{"id":873,"date":"2018-06-21T05:54:46","date_gmt":"2018-06-21T05:54:46","guid":{"rendered":"https:\/\/az.research.umich.edu\/medschool\/document\/statement-practice-document-revision-guidance-naming-convention-and-version\/"},"modified":"2026-04-08T10:55:51","modified_gmt":"2026-04-08T14:55:51","slug":"statement-practice-document-revision-guidance-naming-convention-and-version","status":"publish","type":"document","link":"https:\/\/az.research.umich.edu\/medschool\/policies\/statement-practice-document-revision-guidance-naming-convention-and-version\/","title":{"rendered":"Statement of Practice: Document Revision Guidance, Naming Convention, and Version Control"},"template":"","categories":[24],"tags":[91,78,57],"content-type":[72],"topic":[43,26,65,46],"update-type":[98,94],"class_list":["post-873","document","type-document","status-publish","hentry","category-institutional-review-boards-irbmed","tag-irbmed-statement-of-practice","tag-study-coordinator","tag-study-teams","content-type-policies","topic-eresearch-regulatory-management-errm","topic-informed-consent-assent","topic-records","topic-statements-of-practice","update-type-new-resource","update-type-review-recommended"],"acf":{"use_legacy_editor":true,"updated_date":"2021-10-15 08:30:00","update_notice":true,"author":"IRBMED","summary":"To assure that study teams are utilizing the most recent IRB approved versions of study documents when making modifications at the time of amendment or when addressing requested changes by IRBMED staff or reviewers, IRBMED has standardized practices for naming convention and version control. The standardized practices, further detailed below, include procedures for:\r\n<ul>\r\n \t<li>Accessing the most recent IRB approved clean version of the consent from the eResearch application in <a href=\"\/medschool\/wp-content\/uploads\/sites\/3\/2024\/12\/res_irbmed_eResearch.Application.Section10-1.2017.03.28.pdf\">Section 10-1<\/a> (Word version)<\/li>\r\n \t<li>Providing a\u00a0'tracked changes' version of study documents for review<\/li>\r\n \t<li>Applying the standard naming conventions for study documents into eResearch<\/li>\r\n<\/ul>","button_links":null,"related_content":[878,851,730,733],"legacy_path":"statement-practice-document-revision-guidance-naming-convention-and-version","legacy_node_id":1019,"legacy_related_nids":"1382, 411, 259, 262","legacy_content_section":[{"legacy_section_type":"heading","legacy_heading":"I. Uploading Consent Documents into eResearch","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":"Upload initial documents for IRB review into each appropriate section of the new study application. This will become the document's\u00a0'tracked' stack. Track all modifications to\u00a0documents after the PI submits the application, even within a new application.\r\n\r\nFor\u00a0amendments modifying study materials, upload a tracked version of the document\u00a0to eResearch.\u00a0Ensure any subtitle &amp; version # in the document (e.g. footer) are updated.\r\n\r\nMaintain one 'tracked stack' of documents in eResearch for each\u00a0 (for studies with multiple consent documents). Each updated\/tracked version for a given document should be stacked via the 'Upload Revision' function into its existing 'tracked' stack. Only 'Add' new document stacks for entirely new documents.\r\n\r\n<strong>Note:<\/strong> Documents uploaded\u00a0into\u00a0section <strong>44 <\/strong>may not require both tracked &amp; clean stacks. Please work with IRBMED Staff when making revisions to these documents.\r\n\r\nFollow the standard naming convention outlined below in Section IV. Updating the stack title is not required, and actual document title (i.e. filename) need not match stack title.\r\n\r\n<strong>Do not delete<\/strong> any documents or stacks of documents from eResearch; these are retained for historical reference purposes.\r\n\r\n<strong>Do not alter or remove<\/strong> the consent\/assent cover page in the IRB-maintained \u201cClean\u201d stack(s) in <strong>10-1.1<\/strong>. This page is \"silent\", meaning it will disappear during eR document finalization.\r\n\r\n<strong>Do not use<\/strong> documents stored outside of eResearch as these may be previous versions instead of the latest IRB approved version. IRBMED Regulatory Staff verify the correct document was used via the document\u2019s cover page and the Microsoft Word \u2018Compare\u2019 function as an initial step in their review.","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":"heading","legacy_heading":"II. Document Revision","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_with_subheading","legacy_heading":"","legacy_subheading":"Microsoft Word Documents","legacy_section_text":"<strong>1. <\/strong>Download the last approved \"Clean\" Word version from eResearch. Locate the most recently approved clean version by clicking on the ellipsis (three dots) then selecting View History.\r\n<p class=\"rteindent1\">Sometimes an irrelevant version is inadvertently uploaded into the Clean stack: using the document stack Resource History ensures you download and make revisions from the latest approved Clean Word version<\/p>","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":"media","legacy_heading":"","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"media-half","legacy_media_file":1355,"legacy_media_url":"https:\/\/az.research.umich.edu\/sites\/default\/files\/media\/embedded\/res_irbmed%20screenshot%20eResearch%20more%20ellipsis.png","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"media","legacy_heading":"","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"media-half","legacy_media_file":1356,"legacy_media_url":"https:\/\/az.research.umich.edu\/sites\/default\/files\/media\/embedded\/res_irbmed%20screenshot%20eResearch%20ellipsis%20options%20visible.png","legacy_glossary_term":"","legacy_glossary_nids":"","legacy_resource":"","legacy_resource_nids":"","legacy_buttons":null},{"legacy_section_type":"media","legacy_heading":"","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"media-half","legacy_media_file":1357,"legacy_media_url":"https:\/\/az.research.umich.edu\/sites\/default\/files\/media\/embedded\/res_irbmed%20screenshot%20eResearch%20version%20history%20detail.png","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":"<p><strong>2.<\/strong> As a best practice, &#8220;Save&#8221; the download with a filename including &#8220;-tracked.&#8221;<\/p>","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":"<p><strong>3.<\/strong> Revise with <strong>Microsoft Word's Track Changes<\/strong> active.<\/p>","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":"media","legacy_heading":"","legacy_subheading":"","legacy_section_text":"","legacy_media_position":"media-full","legacy_media_file":1358,"legacy_media_url":"https:\/\/az.research.umich.edu\/sites\/default\/files\/media\/embedded\/res_irbmed%20screenshot%20Word%20track%20changes.png","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":"<p><strong>4.<\/strong> Upload into the same document&#8217;s &#8216;tracked stack&#8217; in eResearch.<\/p>","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_with_subheading","legacy_heading":"","legacy_subheading":"Versions to provide by document function","legacy_section_text":"For<strong> informed consent documents<\/strong>, provide only a \u2018tracked-changes\u2019 version. IRB staff will \u2018Accept All Changes,\u2019 and manage the \u2018clean\u2019 stack. See also section IV below.\r\n\r\nFor <strong>protocol documents<\/strong> and <strong>test article investigator\u2019s brochure (IB)<\/strong>, provide\r\n<ul>\r\n \t<li>a clean version and<\/li>\r\n \t<li>a tracked\/redlined version and\/or a comprehensive Summary of Changes (SOC) for review.<\/li>\r\n<\/ul>\r\n<p class=\"rteindent1\">The SOC may be a separate document stack, or embedded in the new draft.<\/p>\r\nFor <strong>recruitment documents<\/strong> (flyers, letters, scripts, etc.), <strong>data collection forms<\/strong> (surveys, questionnaires, case report forms, etc.), and <strong>other types of documents<\/strong> (including but not limited to screenshots of mobile interfaces, \u2018Dear Doctor\u2019 letters, wallet cards, reminder letters, etc.) \u2018clean\u2019 and\/or \u2018tracked-changes\u2019 versions are usually acceptable. Study team is responsible for providing \u2018clean\u2019 versions if desired. Recruitment documents that will be outward-facing \u2018as is\u2019 (e.g., flyers for posting but not email text), require a \u2018clean\u2019 version for eResearch finalization process.","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":"heading","legacy_heading":"III. Standard Naming Convention for Study Documents","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":"The standardized naming convention for uploads maintains consistency, provides historical documentation, and reduces errors. Tracked documents should be labeled with the '-tracked' suffix.\r\n\r\n<strong>Note: <\/strong>Exceptions to the standard naming convention can be made on a case-by-case basis at the discretion of IRBMED staff. Please reach out to IRBMED with any questions.\r\n<ul>\r\n \t<li>Protocol-tracked<\/li>\r\n \t<li>Phone Script-tracked<\/li>\r\n \t<li>Email Template-tracked<\/li>\r\n \t<li>UM Flyer-tracked<\/li>\r\n \t<li>Flyer 18-40yo-tracked<\/li>\r\n \t<li>Flyer 41-80yo-tracked<\/li>\r\n \t<li>Social Media Kit-tracked<\/li>\r\n \t<li>Consent-tracked<\/li>\r\n<\/ul>\r\nAdd a one- or two-word\u00a0<em>Concise<\/em><em> Subtitle\u00a0<\/em>when there are multiple consents associated with the study.\r\n\r\nFor example:\r\n<ul>\r\n \t<li>Consent - Control group-tracked<\/li>\r\n \t<li>Consent - Intervention group-tracked<\/li>\r\n<\/ul>\r\nFor multi-site studies\r\n<ul>\r\n \t<li>UM Consent-tracked<\/li>\r\n \t<li>Stanford Consent-tracked<\/li>\r\n<\/ul>\r\nFor studies with minors\r\n<ul>\r\n \t<li>Assent Script 10-13yo-tracked<\/li>\r\n \t<li>Assent Written 14-17yo-tracked<\/li>\r\n \t<li>Parental Permission-Tracked<\/li>\r\n<\/ul>\r\nFor studies with multiple languages:\r\n<ul>\r\n \t<li>English Consent-tracked<\/li>\r\n \t<li>English Assent script-tracked<\/li>\r\n \t<li>Spanish Consent-tracked<\/li>\r\n \t<li>Spanish Assent script-tracked<\/li>\r\n<\/ul>","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":"heading","legacy_heading":"IV. Finalization &amp; eResearch Watermark","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":"<strong>Note:<\/strong> For <a href=\"\/medschool\/guidance\/single-irb-sirb-and-cooperative-multi-site-research\">Multi-Site Research\/sIRB<\/a> studies, IRBMED staff will not finalize\/watermark the final documents since they are template documents to be used by all sites. Finalization\/watermarks will be applied at the performance site level after review is complete.\r\n\r\nIRBMED Staff label and clean all applicable Informed Consent Documents in question <strong>10-1.1<\/strong> and upload the final version for approval into their respective clean stack. The system finalizes documents into a .pdf with IRBMED approval watermark.\r\n\r\nStudy teams are responsible for providing \u2018clean\u2019 versions for finalization of Recruitment Documents in question <strong>8-1.8<\/strong>.\r\n\r\nFinalized documents may not be altered without review and approval via an amendment. For more information on Finalization and watermarking exceptions see Statement of Practice: <a href=\"\/medschool\/policies\/statement-practice-irbmed-finalization-study-documents\">IRBMED Finalization of Study Documents<\/a>.","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":[98,94],"update_notice_start":"2021-10-13 14:00:00","update_notice_end":"2021-12-22 14:00:00","update_notice_text_blocks":[{"update_notice_text":"<p>This expanded Statement of Practice includes version control expectations for protocols and other study documents, in addition to informed consent documents.<\/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\n2800 Plymouth Road, Ann Arbor, MI 48109-2800\r\n\r\n<p>A <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.<\/p>\r\n\r\nEdited By: <a href=\"mailto:larkspur@umich.edu\">larkspur@umich.edu<\/a>\r\nLast Updated: April 8, 2026 11:00AM","global_contact_block_select":null},"_links":{"self":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/873","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":1,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/873\/revisions"}],"predecessor-version":[{"id":1958,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/873\/revisions\/1958"}],"acf:term":[{"embeddable":true,"taxonomy":"update-type","href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type\/94"},{"embeddable":true,"taxonomy":"update-type","href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type\/98"}],"acf:post":[{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/733"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/730"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/851"},{"embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/document\/878"}],"wp:attachment":[{"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/media?parent=873"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/categories?post=873"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/tags?post=873"},{"taxonomy":"content-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/content-type?post=873"},{"taxonomy":"topic","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/topic?post=873"},{"taxonomy":"update-type","embeddable":true,"href":"https:\/\/az.research.umich.edu\/medschool\/wp-json\/wp\/v2\/update-type?post=873"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}