CINXE.COM

<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML+RDFa 1.0//EN" "http://www.w3.org/MarkUp/DTD/xhtml-rdfa-1.dtd"> <html xmlns="http://www.w3.org/1999/xhtml" lang="en" version="XHTML+RDFa 1.0" dir="ltr" xmlns:content="http://purl.org/rss/1.0/modules/content/" xmlns:dc="http://purl.org/dc/terms/" xmlns:foaf="http://xmlns.com/foaf/0.1/" xmlns:og="http://ogp.me/ns#" xmlns:rdfs="http://www.w3.org/2000/01/rdf-schema#" xmlns:sioc="http://rdfs.org/sioc/ns#" xmlns:sioct="http://rdfs.org/sioc/types#" xmlns:skos="http://www.w3.org/2004/02/skos/core#" xmlns:xsd="http://www.w3.org/2001/XMLSchema#"> <head profile="http://www.w3.org/1999/xhtml/vocab"> <meta http-equiv="Content-Type" content="text/html; charset=utf-8" /> <meta name="Generator" content="Drupal 7 (http://drupal.org)" /> <link rel="canonical" href="/faqs" /> <link rel="shortlink" href="/node/46" /> <link rel="shortcut icon" href="https://osr.ucsf.edu/profiles/ucsf_b1gfoot/themes/ucsf_b1gfoot_theme/favicon.ico" type="image/vnd.microsoft.icon" /> <meta name="viewport" content="width=device-width, initial-scale=1, maximum-scale=1" /> <meta property="og:image" content="https://osr.ucsf.edu/profiles/ucsf_b1gfoot/themes/ucsf_b1gfoot_theme/img/img-metatag.jpg" /> <meta property="og:image:width" content="940" /> <meta property="twitter:image" content="https://osr.ucsf.edu/profiles/ucsf_b1gfoot/themes/ucsf_b1gfoot_theme/img/img-metatag.jpg" /> <meta property="twitter:card" content="summary" /> <meta property="og:site_name" content="Office of Sponsored Research" /> <meta property="twitter:url" content="https://osr.ucsf.edu/faqs" /> <meta property="og:url" content="https://osr.ucsf.edu/faqs" /> <meta property="twitter:title" content="FAQs | Office of Sponsored Research" /> <meta property="og:title" content="FAQs" /> <title>FAQs | Office of Sponsored Research</title> <link type="text/css" rel="stylesheet" href="https://osr.ucsf.edu/sites/g/files/tkssra1766/f/css/css_kShW4RPmRstZ3SpIC-ZvVGNFVAi0WEMuCnI0ZkYIaFw.css" media="all" /> <link type="text/css" rel="stylesheet" href="https://osr.ucsf.edu/sites/g/files/tkssra1766/f/css/css_wXb98JjBvtHtCS6a9kKIzrP5h-l0s8MgIzxy5j-QOaE.css" media="all" /> <link type="text/css" rel="stylesheet" href="https://osr.ucsf.edu/sites/g/files/tkssra1766/f/css/css_rV3Wod_e6ST6El0CA65NgFrvcFHnCpm1z0SGwM9reQg.css" media="all" /> <style type="text/css" media="all"> <![CDATA[/*> </style> <link type="text/css" rel="stylesheet" href="https://cdnjs.cloudflare.com/ajax/libs/hopscotch/0.2.5/css/hopscotch.min.css" media="all" /> <link type="text/css" rel="stylesheet" href="https://maxcdn.bootstrapcdn.com/font-awesome/4.4.0/css/font-awesome.min.css" media="all" /> <link type="text/css" rel="stylesheet" href="https://osr.ucsf.edu/sites/g/files/tkssra1766/f/css/css_-5KGL3kpG9BJtjhjan_sSs2LNKUh8DXr0FbFKbHMQxM.css" media="all" /> <link type="text/css" rel="stylesheet" href="https://osr.ucsf.edu/sites/g/files/tkssra1766/f/css/css_47DEQpj8HBSa-_TImW-5JCeuQeRkm5NMpJWZG3hSuFU.css" media="print" /> <style type="text/css" media="all"> <![CDATA[/*> </style> <link type="text/css" rel="stylesheet" href="https://osr.ucsf.edu/sites/g/files/tkssra1766/f/css/css_zf20glj0zlt-i5VyoLzB0ei0GolLQsGYQTTXFJ83i0o.css" media="all" /> <script type="text/javascript" src="https://osr.ucsf.edu/sites/g/files/tkssra1766/f/js/js_Pt6OpwTd6jcHLRIjrE-eSPLWMxWDkcyYrPTIrXDSON0.js"></script> <script type="text/javascript" src="https://osr.ucsf.edu/sites/g/files/tkssra1766/f/js/js_onbE0n0cQY6KTDQtHO_E27UBymFC-RuqypZZ6Zxez-o.js"></script> <script type="text/javascript" src="https://osr.ucsf.edu/sites/g/files/tkssra1766/f/js/js_gHk2gWJ_Qw_jU2qRiUmSl7d8oly1Cx7lQFrqcp3RXcI.js"></script> <script type="text/javascript" src="https://osr.ucsf.edu/sites/g/files/tkssra1766/f/js/js_xe_uRFgIncjVWm4-Oa-ayIcSuU7G-5paEa2xC6Asbdg.js"></script> <script type="text/javascript" src="https://cdnjs.cloudflare.com/ajax/libs/hopscotch/0.2.5/js/hopscotch.min.js"></script> <script type="text/javascript" src="https://osr.ucsf.edu/sites/g/files/tkssra1766/f/js/js_7PbaJTSu-LxJaTVbKUqW3Gf_NGEIE3gHP-pkSD63kK8.js"></script> <script type="text/javascript"> <![CDATA[//><!]]> </script> <script type="text/javascript" src="https://osr.ucsf.edu/sites/g/files/tkssra1766/f/js/js_3KU2G0XuUwThidq7lpTBQghUO1g1ty4dEdv-co66Xqw.js"></script> <script type="text/javascript" src="https://osr.ucsf.edu/sites/g/files/tkssra1766/f/js/js__pev76oqunwyHrozBOUwthVLhzUZgLLfKlmOonOmdkg.js"></script> <script type="text/javascript"> <![CDATA[//><!]]> </script> </head> <body class="html not-front not-logged-in page-node page-node- page-node-46 node-type-page slider-secondary ucsf-b1gfoot font--header--helveticaneue nav--lock slider-secondary-no-image profile--expanded no-sidebar no-sidebar--right" > <div id="skip-link"> <a href="#main-content" class="element-invisible element-focusable">Skip to main content</a> </div> <div id="page-wrapper"> <div id="page"> <div class="ucsf-top-header row-full-width no-logo"> <div class="inside"> <ul class="menu"> <li class="first"><a href="https://www.ucsf.edu">University of California San Francisco</a></li> <li><a href="https://www.ucsfhealth.org/">UCSF Health</a></li> <li><a href="https://www.ucsf.edu/search" title="">Search UCSF</a></li> <li><a href="https://www.ucsf.edu/about">About UCSF</a></li> </ul> </div> </div> <div id="header" class="row-full-width"> <div class="inside clearfix"> <h1 id="site-name"> <a href="/" title="Home" rel="home"> Office of Sponsored Research </a> </h1> <div class="region region-header"> <div id="block-search-form" class="block block-search"> <div class="content"> <form onsubmit="if(this.search_block_form.value=='Search'){ alert('Please enter a search'); return false; }" action="/faqs" method="post" id="search-block-form" accept-charset="UTF-8"><div><div class="container-inline"> <h2 class="element-invisible">Search form</h2> <div class="form-item form-type-textfield form-item-search-block-form"> <label class="element-invisible" for="edit-search-block-form--2">Search... </label> <input title="Enter the terms you wish to search for." placeholder="Search..." class="text-input fa fa-search form-text" aria-hidden="" type="text" id="edit-search-block-form--2" name="search_block_form" value="" size="40" maxlength="128" /> </div> <div class="form-actions form-wrapper" id="edit-actions"><input type="submit" id="edit-submit" name="op" value="" class="form-submit" /></div><input type="hidden" name="form_build_id" value="form-QNkp9q0-Bq2Oz7Y6glaBehZTYfxzuIx-FoyN36-x7ko" /> <input type="hidden" name="form_id" value="search_block_form" /> </div> </div></form> </div> </div> <div id="block-ucsf-b1gfoot-tweaks-header-socialmedia" class="block block-ucsf-b1gfoot-tweaks"> <div class="content"> <div class="nav-social"><a href="https://www.youtube.com/channel/UCZkvnGm7glGVPc0xpvZxmRw" class="fa fa-youtube" target="_blank">Youtube</a></div> </div> </div> <div id="block-block-146" class="block block-block"> <div class="content"> <p style="text-align: right;"> </p> <p style="text-align: right;"><small><u><a href="http://osrintranet.ucsf.edu" target="_blank">OSR Intranet</a></u></small></p> </div> </div> <div id="block-menu-block-1" class="block block-menu-block"> <div class="content"> <div class="menu-block-wrapper menu-block-1 menu-name-main-menu parent-mlid-0 menu-level-1"> <ul class="menu"><li class="first leaf menu-mlid-1431"><a href="/">Home</a></li> <li class="expanded menu-mlid-2226"><a href="/about">About Us</a><ul class="menu"><li class="first leaf menu-mlid-12391"><a href="/proposals-and-grants">Proposals and Grants</a></li> <li class="leaf has-children menu-mlid-12396"><a href="/contracts-and-awards">Contracts and Awards</a></li> <li class="leaf menu-mlid-12406"><a href="https://icd.ucsf.edu/about" title="">Industry Contracts Division (ICD)</a></li> <li class="leaf menu-mlid-14206"><a href="/pi-desk-reference">PI Desk Reference</a></li> <li class="leaf menu-mlid-12416"><a href="/osr-advisory-board">OSR Advisory Board</a></li> <li class="last leaf menu-mlid-12421"><a href="/rms-service-partnership-agreement-spa">RMS Service Partnership Agreement (SPA)</a></li> </ul></li> <li class="expanded menu-mlid-2221"><a href="/project-life-cycle">Project Life Cycle</a><ul class="menu"><li class="first leaf has-children menu-mlid-8266"><a href="/find-funding">Find Funding</a></li> <li class="leaf menu-mlid-8271"><a href="/plan-project">Plan Project</a></li> <li class="leaf has-children menu-mlid-9416"><a href="/develop-budget">Develop Budget</a></li> <li class="leaf has-children menu-mlid-8281"><a href="/compile-proposal">Compile Proposal</a></li> <li class="leaf menu-mlid-8286"><a href="/submit-proposal">Submit Proposal</a></li> <li class="leaf menu-mlid-8291"><a href="/negotiate-award">Negotiate Award</a></li> <li class="leaf menu-mlid-8296"><a href="/award-setup">Award Setup</a></li> <li class="leaf menu-mlid-8301"><a href="/set-sub-awards">Issue Subawards</a></li> <li class="leaf has-children menu-mlid-8306"><a href="/administer-award">Administer Award</a></li> <li class="last leaf menu-mlid-12386"><a href="/closeout">Closeout Award</a></li> </ul></li> <li class="leaf active-trail active menu-mlid-2231"><a href="/faqs" class="active-trail active">FAQs</a></li> <li class="expanded menu-mlid-2241"><a href="/training">Training</a><ul class="menu"><li class="first leaf menu-mlid-12441"><a href="/investigator-training">Investigator Training</a></li> <li class="last leaf has-children menu-mlid-12446"><a href="/research-administrator-training">Research Administrator Training</a></li> </ul></li> <li class="expanded menu-mlid-2236"><a href="/resources">Resources</a><ul class="menu"><li class="first leaf menu-mlid-7891"><a href="/institutional-information">Institutional Information</a></li> <li class="leaf has-children menu-mlid-11976"><a href="/fa-rates">F&A (Indirect Costs)</a></li> <li class="leaf menu-mlid-12371"><a href="/fringe-benefit-rates">Fringe Benefit Rates</a></li> <li class="leaf has-children menu-mlid-12521"><a href="/compliance">Compliance and Policies</a></li> <li class="leaf menu-mlid-12551"><a href="/forms" title="">Forms</a></li> <li class="leaf has-children menu-mlid-12376"><a href="/electronic-systems">Electronic Systems</a></li> <li class="leaf menu-mlid-12431"><a href="/uc-links">UC Links</a></li> <li class="leaf menu-mlid-12426"><a href="/ucsf-research-administration-glossary">UCSF Research Administration Glossary</a></li> <li class="last leaf menu-mlid-12456"><a href="https://brm.ucsf.edu/emf/guidelines-requirements-funds-received-extramural-sources" title="">Guidelines & Requirements for Funds Received from Extramural Sources</a></li> </ul></li> <li class="expanded menu-mlid-14211"><a href="/news-0">News</a><ul class="menu"><li class="first leaf menu-mlid-1791"><a href="/news" title="">Campus News</a></li> <li class="last leaf menu-mlid-12576"><a href="/nih-updates">NIH Updates</a></li> </ul></li> <li class="last leaf menu-mlid-8311"><a href="/find-my-support" title="">Find My Support</a></li> </ul></div> </div> </div> </div> </div> </div> <div id="breadcrumb" class="row-full-width"><div class="inside"><h2 class="element-invisible">You are here</h2><div class="breadcrumb"><a href="/">Home</a> > <span class="breadcrumb-page-title">FAQs</span></div></div></div> <h1 class="title" id="page-title">FAQs</h1> <div class="content-top"> </div> <div id="main-wrapper"> <div id="main" class="clearfix"> <div id="content" class="column"> <div class="inside"> <a id="main-content"></a> <div class="tabs"></div> <div class="region region-content"> <div id="block-system-main" class="block block-system"> <div class="content"> <div id="node-46" class="node node-page slider-secondary clearfix" about="/faqs" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="FAQs" class="rdf-meta element-hidden"></span><span property="sioc:num_replies" content="0" datatype="xsd:integer" class="rdf-meta element-hidden"></span> <div class="content"> <div class="field field-name-field-body field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even"><h3 style="text-align: center;"> </h3> <h3 style="text-align: center;"><a id="top" name="top"></a>What can we help you with?</h3> <div class="wysiwyg_threecols layout--20-60-20"> <div class="wysiwyg_threecols--first bg--undefined bg--transparent"> <p> </p> </div> <div class="wysiwyg_threecols--second bg--undefined bg--transparent"> <div class="wysiwyg_twocols layout--50-50"> <div class="wysiwyg_twocols--first bg--transparent"> <p style="text-align: center;"><a href="#general">General</a></p> <p style="text-align: center;"><a href="#proposal">Proposal Preparation and Submission</a></p> <p style="text-align: center;"><a href="#budget">Budget Preparation</a></p> <p style="text-align: center;"><a href="#OS">NIH Other Support</a></p> <p style="text-align: center;"><a href="#sub">Outgoing Subawards/Subcontracts</a></p> </div> <div class="wysiwyg_twocols--second bg--transparent"> <p style="text-align: center;"><a href="#clinicaltrials">Clinical Trials</a></p> <p style="text-align: center;"><a href="#bc">Business Contracts</a></p> <p style="text-align: center;"><a href="#award">Award Set-up and Administration</a></p> <p style="text-align: center;"><a href="#ahs">Animal and Human Subjects</a></p> <p style="text-align: center;"><a href="#psa_taa">PSA/TAA Platform</a></p> </div> </div> </div> <div class="wysiwyg_threecols--third bg--undefined bg--transparent"> <p> </p> </div> </div> <hr /> <h3><a id="general" name="general"></a>General</h3> <ol> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Where can I find the Office of Sponsored Research (OSR) forms? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The <a href="/forms" target="_blank">Forms</a> page on our website contains many research administration forms you may need to submit a proposal. Contact your <a href="/find-my-support" target="_blank">OSR staff</a> if you cannot find what you need. </p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Where do I find policies related to research administration at UCSF? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Relevant UC, UCSF and sponsor policies are often noted on the specific webpage on the OSR site. Contact <a href="/cdn-cgi/l/email-protection#177864657e797178576274647139727362"><span class="__cf_email__" data-cfemail="ed829e9f84838b82ad988e9e8bc3888998">[email protected]</span></a> to sign up for the OSR Announce Listserv for updates on processes, policies, meetings and other information.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How do I find institutional information for UCSF, such as the EID and DUNS numbers?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The <a href="/institutional-information" target="_blank">Institutional Information</a> page includes much of the detail you may need. For additional guidance, please <a href="/find-my-support" target="_blank">contact OSR Staff</a>.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Where can I find sources of funding for my project? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Funding sources can be researched through <a href="https://pivot.proquest.com/funding_main" target="_blank">COS/PIVOT</a>, <a href="http://www.grants.gov/" target="_blank">Grants.gov</a>, <a href="https://www.fbo.gov/" target="_blank">FedBizOpps</a> and a number of other federal and non-federal websites. Learn more on the <a href="https://rdo.ucsf.edu/funding-opportunities" target="_blank">UCSF Research Development Office's website. </a></p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How do I find my OSR staff support? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Search for your OSR staff support in the <a href="/find-my-support" target="_blank">Find My Support</a> section. </p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How do I submit a Material Transfer (MTA) or Data Agreement (DUA)?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>A Material Transfer Agreement (MTA) or Data Agreement is needed any time a UCSF investigator sends or receives materials, samples, software, or data into or out of UCSF. The <a href="https://icd.ucsf.edu/material-transfer-and-data-agreements" target="_blank">Industry Contracts Division (ICD)</a> handles <u>all</u> incoming materials, outgoing human materials (i.e. blood, tissue, resected tumors, etc.), and all incoming/outgoing data.</p> <p>For outgoing non-human material transfers (i.e. mice, modified cell lines, reagents, etc.), please refer the <a href="https://innovation.ucsf.edu/outgoing-material-transfer-agreements-non-human-material" target="_blank">Office of Technology Management</a> (OTM) website or e-mail <a href="/cdn-cgi/l/email-protection#baf5eef7f2dfd6cafacfd9c9dc94dfdecf85c9cfd8d0dfd9ce87f5cfceddd5d3d4dd9f888af4d5d497f2cfd7dbd49f888af7dbcedfc8d3dbd69f888aeec8dbd4c9dcdfc89f888afbddc8dfdfd7dfd4ce"><span class="__cf_email__" data-cfemail="0a455e47426f667a4a7f69796c246f6e7f">[email protected]</span></a>.</p> <p>When materials and/or data are exchanged in <u>both</u> directions, this should be treated as a collaboration. For collaborations with industry partners, please see the ICD <a href="https://icd.ucsf.edu/industry-collaborations" target="_blank">Industry Collaborations</a> page. For collaborations with other academic institutions or non-profits, please e-mail <a href="/cdn-cgi/l/email-protection#5b181c1a2c3a293f0f3e3a361b2e38283d753e3f2e">OSR</a>.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p style="text-align: left;">What is a Foreign Component on an NIH project. </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p style="text-align: left;"> </p> <p style="text-align: left;">Foreign Component is existence of any <strong>“significant scientific element or segment of a project”</strong> outside of the United States, in other words</p> <p style="text-align: left;">performance of work by a researcher or recipient in a foreign location, whether or not NIH grant funds are expended and/or performance of work by a researcher in a foreign location employed or paid for by a foreign organization, whether or not NIH grant funds are expended.</p> <p style="text-align: left;">For Postdoctoral scholars that are required to work on their originally approved work remotely from a foreign country due to COVID-19 travel restrictions, where no grant funds are going to a foreign entity, NIH has determined this scenario does <strong>not</strong> constitute the performance of a significant element or segment of the project outside the US. Therefore, this is not considered a foreign component and does not require prior approval. </p> <p style="text-align: left;">If project staff (including visiting faculty, scientists, etc.) leave the country to return home due to <strong>COVID-19</strong> and continue to work on the project, whether paid by the project or not, <strong>this could qualify as a foreign component and would require prior approval from the NIH IC.</strong></p> <p style="text-align: left;">SOURCE: <a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-114.html" target="_blank">NIH NOT-OD-19-114</a>, <a href="https://grants.nih.gov/faqs#/covid-19.htm?anchor=question55901" target="_blank">NIH COVID-19 FAQ</a></p> <p style="text-align: left;"> </p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>What are some examples of a “significant element of a project” when making determinations regarding a foreign component?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The recipient institution should evaluate the element of the project that is being conducted outside of the United States within the context of the project as a whole when making determinations about significance. Some examples of activities that may be considered a significant element of the project include, but are not limited to:</p> <ul class="bullets-list"> <li>collaborations with investigators at a foreign site anticipated to <strong>result in co-authorship</strong></li> <li><strong>use of facilities or instrumentation</strong> at a foreign site</li> <li>receipt of financial support or <strong>resources from a foreign entity</strong></li> </ul> <p>SOURCE: <u><a href="https://grants.nih.gov/faqs#/other-support-and-foreign-components.htm?anchor=question55611" target="_blank">NIH FAQs</a></u></p> </div> </div> </li> </ol> <p style="text-align: right;"><a href="#top">Top</a></p> <hr /> <h3><a id="proposal" name="proposal"></a>Proposal Preparation and Submission</h3> <ol> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How do I submit my proposal? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>OSR staff will assist you throughout the <a href="/submit-proposal" target="_blank">proposal submission</a> process. Work with <a href="/find-my-support" target="_blank">your OSR staff</a> in order to obtain information on preparing and submitting a proposal through OSR. Note that your sponsor type and/or agreement type will determine which OSR team will provide support. </p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How do I find institutional information for UCSF, such as the EID and DUNS numbers need for proposal preparation?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The <a href="/institutional-information" target="_blank">Institutional Information</a> page includes much of the detail you may need. For additional guidance, please <a href="/find-my-support" target="_blank">contact OSR Staff</a>.</p> </div> </div> </li> </ol> <p style="text-align: right;"><a href="#top">Top</a></p> <hr /> <h3><a id="budget" name="budget"></a>Budget Preparation</h3> <ol> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>I have a postdoc or research associate that is coming from outside the U.S. to work on my federal award, can I charge the cost of their visa to the grant?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>According to the new Uniform Guidance [§ 200.463 (d) “Recruiting Costs” you may charge visa application fees to your grant provided the postdoc/researcher is critical and necessary for the conduct of the project. </p> </div> </div> </li> <li style="text-align: right;"> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p style="text-align: left;">How do I determine the F&A/indirect cost rate to use for my project? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p style="text-align: left;">UCSF's negotatiated F&A rates should be used in <strong>most </strong>cases. The rate will depend upon the sponsor, project type and location. <a href="/fa-rates" target="_blank">Learn more</a>. </p> </div> </div> <p><a href="#top">Top</a></p> </li> </ol> <hr /> <h3><a id="OS" name="OS"></a>NIH Other Support</h3> <ol> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Should the budget amount during an NCE be the last year's direct costs, total costs or what is remaining?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The budget amount should be the Total Costs for the entire project period. </p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Do we need to include awards where the PI has no measurable effort? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Yes, even if there is no measurable effort, if the award supports the PI's research endeavors it must be included. </p> <p>OSR recommendation is to put “Effort as Needed*” in the table and then have an explanation below the table including that the effort will not exceed XX amount. Keep in mind PI effort should not be more than 12 months in the current year. Also include the statement “This sponsor funds the research but does not allow PI support and does not require PI effort”. </p> <p>Be aware different GMSs may require additional information or clarification. </p> <p>Example:</p> <p><img alt="" height="200" src="/sites/g/files/tkssra1766/f/wysiwyg/OS_table_effortASneeded_2.jpg" width="751" /></p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>When a research is including information on a subproject, should the researcher provide thet total award for the averall award, or only the subproject. Also how should we report the effort if they are on more than one subproject? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>According to <a href="https://grants.nih.gov/faqs#/other-support-and-foreign-components.htm" target="_blank">NIH's FAQs</a>: For subprojects, recipients should provide the project number and PD/PI name for the overall project. All other information, including total award amount and person months, for the subproject only.</p> <p>NIH does not provide guidance on how to report the effort if they are on more than one project. OSR recommendation, is to have a separate column in the effort table for each Project/Core. <img alt="" height="203" src="/sites/g/files/tkssra1766/f/wysiwyg/Project_Effort_table.jpg" width="846" /></p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How should we calculate effort? Should it be a "snapshot"? Or based on Calendar Year, Fiscal year, or on the Budget Period? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>NIH guidance states: PD/PI's need to provide person months of effort for the current budget period and indicate the proposed level effort for each remaining budget period.</p> <p>OSR recommends 2 options:</p> <p>Option1: Snapshot - For the current year, use a snapshot of what the effort currently is today. If PI efforts remains consistent, then this a more simplified option. However, if the PI effort fluctuate across different times of the year, it may incorrectly show a lower effort level. Reminder, if the researcher is listed as Key Personnel in the NOA, then prior approval is required. This may give a false impression that prior approval is needed even if over the course of the year they effort is not reduced by more than 25%. </p> <p>Option 2: Budget Period -- So for each award listed, calculate effort based on that AWARDS budget period. The budget period will not be the same across the different awards. This may prevent the problems that can occur with option 1 when effort fluctuate across the year. However, because the dates vary, it makes cause the effort to appear to be over 12 CM because of the timing of when certain awards end. It is important that if the effort for the current year (the first entry in each of the effort tables) adds up to more than 12CM that and Overlap statement is included that describes how it is not a commitment overlap. For example, explain that the effort for Award Y is reduced for a few months until Award X ends. </p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>When should we remove something from the pending section?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Either if the start date has already passed, or if the PI hears from the sponsor that it will not be funded.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Do you need prior approval from the NIH’s GMS for subsumed effort on a K award?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>No, subsumed effort is complementary effort and does not require prior approval but you do need approval for concurrent support. For more information go <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_12/12_research_career_development__k__awards.htm" target="_blank">NIH GPS Chapter 12 </a>(see 12.3.6.1 and 12.3.6.2)</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>If my faculty is a co-investigator on a grant, should I list the project costs for the whole project, or for just his/her portion of the project? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The project costs for the whole project. If this is a large project grant (for example a P50), list only projects/core that the faculty member work on, list the project costs for the project/core</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How do I get previous copies of NIH RPPR progress reports?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>NIH RPPR progress reports are uploaded to eProposal. To find documents in eProposal follow the <a href="https://iris-help.ucsf.edu/sites/iris-help.ucsf.edu/files/eProposal%20Quick%20Guide%20-%20Navigating.pdf" target="_blank">Finding Projects and eProposal Navigation guide</a> (Must have an UCSF Myaccess account to view). Search by the A#. </p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Should I Submit the Other Support directly to NIH, or should it go to OSR?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Submit the Other Support to your <a href="/find-my-support" target="_blank">OSR staff</a>. OSR will submit to NIH.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Do we need prior approval for an increase of effort?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>For NIH, no. You only need prior approval for REDUCTIONS of 25% or more (if they are listed as Key Personnel in the Notice of Award). If not NIH, please check the sponsor policy.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>What if we have received prior approval to reduce effort?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>This is the new baseline of effort. If you make further reductions, you need to ask for prior approval if you reduce by 25% of this NEW approved effort level. </p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>What should I do if NCE is pending?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Keep it listed in the active section. Put the proposed new dates and next to the dates, put in Parentheses, NCE Pending.</p> <p>Example: </p> <p>R01 HL 0000002 (Anderson) (AXXXXXX) 03/1/10– 02/28/16(NCE Pending) 5.60 calendar</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>What are differet types of overlap?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Identify any scientific, budgetary, or commitment overlap that would occur if the current proposal were approved. Then state how it would be resolved.The goals in identifying and eliminating overlap are to ensure that sufficient and appropriate levels of effort are committed to the project; that there is no duplication of funding for scientific aims, specific budgetary items, or an individual’s level of effort; and that only funds necessary to the conduct of the approved project are included in the award.</p> <p>Budgetary overlap occurs when duplicate or equivalent budgetary items (e.g., equipment, salary) are requested in an application but are already provided for by another source.</p> <p>Commitment overlap occurs when a person’s time commitment exceeds 100 percent (i.e., 12 person months), whether or not salary support is requested in the application. While information on other support is only requested for Senior/key Personnel (excluding consultants), no individuals on the project may have commitments in excess of 100 percent or 12 person months.</p> <p>Scientific overlap occurs when: (1) substantially the same research is proposed in more than one application or is submitted to two or more different funding sources for review and funding consideration, or (2) a specific research objective and the research design for accomplishing that objective are the same or closely related in two or more applications or awards, regardless of the funding source. Potential scientific overlap is to be addressed by the SRG <em>only </em>by its identification in an Administrative Note in the Summary Statement.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>What are some examples of Overlap statements?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Example 1:</p> <p>There is commitment overlap for Dr. XYZ between 5R01WE1234546-01 and the application under consideration. If this application is funded Dr. XYZ will request approval to reduce his effort on 5R01WE1234546-01 to 2 calendar months. If other pending applications are funded, Dr. XYZ will reduce his effort appropriately. </p> <p>Example 2:</p> <p>There is scientific overlap commitment overlap for Dr. XYZ between aim 1 of 5R01WE1234546-01 and aim 2 of the application under consideration. If this application is funded, Dr. XYZ’s effort will be adjusted on 5R01WE123456-01 to remove the overlap.</p> <p>As noted above, the Institute/Center’s scientific program and grants management staff will review other support information prior to award.</p> <p><strong>Resolution of overlap</strong> occurs at the time of award in conjunction with applicant institution officials, the principal investigator, and awarding agency staff. NIH staff continue to monitor changes to other support information throughout the project as part of the annual progress reviews.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Does UCSF have any additional resources regarding Foreign Influence?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Yes, the <a href="https://compliance.ucsf.edu/foreign-collaborations-funding-transactions" target="_blank">Ethics and Compliance website </a>about <a href="https://compliance.ucsf.edu/Improper-Foreign-Government-Influence" target="_blank">Foreign Influence</a> and <a href="https://compliance.ucsf.edu/importance-export-control-compliance" target="_blank">Export Control</a>. </p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>If a PI has an appointment or receives resources from another entity, does this need to be reported internal at UCSF?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Yes, this is considered a “Conflict of Commitment” and certain categories of outside activities require prior approval. PI should consult with their department chairs and/or use <a href="https://facultyacademicaffairs.ucsf.edu/online-systems/OATS" target="_blank">OATS (Outside Tracking System)</a> to report activity. </p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>For NIH Other Support, should we use Annual Direct Costs or Total Costs?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p><a href="https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-114.html" target="_blank">NOT-OD-19-114</a> indicates using Total Costs.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Is the department’s role w/ foreign influence just to help make faculty aware and direct them to appropriate offices? Or are we expected to verify all information against other sources of information? For instance, do we need to be vetting non-US sponsors of research against entities subject to Restricted Persons Screening?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Yes, the department’s role is to ask faculty whether they are engaging with foreign entities for research purposes, and make faculty aware and direct them to appropriate offices. Postaward and OSR staff are not expected to verify all information against other sources of information outside of the financial system. If a faculty member mentions that they have a collaboration with a researcher at a foreign institution, Postaward and OSR staff should consider whether the activity requires reporting to NIH as Other Support or a Foreign Component, and make the faculty member aware that they need to report.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Does a Foreign Component need to be included on Other Support?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The Foreign component should be part of the proposal, <a href="https://grants.nih.gov/grants/how-to-apply-application-guide/forms-f/general/g.220-r&r-other-project-information-form.htm#6" target="_blank">R&R Other Project Information Form</a>, not the Other Support document. The addition of a foreign component to an ongoing NIH grant continues to require NIH prior approval, as outlined in the NIHGPS, <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.1.2_prior_approval_requirements.htm?Highlight=prior%20approval" target="_blank">Section 8.1.2</a>, Prior Approval Requirements. Principal Investigator’s should work with <a href="/find-my-support">their</a><a href="/find-my-support" target="_blank"> OSR staff</a> to submit the prior approval request.</p> <p>If an activity does not meet the definition of foreign component because all research is being conducted within the United States, but there is a non-U.S. resource that supports the research of an investigator and/or researcher, it must be reported as other support.</p> <p>For example, if a PD/PI of an NIH-funded grant has a collaborator outside of the U.S. who performs experiments in support of the PD/PI’s NIH-funded project, this would constitute a foreign component, regardless of whether the foreign collaborator receives funding from the PD/PI’s grant. Additional funding from a foreign source for the NIH-supported research of a PD/PI at a U.S. institution would not constitute a foreign component but would necessitate reporting as other support.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How should effort be listed for Industry Clinical Trials when the effort varies depending on the current progress? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>One option is to list as "aggregated effort" for all Industry Clinical Trials. List the information for each individual study and then have 1 effort table at the bottom that represents the aggregated effort. Introduce the Clinical Trials section with the following statement:</p> <p>"Each of these individual projects has a varying need of effort depending on the type of activity currently in progress: protocol development, start-up, patient recruitment, enrollment, follow-up, monitoring, data analysis, publication, and closeout. Faculty determines each project's need and adjust their effort between projects within the total aggregated effort assigned to the clinical projects. Effort is reviewed and confirmed by the department based on the activity of each project."</p> <p><a href="https://osr.ucsf.edu/sites/g/files/tkssra1766/f/Example_for_IndustrySponsoredClinicalTrials_OtherSupport.docx">Example of Industry Sponsored Clinical Trials Entry for Other Support</a></p> </div> </div> <p style="text-align: right;"><a href="#top">Top</a></p> </li> </ol> <hr /> <h3><a id="sub" name="sub"></a>Outgoing Subawards/Subcontracts</h3> <ul style="margin-left: 40px;"> <li><a href="#sub-gen">General</a></li> <li><a href="#sub-budget">Budget/Scope of Work (SOW)</a></li> <li><a href="#sub-carryforward">Carryforward</a></li> <li><a href="#sub-ein">EIN/UEI</a></li> <li><a href="#sub-iacuc">Human and Animal Subjects (IRB/IACUC)</a></li> <li><a href="#sub-indirects">Indirect Costs and F&A Rate Agreements</a></li> <li><a href="#sub-oakland">BCH Oakload Work Orders</a></li> <li><a href="#sub-wa">Working Capital Advance</a></li> </ul> <h5><a id="sub-gen" name="sub-gen"></a>General</h5> <ol> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How do I determine if the subaward should be set up as a cost reimbursable, fixed rate, or fixed amount?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>This is determined at the time the subaward is proposed. If the subaward will cover actual costs and UCSF will reimburse the subrecipient for its actual costs, then the subaward is cost-reimbursable. If the project meets the definition of fixed rate from the NIH and the subaward is under an NIH award, then the subaward will be fixed rate. If the project meets the definition of fixed amount under the <a href="https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200" target="_blank">Uniform Guidance (2 CFR 200.1)</a>, then the subaward will be a fixed amount subaward. The SOW and budget/milestone payment schedule provide most of the information for making this determination.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>What is the difference between Fixed Rate and Fixed Amount?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Fixed Amount is defined in the <a href="https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200" target="_blank">Uniform Guidance at 2 CFR 200.1</a>. Fixed Rate is an NIH term defined in the <a href="https://grants.nih.gov/grants/policy/nihgps/html5/section_8/8.1.2_prior_approval_requirements.htm#Provid" target="_blank">Grants Policy Statement at 8.1.2.11</a>. Fixed amount is a predetermined amount for the activities performed. Fixed rate is a predetermined rate for an activity but the total number of that activity is unknown. Other federal agencies have not adopted that term; however, check the federal agencies applicable policies because they may have similar guidance. For example, the Department of Defense has a similar situation described under <a href="https://www.ecfr.gov/current/title-2/subtitle-B/chapter-XI/subchapter-D/part-1138/subpart-L/section-1138.1205" target="_blank">DOD General Terms and Conditions SUB Article XII Section B</a>. View more <a href="/sites/g/files/tkssra1766/f/wysiwyg/2021.03_Fixed%20Rate%20Guidance.pdf" target="_blank">Fixed Rate Guidance</a>.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Should indirect costs be added to a fixed rate or should the fixed rate be inclusive of indirect costs?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The Subcontracts Team prefers that the indirect costs be included in the fixed rate amount. No verification of the indirect rate is needed when the fixed rate amount is inclusive of indirects.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Can an amendment include more than one action or do we need to submit separate request forms for different amendment actions?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>An amendment can include as much actions as needed. For example, if the amendment needs to extend the end date, change the subrecipient PI, and include a revised budget, all of the actions may be included in the one request form. Utilize the comments section to help clarify the intent of the amendment.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Where can I locate the status of my subaward requests?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The Subcontracts Team tracks all of its transactions in CACTAS. Since May 2020, the Subcontracts Team has had its own record type. Some of the fields are specific to the Subcontract record type. <a href="/cactas" target="_blank">Learn more about CACTAS and find guides for now to search and create views</a>.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Why does the Subcontracts Team need the RAS Project ID?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The Subcontracts Team needs the RAS Project ID when setting up new subawards/subcontracts because the “SC#” is created under a specific Project ID. Therefore, if the Department wants to track and manage the subawards under different Project IDs, then the Department will need to request these and have them setup prior to initiating the subaward request. Once the SC# has been created, the Subcontracts Team cannot move them.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How can I get this subaward agreement expedited?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>For many requests we are sending out the subaward or amendment in less than 5 business days from receiving the request. Request forms submitted with a request to expedite will not be expedited. In order to have a subaward expedited, the request for expedite must be determined prior to submitting the request form. If the request is going through the Proposal and Grants Teams, the Assistant Team Manager and Team Manager will first review the request to ensure the request is reasonable. If the ATM and TM believe the request is reasonable, they will contact the Subcontracts Team Manager to discuss. This process can run concurrently to collecting the information for the request form. For all other requests, please send an email to <a href="/cdn-cgi/l/email-protection#5c1f1b0f293e13292808393d311c293f2f3a72393829"><span class="__cf_email__" data-cfemail="1655514563745963624273777b566375657038737263">[email protected]</span></a> and the Subcontracts Team will discuss with the options.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Can the Subrecipient PI have 0 calendar months effort or effort as needed?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Review the sponsor’s policies regarding effort. Subawards under federal flow through require the subrecipient PI to have measurable effort. For cost-reimbursable subawards, the detailed budget and justification will include this detailed information. For fixed rate/fixed amount subawards, the effort and commensurate salary are calculated into the fixed rate/fixed amount cost.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Can the subaward/subcontract extend beyond the prime award dates?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>No unless the sponsor has provided pre-award spending and our PI has approved the subrecipient to pre-award spend. Otherwise dates that are outside of the prime award create an unfunded liability for the University. The University (and ultimately the PI and Department) would be responsible for covering the expenses that are outside of the prime award and not covered by the prime award. Therefore, the Subcontracts Team is not in the position to commit the Department and PI to cover such expenses.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Can we process an NCE and a carry forward at the same time?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>An NCE extends the current budget period through the new end date. It does not create an additional budget period. Carryforward requires the addition of a new budget period so that funds may be carried forward from one budget period into another. So, carryforward would not be applicable in this instance because with the NCE we are allowing the subrecipient to continue spending the funds already allocated. If we need to create a new budget period, then the transaction would not be an NCE but an additional budget period with carryforward. The “Other” field in the Amendment Request section can be utilized to explain the request.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Can the Subcontracts Team process the subaward if the Notice of Award is in CACTAS but not in PeopleSoft?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>No, PeopleSoft is the system of record. If the NOA is not in PeopleSoft yet, then the award has not been fully setup. Most awards allow us to spend back to the start date and we can allow our subrecipients to do the same. Therefore, we wait till the NOA to be setup in PeopleSoft before issuing the subawards. Otherwise, this creates an unfunded liability for the Department and PI. Moreover, for new subawards, we need the A# and Project ID setup before we can setup the SC# and we need the SC# for the subaward.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>The department wants to revise the budget amount or some other item after the subaward has been sent out, what action is needed from my end to ensure we grant the subsite with the correct budget or revised item? Do I need to submit another request form?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>No, another request form is not needed. Please work with whomever is processing the transaction to update the budget amount instead of emailing the central Subcontracts Team email box. Also provide the PI’s approval of the new budget amount in lieu of submitting another request form.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>When is a budget justification required?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>A budget justification is required for all new cost-reimbursable subawards and amendments that add budget items that were not previously described in a budget justification. The budget justification is part of the subrecipient monitoring required under the <a href="https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200#200.332" target="_blank">Uniform Guidance (2 CFR 200.332(d))</a>. We as the pass-through entity are required to monitor the activities of the subrecipient as necessary to ensure that the subaward is used for authorized purposes, in compliance with Federal statutes, regulations, and the terms and conditions of the subaward.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Does the Subcontracts Team review every single line item of the budget and justification?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>We review the budget and justification to ensure they conform to the regulations and policies of the sponsor and to meet our obligations of monitoring the subrecipient under the <a href="https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200#200.332" target="_blank">Uniform Guidance (2 CFR 200.332(d))</a>. We will give a quick review of the calculations to ensure the budget adds up to the total amount being provided. This ensures there are no legal inconsistencies and reduces the need to issue amendments correctly errors later on.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How do I know when we need to fill out a subaward request form?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>A completed form is required for each transaction. The form collects the necessary information for putting together the transaction as well as the contact information for where to send it. In addition, the form collects the PI’s signature and therefore approval of the transaction.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>In what type of situations, would I need to get the SRF resigned or concurred by the PI again?</p> <ul class="list-bullets"> <li>Change in budget amount (does it matter if the budget increased or decreased?)</li> <li>Change in project dates?</li> <li>Change in Intent (I originally submitted it as in increased in funds, but realized it was actually for a carry forward request).</li> </ul> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The PI is responsible for the overall management of their award including the subawards. When the PI signs the SRF, they are approving the scope of work, budget, budget justification, and the compliance pieces required for managing the subaward. The Subcontracts Team can only process the transactions as has been requested. We cannot assume what was intended. For instance, if the PI wanted to restrict carryforward but the form said it was automatic, then the Subcontracts Team will need PI concurrence that the carryforward should be restricted. Processing the transaction incorrectly may lead to a financial liability for the University. The SRF may either be corrected and resigned, or an email with PI concurrence to the corrections is allowable.</p> <ul class="list-bullets"> <li>Yes, a change in budget amount requires PI approval regardless if the change is an increase or decrease.</li> <li>Yes, a change in project dates requires PI approval.</li> <li>Yes, if the incorrect box was marked for an amendment, the PI does need to reapprove because they approved a different transaction and we cannot assume what was intended.</li> </ul> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Can the budget period be longer than 1 year?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>It depends. For federal flow through, the budget period is capped at one year even if we received a multi-year award from the NIH or other Federal agency. This ensures we are monitoring the subrecipient in compliance with the Federal regulations and agency specific requirements. For non-Federal flow through, check the prime terms and conditions. We may be able to issue the subaward for the full period of performance.</p> </div> </div> </li> </ol> <p style="text-align: right;"><a href="#top">Top</a></p> <h5><a id="sub-budget" name="sub-budget"></a>Budget/Scope of Work (SOW)</h5> <ol> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>What should be included in the Scope of Work (SOW)?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The Scope of Work (SOW) needs to describe the work that is to be performed by the subrecipient. It should contain sufficient detail so that there is no ambiguity about the activities to be performed and the deliverables required from the subrecipient. The deliverables would include any technical/scientific reports required. If the SOW contains information related to the agreement like dates, PI names, budget amounts, etc., please review to ensure they have been updated and align with the request. Inconsistent dates, amounts, etc., create legal inconsistencies in the subaward contract and can lead to issues later.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>When is a Scope of Work (SOW) required?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>A SOW is required for all new subawards. For fixed rate/fixed amount subawards, the SOW may be included on the milestone and payment schedule as one document instead of two.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>If the project dates are updated/extended, does that count as a change in the Scope of Work (SOW)?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Yes, but we do not need a revised or updated SOW. The language in our subaward amendments updates the end date throughout the subaward contract. A revised SOW including the new end date is not required but may be provided.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>When is a revised budget and/or revised scope of work (SOW) needed for a budget decrease?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>It depends on the purpose of the decrease. If the decrease is a general decrease and there is no changes to the scope of work a revised budget is not needed. If the decrease is needed to remove specific tasks or budget line items, a revised budget/scope of work is needed. The revised documents can then be incorporated into the subaward agreement.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Do we need a revised/additional scope of work when adding supplemental funds?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Often yes but it depends on for what the funds will be used. If the additional funds are being provided to cover more work, then yes, a scope of work (additional or revised) is required. For example, the original SOW stated that the subrecipient would process 100 samples. We now need the site to process an additional 25 samples. The SOW should be updated to reflect that the subrecipient is processing a total of 125 samples. Otherwise, they may not be contractually obligated to process the additional samples. We may have just allowed them to invoice for more funds to process the original 100 samples.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Do we need a revised/additional budget when adding supplemental funds?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Yes, we need either a revised budget for the new total or an additional budget which details how the funds will be spent. If the project is a fixed rate project and we need to increase the ‘do not exceed amount’, a budget is not required because we already have the fixed rate amount. Please provide a comment in the Comment section detailing what is changing. For example, the total number of patients the subrecipient is allowed to enroll is increasing from 5 patients to 10 patients.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Why do we need to include the total estimated period and total estimated amount for federal flow through subawards?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Effective November 12, 2020, the Uniform Guidance was updated. Every five years the regulations are required to be reviewed and updated as needed. These are now required data elements that we need to include in the federal flow through subawards. See <a href="https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200#200.332" target="_blank">2 CFR 200.332 (a)(1) (v) and (ix)</a>.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Do we need to include the total estimated period and total estimated amount for non-federal flow through subawards?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>No, these data elements are only required for federal flow through but may be included for all other subawards.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Is there a preferred format for the detailed budget?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>No, the Subcontracts Team does not have a preferred format for the budget. Although the <a href="https://www.grants.gov/forms/r-r-family.html" target="_blank">SF424 budget page</a> is a good example because it breaks the costs down by major category and includes a calculation of the indirect costs with the appicable rate and base.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Why can't we use the PHS 398 budget page for fixed rate?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The PHS 398 budget page does not provide the details needed for issuing a fixed rate agreement. The Subcontracts Team needs more than just the fixed rate amount. A milestone or payment schedule is needed for the fixed rate agreements. The payment/milestone schedule details the amount of each payment, what activities trigger a payment, and/or when that payment will happen. The detail needed for each payment/milestone schedule will be dependent on the project. The description of what triggers a payment should be clear and unambiguous. See <a href="/sites/g/files/tkssra1766/f/wysiwyg/2021.03_Fixed%20Rate%20Guidance.pdf" target="_blank">Fixed Rate Guidance</a> for more information.</p> </div> </div> </li> </ol> <p style="text-align: right;"><a href="#top">Top</a></p> <h5><a id="sub-carryforward" name="sub-carryforward"></a>Carryforward</h5> <ol> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How do I determine if the UCSF award was granted with automatic carryforward?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The NIH Notice of Award will affirmatively state if carryforward is automatic or requires prior approval from the GMS/GMO. For all others review the sponsor’s terms and conditions.</p> </div> </div> </li> </ol> <p style="text-align: right;"><a href="#top">Top</a></p> <h5><a id="sub-ein" name="sub-ein"></a>EIN/UEI</h5> <ol> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>When do we need to provide the EIN on the request form?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The EIN is needed for all domestic subrecipients when the subaward/subcontract contains federal flow through funding.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Why is the EIN limited to 9 digits on the request form?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The Subcontracts Team uses the 9 digit EIN to locate the Single Audit in the Federal Audit Clearinghouse (FAC). As part of our obligations under the Uniform Guidance (<a href="https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200#200.332" target="_blank">2 CFR 200.332(b)</a>), the Subcontracts Team is required to locate the Single Audits for the subrecipients with which we contract. The FAC does not recognize the longer versions used by the NIH or federal agencies. Moreover, searching in the FAC by name can return inaccurate or incomplete results.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>When do we need to provide the UEI on the request form?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The UEI is needed for all subrecipients when the subaward/subcontract contains federal flow through funding.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Can we still include the DUNS instead of the UEI?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>No, as of April 4, 2022 the Federal Government stopped accepting the DUNS as the unique entity identifier. The UEI created in <a href="https://sam.gov/content/home" target="_blank">SAM.gov</a> is the official unique entity identifier.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Can we issue a subaward or amendment to a subrecipient that does not have a SAM.gov UEI?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>No, we may not make a subaward to a subrecipient unless that subrecipient has obtained and provided to us a unique entity identifier (<a href="https://www.ecfr.gov/current/title-2/subtitle-A/chapter-I/part-25/subpart-C/section-25.300" target="_blank">2 CFR 25.300</a>). Moreover, we are required to include the UEI in the subaward because it is a required data element under <a href="https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200#200.332" target="_blank">2 CFR 200.332(a)(1)(ii)</a>.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Does a subrecipient have to register with SAM.gov and have an active registration before we can issue a subaward to them?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Maintaining an active <a href="https://sam.gov/content/home" target="_blank">SAM.gov</a> registration is for entities that receive funding directly from a federal agency. See <a href="https://www.ecfr.gov/current/title-2/subtitle-A/chapter-I/part-25/subpart-B/section-25.200" target="_blank">2 CFR 25.200</a>. A subrecipient may obtain a UEI from <a href="https://sam.gov/content/home" target="_blank">SAM.gov</a> without completing the fully registration process. Although review prime sponsor’s policies because they may require that the subrecipients also maintain an active SAM.gov registration.</p> </div> </div> </li> </ol> <p style="text-align: right;"><a href="#top">Top</a></p> <h5><a id="sub-iacuc" name="sub-iacuc"></a>IRB/IACUC</h5> <ol> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>When do we need to include the IACUC and IRB letters with the request form?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The Subcontracts Team collects the IACUC and IRB letters from the foreign subrecipients. This is a compliance check that Subcontracts Team has performed for many years to ensure the subrecipients have the approvals prior to working on vertebrate animals or human subjects research.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Does the IRB or IACUC letter need to be in English?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>No, the Subcontracts Team will accept the letter in a foreign language. If the letter can be translated by Google Translate or another service, please provide that. Otherwise please provide PI concurrence that the IRB or IACUC letter is in fact the appropriate approval.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Does the IRB or IACUC need to have an expiration date?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>No, some foreign IRBs and IACUCs do not include an expiration date. However, if the letter does have an expiration date, please make sure that the date is in the future and not about to expire. If it is expired or about to expire, please add a comment that an updated IRB or IACUC letter will be provided once received by the PI.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Does the Subcontracts Team need the UCSF IRB or IACUC?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>No. The IRB or IACUC numbers can be found in CACTAS and PeopleSoft. If the Subcontracts Team needs to review, then we can find the information in our systems. Even when the site is relying on the UCSF IRB, the Subcontracts Team does not need a copy of the UCSF IRB.</p> </div> </div> </li> </ol> <p style="text-align: right;"><a href="#top">Top</a></p> <h5><a id="sub-indirects" name="sub-indirects"></a>Indirect Costs and F&A Rate Agreements</h5> <ol> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>What F&A/indirect cost rate should be applied to the outgoing subaward? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Unless the sponsor indicates a specific indirect cost rate in their written guidelines/policy, subrecipients on UCSF projects should apply their Federally-negotiated F&A rate, their State-negotiated rate for State of California agencies (e.g., City and County of San Francisco) the de minimis rate of 10%, or elect to not apply indirect costs. UCSF does not negotiate F&A rates with the subrecipient entity.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>When do we include the F&A rate agreement?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The F&A rate agreement is needed whenever the subrecipient will use their negotiated rate for calculating the indirect costs. If the sponsor has a different policy like 0% on some non-profit funded projects or 8% for NIH K awards, then the negotiated rate agreement does not need to be provided. We are required to include the applicable rate in the subaward because it is a required data element under <a href="https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-D/subject-group-ECFR031321e29ac5bbd/section-200.332" target="_blank">2 CFR 200.332(a)(1)(xiv)</a>.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Why do we need to include the F&A rate agreement with each request form?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>As part of our obligations to monitor the subrecipients under the Uniform Guidance (<a href="https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-D/subject-group-ECFR031321e29ac5bbd/section-200.332" target="_blank">2 CFR 200.332</a>), we need to review the budget each time to ensure the F&A rate used on the budget is an allowable rate. If the rate changes, we need to include the new rate in the amendment because it is a required data element under <a href="https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-D/subject-group-ECFR031321e29ac5bbd/section-200.332" target="_blank">2 CFR 200.332 (a)(1)(xiv)</a>.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>What if the F&A rate has not changed from the previous year?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Yes, we still need a copy to review the budget that has been provided to us. This review becomes a part of the auditable record and we need the back-up documentation each time.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Can we determine the indirect rate to be used on the subaward budget?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>No, we must follow the sponsor’s policy regarding indirect costs. The subrecipient institution may decide to accept less than they are allowed. Moreover, under the Uniform Guidance we are required to honor the negotiated rate agreement of the subrecipient (<a href="https://www.ecfr.gov/current/title-2/subtitle-A/chapter-II/part-200/subpart-D/subject-group-ECFR031321e29ac5bbd/section-200.332" target="_blank">2 CFR 200.332(a)(4)</a>).</p> </div> </div> </li> </ol> <p> </p> <p style="text-align: right;"><a href="#top">Top</a></p> <h5><a id="sub-oakland" name="sub-oakland"></a>BCH Oakland Work Orders</h5> <ol> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>What is needed to issue a Work Order to BCH Oakland?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The <a href="https://bchdean.ucsf.edu/research-administration" target="_blank">Dean’s Office for BCH Oakland</a> contains a lot of information regarding the Work Orders. The Department will need to provide a RAS Project ID that is tied to an Oakland location code. This allows the Department to create a Speedtype that can be used by Oakland to direct charge Oakland personnel costs and clinical care costs. Per the Research Services Agreement with BCH Oakland, the Subcontracts Team will process a Work Order, which include a Scope of Work for the Oakland portion, a detailed budget of the Oakland direct costs only, and a copy of the agreement.</p> </div> </div> </li> </ol> <p style="text-align: right;"><a href="#top">Top</a></p> <h5><a id="sub-wa" name="sub-wa"></a>Working Capital Advance</h5> <ol> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>What are Low and Middle Income Countried?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The World Bank defines Low and Middle Income Countries are those countries with Gross National Income per capita of less than $13,205. The Wellcome charitable foundation maintains an<a href="http://a.	The World Bank defines Low and Middle Income Countries are those countries with Gross National Income per capita of less than $13,205. The Wellcome charitable foundation maintains an easily readable list of countries that meet this definition." target="_blank"> easily readable list of countries</a> that meet this definition.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Why is the working capital advance limited to 25% of the annual amount?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The purpose of the advance is to provide enough capital so that the subrecipient has funds on hand to pay for the project. </p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How is the working capital advance calculated?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The working capital advance is limited to 25% of the annual amount plus upfront costs including the purchase of equipment. </p> <ul> <li>Example 1: If the subaward is for 1 year and the total amount for that year is $120,000, then 25% of the annual is $30,000. $120,000*25% = $30,000</li> <li>Example 2: If the subaward is for 6 months and the total amount for that six-month period is $60,000, then 25% of the annual is $30,000. To obtain the annual amount double the total since that would make the project theoretically 12 months. That theoretical total is $120,000 and the monthly amount is $10,000. $120,000*25% = $30,000</li> <li>Example 3: The subaward is for 1 year and the total amount is $65,000 with $5,000 being included for the purchase of equipment. The equipment costs are excluded. So the annual amount is $60,000. 25% of $60,000 is $15,000.The working capital advance would then be the $15,000 plus the $5,000 for the equipment for a total of $20,000.</li> </ul> </div> </div> </li> </ol> <p style="text-align: right;"><a href="#top">Top</a></p> <hr /> <h3><a id="clinicaltrials" name="clinicaltrials"></a>Clinical Trials</h3> <ol> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How do I set up a Clinical Trial? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The <a href="http://trialactivation.ucsf.edu/" target="_blank">Office of Clinical Trial Activiation (OCTA)</a> works with investigators and industry sponsors to negotiate the contracts and budgets for all clinical research studies funded by a private, for-profit entity. <a href="https://trialactivation.ucsf.edu/" target="_blank">Contact OCTA </a>to set-up an industry-sponsored clinical trial. </p> <p>For clinical trials funded by nonprofit or governmental entities, please <a href="/find-my-support" target="_blank">contact your OSR staff.</a></p> </div> </div> </li> </ol> <p style="text-align: right;"><a href="#top">Top</a></p> <hr /> <h3><a id="bc" name="bc"></a>Business Contracts</h3> <ol> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How do I request a business contract? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>For information and contacts for business contracts, visit the <a href="/business-contracts" target="_blank">Business Contracts</a> page.</p> </div> </div> </li> </ol> <p style="text-align: right;"><a href="#top">Top</a></p> <hr /> <h3><a id="award" name="award"></a>Award Set-up and Administration</h3> <ol> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How do I find institutional information for UCSF, such as the EID and DUNS numbers for award documents?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The <a href="/institutional-information" target="_blank">Institutional Information</a> page includes much of the detail you may need. For additional guidance, please <a href="/find-my-support" target="_blank">contact OSR Staff</a>.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How do I find the status of my award?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The <a href="/find-my-support" target="_blank">OSR staff member </a>who assisted with your proposal submission will be able to answer questions about an award that is currently in-process or a proposal that was submitted but not yet funded.</p> <p>Contact <a href="https://trialactivation.ucsf.edu/contact-us" target="_blank">OCTA </a>for Clinical Trial proposals submitted through <a href="http://trialactivation.ucsf.edu/" target="_blank">Office of Clinical Trial Activiation (OCTA)</a>.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How do I make a change to an existing award? Which OSR team should I work with?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Amendment term changes that do not require substantive negotiation and can be reviewed by Proposal and Grants team:</p> <ul style="margin-left: 40px;"> <li>Timeline Changes such as financial reporting periods period of performance, budget periods, no-cost extension</li> <li>Funding increases/decreases</li> <li>Administrative changes in the status of PI/Key Personnel/Department, contact information, carryforward, rebudgeting, placing/lifting restrictions, early termination</li> </ul> <p>Amendment term changes that require substantive negotiations for alignment with UC policy and should be reviewed by the Awards team:</p> <ul style="margin-left: 40px;"> <li>Publication, publicity</li> <li>Intellectual property, patents, licenses, copyright</li> <li>Rights to research results and use of data and materials</li> <li>Confidentiality Insurance, liability, indemnity</li> <li>Governing law, dispute resolution</li> </ul> </div> </div> <p style="text-align: right;"><a href="#top">Top</a></p> </li> </ol> <hr /> <h3><a id="ahs" name="ahs"></a>Animal and Human Subjects</h3> <ol> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How do I make changes to/or file my IRB or IACUC ?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>View the HRRP webstie for IRB <a href="https://irb.ucsf.edu/submissions" target="_blank">submissions</a> and <a href="https://irb.ucsf.edu/modification" target="_blank">modifications</a>. <a href="https://irb.ucsf.edu/contact-us" target="_blank">Contact IRB staff </a>for assistance. </p> <p>View the IACUC website for <a href="https://iacuc.ucsf.edu/protocol-submission" target="_blank">protocol submission</a> and their FAQ regarding <a href="http://iacuc.ucsf.edu/faqs-after-approval" target="_blank">submitting</a><a href="https://iacuc.ucsf.edu/faqs-after-approval" target="_blank"> </a><a href="http://iacuc.ucsf.edu/faqs-after-approval" target="_blank">a modification</a>. <a href="https://iacuc.ucsf.edu/contacts" target="_blank">Contact IACUC staff</a> for assistance. </p> <p><a href="/find-my-support" target="_blank">Contact your OSR staff</a> if you have further questions regarding the steps necessary to make an administrative modification.</p> </div> </div> </li> </ol> <p style="margin-left: 40px; text-align: right;"><a href="#top">Top</a></p> <hr /> <h3><a id="psa_taa" name="psa_taa"></a>PSA/TAA Platform</h3> <ol> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>What is different with the PSA Request Page in Lightning? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>A majority of the help hover texts were updated to assist department requesters in completing the Professional Services Agreement (PSA) request form. Clinical services provided by UCSF campus faculty/personnel to another entity are documented in a PSA. The most significant updates can be found in the Billing Section. There are new fields requesting the sources used to support compensation rates and the ability to upload documents to justify rates as fair market value (FMV).</p> <p><a href="https://youtu.be/7mZ6DylfhF8" target="_blank">Instructional Video on submitting a PSA Request </a></p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Why was the Billing Section in the PSA Request Page updated?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The Billing Section was updated based on findings from an internal UCSF audit that as a campus, UCSF can do better in complying with federal rules and regulations, such as the Anti-Kickback Statutes and Stark Laws, regarding the provision of clinical services to another entity. FMV is a key component for compliance with these rules and regulations. The new Billing Section was designed in collaboration with the School of Medicine’s Dean’s Office, UCSF Office of Healthcare Compliance & Privacy, and UCOP Legal. This new section was built with various help texts, flags, fields with a selection of FMV sources and other mechanisms to assist departments in thinking about FMV; thus, moving the whole UCSF community toward compliance.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Will I be able to submit a request without uploading documentation supporting the compensations rates as FMV? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Yes, you can submit a request without uploading supporting documents. However, the request may be declined by the Vice Dean for Clinical Affairs from the School of Medicine. This office provides a quick review of all PSA requests. If the Vice Dean approves the request, it is routed to the Business Contracts Unit (BC). A Contract Specialist in BC will further review the request to ensure a PSA is appropriate for the activity and follow up with department requesters on any missing information and documentation.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>What is Buisness Contract Unit (BC)’s role in the PSA process?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>BC supports outgoing campus clinical services. BC acts as a conduit with other UCSF offices such as Risk Management, Privacy and Legal, along with other campus stakeholders when necessary to ensure the agreements meet UCSF policies and procedures.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>What is FMV? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>FMV means the value in arm’s-length transactions, consistent with the compensation that would be included in a service agreement, as the result of bona fide bargaining between well-informed parties to the agreement who are not otherwise in a position to generate business for the other party at the time of the service agreement. Questions about FMV for a particular agreement can be discussed further with the subject matter expert at UCOP Legal.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How will I determine that a rate is FMV? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Sources for documenting FMV include, but are not limited to, independent evaluation firms, MGMA Salary Survey, Sullivan Cotter Survey, other party fee schedule, etc. The new Billing Section provides a list of sources that may be used. Although FMV is required for legal compliance, it is ultimately a business practice question.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Are old reports still available?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Yes, old reports generated before Lightning are still available in Lighting. </p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>What is Lightning in relation to CACTAS and Salesforce? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Salesforce is the overall system housing the CACTAS platform and the TAA/PSA platform. At UCSF, Salesforce and CACTAS are used interchangeably. UCSF was operating on an old version of Salesforce (Classic). The more current version of Salesforce (Lightning) will allow us to utilize the system to its fullest.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>What is different with the TAA Request Page in Lightning? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>Aside from a different look, the TAA Request Page has minimal changes. </p> <p><a href="https://youtu.be/-T8euCrmxmI" target="_blank">Instructional Video on submitting a TAA Request</a></p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>Does the Clone feature work? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>YES! The Clone feature works in Lightning. </p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p> How do I do a search in Lightning? </p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p>The Global Search feature will provide results for Service Agreement (SA) records and requests, files, and folders. Use the search bar up at the top of the page to refine your search criteria by: Department or Name of Other Party (PSA); School or Name of Affiliate (TAA). The columns in the results page can be used to sort records by Agreement and Amendment End Dates.</p> <p>If known, a specific department can be typed into the search bar at top of the page. This will yield the best results.</p> <p>If unknown, try doing a broad search ex: the Department of Pediatrics uses the abbreviation “PEDS” before any specialty/sub-department. Keep in mind that typing in “M_Orthopaedic Surgery” vs. “Orthopaedic Surgery” may yield different results.</p> <p><a href="https://youtu.be/HGdisrxwm0o">Instruction Video on the Global Search Feature for PSAs</a></p> <p>Search for specific Schools by spelling out the school: “Nursing”, “Medicine”, “Dentistry”, or “Pharmacy”; or use the school acronym: “SON”, “SOM”, “SOD”, or “SOP”.</p> <p><a href="https://youtu.be/ZJkiCdOV9U4">Instruction Video on the Global Search Feature for TAAs</a></p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How do I run reports for my department’s PSAs in the Salesforce system?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p><a href="https://youtu.be/-pRsJx30JBA">Instruction Video on PSA reporting</a></p> <p>Available Report: PSA For Department with Amendment and agreement end dates. <a href="https://ucsf.lightning.force.com/lightning/r/Report/00O2K000007DtzbUAC/view" target="_blank">Open the PSA report</a>. Select “Edit” in the top right-hand corner to go to the report customization page. On the left-hand column, switch over to the “Filters” tab. Select the “Department” field, then set the operator to “contains” if you’re doing a broad search, or “equal” if you know how the department is coded in CACTAS. Type in the Department parameters and apply your changes. Select “Run” in the top right-hand corner to see the full list of records. Click on the “Agreement End Date” and “Amendment End Date” columns to sort the results chronologically.</p> </div> </div> </li> <li> <div class="collapse-item"> <div aria-expanded="false" class="header-text" role="button" tabindex="0"> <p>How do I run reports for my School’s TAAs in the Salesforce system?</p> </div> <div aria-hidden="true" class="content-text" role="region" tabindex="-1"> <p><a href="https://youtu.be/aJORFrtZsIk" target="_blank"> Instruction Video on TAA reporting</a></p> <p>Available Report: TAA For Schools with Amendment and agreement end dates. <a href="https://ucsf.lightning.force.com/lightning/r/Report/00O2K000007DtzlUAC/view" target="_blank">Open the TAA report</a>. Select “Edit” in the top right-hand corner to go to the report customization page. On the left-hand column, switch over to the “Filters” tab. Select the “School” field, type in the School you’re searching for and apply your changes. Select “Run” in the top right-hand corner to see the full list of records. Click on the “Agreement End Date” and “Amendment End Date” columns to sort the results chronologically.</p> </div> </div> </li> </ol> <p style="text-align: right;"><a href="#top">Top</a></p> <p> </p> <p> </p> <p> </p> <p> </p> <p> </p> <hr /></div></div></div> <div class="paragraphs-items paragraphs-items-field-paragraph-sections paragraphs-items-field-paragraph-sections-full paragraphs-items-full"> <div class="field field-name-field-paragraph-sections field-type-paragraphs field-label-hidden"><div class="field-items"><div class="field-item even"><div class="entity entity-paragraphs-item paragraphs-item-blockreferences"> <div class="content"> <div class="field field-name-field-pg-blockref-blockref field-type-blockreference field-label-hidden"><div class="field-items"><div class="field-item even"><div id="block-block-116" class="block block-block"> <div class="content"> <p><a class="btn--small btn--white--underline" href="https://ucsf.co1.qualtrics.com/jfe/form/SV_8HOu4QbWPyMy0zI" target="_blank">Provide Website Feedback</a></p> <p> </p> </div> </div></div></div></div> </div> </div> </div></div></div></div> </div> </div> </div> </div> </div> </div> </div> <div id="sidebar" class="column"> </div> </div></div> <div id="footer"> <div class="section"> <div class="footer-bottom"> <nav aria-label="Footer Navigation" class="footer--navigation"> <ul> <li><a href="/cdn-cgi/l/email-protection#fc938f8e95929a93bc899f8f9ad2999889">Contact Us</a></li> <li><a href="https://www.ucsf.edu/accessibility-resources">Accessibility</a></li> <li><a href="https://www.ucsf.edu/website-privacy-policy">Privacy Policy</a></li> <li><a href="https://websites.ucsf.edu/website-terms-use">Terms of Use </a></li> <li><a href="https://websites.ucsf.edu/azlist">A-Z Website List</a></li> </ul> </nav> <div class="footer--copyright"> <p>© 2024 The Regents of the University of California</p> </div> </div> </div> </div> </div> </div> <script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script><script type="text/javascript"> /*<![CDATA[*/ (function() { var sz = document.createElement('script'); sz.type = 'text/javascript'; sz.async = true; sz.src = '//siteimproveanalytics.com/js/siteanalyze_8343.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(sz, s); })(); /*]]>*/ </script> </body> </html>