{"id":9204,"date":"2017-02-21T14:41:35","date_gmt":"2017-02-21T22:41:35","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=9204"},"modified":"2026-01-30T10:37:09","modified_gmt":"2026-01-30T18:37:09","slug":"clinical-trials-registration-and-reporting-questions-and-answers","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/clinical-trials\/clinical-trials-registration-and-reporting-questions-and-answers\/","title":{"rendered":"CT.gov Registration and Reporting FAQ"},"content":{"rendered":"<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">I'm not sure whether my clinical trial requires registration on ClinicalTrials.gov. How do I decide?<\/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>HSD will assess your study when you submit an IRB application or Request for External IRB Review in Zipline. See the related information on <a href=\"https:\/\/www.washington.edu\/research\/hsd\/clinical-trials\/\">our main ClinicalTrials.gov webpage<\/a>. <em>Note: HSD\u2019s assessment may be overridden by a federal agency or sponsor but not by the  91探花PI<\/em>.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">My study involves a drug or device but it doesn't need an IND or IDE from the FDA. Is it still an applicable clinical trial that requires registration on ClinicalTrials.gov?<\/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>Having an <a href=\"https:\/\/www.washington.edu\/research\/glossary\/investigational-new-drug-ind\/\" target=\"_blank\" rel=\"noopener noreferrer\">IND<\/a> or <a href=\"https:\/\/www.washington.edu\/research\/glossary\/investigational-device-exemption-ide\/\" target=\"_blank\" rel=\"noopener noreferrer\">IDE<\/a> is not an essential part of the U.S. Food and Drug Administration&#8217;s (FDA) definition of \u2018applicable clinical trial\u2019 (ACT). Clinical trials that are determined to be <a href=\"https:\/\/grants.nih.gov\/grants\/glossary.htm#ApplicableClinicalTrial(ACT)\" target=\"_blank\" rel=\"noopener noreferrer\">ACTs<\/a> per <a href=\" https:\/\/clinicaltrials.gov\/policy\/fdaaa-801-final-rule\" target=\"_blank\" rel=\"noopener noreferrer\">Section 801 of the Food and Drug Administration Amendments Act (FDAAA)<\/a>, are required to register and report results information on CT.gov. ACTs include the following:<\/p>\n<ul>\n<li>Controlled clinical investigations (other than phase 1 investigations) of any FDA-regulated drug or biological product for any disease or condition<\/li>\n<li>Certain studies of FDA-regulated medical devices, excluding small clinical trials to determine feasibility and certain clinical trials to test prototype devices, but including FDA-required <a href=\"https:\/\/clinicaltrials.gov\/policy\/fdaaa-801-final-rule#PedPostmarket\" target=\"_blank\" rel=\"noopener noreferrer\">pediatric postmarket surveillances<\/a> of a device product<\/li>\n<\/ul>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">My clinical trial is being conducted with study participants in another country. Does it require registration on ClinicalTrials.gov'?<\/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>Yes, if the study meets FDAAA or National Institutes of Health (NIH) registration and results reporting requirements. Conducting the trial internationally does not exempt it from registration.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">My study is an 'applicable clinical trial' as defined by the FDA and is also funded by NIH. Does that mean I need to register my study twice?<\/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>No. A single registration covers both requirements.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">I am the PI on a  91探花site that is participating in a multi-site clinical trial. Do I need to register the study?<\/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>No, you do not need to register the study unless you are the sponsor or Lead PI for the overall trial.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">My study is not yet approved by the IRB. Can I complete registration for it on ClinicalTrials.gov?<\/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>Yes, after you receive an email from HSD regarding initiation of trial registration. However, you must update the record when you receive IRB approval. If registration is voluntary, email <a href=\"mailto:hsdreprt@uw.edu\">hsdreprt@uw.edu<\/a> to initiate study registration. <\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">Can a study coordinator (or other person) register the trial instead of the PI?<\/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>Yes. Anyone who has a user account in ClinicalTrials.gov <a href=\"https:\/\/register.clinicaltrials.gov\/\" target=\"_blank\" rel=\"noopener noreferrer\">Protocol Registration and Results System (PRS)<\/a> can enter the information in the record. However, entering the data requires someone who is thoroughly knowledgeable about the specific details of the study design, eligibility criteria, intervention\/cohorts, and outcome measures. Entering study results may require someone with a deep understanding of the data and the statistical analyses that were performed. <strong>Regardless of who enters the information, only the Responsible Party (at UW, this is the PI) can initiate the Approve and Release actions required for the record.<\/strong><\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">I am the PI on two clinical trials. Do I need a different user account for each clinical trial?<\/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>No, unless you are acting as an agent of one institution for one trial and the agent of another institution for the second trial. You can use your  91探花user account for any number of clinical trials in which the  91探花is engaged in the research.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">Is the registration process different for my studies that are reviewed by the Fred Hutch IRB?<\/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>The Fred Hutch Clinical Research Support (CRS) Office  assists with the registration process for relevant oncology studies by Cancer Consortium members. Following the initial CT.gov registration, the CRS Office also provides assistance with subsequent record updates and results reporting questions. For assistance from the CRS Office, contact the CRS CT.gov team at CTgov@fredhutch.org. More information can also be found on the <a href=\"https:\/\/urldefense.com\/v3\/__https:\/www.cancerconsortium.org\/research-support\/clinical-research-support\/resources\/clinical-trial-registries.html__;!!K-Hz7m0Vt54!mbXZ9nAISRh998AX4G7hdf5bdES5wbPm2czu_QZ-2iB4OgpsedaXrdMofcfra1h4-iMjrE6dFe1zgEBTFtXU$\" target=\"_blank\" rel=\"noopener noreferrer\">Cancer Consortium webpage<\/a>.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">What if my  91探花study is reviewed by a non- 91探花IRB, such as WCG IRB or Seattle Children's IRB?<\/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>If the  91探花study meets the criteria for registration and reporting on ClinicalTrials.gov, and you are the Responsible Party, you must register your study through the <strong>UWashington<\/strong> organizational PRS account, regardless which IRB conducts review. <\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">Can I register my study any time after it has started, has closed to recruitment or has been completed?<\/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>Only if the registration is voluntary.  For trials that are required to register, see <a href=\"https:\/\/www.washington.edu\/research\/hsd\/clinical-trials\/\">our main ClinicalTrials.gov webpage<\/a> for registration deadlines, as well as consequences and penalties for not registering as required.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">When will the registration number (called the NCT number) be assigned to my study?<\/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>Your registration record must be \u201creleased\u201d by the Responsible Party (the PI), and then it must be released by the ClinicalTrials.gov PRS staff after passing their QC (quality control) review. At that time, an email notification with the NCT number is sent. The record, including its NCT number, will typically be available on ClinicalTrials.gov within 2-5 business days after final release.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">What are the most common causes of delayed PRS reviews?<\/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>PI failure to approve and release a study record. Failure to fully address PRS review comments. The PRS sends automated emails to the Record Owner and PI when additional actions are required. These emails are often overlooked or end up in a spam folder. For this reason, it is advisable to review the PRS record periodically after releasing an updated record for PRS review so that you can submit a timely response.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">Do I need to tell my study participants that the trial will be registered?<\/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>Yes. The FDA regulations and the NIH policy require the following statement to be provided, without revision, in the consent form(s): <\/p>\n<p><em>A description of this clinical trial will be available on http:\/\/www.clinicaltrials.gov, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time.<\/em><\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">What should I tell my study participants if they are concerned about this website?<\/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>All results information is aggregated, summary level data. No data for individually-identifiable study participants is reported.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">Can a clinical trial's record in ClinicalTrials.gov be transferred from one organization's account to another? (For example, when a PI moves to the  91探花from another institution, or leaves the UW)<\/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>Yes, and it is important to do this as soon as possible. Contact HSD through <a href=\"mailto:hsdreprt@uw.edu\">hsdreprt@uw.edu<\/a> for assistance.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">Am I still required to report results if my registered study terminates (stops prematurely) before completing the planned enrollment?<\/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>Yes, even if no study participants were ever recruited.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">How do I submit results for a clinical trial that was terminated (i.e., stopped prematurely) and had no participants enrolled?<\/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>If no participants were enrolled in the trial, set the Overall Recruitment Status to Withdrawn, and no results information will need to be submitted.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">How do I submit results for a terminated trial where participants were enrolled, but no data was collected for one or more Outcome Measures?<\/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>For a trial that was terminated after participants were enrolled, provide any available data. If no data are available for any of the Outcome Measures, specify zero (\u201c0\u201d) for the Number of Participants Analyzed and leave the data fields blank in each Arm\/Group. Provide an explanation in the Analysis Population Description to explain that the trial was terminated before the outcome measure data were collected. If applicable, provide additional details in the Limitations and Caveats module. All other required results information collected for the enrolled participants will need to be submitted in each results module even though no data were collected for one or more Outcome Measures.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">How will reporting my results on ClinicalTrials.gov affect my ability to publish the results?<\/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>There will be no effect on your ability to publish. The results are posted on ClinicalTrials.gov as aggregates and summaries. The International Committee of Medical Journal Editors (ICMJE) has stated that submission of summary results to ClinicalTrials.gov will not be considered to be \u201cprior publication\u201d and will therefore not interfere with journal publication.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">Can I meet the results reporting requirement by uploading a manuscript or publication?<\/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>No. The results must be reported within the tabular format required by the PRS system.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">My publisher is saying they cannot publish my results because the study wasn\u2019t registered in ClinicalTrials.gov, even though registration wasn\u2019t otherwise required. What do I do?<\/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>Contact the  91探花PRS administrators at <a href=\"mailto:hsdreprt@uw.edu\">hsdreprt@uw.edu<\/a> as soon as possible to request assistance with study registration.<\/p>\n<\/div>\n<\/div>\n<\/div>\n<div class=\"accordion non-bold\" id=\"accordion\">\n<div class=\"screen-reader-text\"><\/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\">How do I confirm that my study results have been posted and no further actions on my part are required?<\/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>Results reporting is considered complete when the PRS record indicates ALL of the following: 1) \u2018Overall Status\u2019 = \u2018Completed\u2019, \u2018Terminated\u2019, or \u2018Withdrawn\u2019, 2) \u2018Record Status\u2019 = \u2018Public\u2019, 3) \u2018Results Status\u2019 = \u2018Posted\u2019, 4) there are no problems noted in the record, and 5) there is a final \u2018Publish\u2019 date under the PRS Review History link. <\/p>\n<\/div>\n<\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"","protected":false},"author":117,"featured_media":0,"parent":9197,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"templates\/page-builder-units-small-hero.php","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-9204","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.1.1 - 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