Record Keeping

The Principal Investigator (PI) must maintain a file of all documents relevant to their IRB approved study for at least 3 years after a Closure request is submitted and the study is closed by the Office of Human Subjects Protections (OHSP). The PI’s records should contain all documents submitted by the research team to the IRB, including all correspondence between the HSP Office and the PI (or appropriate personnel). More specifically, the PI’s IRB documentation should include:

  • Reviewed research protocol applications (including approved study measures, recruitment docs, letters of collaboration / support, etc.)
  • Scientific evaluations
  • Approved sample consent documents
  • Signed participant consent documents
  • Progress reports (if applicable)
  • Documentation of incident reports
  • Renewal applications and documentation
  • Modification applications and documentation
  • Correspondence between IRB / HSP Office and the research team
  • Significant new findings provided to participants
  • Copies of inspection / audit reports

Per UTD record retention policy, all study materials (hard copies, electronic copies, etc.) related to the research study should be deleted three (3) years after the close of the study unless otherwise specified in the approved IRB application, grant proposal or contract terms.

Data Storage

The PI should take precautions to avoid any collection or recording of identifiable information that is unnecessary to the study and to guard against unauthorized release of identifiable information. Identifiable study data must be stored securely at all times, whether it is kept in electronic format or in hard copy, so that only trained individuals who are listed on the IRB protocol have access.

In addition, the PI is responsible for ensuring that identifiable study data are permanently deidentified or destroyed at the conclusion of a project, in accordance with the IRB-approved protocol. If the PI wishes to maintain identifiable information after the conclusion of a study or transfer identifiable information to an unaffiliated institution, prior IRB approval must be obtained.