behind 2 locks and permanently redact at the earliest possible time.