Records and documentation that is associated with grant/contract sponsored 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.
Note: Identifiers collected as part of the research (such as name and birth date) must be retained for the full retention period. However, the format, storage medium, location, and accessibility of identifiers and any master key or list that links coded data to identifiers must comply with the approval conditions of the reviewing Institutional Review Board (IRB).
Official Copy: Principal Investigator
Retention: 6 years after close of study
Disposition Method: Shred or Delete