The records retention and secure storage of data section is important and is used to indicate what information will be retained for each subject and by whom.

  • The principal investigator will need to explain if they are keeping a linking list that will contain identifiable information such as subject’s names or medical records numbers that link to a coded study number.
  •  In addition, the principal investigator should describe methods for maintaining confidentiality of subject records.
    • For example, the principal investigator may write: Information will be collected on a data collection sheet (attached) and stored in a password-protected database/spreadsheet. As soon as all data points are entered into the research record, the medical record number for that chart will be destroyed by being [shredded/blacked out/deleted] or a master linking list will be maintained that links the subject’s medical record number with their study number. 
  • This section should also include a description of the clinical site responsibilities in data collection and management or if to be done in conjunction with the medical information technology department, and what is their role and how will it be maintained there.
  • It is a common requirement that sensitive data, including research data, must be stored on a file server on the organization’s network domain; and not on a workstation hard drive.