Manual for Conducting Human Subject Research

Research Records

10.1 Investigator Records

Record (e.g., consent forms, study-related correspondence, treatment records, records of distribution and use of investigative products, copies of Case Report Forms) retention requirements vary depending upon the nature of a research study, but the general rules are as follows:

  1. In no case should treatment-related records be destroyed before ten years.

  2. Signed HIPAA Authorizations and documentation of HRRC granted waivers of HIPAA authorization must be retained for 6 years from the date of creation or the date it was last in effect, whichever is later.

  3. For drug studies, records must be kept for at least two years following the date of approval of a marketing application for the drug studied, or for two years after the investigation is terminated and FDA is notified of termination. 21 C.F.R. 312.62.

  4. For device studies, records must be kept for two years after the latter of 1) the date on which the investigation is terminated or completed, or 2) the date that the records are no longer required for purposes of supporting a premarket application or a notice of completion of a product development protocol. 21 C.F.R. 812.140.

  5. For non-FDA studies, records must be kept for at least three years.

  6. For VA studies, records must be kept for at least five years after the study closes.

  7. Maintain records in a secured place with limited access for the research team, to maintain the confidentiality that has been promised to the subjects, as well as to the sponsors.

  8. Before transferring custody of the records or destroying study records, contact the sponsor of the study.

  9. Where a subject’s participation may affect his or her medical care, a copy of the consent form should also be placed in the subject’s medical chart.

10.2 HRRC Records

The HRRC Support Office maintains a study file for each study, containing the following information:

  1. application forms,
  2. consent documents,
  3. research protocol(s) (all versions of the protocol are retained in some format and location),
  4. investigator's brochure for test articles,
  5. any other approval documents from other committees or agencies,
  6. texts of advertisements for subject recruitment,
  7. notifications of HRRC decisions,
  8. records of continuing review activities,
  9. reports on amendments and adverse events,
  10. statements on significant new findings,
  11. correspondence between HRRC and investigators of the project,
  12. closure reports.

The files on a research project will be retained for at least three years after completion of the research and any record related to granting of a waiver of HIPAA authorization will be retained for at least six years from the date of creation or the date it was last in effect, whichever is later.

10.3 HRRC Meeting Records

Agendas and minutes of the HRRC meetings are stored either on the computer or by hard copy and are kept for three years.

10.4 HRRC Member Records

Curricula vitae of active members of the HRRC will be maintained in the files of the HRRC Support Office, and will be updated in content as necessary. Each member's membership term status will be monitored and updated, as necessary (Section 3).