{"id":4046,"date":"2024-01-05T15:03:46","date_gmt":"2024-01-05T20:03:46","guid":{"rendered":"https:\/\/www.rochester.edu\/ohsp\/?page_id=4046"},"modified":"2024-02-07T14:44:14","modified_gmt":"2024-02-07T19:44:14","slug":"requirements","status":"publish","type":"page","link":"https:\/\/www.rochester.edu\/ohsp\/resources\/study-documentation\/requirements\/","title":{"rendered":"Requirements"},"content":{"rendered":"<h2>Why is study documentation important?<\/h2>\n<p>Study documentation (also referred to as essential documentation, a regulatory file, and\/or site file) serves as evidence to demonstrate the conduct of the research, the quality of the data collected, and the compliance of the Investigator with applicable regulatory and institutional requirements.<\/p>\n<p>In other words, your study documentation should:<\/p>\n<ul>\n<li>Exhibit what took place over the course of the research (i.e., confirm adherence with all study procedures defined in the study protocol approved by the Reviewing Institutional Review Board [IRB]).<\/li>\n<li>Validate the accuracy, completeness and reliability of the data collected; and<\/li>\n<li>Corroborate the compliance of the study team with regulatory and institutional requirements (i.e., confirm adherence with federal regulations, state law and institutional policy).<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Why is study documentation important? Study documentation (also referred to as essential documentation, a regulatory file, and\/or site file) serves as evidence to demonstrate the conduct of the research, the&hellip;<\/p>\n","protected":false},"author":36,"featured_media":0,"parent":4006,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":"","_members_access_role":[],"_members_access_error":""},"class_list":["post-4046","page","type-page","status-publish","hentry"],"acf":{"lead_in":"","display_title":"Study Documentation Requirements","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":"text","anchor":"","css_class":"title-line t-navy t-below pb-0","title":"<h2>What study documentation is required?<\/h2>","content":"Just as the nature of research varies from study-to-study, so does the type of documentation required to meet the aims identified above. Required documentation depends on factors such as the:\r\n<ul>\r\n \t<li>Regulations that apply to the research (e.g., whether the Food &amp; Drug Administration regulations apply and requirements set forth in the Health Insurance Portability and Accountability Act apply to the research);<\/li>\r\n \t<li>Institutional policies that apply to the research; and<\/li>\r\n \t<li>Procedures, populations, risks and safety monitoring involved in the research.<\/li>\r\n<\/ul>\r\nMost research, however, based on federal regulations and institutional policy have some common threads. As such, <em>all<\/em> study teams (including those conducting research deemed exempt) are <strong>minimally<\/strong> required to maintain documentation that supports:\r\n<ul>\r\n \t<li>IRB approval or determination (inclusive of <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_503_Ancillary_Committee_Reviews.pdf\">Ancillary Committee Review<\/a>);<\/li>\r\n \t<li>Protocol adherence; and<\/li>\r\n \t<li>Adherence to <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_801_Reporting_Research_Events.pdf\">OHSP Policy 801: Reporting Research Events<\/a>.<\/li>\r\n<\/ul>\r\nAdditional types of study documentation that study teams <em>may<\/em> be required to maintain (<a href=\"#additionaltypes\">described further below<\/a>), including documentation of informed consent, conflict of interest management plans and\/or transparency checklists, staff oversight (including training and delegation of tasks), and laboratory certifications.\r\n\r\n<a class=\"button ghost-button--blue\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/SiteFileContentsDescription.docx\">Download our study site file contents description<\/a>","background_color":"#ffffff","width":"width-medium"},{"acf_fc_layout":"card_grid","anchor":"","css_class":"pt-0 pb-0","title":"","description":"","background_color":"#FFFFFF","width":"width-medium","columns":"1","cards":[{"card_title":"","card_text":"<strong>Reminder: <\/strong>All study documentation should be stored in the manner described in the IRB-approved protocol and data security assessment form.","card_background_color":"#f4f4f4","card_hover_color":"transparent","card_link":"","card_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":"","classes":"pt-0","title":"","description":"","background":"plain","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"Documentation to support IRB approval","icon":"","row_content":"Given that<strong> all<\/strong> human subject research conducted at the University of Rochester requires IRB review and approval or exempt determination (per <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_301_RSRB_Scope_and_Authority.pdf\">OHSP Policy 301: RSRB Scope and Authority<\/a>), <em>all<\/em> study teams are required to maintain documentation to support this review.\u00a0 This includes maintaining documentation of:\r\n<ul>\r\n \t<li><strong>ALL<\/strong> IRB approval\/determination letters, including approval\/determination letters for all modifications, continuing reviews, and reports of new information.<\/li>\r\n \t<li><strong>All<\/strong> versions of approved documents (meaning, all approved versions [current <em>and<\/em> previous] of <em>each<\/em> document included within an IRB submission, including all modifications, continuing reviews and reports of new information \u2013 e.g., study protocol, consent forms, recruitment materials, subject educational\/instructional materials, Investigator\u2019s Brochure, <a href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Guideline_on_HSR_Research_Electronic_Data_Security_Assessment_Form.doc\">Data Security Assessment Forms [icon name=\"file-word\" prefix=\"fas\"]<\/a>, corrective and preventative action plans, letters of support).\r\n<ul>\r\n \t<li>When an approved document is watermarked (i.e., consent and recruitment materials), the watermarked version of the document should be maintained.<\/li>\r\n \t<li>When an approved protocol includes a Principal Investigator (PI) signature page, the original, signed version of the approved protocol should be maintained.<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li><strong>All<\/strong> Ancillary Committee approval letters, when provided (when required is per <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_503_Ancillary_Committee_Reviews.pdf\">OHSP Policy 503: Ancillary Committee Reviews<\/a>).<\/li>\r\n \t<li>IRB closure, for all non-exempt research.<\/li>\r\n<\/ul>\r\nA thoughtful approach to how these documents will be organized and maintained should be considered <strong>prior <\/strong>to the initiation of the research.\u00a0These documents can be stored in paper or electronic format (or a combination of both); they must be accessible to the entire study team and be kept up-to-date (audit ready).\r\n\r\nConsider:\r\n<ul>\r\n \t<li>For hard-copy\/paper files, utilize one file folder or binder section\/tab to identify specific IRB submissions (or approved documents) easily. File submissions\/documents in chronological order. When adding a new version of a document to file (e.g., a newly approved version of a revised protocol), draw a single cross over the initial page of a previous version and write \u2018Superseded by version X, approved Y.\u2019<\/li>\r\n \t<li>For electronic files, organize files systematically. Utilize a standard naming convention for all folders and all files stored within a folder.\u00a0Add dates to folder\/file names to identify when a submission\/document was approved.\r\n<ul>\r\n \t<li>Note: If the research involves a drug, device, biologic or supplement and is subject to Food &amp; Drug Administration regulations, electronic study documentation must be stored in a manner that is compliant with <a class=\"u-link-external\" href=\"https:\/\/www.ecfr.gov\/current\/title-21\/chapter-I\/subchapter-A\/part-11\">21CFR11<\/a>.<\/li>\r\n<\/ul>\r\n<\/li>\r\n \t<li>Although not required by all Reviewing IRBs, maintain a tracked version of all revised documents (in addition to the approved, watermarked version provided by the Reviewing IRB). Maintaining tracked versions can be useful for notifying and training study staff of revisions.<\/li>\r\n<\/ul>\r\n<strong>Note: Study teams <em>cannot<\/em> rely on the Click IRB system (or any other Reviewing IRB system) to maintain documentation to support IRB approval; this type of documentation must be maintained by the study team independent from any Reviewing IRB system.<\/strong>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Documentation to support protocol adherence","icon":"","row_content":"Documentation to support protocol adherence (also referred to as subject-specific documentation) should reflect the procedures defined by your study protocol. Based on the nature of the research, this includes (as applicable) documentation of:\r\n<ul>\r\n \t<li>Randomization procedures and assignment;<\/li>\r\n \t<li>Study-specific procedures, including but not limited to: screening and enrollment procedures, including confirmation of subject eligibility; assessments and measures; surveys\/questionnaires\/interviews; and the collection of pre-existing or secondary data; and<\/li>\r\n \t<li>Study and\/or department-specific standard operating procedures (SOPs) applicable to the research (e.g., a manual of procedures defining how biological samples will be collected and stored).<\/li>\r\n<\/ul>\r\nIn consideration of this type of study documentation, be aware of protocol-specific details related to study procedures. Study documentation should not only reflect that a procedure was completed, but that the procedure was completed within the confines defined in the study protocol. For example, if the study protocol specifies that a procedure is to be performed by a specific study team member, or that procedures must occur in a specific order, the documentation should validate compliance with these details.\r\n\r\nAlthough not necessarily subject-specific, documentation to support protocol adherence also includes documentation of all protocol-defined data and safety monitoring measures.\u00a0 <a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/data-safety-monitoring-plans\/\">Data and safety monitoring<\/a> measures may be as simple as complying with the Reviewing IRB\u2019s event reporting requirements (as described below) or, typically for research involving greater than minimal risk, may involve a more detailed, study-specific Data and Safety Monitoring Plan (DSMP).\r\n\r\n<strong>NOTE:<\/strong> While often unintentional, protocol non-compliance (also referred to as protocol non-adherence, protocol violations, or protocol deviations) often occurs over the course of the research (e.g., a subject misses a study visit, completes a study visit out of the protocol-defined window, or skips a study measure). All protocol non-compliance should be documented and explained. Learn more about protocol non-compliance on our <a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/study-documentation\/faq\/\">FAQs page<\/a>.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Documentation to support adherence to OHSP Policy 801: Reporting Research Events","icon":"","row_content":"In accordance with <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_801_Reporting_Research_Events.pdf\">OHSP Policy 801 Reporting Research Events<\/a> and the associated <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/801a_GDL_Reporting_Research_Events.pdf\">OHSP Guideline for Reporting Research Events<\/a>, Investigators are responsible for <strong>assessing<\/strong> potential research events (in a timely manner) as they arise and <strong>reporting<\/strong> research events to the Reviewing IRB (per Reviewing IRB policy) <strong>regardless of the risk level of the research <\/strong>(i.e., for all exempt and non-exempt research). This means that, when a research event occurs, the study team must <strong>document<\/strong>:\r\n<ol>\r\n \t<li>The assessment of the event against the Reviewing IRBs reporting requirements (e.g., is the event unanticipated, serious and related to participation in the research or does the event involve increased risks to subjects or others?).; and<\/li>\r\n \t<li>That the event was reported to the Reviewing IRB, if the event meets reporting requirements.<\/li>\r\n<\/ol>","accordion_anchor":""}]},{"acf_fc_layout":"accordion_new","anchor_id":"additionaltypes","classes":"","title":"<h2>Additional types of study documentation<\/h2>","description":"Learn about additional study documentation if the research involves or requires the following:","background":"decorative","background_color":"#ffffff","style":"row_blank","expand":"yes","accordions":[{"acf_fc_layout":"accordion","accordion_title":"A team member with a conflict of interest (COI)","icon":"","row_content":"Maintain the team member\u2019s COI management plan and\/or transparency checklist in accordance with <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_902_Investigator_Conflict_of_Interest.pdf\">OHSP Policy 902: Investigator Conflict of Interest<\/a>.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Obtaining informed consent","icon":"","row_content":"<ul>\r\n \t<li>Retain the original, signed consent from <strong>each<\/strong> subject enrolled into the research, in accordance with <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_701_Informed_Consent.pdf\">OHSP Policy 701: Informed Consent<\/a>. Consent must be obtained using the <strong>current<\/strong> version of the applicable IRB-approved consent form, bearing the Reviewing IRB approval <strong>watermark<\/strong> (if applicable), with the first page of the document printed on institutional letterhead. For additional information, reference our <a href=\"https:\/\/www.rochester.edu\/ohsp\/resources\/consent\/documentation\/\">Documentation of Informed Consent page<\/a>.<\/li>\r\n \t<li>For clinical trials funded by a federal agency, maintain documentation that demonstrates the consent form was <a class=\"u-link-external\" href=\"https:\/\/www.hhs.gov\/ohrp\/regulations-and-policy\/informed-consent-posting\/index.html\">posted on a publically available federal website<\/a>, in accordance with <a class=\"u-link-external\" href=\"https:\/\/www.ecfr.gov\/on\/2018-07-19\/title-45\/subtitle-A\/subchapter-A\/part-46#46.116\">45 CFR 46.116(h)<\/a> and <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_701_Informed_Consent.pdf\">OHSP Policy 701: Informed Consent<\/a>.<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"HIPAA authorization","icon":"","row_content":"HIPAA authorization from each subject enrolled into the research must be maintained, in accordance with <a class=\"u-link-pdf\" href=\"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/Policy_702_HIPAA.pdf\">OHSP Policy 702: HIPAA Privacy Rule<\/a>.\r\n\r\nNote: HIPAA authorization is routinely embedded in the consent form. However, if the authorization is not included within the consent form, it must be obtained separately, and a signed, original, must be maintained.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Subject payment and\/or reimbursement for expense","icon":"","row_content":"Documentation the amount, timing, and method of disbursement. For additional information, reference <a href=\"https:\/\/www.rochester.edu\/adminfinance\/finance\/accounts-payable\/policies-and-procedures\/\">Accounts Payable Policies and Procedures<\/a>.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Analysis of biological specimens by a clinical laboratory","icon":"","row_content":"<ul>\r\n \t<li>Maintain documentation of the laboratory\u2019s certification\/license (Clinical Laboratory Improvement Amendment [CLIA] certification and\/or College of American Pathologists [CAP] accreditation). Review the <a href=\"https:\/\/www.urmc.rochester.edu\/pathology-labs\/clinical\/permits-certifications.aspx\">University\u2019s Clinical Laboratory Services certifications<\/a>.<\/li>\r\n \t<li>Maintain documentation of normal value ranges. The University\u2019s Clinical Laboratory Services normal ranges are available in their <a href=\"https:\/\/www.testmenu.com\/rochester\">test directory<\/a>.<\/li>\r\n<\/ul>","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Retaining biological specimens for future use","icon":"","row_content":"Maintain a log of retained specimens, including location and temperature monitoring (if applicable).","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Shipping biological specimens","icon":"","row_content":"Maintain a log of shipped samples, including the shipment information.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Point of Care testing","icon":"","row_content":"Maintain documentation supporting adherence to the <a href=\"https:\/\/sites.mc.rochester.edu\/departments\/point-of-care-testing\/policies-procedures\/\">糖心传媒 Medical Center\u2019s Point of Care Testing policy<\/a>, including training and quality control measures.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Applicable Clinical Trials, as defined by OCR Policy 001 Public Disclosure of Clinical-Trial Information","icon":"","row_content":"Maintain documentation that demonstrates the trial was registered within 21 days of first subject enrollment and results reported no later than 12 months after the date of final data collection by the responsible party on ClinicalTrials.gov. For additional information, reference <a href=\"https:\/\/www.urmc.rochester.edu\/MediaLibraries\/URMCMedia\/ctsi\/about\/images\/Policy-on-Public-Dislcosure-of-Clinical-Trial-Information_V2_102419.pdf\">OCR Policy 001 Public Disclosure of Clinical-Trial Information<\/a>.","accordion_anchor":""},{"acf_fc_layout":"accordion","accordion_title":"Products regulated by the Food & Drug Administration (FDA), i.e., drugs, devices, biologics & supplements","icon":"","row_content":"Maintain the following:\r\n<ul>\r\n \t<li>Clinical Trial Agreement (CTA)<\/li>\r\n \t<li>Investigator and study staff qualifications (curriculum vitae and professional license, as applicable)<\/li>\r\n \t<li>Screening\/enrollment log accounting for all screened, screen-failed, enrolled, withdrawn, lost to follow-up, and completed subjects<\/li>\r\n \t<li>Delegation log accounting for all individuals the Investigator has delegated study-related tasks\/duties<\/li>\r\n \t<li>Study staff signature log (to document staff signatures and initials; may be combined with delegation log above)<\/li>\r\n \t<li>Study staff training (to document study staff completed the training required by the Institution and\/or Study Sponsor [e.g., Human Subject Protection and Good Clinical Practice training, as applicable] and received study-specific training [e.g., on the study protocol and all modifications])<\/li>\r\n \t<li>Investigational product (IP) accountability documentation including a sample label, instructions for handling IP, shipping records, temperature monitoring (if applicable), an accounting of IP dispensed to and returned by subjects, and an accounting of IP returned to the sponsor (or destroyed) at the close of the study<\/li>\r\n \t<li>Monitoring reports (including pre-trial, site initiation, interim and trial close-out reports)<\/li>\r\n \t<li>Relevant communications with the sponsor, monitor and Reviewing IRB (\u2018relevant\u2019 meaning significant discussions and\/or determinations regarding trial conduct, protocol deviations\/violations\/non-compliance and safety-related events and reporting)<\/li>\r\n \t<li>For research conducted under an Investigational New Drug (IND) or Investigational Device Exemption (IDE) submission:\r\n<ul>\r\n \t<li>Copy of the Form FDA 1572 (or Investigators Agreement, for device trials)) signed by the Investigator<\/li>\r\n \t<li>Copy of the Form FDA 3454 (Certification) or Form FDA 3455 (Disclosure) signed by the Investigator<\/li>\r\n \t<li>If the Investigator holds the IND\/IDE, copies of all submissions, reports and relevant correspondence with the FDA<\/li>\r\n<\/ul>\r\n<\/li>\r\n<\/ul>","accordion_anchor":""}]},{"acf_fc_layout":"card_grid","anchor":"","css_class":"","title":"<h2 style=\"text-align: center;\">Help is available!<\/h2>","description":"","background_color":"#FFFFFF","width":"width-medium","columns":"1","cards":[{"card_title":"<h5>Templates<\/h5>","card_text":"Templates are available to support the documentation of study procedures and research events.","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"Templates","url":"https:\/\/www.rochester.edu\/ohsp\/templates\/#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>Post-Approval Consultations<\/h5>","card_text":"The OHSP Division of Quality Improvement (OHSP-QI) offers Post-Approval Consultation to all 糖心传媒 study teams. If you are unsure of what documentation you are required to maintain for a specific study, this free service will help you identify required documentation.","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"Post-Approval Consultation","url":"https:\/\/www.rochester.edu\/ohsp\/quality-improvement\/post-approval-consultation\/","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>Quality Management Consultation<\/h5>","card_text":"Knowing what to document is just one hurdle in the process, maintaining study documentation is another. OHSP-QI also provides free Quality Management Consultations to help study teams implement quality review processes (self-checks) to help ensure compliance and identify non-compliance early so that it can be corrected readily and future occurrences can be prevented.","card_background_color":"#f4f4f4","card_hover_color":"#283faf","card_link":{"title":"Quality Management Plan Guidance","url":"https:\/\/www.rochester.edu\/ohsp\/quality-improvement\/qmp\/","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>Recorded training sessions<\/h5>","card_text":"Archived <a href=\"https:\/\/www.rochester.edu\/ohsp\/training\/educational-forum\/\">UR-HRPP Educational Forums<\/a> are available. To access recordings listed below, follow our <a href=\"https:\/\/www.rochester.edu\/ohsp\/training\/self-enrollment-instructions\/\">Blackboard Self-Enrollment Instructions<\/a> and enroll in the course titled \u2018UR-HRPP Educational Materials\u2019:\r\n<ul>\r\n \t<li>12\/9\/2021: Essential Study Documentation \u2013 Part 1<\/li>\r\n \t<li>1\/21\/2022: Essential Study Documentation \u2013 Part 2<\/li>\r\n<\/ul>","card_background_color":"#f4f4f4","card_hover_color":"transparent","card_link":"","card_hover_arrow":"","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""}]},{"acf_fc_layout":"card_grid","anchor":"","css_class":"","title":"<h2 style=\"text-align: center;\">Related resources<\/h2>","description":"","background_color":"#f4f4f4","width":"width-large","columns":"2","cards":[{"card_title":"<h5>Good Documentations Practices (GDP)<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Good Documentation Practices (GDP)","url":"https:\/\/www.rochester.edu\/ohsp\/resources\/study-documentation\/gdp\/","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>Source documents and source data<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Source Documents and Source Data","url":"https:\/\/www.rochester.edu\/ohsp\/resources\/study-documentation\/source\/","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 FAQs<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"Frequently Asked Questions","url":"https:\/\/www.rochester.edu\/ohsp\/resources\/study-documentation\/faq\/","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 site file contents description<\/h5>","card_text":"","card_background_color":"#FFFFFF","card_hover_color":"#283faf","card_link":{"title":"","url":"https:\/\/www.rochester.edu\/ohsp\/wp-content\/uploads\/2024\/01\/SiteFileContentsDescription.docx","target":""},"card_hover_arrow":"hover_arrow","card_image":"","card_image_size":"","card_image_placement":"","card_image_hover_state":"hover_fade","card_image_link":""}]}]},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Study Documentation Requirements - Office for Human Subject Protection - 糖心传媒<\/title>\n<meta name=\"description\" content=\"Learn about study document requirements for human subject research, with details for specific types of studies. 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