Research and Grant/Contract Records

A record of project progress, summaries or evaluations prepared during the course of and/or at the end of the study and submitted to the sponsor.

Official Copy: Principal Investigator
Retention: 6 years after close of study
Disposition Method: Shred or Delete

Research documentation and raw data (including personal identifiers) obtained in the course of a FDA-regulated study to develop a device. May include Investigators' Notebooks (laboratory notes documenting the results of experiments), patient files, case files, and other records of the dates, quantity and use of a device on subjects. Also includes all correspondence with other investigators, the IRB, the sponsor, a monitor, or FDA, including required reports.

This retention schedule refers to data in any format that it can exist in. To determine the retention of objects that are not expressions of information and are instead actual research products (such as cell lines, biological samples collected for research purposes, synthetic compounds, and organisms) refer to any relevant regulations, laws, or instructions from funding sources.

Official Copy: Principal Investigator
Retention: 30 Years after the close of the study if FDA status is unknown; or, 2 years after the latter of the following two dates: The date on which the investigation is terminated or completed, or the date that the records are no longer required for purposes of supporting a premarket approval application, a notice of completion of a product development protocol, a humanitarian device exemption application, a premarket notification submission, or a request for De Novo classification.
Disposition Method: Shred or Delete

Records and documentation that is associated with research activities. Includes records relating to research and data collection methods for human subjects research, human subject research that has “exempt” status, clinical trials or studies (all phases), and animal research.

May include: research protocols and instruction documentation; case report forms; subject recruitment; screening, selection and eligibility documentation; correspondence with subjects and organizations providing subjects; computer software for administering tests to research participants; abstracted information from medical records; assay results; data gathering, responses (e.g., interviews, notes, questionnaires, abstracted or summarized information); evaluations and research analysis; notes, interviews, summary sheets, data analysis; summary documentation; reports; logs; forms; PI notes; lab manuals and notebooks; non-study-specific guidelines, protocols, checklists; contracts and other agreements; pre-site documentation; study close out documentation; and all correspondence.

Also includes records, correspondence and reports relating to non-financial compliance activity as well as industry, federal, state, non-profit, or international regulatory requirements regarding research activities.

May include IRB or IRB subcommittee applications (including all attachments and all correspondence with the IRB and the IRB office); delegation documentation, required training documentation; drug and device logs; safety documentation; confidentiality documentation; data and safety monitoring reports; records related to adverse events, data breaches, non-compliance issues, and any unanticipated problems; records related to external monitoring or auditing of research activity; records associated with specialized compliance requirements such as Radiation Safety, Institutional Biosafety, FERPA, CLIA laboratory certification, and use of embryonic stem cells (ESCRO).

May also include any records created or gathered during the course of anticipating research activity, but due to lack of funds or termination by sponsor, the trial or study did not open, and in the case of human subject research, human subjects were not enrolled.

These record series were merged into Research Records and Data:

• Clinical Trials Phase I-IV Research Data
• Investigator; Report of Project Status
• Research Data -- Biomedical Treatment or Intervention (Drug, Device or Surgical Procedure/Intervention)
• Research Data -- Non-Biomedical Treatment or Intervention (Non Drug, Device or Surgical Procedure/Intervention)
• Research Data-- Sponsor Required Contractual Obligation
• Research Data -- Exempt from Human Subjects Review

Note: Longer retention periods may be required for international or multi-site research or trials, which may be determined by the location of the primary PI. Longer retention periods may also be required by corporate sponsors or certain agencies (e.g., federal Department of Justice). Note: This does not include research requiring FDA approval or involvement. Note: Does not include consent forms, assent forms or HIPAA authorizations.

This retention schedule refers to data in any format that it can exist in. To determine the retention of objects that are not expressions of information and are instead actual research products (such as cell lines, biological samples collected for research purposes, synthetic compounds, and organisms) refer to any relevant regulations, laws, or instructions from funding sources.

Official Copy: Principal Investigator
Retention: 6 years after close of study
Disposition Method: Shred or Delete