{"id":866,"date":"2023-12-22T13:13:34","date_gmt":"2023-12-22T18:13:34","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=866"},"modified":"2026-09-09T18:15:36","modified_gmt":"2026-09-09T22:15:36","slug":"templates","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/templates\/","title":{"rendered":"Templates"},"content":{"rendered":"","protected":false},"excerpt":{"rendered":"","protected":false},"author":36,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-866","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"","subtitle":"","call_to_action":"","hero_image_placement":"no_image","hero_media":"images","hero_pattern_option":"","hero_video":"","hero_image_landing":"","hero_image_landing_two":"","hero_image_landing_three":"","content_modules":[{"acf_fc_layout":"card_grid","anchor":"","css_class":"pt-0","title":"<h2 style=\"text-align: left;\">Explore template types<\/h2>","description":"<p style=\"text-align: left;\">Downloadable templates are available for a variety of uses and research needs. If you have questions or need assistance accessing these files, <a href=\"https:\/\/www.rochester.edu\/ohsp\/contact\/\">contact our office<\/a>.<\/p>","background_color":"#FFFFFF","width":"width-medium","columns":"2","cards":[{"card_title":"<h5>Protocol templates<\/h5>","card_text":"","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"","url":"#protocol","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>Consent templates<\/h5>","card_text":"","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"","url":"#consent","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>Study documentation templates<\/h5>","card_text":"","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"","url":"#studydocumentation","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""},{"card_title":"<h5>Self-audit templates<\/h5>","card_text":"","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"","url":"#selfaudit","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""}]},{"acf_fc_layout":"accordion_new","anchor_id":"protocol","classes":"","title":"<h2>Protocol templates<\/h2>","description":"The templates below serve as <strong>starting points<\/strong> for developing your research protocol. If you have questions about the templates below, <a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/coordinator\/\">contact your IRB Coordinator<\/a>.","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Biomedical Research Protocol Template ","icon":"","row_content":"Use this template when the research involves:\r\n<ul>\r\n \t<li>Observations that contribute to the development of biomedical knowledge;<\/li>\r\n \t<li>Products regulated by the Food &amp; Drug Administration (i.e., a drug, biologic, supplement and\/or device); or<\/li>\r\n \t<li>Enrolling subjects via the University of Rochester Medical &amp; Affiliates covered entity.<\/li>\r\n<\/ul>\r\n<a class=\"button ghost-button--blue\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/ProtocolTemplate.doc\">Download the Biomedical Research Protocol Template<\/a>","accordion_anchor":"biomedical"},{"acf_fc_layout":"accordion","accordion_title":"Social-Behavioral-Educational Research Protocol Template","icon":"","row_content":"Use this template when the research involves:\r\n<ul>\r\n \t<li>Collection of and\/or interventions related to human attitudes, beliefs, and behaviors; or<\/li>\r\n \t<li>Systematic attempts to define\/investigate methods, conditions, or other factors involved in teaching and learning.<\/li>\r\n<\/ul>\r\n<a class=\"button ghost-button--blue\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Protocol_Template_SocialBehavioralEducational.doc\">Download the Social-Behavioral-Educational Research Protocol Template<\/a>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Specimen & Record Review Protocol Template","icon":"","row_content":"Use this template when the research <em>only<\/em> involves:\r\n<ul>\r\n \t<li>Secondary analysis of data and\/or biospecimens; or<\/li>\r\n \t<li>Retrospective chart review.<\/li>\r\n<\/ul>\r\n<a class=\"button ghost-button--blue\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/protocol_template_specimen_and_Record_Review.doc\">Download the Specimen &amp; Record Review Protocol Template<\/a>","accordion_anchor":"specimen"},{"acf_fc_layout":"accordion","accordion_title":"Exemption Request Protocol Template","icon":"","row_content":"Use this template when the research involves:\r\n<ul>\r\n \t<li>Routine educational practices conducted in commonly accepted educational settings;<\/li>\r\n \t<li>Benign surveys, interviews, educational tests, or observations of public behavior;<\/li>\r\n \t<li>Benign behavioral interventions involving the collection of verbal or written information from adults only; or<\/li>\r\n \t<li>Evaluations of public benefit or service programs<\/li>\r\n<\/ul>\r\n<a class=\"button ghost-button--blue\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/protocol_template_exemption_requests.doc\">Download the Exemption Request Protocol Template<\/a>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Repository Protocol Template","icon":"","row_content":"Use this template to <em>establish, create and maintain<\/em> a research database, registry or repository. If the research involves using data\/specimens from an established database, registry or repository, use the <a href=\"#specimen\">Specimen &amp; Record Review Protocol Template<\/a> above.\r\n\r\n<a class=\"button ghost-button--blue\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/protocol_template_repositories.doc\">Download the Repository Protocol Template<\/a>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"HRP Review Form when Relying on External IRB","icon":"","row_content":"Use this form when the University of Rochester is relying on an External IRB.\r\n\r\n<a class=\"button ghost-button--blue\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2026\/03\/HRP-Review-Questions-When-UR-Relying.pdf\">Download the HRP Review Form When Relying on External IRB<\/a>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Treatment Use Protocol Template","icon":"","row_content":"Use this template to request the use of an investigational product (drug, biologic, supplement or device) to <em>trea<u>t<\/u><\/em> a single patient or group of patients in a non-emergency setting. If <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/301b_GDL_for_Determining_Human_Subj_Research.pdf\"><em>research<\/em><\/a> will be conducted, use the <a href=\"#biomedical\">Biomedical Research Protocol Template<\/a> above.\r\n\r\n<a class=\"button ghost-button--blue\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/protocol_template_treatment.doc\">Download the Treatment Use Protocol Template<\/a>","accordion_anchor":""},{"acf_fc_layout":"title","sub_heading":"Best Practices"},{"acf_fc_layout":"accordion","accordion_title":"Best Practices for Protocol Templates","icon":"","row_content":"<ul>\r\n \t<li>Only identify the Principal Investigator in the heading (and mentor, for student research). Adding other Investigators\/team members is not necessary and will require revision each time staff update.<\/li>\r\n \t<li>Ensure all content is consistent. Conflicting information prevents the IRB from validating the criteria for IRB approval have been met.<\/li>\r\n \t<li>To avoid inconsistencies, group content in a step-by-step format. Stick to the section headings identified in the template. Avoid repeating procedures\/details (refer other sections when necessary).<\/li>\r\n \t<li>Complete all sections; enter 'N\/A' if a section does not apply to the research.<\/li>\r\n<\/ul>\r\n<ul>\r\n \t<li style=\"list-style-type: none;\">\r\n<ul>\r\n \t<li><strong>Exception:\u00a0<\/strong>When utilizing a protocol template to create a protocol addendum, remove all unnecessary sections; only include content that is not addressed in the primary protocol. Do not repeat information in the protocol addendum that is address in the primary protocol.<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>\r\n<ul>\r\n \t<li>Delete all guidance text <em>prior<\/em> to IRB submission.\u00a0Guidance language is only meant to assist Investigators during the protocol development process. Thee protocol submitted to the IRB should be in a 'final product' state<\/li>\r\n \t<li>Review the questions posed in the <a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/approval-criteria\/\">Criteria for IRB Approval Guide<\/a> as a 'double-check' prior to IRB submission.<\/li>\r\n<\/ul>","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"","css_class":"pt-0","title":"","content":"<p style=\"text-align: center;\"><a class=\"button ghost-button--blue\" href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/coordinator\/\">Contact your IRB Coordinator with any questions<\/a><\/p>\r\n\r\n\r\n<hr \/>","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"consent","classes":"pt-0","title":"<h2>Consent templates<\/h2>","description":"The templates below serve as <strong>starting points<\/strong> for drafting informed consent documents. If you have questions, <a href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/coordinator\/\">contact your IRB Coordinator<\/a>.","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Consent Templates for Enrolling Adults","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Consent_Form_Template_Biomedical.docx\">Consent Form for Biomedical Study<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Consent_Form_Template_NonBiomedical.docx\">Consent Form for Social-Behavioral-Educational Study<\/a><\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Consent Templates for Enrolling Minors","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Permission_Form_Template.doc\">Parent Permission Form<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Assent_Form_13-17_Template.doc\">Written Assent Form (13-17 year olds)<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Assent_Script_8-12_Template.doc\">Verbal Assent Script (8-12 year olds)<\/a><\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Consent Templates for Deception Studies","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Consent_to_Procedures_Template.doc\">Consent Form to Procedures<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Consent_to_Data_Use_Template.doc\">Consent Form to Data Use<\/a><\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Consent Templates for Treatment","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Consent_to_Treatment_Template.doc\">Consent Form for Treatment Use<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Emergency_Use_Consent_Template.doc\">Consent Form for Emergency Use<\/a><\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Information Sheets","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Information_Sheet_Template.doc\">Information Sheet<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Information_Sheet_MTurk_Template.doc\">Information Sheet for Studies Using MTurk<\/a><\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Additional\/Supplemental Consent Templates","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Consent_Addendum_Template.doc\">Consent Addendum<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Verbal_Script_Template.doc\">Verbal Consent Script<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Future_Contact_Database_Consent_Template.doc\">Consent Form for Future Contact Database <\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Future_Contact_Script_Template.doc\">Verbal Consent Script for Future Contact<\/a><\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Short Forms","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/English_Short_Form_for_Translation_Template.doc\">English Short Form<\/a> (for translation purposes)<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Spanish_Short_Form_Template.doc\">Spanish Short Form<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Russian_Short_Form_Template.doc\">Russian Short Form<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Mandarin_Short_Form_Template.doc\">Mandarin Short Form<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Translator_Declaration_Form.docx\">Translator Attestation<\/a><\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Supplemental Template\/Sample Language ","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.urmc.rochester.edu\/del-monte-neuroscience\/ur-cabin\/mri\/forms-and-policies.aspx\">CABIN Consent Templates<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Consent_Sample_Language_Guide.docx\">Consent Form Sample Language<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2026\/04\/608c-Guideline-Genetic-Testing.pdf\">Guideline on Requirements for Genetic Testing Research<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Genomic_Data_Sharing_Controlled_Access.docx\">Genomic Data Sharing Controlled Access<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Genomic_Data_Sharing_Open_Access.docx\">Genomic Data Sharing Open Access<\/a><\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"International Privacy","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2026\/04\/GDPR_Notification.docx\">GDPR Notification<\/a><\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2026\/04\/PIPL_Notification.docx\">PIPL Notification<\/a><\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"When the University of Rochester Relies on an External IRB","icon":"","row_content":"<a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2026\/06\/Consent-Language-When-Relying-on-External-IRB.docx\"><span data-olk-copy-source=\"MessageBody\">Consent Language When Relying on External IRB<\/span><\/a>\r\n\r\n&nbsp;\r\n\r\n&nbsp;","accordion_anchor":"relying"},{"acf_fc_layout":"title","sub_heading":"Best practices"},{"acf_fc_layout":"accordion","accordion_title":"Best practices for consent templates","icon":"","row_content":"<ul>\r\n \t<li>All content must be written at an appropriate reading level. Health literacy and plain language resources are available on the web. Recommended resources include:\r\n<ul>\r\n \t<li>Agency for Healthcare Research and Quality's <a class=\"u-link-external\" href=\"https:\/\/www.ahrq.gov\/sites\/default\/files\/publications2\/files\/ictoolkit.pdf\">Informed Consent and Authorization Toolkit for Minimal Risk Research<\/a><\/li>\r\n \t<li>Center for Disease Control's <a class=\"u-link-external\" href=\"https:\/\/stacks.cdc.gov\/view\/cdc\/11938\">Simply Put <\/a><\/li>\r\n \t<li><a href=\"https:\/\/libguides.urmc.rochester.edu\/healthliteracy\">Miner Library's Health Literacy Webpage<\/a><\/li>\r\n \t<li>Multi-Regional Clinical Trial (MRCT) Center's <a class=\"u-link-external\" href=\"https:\/\/mrctcenter.org\/clinical-research-glossary\/\">Clinical Research Glossary<\/a><\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>Information highlighted in yellow on the templates is guidance and <em>must<\/em> be addressed or deleted prior to IRB submission.<\/li>\r\n<\/ul>","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"","css_class":"pt-0","title":"","content":"<p style=\"text-align: center;\"><a class=\"button ghost-button--blue\" href=\"https:\/\/www.rochester.edu\/ohsp\/irb-review\/coordinator\/\">Contact your IRB Coordinator with any questions<\/a><\/p>\r\n\r\n\r\n<hr \/>","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"studydocumentation","classes":"pt-0","title":"<h2>Study documentation templates<\/h2>","description":"<span data-contrast=\"auto\">The templates and tools below serve as <\/span><b><span data-contrast=\"auto\">starting points<\/span><\/b><b><span data-contrast=\"auto\">;<\/span><\/b><span data-contrast=\"auto\">. <\/span><span data-contrast=\"auto\">they<\/span><span data-contrast=\"auto\"> can be used <\/span><span data-contrast=\"auto\">to:<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span>\r\n<ul>\r\n \t<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"11\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"3\" data-aria-level=\"1\"><span data-contrast=\"auto\">Identify <\/span><a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/study-documentation\/requirements\/\"><span data-contrast=\"auto\">required study documentation<\/span><\/a><span data-contrast=\"auto\">;\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:540,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/li>\r\n \t<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"11\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"4\" data-aria-level=\"1\"><span data-contrast=\"auto\">Draft and organize study <\/span><span data-contrast=\"auto\">documents;<\/span><span data-contrast=\"auto\">\u00a0\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:540,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/li>\r\n \t<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"11\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"5\" data-aria-level=\"1\"><span data-contrast=\"auto\">Track study procedures and activities; and<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:540,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span><\/li>\r\n \t<li data-leveltext=\"\uf0b7\" data-font=\"Symbol\" data-listid=\"11\" data-list-defn-props=\"{&quot;335552541&quot;:1,&quot;335559684&quot;:-2,&quot;335559685&quot;:720,&quot;335559991&quot;:360,&quot;469769226&quot;:&quot;Symbol&quot;,&quot;469769242&quot;:[8226],&quot;469777803&quot;:&quot;left&quot;,&quot;469777804&quot;:&quot;\uf0b7&quot;,&quot;469777815&quot;:&quot;multilevel&quot;}\" aria-setsize=\"-1\" data-aria-posinset=\"6\" data-aria-level=\"1\"><span data-contrast=\"auto\">Demonstrate compliance with your study protocol, federal <\/span><span data-contrast=\"auto\">regulation<\/span><span data-contrast=\"auto\"> and institutional policy.\u00a0<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559685&quot;:540,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\r\n<\/span><\/li>\r\n<\/ul>\r\n<span data-contrast=\"auto\">All templates are in Microsoft document format. <\/span><b><span data-contrast=\"auto\">Modify\/customize templates to collect the information you need, based on the study protocol.<\/span><\/b> <span data-contrast=\"auto\">Variations of these forms are also available from other research-related sites via web search.<\/span><span data-ccp-props=\"{&quot;201341983&quot;:0,&quot;335559739&quot;:0,&quot;335559740&quot;:240}\">\u00a0<\/span>\r\n\r\n<span class=\"TextRun SCXW117255165 BCX0\" lang=\"EN-US\" xml:lang=\"EN-US\" data-contrast=\"auto\"><span class=\"NormalTextRun SCXW117255165 BCX0\">If you have questions, email <a href=\"mailto:ohspqi@urmc.rochester.edu\">ohspqi@urmc.rochester.edu<\/a>.<\/span><\/span>","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Site File","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2025\/06\/Site-File-Contents-Description-13JUN2025.pdf\">Study Site File Contents Description<\/a>: Use this guidance document to identify the types of study documentation that need to be maintained as part of a study file.<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Regulatory_File_Template_GCP.zip\">Study Site File Template GCP<\/a>: Use this zip file as a template for organizing site file documents for research subject to Food &amp; Drug Administration regulations (involving drugs, biologics, supplements, and\/or devices).<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Site_File_Template_nonGCP1.zip\">Study Site File Template Non-GCP<\/a>: Use this zip file as a template for organizing site file documents for research that is <em>not<\/em> subject to Food &amp; Drug Administration regulations (e.g., research deemed exempt, social-behavioral-educational research, minimal risk biomedical research).<\/li>\r\n<\/ul>\r\nReference our <a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/study-documentation\/\">Study Documentation page<\/a> for additional information.","accordion_anchor":"sitefile"},{"acf_fc_layout":"accordion","accordion_title":"Logs","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Adverse_Event_Log_Template_2.doc\">Adverse Event Log<\/a>: Use this template to document the occurrence, assessment of, and measures taken to address adverse events.<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Concomitant_Medication_Log_Template_1.doc\">Concomitant Medication Log<\/a>: Use this template to record information regarding medications individual subjects are taking.<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Consent_Log_Template.docx\">Consent Log<\/a>: Use this template to document pertinent details about the consent process.<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Enrollment_Log_Template_2.xlsx\">Enrollment Log<\/a>: Use this template to document, track and follow the process of enrolled study subjects throughout the course of the study.<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Investigational_Product_Inventory_Log_Template_2.doc\">Investigational Product Inventory Log<\/a>: Use this template to track when and how investigational product is used throughout the course of the study, from receipt, dispensing, return and destruction of the product.<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Lab_Sample_Log_Template.doc\">Laboratory Sample Log<\/a>: Use this template to document laboratory samples collected from subjects.<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Signature_and_Delegation_of_Authority_Log_Template_1.doc\">Signature &amp; Delegation of Authority Log<\/a>: Use this combined template to document duties\/roles of individual study team personnel, as designated by the Principal Investigator (qualifications, expertise and training of all study personnel must aligned with their respective assigned duties) and to authenticate\/verify the signatures of study team personnel against study documentation and their corresponding qualifications (signatures must be handwritten and original (do not use signature stamps)).<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Signature_Log_Template_2.doc\">Signature Log<\/a>: Use this template to authenticate\/verify the signatures of study team personnel against study documentation and their corresponding qualifications; signatures must be handwritten and original (do not use signature stamps).<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Study_Drug_Temperature_Log_Template.xlsx\">Investigational Product Temperature Log<\/a>: Use this template to routinely record the temperature of investigational product storage space, in accordance with storage requirements defined by the study protocol.<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Subj_IP_Accountability_Log_Template_1.doc\">Subject Investigational Product Accountability Log<\/a>: Use this template to record when and how much investigational product is dispensed to and subsequently returned by an individual study subject.<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/TELEPHONE_RECORD_LOG_Template_1.docx\">Telephone Record Log<\/a>: Use this template to document important conversations with the study sponsor (and their designees) and study subjects, concerning the conduct of the research, subject eligibility, adverse events, and compliance.<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Training_Log_Template_1.docx\">Training Log<\/a>: Use this template to document training of study team personnel.<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Source Documents","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Inclusion_Exclusion_Criteria_Template_1.doc\">Inclusion\/Exclusion Criteria<\/a>: Use this template to document confirmation of subject eligibility.<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/PHYSICAL_EXAM_Template_1.doc\">Physical Examination Form<\/a>: Use this template to document the health history of a subject.<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Routine_Study_Visit_Summary.docx\">Routine Study Visit<\/a>: Use this template to document observations and procedures conducted during the course of the study, in accordance with the study protocol.<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Screening_Baseline_Visit_Source_Doc_Template_1.doc\">Screening &amp; Baseline Visit<\/a>: Use this template to document screening and baseline visits, in accordance with the measures\/procedures defined by the study protocol.<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Documentation\/Note to File (NTF) Samples","icon":"","row_content":"<ul>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/CAPA_Plan_Template.docx\">CAPA Plan<\/a>: Use this template following an incident of non-compliance and\/or protocol deviation to document the nature of the incident and the measures taken to address the incident. This should minimally include what happened, the root cause of the error, corrective actions taken to address the incident, and preventative actions implemented to prevent future re-occurrence of the error.<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/DSMP_Documentation.docx\">Data &amp; Safety Monitoring Plan Documentation<\/a>: Use this template to document the conduct of data and safety monitoring measures defined by the study protocol.<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Consenting_Note_Sample.docx\">Informed Consent Discussion Note<\/a>: Use this template to document the consent process including, informing subjects about consent (disclosure of the elements of consent), assessing subject understanding, answering subjects questions, and the documentation of consent.<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Note_to_File_Template_1.docx\">Note to File (NTF)<\/a>: Use this template to document and address issues that arise during the conduct of the study.<\/li>\r\n \t<li><a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Consenting_Error_NTF_Sample.doc\">NTF for Consent Error<\/a>: Use this template following an error in the consent process to document the error and the measures taken to address the error.\u00a0 This should minimally include what happened, the root cause of the error, corrective actions taken to address the incident, and preventative actions implemented to prevent future re-occurrence of the error.<\/li>\r\n<\/ul>","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"","css_class":"pt-0","title":"","content":"<p style=\"text-align: center;\"><a class=\"button ghost-button--blue\" href=\"mailto:ohspqi@urmc.rochester.edu\">Email ohspqi@urmc.rochester.edu with any questions<\/a><\/p>\r\n\r\n\r\n<hr \/>","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"accordion_new","anchor_id":"selfaudit","classes":"pt-0","title":"<h2>Self-audit templates<\/h2>","description":"The templates and tools below serve to assist study teams in reviewing the quality of their study documentation. Self-reviews may be conducted for general quality-related purposes or as a means to prepare for a quality improvement review, monitoring visit, audit or inspection.\u00a0If you have questions, email <a href=\"mailto:ohspqi@urmc.rochester.edu\">ohspqi@urmc.rochester.edu.<\/a>","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Consent Form Checklist - Single Consent","icon":"","row_content":"Use this checklist assess whether consent been documented properly for a single singed consent form.\r\n\r\n<a class=\"button ghost-button--blue\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/ConsentFormChecklist_SingleConsent.docx\">Download the Consent Form Checklist - Single Consent Template<\/a>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Consent Form Checklist - Multiple Consents","icon":"","row_content":"Use this checklist to assess whether consent has been properly documented for multiple signed consent forms.\r\n\r\n<a class=\"button ghost-button--blue\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/ConsentFormChecklist_MultipleConsents.docx\">Download the Consent Form Checklist - Multiple Consents Template<\/a>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Study Site File Checklist ","icon":"","row_content":"Use this checklist to assess whether the research study site file is complete.\r\n\r\n<a class=\"button ghost-button--blue\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/SiteFileContentsDescription.docx\">Download the Study Site File Checklist Template<\/a>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Study Site File Timeline","icon":"","row_content":"Use this template to ensure all required items are present in the research study site file (all items, regardless of type and\/or funding, are required to be documented).\r\n\r\n<a class=\"button ghost-button--blue\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Study_Regulatory_Timeline.xlsx\">Download the Study Site File Timeline Template<\/a>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Subject Review Tool","icon":"","row_content":"Use this template to ensure all required items are documented in the research study subject file (some items will not apply to all studies).\r\n\r\n<a class=\"button ghost-button--blue\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Subject_Review.xlsx\">Download the Subject Review Tool Template<\/a>","accordion_anchor":""}]},{"acf_fc_layout":"text","anchor":"","css_class":"pt-0","title":"","content":"<p style=\"text-align: center;\"><a class=\"button ghost-button--blue\" href=\"mailto:ohspqi@urmc.rochester.edu\">Email ohspqi@urmc.rochester.edu with any questions<\/a><\/p>","background_color":"#ffffff","width":"width-medium"}]},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - 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