Subject confidentiality is extremely important in study protocols and throughout the study itself.

  • The principal investigator should explain all of the steps from the person who collects the subject’s data, to who and how the data is entered into the system, and finally where all records will be kept, preferably in a locked file cabinet.
  • Human subject’s names should be kept on a password-protected database and will be linked only with a study identification number for this study.
  • There should be no patient identifiers recorded in the research record.
  • All computer entry and networking programs should be done using study identification only.
  • All data should be entered into a computer that is password protected.
  • Clinical information should not be released without written permission of the subject, except as necessary for monitoring by IRB, the FDA, the OHRP, the Sponsor, or the Sponsor’s designee.
  • Data should be stored in a locked office of the investigators and maintained for a minimum of three years after the completion of the study.
  • Some sponsors have different period for the storage of data, the principal investigator should check the sponsor contract. The longest record retention period should be applied.