What IRB records should the principal investigator keep?
The principal investigator must maintain the data/samples/records that the protocol plan states will be maintained. This file could include: 1) signed consents, 2) paper instruments, 3) electronic records, 4) field notes, 5) audio recordings, 6) biological samples, or 7) other data records discussed in the protocol. These materials must be kept in secure storage and handled appropriately as planned for in the protocol. These records may be audited as part of the IRB's post-approval monitoring, which is conducted by the Office of Research Integrity.
The IRB has developed guidelines regarding secure data storage and handling of research data. These are also available for download in IRBNet.