ALLA B C D E F G H I J K L M N O P Q R S T U V W X Y Z
This series provides a record of participants consenting to join a registry pool so they may be selected to participate in future research studies.
Official Copy: Principal Investigator
Retention: 6 years after termination or expiration of instrument
Disposition Method: Shred or Delete
Note: If an individual is removed from the registry pool before the pool is terminated, begin counting the six year retention period at that time.
This series provides a record of individuals who have consented to allow human subjects research data to be placed in a data repository. This research data may then be used by researchers during the course of future studies. Collected research data may include blood, urine, saliva, survey data, x-rays, etc. Once entered into a repository, collected research data is maintained without personal identifiers until the repository closes.
Official Copy: Principal Investigator
Retention: 6 years after repository closed
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.
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
Research documentation and raw data (including personal identifiers) obtained in the course of a FDA-regulated study to develop a drug. 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 drug on subjects. Also includes all correspondence with other investigators, the IRB, the sponsor, a monitor, or FDA, including required reports.
Official Copy: Principal Investigator
Retention: 30 Years after close of study if FDA status is unknown; or 2 years following the date a marketing application is approved by the FDA; or, for drug studies where no application is to be filed or if the application is not approved for such indication, retain all records for 2 years after the investigation is discontinued and FDA is notified.
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:
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.
Official Copy: Principal Investigator
Retention: 6 years after close of study
Disposition Method: Shred or Delete