{"id":778,"date":"2018-05-08T11:55:35","date_gmt":"2018-05-08T11:55:35","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/record-keeping-guidelines\/"},"modified":"2026-03-30T12:17:53","modified_gmt":"2026-03-30T16:17:53","slug":"record-keeping-guidelines","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/guidance\/record-keeping-guidelines\/","title":{"rendered":"Record Keeping Guidelines"},"template":"","categories":[24],"tags":[77,78,57],"content-type":[41],"topic":[66,75],"update-type":[97],"class_list":["post-778","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","tag-regulatory","tag-study-coordinator","tag-study-teams","content-type-guidance","topic-investigator-study-team-responsibilities","topic-regulations-policies-federal-state-local","update-type-information-only"],"acf":{"use_legacy_editor":true,"updated_date":"2021-03-08 14:00:00","update_notice":false,"author":"IRBMED","summary":"Research records include, but may not be limited to,\r\n<ul>\r\n \t<li>consent forms<\/li>\r\n \t<li>case report forms (CRFs)<\/li>\r\n \t<li>subject-specific forms for adverse events, notes to file, and protocol deviations<\/li>\r\n<\/ul>\r\nRecord retention must be consistent with\r\n<ul>\r\n \t<li>IRB-approved methods for data confidentiality in eResearch section 11 and the protocol<\/li>\r\n \t<li><a href=\"https:\/\/safecomputing.umich.edu\/\">U-M Safe Computing<\/a> guidance (e.g. <a href=\"https:\/\/safecomputing.umich.edu\/protect-the-u\/compliance\">Compliance<\/a> and <a href=\"https:\/\/safecomputing.umich.edu\/dataguide\/\">Sensitive Data Guide<\/a>)<\/li>\r\n \t<li>HRPP <a href=\"https:\/\/hrpp.umich.edu\/irb-health-sciences-and-behavioral-sciences-hsbs\/irb-application-process\/data-security-guidelines\/\">Data Security Guidelines<\/a> and Guidance on <a href=\"https:\/\/hrpp.umich.edu\/wp-content\/uploads\/sites\/4\/2024\/10\/privacy_confidentiality_hrppguidance_final.pdf\" target=\"_blank\" rel=\"noopener\">Protecting Participant Privacy and Maintaining Confidentiality of Data<\/a><\/li>\r\n<\/ul>\r\nRecords may be kept in hard-copy or electronically. HRPP offers best-practice guidance for <a href=\"https:\/\/hrpp.umich.edu\/wp-content\/uploads\/sites\/4\/2024\/10\/electronic_documents_certification_guidance.pdf\">creating certified electronic copies of documentation<\/a>, should there be a reason to dispose of hard-copy records.","button_links":null,"related_content":[902],"legacy_path":"record-keeping-guidelines","legacy_node_id":320,"legacy_related_nids":"","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"Guidelines","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"Investigators frequently ask how long they should keep research records after a study has ended. Because different regulations apply to different types of studies there is not a simple answer to this question.\r\n\r\nTen years is a safe default standard,\u00a0however, 10 years\u00a0could be\u00a0longer\u00a0than what is required for many studies (note--gene therapy studies and those where the research may have contributed to a minor's incompetency have longer requirements as noted below).\r\n\r\nThe chart below lists types of records to keep and the different criteria that apply (<a href=\"https:\/\/az.research.umich.edu\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_Record-Keeping-Guidelines.pdf\">or\u00a0click here for a printer-friendly version<\/a>). If you need further assistance contact the Office of General Counsel <a href=\"https:\/\/ogc.umich.edu\/practice-areas\/u-m-health-system\/\">Health Law<\/a> group\u00a0at (734) 764-2178 .\r\n\r\n<em>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.<\/em>","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"text_area","legacy_heading":"","legacy_subheading":"","legacy_section_text":"<table style=\"width: 100%\" border=\"1\" cellspacing=\"1\" cellpadding=\"1\"><caption>Record Keeping Guidelines<\/caption>\r\n<thead>\r\n<tr>\r\n<th scope=\"row\">Study Descriptors\r\n\r\nWhat to keep<\/th>\r\n<th scope=\"col\">Federally Funded<\/th>\r\n<th scope=\"col\">All Data Abstracted from Clinical or Dental Records<\/th>\r\n<th scope=\"col\">Health Information Abstracted from Non-Clinical Sources<\/th>\r\n<th scope=\"col\">Health Related Data Collected through Interaction or Intervention with Participants<\/th>\r\n<th scope=\"col\">Dental Research Involving Interaction\u00a0or Intervention with Subjects<\/th>\r\n<th scope=\"col\">Non-Health Related Data Collected through Interaction with Subjects<\/th>\r\n<th scope=\"col\">Findings Submitted to FDA<\/th>\r\n<th scope=\"col\">Gene Therapy\/Cell Therapy Research<\/th>\r\n<\/tr>\r\n<\/thead>\r\n<tbody>\r\n<tr>\r\n<th scope=\"row\">Research records, including signed consent documents and case report forms<\/th>\r\n<td><strong>3 years<\/strong> from the date of the final expenditure report\u00a0or the study is completed, whichever is later, per <a href=\"https:\/\/www.ecfr.gov\/on\/2021-03-08\/title-45\/section-75.361\">45 CFR 75.361<\/a><\/td>\r\n<td>No retention requirements on records that are simply duplicates of existing clinical or dental records<\/td>\r\n<td colspan=\"2\"><strong>7 years<\/strong> from the date the study is completed,per <a href=\"https:\/\/research-compliance.umich.edu\/operations-manual-contents-page\">HRPP Operations Manual<\/a> Part 6.II.B<\/td>\r\n<td><strong>10 years<\/strong> from the date the study is completed, per Michigan <a href=\"http:\/\/legislature.mi.gov\/doc.aspx?mcl-Act-368-of-1978\">Public Health Code<\/a><\/td>\r\n<td><strong>3 years<\/strong>\u00a0from the date the study is completed, per <a href=\"https:\/\/research-compliance.umich.edu\/operations-manual-contents-page\">HRPP Operations Manual<\/a> Part 6.II.B<\/td>\r\n<td><strong>2 years<\/strong>\u00a0from study Termination or submission (by sponsor or researcher) to FDA, whichever is later; per <a href=\"https:\/\/www.ecfr.gov\/on\/2021-03-08\/title-21\/section-58.195\">21 CFR 58.195<\/a><\/td>\r\n<td><strong>Forever<\/strong>, until further notice<\/td>\r\n<\/tr>\r\n<tr>\r\n<th scope=\"row\">HIPAA Waiver Documentation<\/th>\r\n<td colspan=\"8\">Included as part of the application to the IRB, stored in <a href=\"\/medschool\/guidance\/eresearch-regulatory-management-errm\" target=\"_blank\" rel=\"noopener\">eResearch<\/a> workspace for the study<\/td>\r\n<\/tr>\r\n<tr>\r\n<th scope=\"row\">Record of PHI Disclosures outside the Michigan Medicine Covered Entity<\/th>\r\n<td colspan=\"8\">Submit tracking logs for disclosures to <a href=\"https:\/\/umhealth.sharepoint.com\/sites\/Corporate-Compliance\/SitePages\/HIPAA.aspx\">Corporate Compliance Office<\/a> in accordance with Michigan Medicine Policy <a href=\"https:\/\/michmed-administration.policystat.com\/policy\/6509419\/latest\/\">01-04-335<\/a> (<em>link requires level-2 or UMHS VPN<\/em>), which shall retain the tracking information for six (6) years from the date when the information was created or was last in effect<\/td>\r\n<\/tr>\r\n<tr>\r\n<th scope=\"row\">IRB Notice of Outcome (Approval letter; exempt or not-regulated determination)<\/th>\r\n<td colspan=\"8\">Stored in <a class=\"gtip\" href=\"\/medschool\/guidance\/eresearch-regulatory-management-errm\">eResearch <\/a>workspace for the study\r\n<ul>\r\n \t<li>Original determination letter available in HUM workspace, \u201cActivities and Correspondence\u201d heading<\/li>\r\n \t<li>Determination letters under Ame, CR, and Adv workspace for each subsequent submission<\/li>\r\n<\/ul>\r\n<\/td>\r\n<\/tr>\r\n<\/tbody>\r\n<\/table>\r\n&nbsp;","legacy_media_position":"","legacy_media_file":"","legacy_media_url":"","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null}],"update_notice_type":[97],"update_notice_start":"2023-04-07 06:00:00","update_notice_end":"2023-06-09 14:00:00","update_notice_text_blocks":[{"update_notice_text":"<p>This page provides guidelines on <strong>regulatory and legal record-keeping requirements<\/strong> for retention of research data\/biospecimens after a study has ended. Study teams may plan to retain study records for&nbsp;maintenance for current research, and\/or to facilitate future research. The new Research A-Z page&nbsp;<a href=\"\/node\/1665\">Retention of Research Data\/Biospecimens<\/a>&nbsp;provides detailed guidance on these scenarios, particularly with respect to how to fill out the eResearch application (HUM) and informed consent document(s) most clearly.<\/p>"}],"global_contact_block":false,"contact_name":"","contact_email":"","contact_additional_info":"Contact us at\u00a0<a href=\"mailto:irbmed@umich.edu\">irbmed@umich.edu<\/a>\u00a0or 734-763-4768 \/ (Fax 734-763-1234)\r\n\r\n2800 Plymouth Road, Ann Arbor, MI 48109-2800\r\n\r\nA <a href=\"https:\/\/medresearch.umich.edu\/office-research\/about-office-research\/our-units\/institutional-review-boards-irbmed\/irbmed-contacts-roster#irbmed-staff\">list of IRBMED staff<\/a> is available at our website.\r\n\r\nEdited By:\u00a0<a href=\"mailto:larkspur@umich.edu\">larkspur@umich.edu<\/a>\r\nLast Updated: March 30, 2026 12:15PM\r\n\r\n&nbsp;\r\n\r\n&nbsp;\r\n\r\n&nbsp;\r\n\r\n&nbsp;","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/778","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document"}],"about":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/types\/document"}],"version-history":[{"count":2,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/778\/revisions"}],"predecessor-version":[{"id":1936,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/778\/revisions\/1936"}],"acf:term":[{"embeddable":true,"taxonomy":"update-type","href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type\/97"}],"acf:post":[{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/902"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=778"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=778"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=778"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=778"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=778"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=778"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}