{"id":1303,"date":"2016-11-17T14:55:29","date_gmt":"2016-11-17T22:55:29","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=1303"},"modified":"2026-03-11T16:27:48","modified_gmt":"2026-03-11T23:27:48","slug":"clinical-research","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/setup\/sponsor-requirements\/clinical-research\/","title":{"rendered":"Clinical Research"},"content":{"rendered":"<p><em>As of 7\/01\/2025, studies that fall under this\u00a0<a href=\"https:\/\/washington.edu\/research\/glossary\/industry-clinical-trial\/\">definition of Industry Sponsored Clinical Trials<\/a>\u00a0are to use\u00a0 a 35% Total Direct Cost (TDC) F&amp;A rate.<\/em><\/p>\n<p>Please review more information and guidance on the\u00a0<a href=\"https:\/\/washington.edu\/research\/announcements\/new-industry-sponsored-clinical-trial-definition-and-rate-effective-july-1\/\">New Industry Sponsored Clinical Trial Definition and F&amp;A Rate \u2013 Effective July 1st<\/a> and these\u00a0<a href=\"\/research\/faq\/new-industry-clinical-trial-definition-fa-rate-effective-july-1st\/\">FAQs<\/a>.<\/p>\n<hr \/>\n<p>Information here defines the variety of clinical research, guidance for initiating contract review, and the steps involved in getting clinical research started at the UW.<\/p>\n<h2>Contents<\/h2>\n<div class=\"table-of-contents\">\n<ul class=\"list-unstyled\">\n<li><a href=\"#defining-clinical-research\">Defining Clinical Research<\/a><\/li>\n<li><a href=\"#redcap-survey\">Use the New Study Submissions RedCap Survey<\/a><\/li>\n<li><a href=\"#getting-started-egc1\">Getting Started: eGC1 Review &amp; Approval<\/a><\/li>\n<li><a href=\"#admin-steps\">Administrative Steps that can happen concurrently<\/a><\/li>\n<li><a href=\"#asr-and-agreement\">Award Setup Requests &amp; the Agreement<\/a><\/li>\n<li><a href=\"#mcta\">Master Clinical Trial Agreements<\/a><\/li>\n<li><a href=\"#abandonded\">Abandoned Trials or Studies<\/a><\/li>\n<li><a href=\"#changes\">Agreement Amendments<\/a><\/li>\n<li><a href=\"#balance\">Remaining Balances on Clinical Trial Awards<\/a><\/li>\n<\/ul>\n<\/div>\n<p><a name=\"defining-clinical-research\"><\/a><\/p>\n<h2>Defining Clinical Research<\/h2>\n<p>Understanding the types of clinical research helps the University determine which processes, templates, terms, and requirements that apply.<\/p>\n<h3><strong>Clinical Trial<\/strong><\/h3>\n<p>A clinical trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.<\/p>\n<p><span style=\"font-weight: 400;\"><\/p>\n<div class=\"accordion non-bold\" id=\"accessible-accordion\">\n<div class=\"screen-reader-text\">Accessible Accordion<\/div>\n<p><\/span><\/p>\n<h3><strong>Clinical Trial Drug Phases<\/strong><\/h3>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Phase I<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.<\/p>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Phase II<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>\u00a0The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.<\/p>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Phase III<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>\u00a0The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.<\/p>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Phase IV<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p>\u00a0Studies are done after the drug or treatment has been marketed to gather information on the drug\u2019s effect in various populations and any side effects associated with long-term use.<\/p>\n<\/div>\n<\/div>\n<div class=\"card\">\n<div class=\"card-header\" id=\"accordion-header\">\n<h3 class=\"mb-0\"><button class=\"btn btn-link\" type=\"button\" data-toggle=\"collapse\" data-target=\"#collapse\" aria-expanded=\"false\" aria-controls=\"collapse\"><span class=\"btn-text\">Other<\/span><span class=\"arrow-box\"><span class=\"arrow\"><\/span><\/span><\/button><\/h3>\n<\/div>\n<div id=\"collapse\" class=\"collapse \" aria-labelledby=\"collapse\" data-parent=\"#accordion\" role=\"region\">\n<p> A study that does not fall into Phase I-IV definition. Examples include expanded access, compassionate use, and humanitarian use studies.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<h3>Industry Sponsored Clinical Trial<\/h3>\n<p><em>As of 7\/01\/2025, studies that fall under this\u00a0<a href=\"https:\/\/washington.edu\/research\/glossary\/industry-clinical-trial\/\">definition of Industry Sponsored Clinical Trials<\/a>\u00a0are to use\u00a0 a 35% Total Direct Cost (TDC) F&amp;A rate.<\/em><\/p>\n<p>Please review more information and guidance on the\u00a0<a href=\"https:\/\/washington.edu\/research\/announcements\/new-industry-sponsored-clinical-trial-definition-and-rate-effective-july-1\/\">New Industry Sponsored Clinical Trial Definition and F&amp;A Rate \u2013 Effective July 1st<\/a> and these\u00a0<a href=\"\/research\/faq\/new-industry-clinical-trial-definition-fa-rate-effective-july-1st\/\">FAQs<\/a>.<\/p>\n<p>Follow instructions for submitting an Industry Clinical Trial under <a href=\"https:\/\/washington.edu\/research\/myresearch-lifecycle\/setup\/sponsor-requirements\/clinical-research\/#getting-started-egc1\">Getting Started : eGC1 Review &amp; Approval<\/a>.<\/p>\n<h3>Federally Funded Clinical Trial<\/h3>\n<p>Funding for clinical trials is available from federal agencies. This funding may be through federal grant funding or contract. See <a href=\"\/research\/myresearch-lifecycle\/setup\/sponsor-requirements\/federal\/\">federal sponsor requirements<\/a> for more details. Federally funded clinical trials use the <a href=\"\/research\/policies\/gim-13\/#policy\">organized research F&amp;A rate<\/a>.<\/p>\n<p>FDA regulated &amp; NIH funded clinical trials have registration &amp; reporting requirements. Information about them must be placed in <a href=\"https:\/\/clinicaltrials.gov\/\" target=\"_blank\" rel=\"noopener\">ClinicalTrials.gov<\/a> (CT.gov), these clinical trials are called <a href=\"\/research\/glossary\/applicable-clinical-trial\/\">applicable clinical trials<\/a>.<\/p>\n<p>Some federal sponsors have specific proposal &amp; award requirements that must be followed. For example <a href=\"https:\/\/grants.nih.gov\/policy\/clinical-trials\/definition.htm\">see NIH Clinical Trial guidance<\/a>.<\/p>\n<h3>Investigator-Initiated Trials \/ Studies<\/h3>\n<p>An investigator-initiated study (IIS) is a study developed by the UW Investigator and can be a clinical trial or clinical study, depending on whether there is an intervention. If a trial, the UW will serve as the sponsor as that is defined in 21 CFR Part 312.3(b). The external party is providing funding, or resources (e.g. study drug), or both.<\/p>\n<p>There are some narrow circumstances in which the investigator-initiated study is non-human subjects research. For instance, a company may be interested in funding an investigator-initiated study that involves use of samples in a biorepository.<\/p>\n<h3>Clinical Study<\/h3>\n<p>A Clinical Study (or observational study) may involve activities similar to a Clinical Trial, but a study is intended for generalized knowledge, not treatment of a patient\/subject\u2019s condition, or intervention in their treatment.<\/p>\n<h3>Compassionate Use or Single Patient Emergency Enrollment<\/h3>\n<p>Review the UW Human Subject&#8217;s Division guidance on <a href=\"\/research\/hsd\/guidance\/expanded-access\/specu\/\">Single Patient Emergency or Compassionate Use<\/a>.<\/p>\n<p>There are two emergency situations that require expedited handling:<\/p>\n<ul>\n<li>Compassionate Use<\/li>\n<li>Single Patient Emergency Enrollment<\/li>\n<\/ul>\n<p><strong>New Emergency Care clinical trials<\/strong>: route a <a href=\"\/research\/faq\/naa-egc1-instructions\/&quot;\">non-award agreement eGC1<\/a> and include a comment indicating &#8220;this includes Emergency Care&#8221; enrollment.<\/p>\n<p><strong>Emergency Care Amendment to existing clinical trials<\/strong>: route an Award Modification (MOD) in SAGE for Emergency Single Patient or Compassionate Use enrollment. Include a comment to OSP indicating this MOD is for &#8220;Emergency Single Patient Enrollment&#8221; or &#8220;Compassionate Use Enrollment&#8221;. OSP will expedite review &amp; handling of the request.<\/p>\n<p><a name=\"redcap-survey\"><\/a><\/p>\n<h2>Use the New Study Submissions REDCap Survey<\/h2>\n<p>While not required prior to routing an eGC1, OSP highly recommends the study team use the <a href=\"https:\/\/www.iths.org\/ctms\/ctms-submissions\/new-study-submissions\/\" target=\"_blank\" rel=\"noopener\">Study Submission REDCap intake form<\/a> first. Benefits of using this survey include:<\/p>\n<ul>\n<li>Determines if study entry into the OnCore Clinical Trial Management System (CTMS) is required for sponsor invoicing purposes, which helps answer the <a href=\"\/research\/tools\/sage\/guide\/egc1-forms\/non-fiscal-compliance-page\/human-subjects\/\">related eGC1 question<\/a> correctly.<\/li>\n<li>Creates an identifier number with the prefix \u201cRG\u201d that should be used in your eGC1 short title and helps link up records.<\/li>\n<li>Helps identify whether CTO review for budgeting and billing purposes is required, and if so, to coincide with contract review<\/li>\n<\/ul>\n<p><a name=\"getting-started-egc1\"><\/a><\/p>\n<h2>Getting Started: eGC1 Review &amp; Approval<\/h2>\n<p>Clinical research agreements will often have two eGC1s, one for the pre-clinical confidentiality\/non-disclosure agreement (CDA\/NDA) and another for the study\/trial agreement. We recommend using the <a href=\"https:\/\/www.iths.org\/ctms\/ctms-submissions\/new-study-submissions\/\" target=\"_blank\" rel=\"noopener\">New Study Submission RedCap Survey<\/a> before submitting an eGC1 for the clinical trial agreement. Additionally, there are some <a href=\"#admin-steps\">administrative steps that can happen concurrently<\/a>.<br \/>\n<a name=\"pre-clinical-cda\"><\/a><\/p>\n<h3>Pre-Clinical Confidentiality Agreement eGC1<\/h3>\n<p>Most sponsors involved in clinical research projects require a confidentiality agreement (CDA) before sharing protocols or other proprietary information.<\/p>\n<p>When a sponsor asks you to enter into a CDA before the clinical study\/trial agreement is set up at the UW, you need to follow the UW\u2019s <a href=\"https:\/\/washington.edu\/research\/faq\/naa-egc1-instructions\/\">Non-Award Agreement (NAA) eGC1 instructions<\/a>. Make sure to attach the sponsor&#8217;s CDA and on the eGC1 select the Sponsored Program Activity Type (SPA): Clinical Trial: Non-Federal (including industry sponsors).<\/p>\n<p>If the sponsor wishes to enter into a Master CDA, review <a href=\"#mcta\">Master Agreement instructions<\/a>.<\/p>\n<p>If you need a confidentiality agreement, review the <a href=\"https:\/\/washington.edu\/research\/forms-and-templates\/sample-mutual-nda\/\">UW Approved Mutual NDA Sample Template<\/a>. Using a UW approved agreement can speed up OSPs review process.<\/p>\n<p>Review more information:<\/p>\n<ul>\n<li><a href=\"\/research\/myresearch-lifecycle\/setup\/collaborations\/sharing-information-and-data\/#cda-nda\">Confidentiality \/ Non-Disclosure Agreements<\/a><\/li>\n<li><a href=\"https:\/\/research-eval.ui.oris.washington.edu\/research\/faq\/naa-egc1-instructions\/\">Non-award agreement eGC1 instructions<\/a><\/li>\n<li><a href=\"https:\/\/research-eval.ui.oris.washington.edu\/research\/myresearch-lifecycle\/setup\/collaborations\/agreement-types\/\">Agreement Types<\/a><\/li>\n<li><a href=\"#gettting-started-egc1\">Getting Started: eGC1 Review &amp; Approval<\/a><\/li>\n<li><a href=\"#mcta\">Master Agreement Instructions<\/a><\/li>\n<\/ul>\n<p><a name=\"ct-cs-egc1\"><\/a><\/p>\n<h3>Clinical Trial\/Study Agreement eGC1<\/h3>\n<p>If the agreement includes funding, route an eGC1 and select <strong>Application Type<\/strong> New and After-the-Fact. Agreements that do not include funding\u00a0but the external party is providing a drug or device, route an eGC1 and select <strong>Non-award Agreement [New]<\/strong> or <strong>[Continuation]<\/strong>.<\/p>\n<p>Submit the following with the eGC1 and route to the Office of Sponsored Programs (OSP):<\/p>\n<ul>\n<li>Draft clinical trial agreement<\/li>\n<li>Draft clinical trial protocol<\/li>\n<li>Draft informed consent form (if available)<\/li>\n<li>eGC1 short title must include the RedCap identifier number that includes the prefix \u201cRG\u201d<\/li>\n<li>Correct F&amp;A rate used, if funding involved\n<ul>\n<li>As of 7\/01\/2025, studies that fall under this\u00a0<a href=\"https:\/\/washington.edu\/research\/glossary\/industry-clinical-trial\/\">definition of Industry Sponsored Clinical Trials<\/a> are to use\u00a0 a 35% Total Direct Cost (TDC) F&amp;A rate<\/li>\n<li>Please review more information and guidance on the\u00a0<a href=\"https:\/\/washington.edu\/research\/announcements\/new-industry-sponsored-clinical-trial-definition-and-rate-effective-july-1\/\">New Industry Sponsored Clinical Trial Definition and F&amp;A Rate \u2013 Effective July 1st<\/a>\u00a0and review these\u00a0<a href=\"https:\/\/washington.edu\/research\/faq\/industry-sponsored-clinical-trials-new-definition-and-fa-rate\/\">FAQs<\/a><\/li>\n<\/ul>\n<\/li>\n<li>Sponsor\/CRO contact information<\/li>\n<li>SFI Disclosures &#8211; All investigators need to be listed on the eGC1 and complete their SFI disclosures via the UW <a href=\"http:\/\/www.washington.edu\/research\/tools\/fids\/\">Financial Interest Disclosure System<\/a> (FIDs)<\/li>\n<li>If there is already a CDA, make sure to include the CDA eGC1 number on this clinical trial eGC1<\/li>\n<li>All new industry-sponsored trials using CTO Central Budget Development\/Negotiations services must follow these <a href=\"\/research\/announcements\/routing-industry-sponsored-trials-utilizing-cto-budget-development-negotiation-services\/\">instructions for REDCap &amp; Additional Information section in SAGE<\/a>. <em>Please note those instructions DO NOT apply to Hematology and Oncology trials.\u00a0<\/em><\/li>\n<\/ul>\n<h3>Advance Spending<\/h3>\n<p>After OSP approves your clinical trial\/study agreement eGC1, you will not yet have an Award created in Workday. However, your project may be eligible for Advance Spend.<\/p>\n<p>Review the <a href=\"\/research\/tools\/sage\/guide\/advances\/advance-request-overview\/\" target=\"_blank\" rel=\"noopener\">SAGE Advances Overview<\/a>. Getting an Advance set up in Workday will allow spending for start up costs before the award is finalized. It also helps if you need external IRB review or external vendor coverage analysis and have to provide HSD and\/or CTO with a UW Worktag.<\/p>\n<h3>IRB Review &amp; Fees<\/h3>\n<p>Human subjects research conducted by UW researchers must be reviewed by an Institutional Review Board (IRB). Industry sponsored clinical research involving human subjects is reviewed by one of the following external IRBs:<\/p>\n<ul>\n<li>An independent IRB such as WCG IRB or Advarra<\/li>\n<li>The Cancer Consortium IRB (CC-IRB) operated by Fred Hutchinson Cancer Research Center (FHCRC)<\/li>\n<\/ul>\n<p>IRB review fees and an <a href=\"\/research\/hsd\/is-the-uw-irb-the-right-irb\/identify-the-correct-irb\/industry-sponsored-research\/#admin\">HSD administrative fee<\/a> may need to be included in the budget.<\/p>\n<p>Review the UW Human Subjects Division information on:<\/p>\n<ul>\n<li><a href=\"h\/research\/hsd\/is-the-uw-irb-the-right-irb\/identify-the-correct-irb\/industry-sponsored-research\/#admin\">HSD Administrative Fee<\/a><\/li>\n<li><a href=\"\/research\/hsd\/do-i-need-irb-review\/\">Do I need IRB Review?<\/a><\/li>\n<li><a href=\"\/research\/hsd\/is-the-uw-irb-the-right-irb\/general-information\/\">Is the UW IRB the right IRB?<\/a><\/li>\n<\/ul>\n<h3>Significant Financial Interest (SFI) Review Complete<\/h3>\n<p>The Office of Research must review disclosures for <a href=\"\/research\/compliance\/financial-conflicts-of-interest-fcoi\/\">Financial Conflict of Interest<\/a> before OSP can release the funding. The Office of Research also will determine if a conflict management plan is required.<br \/>\n<a name=\"admin-steps\"><\/a><\/p>\n<h2>Administrative Steps that can Happen Concurrently<\/h2>\n<p>Many of the required administrative steps can happen concurrently. These include:<\/p>\n<ul>\n<li>OSP can begin review &amp; negotiation of the contract\/agreement after you submit the clinical trial\/study agreement eGC1<\/li>\n<li>Institutional Review Board (IRB) <a href=\"\/research\/hsd\/\">human subjects<\/a> research review<\/li>\n<li><a href=\"https:\/\/clinicaltrials.uwmedicine.org\/\" target=\"_blank\" rel=\"noopener\">Clinical Trial Office (CTO) billing compliance review<\/a><\/li>\n<li>Significant Financial Interest (SFI) Disclosure review<\/li>\n<\/ul>\n<p><a name=\"asr-and-agreement\"><\/a><\/p>\n<h2>Award Setup Requests &amp; the Agreement<\/h2>\n<p>After OSP approves your clinical trial\/study agreement eGC1, OSP creates an Award Set-Up Request (ASR) with basic information. OSP then begins review and negotiation of terms on the agreement with the external party.<\/p>\n<h3>Budget &amp; Approval of the Budget Summary<\/h3>\n<p>The UW Clinical Trials Office (CTO) performs coverage analysis, creates the billing plan, and conducts compliance review. CTO may also develop and negotiate your clinical trial budget upon request. Using the <a href=\"https:\/\/www.iths.org\/ctms\/ctms-submissions\/new-study-submissions\/\" target=\"_blank\" rel=\"noopener\">Study Submission Institutional Intake REDCap form<\/a> helps determine which studies must be entered into CTMS and undergo CTO billing review process.<\/p>\n<p>Once the budget is finalized, CTO performs the Summary Review by confirming that the budget terms align with the billing grid, the ICF and the contract. Once review is complete, CTO sends the final billing grid and budget to PI, and the PI responds to CTO with their approval.<\/p>\n<p>After the PI approves the budget &amp; billing grid, the PI\/study team must attach the following with the Award Setup or Modification request in SAGE:<\/p>\n<ul>\n<li>CTO summary review<\/li>\n<li>All summary review attachments<\/li>\n<li>PI approval of the budget as reviewed by CTO\n<ul>\n<li>Always include the final agreed upon draft budget and payment terms<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n<p>If these are not attached to the Award Setup Request (ASR) or Modification (MOD) before OSP completes their review, OSP will return the ASR\/MOD requesting these items.<\/p>\n<p>OSP cannot approve the ASR\/MOD and send to GCA for processing without these attachments.<\/p>\n<p>This is also a good time to link a SAGE Budget worksheet that follows the instructions on <a href=\"\/research\/learning\/online\/index.php\/lessons\/creating-a-clinical-trial-budget-for-sage-awards\/\" target=\"_blank\" rel=\"noopener\">Creating a Clinical Trials Budget for SAGE Awards Job Aid<\/a>.<\/p>\n<p>The OnCore Clinical Trial Management System (CTMS) handles generation of the invoices for these studies. OnCore is integrated with Workday so that once an invoice is generated in the OnCore CTMS, an invoice is generated in Workday, since Workday is the UW\u2019s system of record. The OnCore CTMS and Workday Invoice integration automatically increases the award total, award authorizations, award line amount, and plan amount (which flows to the budget seen in the R1234 report) based on the amount of the invoice generated in OnCore. This integration between the two systems is why ASRs and MODs in SAGE are sent over with a zero dollar SAGE budget. The Department remains responsible for tracking costs and accuracy of invoicing based on the current terms.<\/p>\n<h3>PI signature on Clinical Trial\/Study Agreements<\/h3>\n<p>For all clinical trial\/study agreements, the PI is responsible for the conduct of the trial, including ensuring that the consent form, clinical trial agreement, and trial budget are consistent with each other regarding who is paying for what (procedures, subject injuries), and who will have access to the identifiable data.<\/p>\n<p>Once the agreement is finalized, the PI must sign the agreement as \u201cread and understood\u201d ahead of OSP. The PI is representing that the final contract language is consistent with the approved consent language, among other terms set out in the agreement.<\/p>\n<p>PIs are not authorized to sign on behalf of the ÂÒÂ×ÉçÇø.<br \/>\n<a name=\"mcta\"><\/a><\/p>\n<h2>Master Clinical Trial Agreements<\/h2>\n<p>The Office of Sponsored Programs has Master Clinical Trial\/Study &amp; Confidentiality Agreements with many companies and Contract Research Organizations (CRO). <a href=\"\/research\/myresearch-lifecycle\/setup\/sponsor-requirements\/clinical-research\/master-clinical-trial-agreements\/\">Review the list<\/a>.<\/p>\n<h3>eGC1 Instructions for Master Agreements<\/h3>\n<p>Prepare a Non-Award Agreement eGC1 with the following fields:<\/p>\n<ul>\n<li>Short title: \u201cMASTER\u201d as a prefix to the short title name<\/li>\n<li>Sponsor: The other entity that is party to the agreement. This may be a CRO, if a Master Confidentiality Agreement. The UW does not typically enter into a Master CTA with a CRO.<\/li>\n<li>PI: Individual designated by involved schools\/colleges who will be responsible for the relationship with the sponsor overall. This PI may differ from PIs for individual work orders\/projects<\/li>\n<li>Cost center hierarchy: Driven by PI selection; at involved schools\u2019\/colleges\u2019 discretion.<\/li>\n<li>Budget: Not required even if Master involves a ceiling or total<\/li>\n<li>Dates: Reflect the effective date and end date of the Master Agreement<\/li>\n<li>Project Type: Contract<\/li>\n<li>Non-fiscal Compliance Information not relevant to a Master Agreement can be answered \u201cNo\u201d<\/li>\n<li>SFI disclosure:\n<ul>\n<li>Required for named PI; contemplated PIs for individual work orders do not need to be listed in the Personnel section and do not need to disclose SFI related to this Master agreement eGC1.<\/li>\n<li>Investigators are responsible for SFI disclosure when participating under subsequent projects and will make disclosures in relation to the Project eGC1s. If a Master CDA and CRO is listed as sponsor, investigators are responsible for disclosing SFI related to the company itself, not the CRO.<\/li>\n<\/ul>\n<\/li>\n<li>Editable version of the draft Agreement must be attached<\/li>\n<li>eGC1 preparer must also include or attach: A description of the envisioned relationship<br \/>\nscope of shared research interest areas and\/or departments\/schools that will be involved, and any advisory committee\/board membership information.<\/li>\n<li>Follow all other <a href=\"\/research\/faq\/naa-egc1-instructions\/\" target=\"_blank\" rel=\"noopener\">NAA eGC1 requirements<\/a><\/li>\n<\/ul>\n<p>The company will provide a study agreement under the Master to document this trial\u2019s details. Attach the study agreement to the eGC1 when routing to OSP.<\/p>\n<p>Review the<a href=\"\/research\/myresearch-lifecycle\/setup\/sponsor-requirements\/clinical-research\/master-clinical-trial-agreements\/\"> Master Agreement lists for clinical trials<\/a>.<br \/>\n<a name=\"abandoned\"><\/a><\/p>\n<h2>Abandoned Trials or Studies<\/h2>\n<p>From time to time, a trial or study is abandoned after start-up costs have been incurred. This happens when we are selected as a site but either the sponsor does not move forward, the UW chooses not to be a site after all, or some other reason prevents us from moving forward.<\/p>\n<p>Depending on what stage a clinical research award is in when it is abandoned, there are different steps you need to follow to be reimbursed by the sponsor.<\/p>\n<h3>Steps to Secure Sponsor Payment for Abandoned Clinical Research<\/h3>\n<p>If abandoned after an ASR is created and still with OSP:<\/p>\n<ul>\n<li>Ask OSP reviewer to return the ASR because it is being abandoned and to discontinue any negotiations.<\/li>\n<li>Attach an email or letter from CRO or sponsor indicating the amount to be reimbursed and this commitment is from an authorized individual with CRO or sponsor.<\/li>\n<li>Link a SAGE Budget with minimal information and a \u201c$0\u201d.<\/li>\n<li>List the anticipated reimbursement amount in the ASR.<\/li>\n<li>Return to OSP.<\/li>\n<\/ul>\n<p>If abandoned before an eGC1 has been created but expenses have been incurred:<\/p>\n<ul>\n<li>Route an <a href=\"\/research\/myresearch-lifecycle\/setup\/collaborations\/agreement-types\/after-the-fact-egc1-process\/\">ATF eGC1<\/a>.<\/li>\n<li>Attach an email or letter from CRO or sponsor indicating the amount to be reimbursed and this commitment is from an authorized individual with CRO or sponsor.<\/li>\n<li>OSP will create the Award Setup Request and return it to campus for completion.<\/li>\n<li>eGC1 Budget section: indicate total reimbursement amount, no budget needed.<\/li>\n<\/ul>\n<p>Generally, OSP does not sign an agreement to require payment for start-up costs ahead of CTA negotiations, in the event of a failed CTA negotiation.<\/p>\n<p>However, if an agreement is recommended due to the start-up cost risk associated with the type of trial, please ensure the general fees\/costs listed are consistent with budget guidelines from CTO and include the IRB fee. Please route the agreement on an NAA eGC1.<\/p>\n<p>If an agreement is put into place, make sure to include the agreement eGC1 number on the clinical trial eGC1.<\/p>\n<p>If the study is abandoned after a fully-executed CTA is in place, the CTA will have a budget\/payment section which includes the Sponsor&#8217;s agreement to provide payment according to the budget that is incorporated. Termination language will require reimbursement for costs incurred for all services properly performed and non-cancelable obligations.<br \/>\n<a name=\"changes\"><\/a><\/p>\n<h2>Agreement Amendments<\/h2>\n<p>Changes to a clinical trial agreement do not require another eGC1.<\/p>\n<p>Submit a Modification request following the guidance available for <a href=\"\/research\/myresearch-lifecycle\/manage\/award-changes\/#cta-changes\">Award Changes on Industry Sponsored Clinical Trials<\/a>.<br \/>\n<a name=\"balance\"><\/a><\/p>\n<h2>Remaining Balance on Clinical Trial Award?<\/h2>\n<p>Review GCA guidance on <a href=\"https:\/\/finance.uw.edu\/gca\/node\/1077\" target=\"_blank\" rel=\"noopener\">What if we have a residual balance? Can we keep it?<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>As of 7\/01\/2025, studies that fall under this\u00a0definition of Industry Sponsored Clinical Trials\u00a0are to use\u00a0 a 35% Total Direct Cost (TDC) F&amp;A rate. Please review more&#8230;<\/p>\n","protected":false},"author":13,"featured_media":0,"parent":449,"menu_order":4,"comment_status":"closed","ping_status":"closed","template":"templates\/page-builder-lifecycle.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-1303","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Clinical Research - UW Research<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.washington.edu\/research\/myresearch-lifecycle\/setup\/sponsor-requirements\/clinical-research\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Clinical Research - UW Research\" \/>\n<meta property=\"og:description\" content=\"As of 7\/01\/2025, studies that fall under this\u00a0definition of Industry Sponsored Clinical Trials\u00a0are to use\u00a0 a 35% Total Direct Cost (TDC) F&amp;A rate. 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