Compare record-keeping requirements below each study descriptor that applies to a study; keep records for the longest period indicated. Note that records generated under a grant or contract with an industry, government, foundation, or other sponsor may require longer retention, depending on the terms and conditions of the grant or contract. For further assistance contact the Health System Legal Office.

Study Descriptors
What to Keep / Findings Submitted to FDA[1] / Federally Funded / All Data Abstracted[2] from Clinical or Dental Records / Health Information Abstracted[3] from Non-Clinical Sources / Gene Therapy Research[4] / Health Related Data Collected through Interaction[5] or Intervention with Subjects / Dental Research involving Interaction or Intervention with Subjects / Non-Health Related Data Collected through Interaction[6] with Subjects
HIPAA Waiver Documentation / 7 years from the date the study is completed / N/A
Research Records[7] / 2 years from study
termination or submission (by sponsor or researcher) to FDA, whichever is later / 3 years from the date the grant is made or study is completed, whichever is later / No retention requirement on records that are simply duplicates of existing clinical or dental records / 7 years from the date the study is completed / Forever, until further notice / 7 years from the date the study is completed / 10 years from the date the study is completed / 3 years from the date the study is completed
Record of PHI[8] Disclosures Outside the UM Covered Entity / The Privacy Office should have been given an accounting of that disclosure at the time it was made,
but if not, rectify that at study closure.
The Privacy Office will maintain the disclosure record for the required time. / N/A
IRB Notice of Outcome (Approval letter; exempt or non-regulated determination) / 2 years from study termination or submission to FDA, whichever is later / 3 years from the date the study is completed, or until final publications of research data, whichever is later.

Timelines are based on federal and State of Michigan legal requirements. Unless storage costs are prohibitive, 10 years storage provides optimal protection with the exception of gene therapy and as noted in footnote #7.

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[1] Findings submitted to FDA as part of a PMA, NDA, IND application, or revised labeling application. Can apply to retrospective data analyses, in-vitro device studies, or in-vivo studies.

[2] Data is collected from existing sources; it is not newly generated for the research being conducted.

[3] Data is collected from existing sources; it is not newly generated for the research being conducted. There is no retention requirement on records that are simply duplicates of existing records - for example, a print-out from CareWeb that is added to the research file, an extract from a clinical database that is added to a research file, etc.

[4] Includes somatic gene therapy and germ-line therapy

[5] Includes surveys as well as any other interactions where investigators and subjects do not meet face-to-face. Includes information regarding health and medical history, and insurance coverage even if gathered directly from subjects rather than from clinical records.

[6] Includes surveys as well as any other interactions where investigators and subjects do not meet face-to-face. Surveys related to health, medical history, or insurance coverage are “health related”.

[7] If research records include data regarding cases where a minor will never become competent and the research may have been a contributing factor, records that are not also part of the clinical record should be kept for the lifetime of the minor.

[8] PHI=Protected Health Information. Contact the Privacy Office (734) 615-4759 for more information.