[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"detail-sidebar-cat-1-en-105":3,"doc-seo-241487-105":53,"doc-detail-241487-en":126},{"code":4,"msg":5,"data":6},0,"success",[7,14,19,24,29,34,39,44,49],{"id":8,"doc_module":9,"doc_module_name":10,"category_name":11,"show_sort_weight":12,"slug":13},11,1,"Template","Presentations",90,"presentations",{"id":15,"doc_module":9,"doc_module_name":10,"category_name":16,"show_sort_weight":17,"slug":18},12,"Resumes",80,"resumes",{"id":20,"doc_module":9,"doc_module_name":10,"category_name":21,"show_sort_weight":22,"slug":23},14,"Invoices",70,"invoices",{"id":25,"doc_module":9,"doc_module_name":10,"category_name":26,"show_sort_weight":27,"slug":28},15,"Posters",60,"posters",{"id":30,"doc_module":9,"doc_module_name":10,"category_name":31,"show_sort_weight":32,"slug":33},16,"Social Media",50,"social-media",{"id":35,"doc_module":9,"doc_module_name":10,"category_name":36,"show_sort_weight":37,"slug":38},17,"Forms",40,"forms",{"id":40,"doc_module":9,"doc_module_name":10,"category_name":41,"show_sort_weight":42,"slug":43},18,"Letters",30,"letters",{"id":45,"doc_module":9,"doc_module_name":10,"category_name":46,"show_sort_weight":47,"slug":48},21,"Paper Templates",5,"papers-templates",{"id":50,"doc_module":9,"doc_module_name":10,"category_name":51,"show_sort_weight":4,"slug":52},158,"General","general-158",{"code":4,"msg":54,"data":55},"ok",{"site_id":56,"language":57,"slug":58,"title":59,"keywords":60,"description":61,"schema_data":62,"social_meta":119,"head_meta":121,"extra_data":123,"updated_unix":125},105,"en","irb-protocol-form","IRB Protocol - Form","","IRB Protocol form content provides structured fields for core study identifiers, investigator details, and funding setup requirements. It specifies obligations for linking research funds to IRB protocols, confirming Epic study codes, and granting appropriate access across Epic and Insight modules for key study staff roles. The form outlines patient care billing responsibilities, qualifying clinical trial assessment prompts, prior authorization workflow for non-Medicare beneficiaries, device notification steps, sponsor invoice tracking, and remuneration or reimbursement rules.",{"@graph":63,"@context":118},[64,80,101],{"@type":65,"itemListElement":66},"BreadcrumbList",[67,71,74,77],{"item":68,"name":69,"@type":70,"position":9},"https://docshare.wps.com","Home","ListItem",{"item":72,"name":10,"@type":70,"position":73},"https://docshare.wps.com/template/",2,{"item":75,"name":36,"@type":70,"position":76},"https://docshare.wps.com/template/forms/",3,{"item":78,"name":59,"@type":70,"position":79},"https://docshare.wps.com/template/irb-protocol-form/241487/",4,{"url":78,"name":59,"@type":81,"image":82,"author":87,"headline":59,"publisher":90,"fileFormat":93,"inLanguage":57,"description":61,"dateModified":94,"datePublished":95,"encodingFormat":93,"isAccessibleForFree":96,"interactionStatistic":97},"DigitalDocument",{"url":83,"@type":84,"width":85,"height":86},"https://docshare.wps.com/thumbnails/irb-protocol-form/241487.png","ImageObject",442,249,{"name":88,"@type":89},"วิน","Person",{"url":68,"name":91,"@type":92},"DocShare","Organization","application/pdf","2026-10-07","2026-09-12",true,{"@type":98,"interactionType":99,"userInteractionCount":15},"InteractionCounter",{"@type":100},"ViewAction",{"@type":102,"mainEntity":103},"FAQPage",[104,110,114],{"name":105,"@type":106,"acceptedAnswer":107},"What information must be completed in the IRB Protocol form?","Question",{"text":108,"@type":109},"The form captures IRB protocol identifiers, principal investigator details, study title, and NCT/IDE-PMA-501K numbers when applicable, along with funding source information including sponsor and start/end dates.","Answer",{"name":111,"@type":106,"acceptedAnswer":112},"What requirements apply to the funding source for an IRB protocol?",{"text":113,"@type":109},"The fund must be a research fund, be set up to accept patient care charges (or include a budget line item greater than $1.00 for patient care charges), and be linked to the IRB protocol in Insight/InfoEd.",{"name":115,"@type":106,"acceptedAnswer":116},"How does prior authorization work for procedures that need payer approval?",{"text":117,"@type":109},"If prior authorization is required, the responsible study team member completes documentation for non-Medicare beneficiaries during the upcoming admission/procedure, sends the request via specified email instructions, and follows payer outcomes by either proceeding as research or removing the research component and booking standard of care.","https://schema.org",{"og:url":78,"og:type":120,"og:title":59,"og:site_name":91,"og:description":61},"article",{"robots":122,"canonical":78},"index,follow",{"doc_id":124,"site_id":56},241487,1789176018,{"code":4,"msg":5,"data":127},{"doc_id":124,"user_id":128,"nickname":88,"user_avatar":129,"doc_module":9,"category_id":35,"category_name":36,"doc_title":59,"doc_description":61,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":15,"is_deleted":4,"is_public":9,"is_downloadable":9,"audit_status":9,"page_count":47,"language":135,"language_code":57,"site_id":56,"html_lang":57,"table_of_contents":136,"faqs":137,"seo_title":138,"seo_description":61,"update_tm":125,"read_time":73},2336475104736,"https://ap-avatar.wpscdn.com/avatar/22000c4c5e0e5b17e70?x-image-process=image/resize,m_fixed,w_180,h_180&k=1786591360781797222","IRB Protocol  \n\n| IRB Protocol \\# |  |\n| --- | --- |\n| Principal Investigator |  |\n| Title |  |\n| NCT \\# |  |\n| IDE/PMA/501K \\#(if applicable): |  |\n\nFunding Source  \n\n| Sponsor |  |\n| --- | --- |\n| Principal Investigator\u003Cbr>(if different from IRB protocol PI) |  |\n| Professional Fee Research Discount Rate |  |\n| Fund \\#: | Start date: End Date: |\n\nFund Reminders:  \n1. Fund must be a “research fund”.  \n2. Fund must be set up to accept patient care charges or have a budget line item > $1.00 for patient care charges.  \n3. Fund must be linked to the IRB protocol in Insight/InfoEd.  \nEpic Study Code:  \nConfirm that study code in active in Epic. The study code is created automatically if the protocol is approved by the IRB and the funding source is set up as detailed above and linked to the IRB protocol in Insight/InfoEd.  \nStudy Team Access Information  \n\n| Name | Role | Epic Research Access | Insight Agreements Module Access | Insight Patient Care Details Access |\n| --- | --- | --- | --- | --- |\n|  | Principal Investigator |  |  |  |\n|  | Grant Manager |  |  |  |\n|  | Research Nurse |  |  |  |\n|  | Study Coordinator |  |  |  |\n|  |  |  |  |  |\n|  |  |  |  |  |\n|  |  |  |  |  |\n|  |  |  |  |  |\n\n\n|  |  |  |  |  |\n| --- | --- | --- | --- | --- |\n\n\n| Financial Delegate Designated in Insight\u003Cbr>(IRB Study Staff page / Humans Module) |  |\n| --- | --- |\n\nPatient Care Billing Responsibilities  \nThe PI is ultimately responsible for the financial management of the study. Responsibilities may be delegated to IRB-approved study staff who have been appropriately trained.  \n\n| Study Staff Name | Enroll Patients in Epic | Link\u003Cbr>Services or\u003Cbr>Encountersin Epic | Epic Charge\u003Cbr>Review | Scheduling / Ordering visits, tests, and procedures | Epic Billing Calendar / Timeline add dates | Maintain Patient Care Log | Monitor Patient Care Details in Insight | Submit\u003Cbr>Patient Care Correctionsin Insight |\n| --- | --- | --- | --- | --- | --- | --- | --- | --- |\n|  |  |  |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |  |  |\n|  |  |  |  |  |  |  |  |  |\n\nAs part of the initial IRB review process the Partners Clinical Trials Office (CTO) assesses each protocol to determine if the study meets the criteria for a Qualifying Clinical Trial as outlined in the National Coverage Decision. A determination notice is sent to the PI and is part of the initial IRB submission documents in Insight. It is also available in InfoEd.  \nQualifying Clinical Trials (QCT)  \n1. Is this study a Qualifying Clinical Trial? Yes No  \nIf yes, have you received the Medicare Coverage Analysis (MCA)? Yes No  \nIf no, then either this study does not include any research-related patient care charges or all research-related patient care charges will be covered by the study fund.  \n2. MCA reviewed by PI and study team? Yes No  \n3. Epic Billing Calendar/Timeline will be used Yes No  \nPrior Authorization  \nDoes this study include any procedures that may require prior authorization from the patient’s insurance? Yes No If yes, please identify responsible study team member:    \n1. This process to Non–Medicare Beneficiaries who are participants in the clinical trial during the upcoming admission/procedure. Complete this process if study participation requires documentation that, at the time of PreAuthorization, the insurance company (payer) is made aware of the patient’s participation in a clinical trial.  \n2. Upon notification of the date of the admission/procedure, attach the 1) PI’s letter explaining the study and 2) this completed form to an email. Enter the following text in the ‘SEND TO’ field in MS Outlook:  \nMGH FAU Expedited Authorization Request .  \n3. If the payer refuses to cover the research case (or the research portion of the case), FAU will email the  \nPI/Pre-Auth Requestor and inquire if the research component sh","cbCaiuGWGjvvvBbm","https://ap.wps.com/l/cbCaiuGWGjvvvBbm","pdf",300412,"English","# IRB Protocol Information\n## Principal Investigator and Study Identifiers\n## Funding Source Requirements\n## Study Team Access Information\n# Patient Care Billing Responsibilities\n## Qualifying Clinical Trials (QCT)\n## Prior Authorization Process\n# Operational Notifications and Billing Reminders\n## Device Notification (if applicable)\n## Sponsor Invoices\n## Remuneration and Reimbursement\n## Clinical Research Patient Care Billing Reminders","[{\"question\":\"What information must be completed in the IRB Protocol form?\",\"answer\":\"The form captures IRB protocol identifiers, principal investigator details, study title, and NCT/IDE-PMA-501K numbers when applicable, along with funding source information including sponsor and start/end dates.\"},{\"question\":\"What requirements apply to the funding source for an IRB protocol?\",\"answer\":\"The fund must be a research fund, be set up to accept patient care charges (or include a budget line item greater than $1.00 for patient care charges), and be linked to the IRB protocol in Insight/InfoEd.\"},{\"question\":\"How does prior authorization work for procedures that need payer approval?\",\"answer\":\"If prior authorization is required, the responsible study team member completes documentation for non-Medicare beneficiaries during the upcoming admission/procedure, sends the request via specified email instructions, and follows payer outcomes by either proceeding as research or removing the research component and booking standard of care.\"}]","IRB Protocol - Form | PDF"]