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The guide outlines legal and policy requirements for registration and results reporting, including key timelines, noncompliance consequences, and responsible party responsibilities.",{"@graph":14,"@context":72},[15,34,55],{"@type":16,"itemListElement":17},"BreadcrumbList",[18,23,27,31],{"item":19,"name":20,"@type":21,"position":22},"https://docshare.wps.com","Home","ListItem",1,{"item":24,"name":25,"@type":21,"position":26},"https://docshare.wps.com/template/","Template",2,{"item":28,"name":29,"@type":21,"position":30},"https://docshare.wps.com/template/forms/","Forms",3,{"item":32,"name":10,"@type":21,"position":33},"https://docshare.wps.com/template/clinicaltrialsgov-registration-and-results-guide-instructions/164523/",4,{"url":32,"name":10,"@type":35,"image":36,"author":41,"headline":10,"publisher":44,"fileFormat":47,"inLanguage":8,"description":12,"dateModified":48,"datePublished":49,"encodingFormat":47,"isAccessibleForFree":50,"interactionStatistic":51},"DigitalDocument",{"url":37,"@type":38,"width":39,"height":40},"https://docshare.wps.com/thumbnails/clinicaltrialsgov-registration-and-results-guide-instructions/164523.png","ImageObject",442,249,{"name":42,"@type":43},"Berry Peter","Person",{"url":19,"name":45,"@type":46},"DocShare","Organization","application/vnd.openxmlformats-officedocument.wordprocessingml.document","2026-09-23","2026-08-31",true,{"@type":52,"interactionType":53,"userInteractionCount":26},"InteractionCounter",{"@type":54},"ViewAction",{"@type":56,"mainEntity":57},"FAQPage",[58,64,68],{"name":59,"@type":60,"acceptedAnswer":61},"When should registration and results reporting happen for a clinical study?","Question",{"text":62,"@type":63},"The guide recommends registering before the first subject enrollment and obtaining an NCT number if results will be published. Standard results submission is due no later than 1 year after the ACT primary completion date.","Answer",{"name":65,"@type":60,"acceptedAnswer":66},"What restrictions exist on requesting delayed results submissions?",{"text":67,"@type":63},"As of January 25, 2022, PRS no longer permits late “Good Cause Extension” requests for ACTs with primary completion dates on or after January 18, 2017. A good cause extension must be requested via the PRS before the results due date.",{"name":69,"@type":60,"acceptedAnswer":70},"What are the consequences of failing to comply with registration and results reporting?",{"text":71,"@type":63},"The FDA issues notices of noncompliance and the violation becomes publicly available on the noncompliant study record. As of July 21, 2022, noncompliance may result in fines per study per day for investigators and institutions, and NIH-funded studies may lose remaining or future funding.","https://schema.org",{"og:url":32,"og:type":74,"og:title":10,"og:site_name":45,"og:description":12},"article",{"robots":76,"canonical":32},"index,follow",{"doc_id":78,"site_id":7},164523,1790163893,{"code":4,"msg":81,"data":82},"success",[83,88,93,98,103,108,112,117,122],{"id":84,"doc_module":22,"doc_module_name":25,"category_name":85,"show_sort_weight":86,"slug":87},11,"Presentations",90,"presentations",{"id":89,"doc_module":22,"doc_module_name":25,"category_name":90,"show_sort_weight":91,"slug":92},12,"Resumes",80,"resumes",{"id":94,"doc_module":22,"doc_module_name":25,"category_name":95,"show_sort_weight":96,"slug":97},14,"Invoices",70,"invoices",{"id":99,"doc_module":22,"doc_module_name":25,"category_name":100,"show_sort_weight":101,"slug":102},15,"Posters",60,"posters",{"id":104,"doc_module":22,"doc_module_name":25,"category_name":105,"show_sort_weight":106,"slug":107},16,"Social Media",50,"social-media",{"id":109,"doc_module":22,"doc_module_name":25,"category_name":29,"show_sort_weight":110,"slug":111},17,40,"forms",{"id":113,"doc_module":22,"doc_module_name":25,"category_name":114,"show_sort_weight":115,"slug":116},18,"Letters",30,"letters",{"id":118,"doc_module":22,"doc_module_name":25,"category_name":119,"show_sort_weight":120,"slug":121},21,"Paper Templates",5,"papers-templates",{"id":123,"doc_module":22,"doc_module_name":25,"category_name":124,"show_sort_weight":4,"slug":125},158,"General","general-158",{"code":4,"msg":81,"data":127},{"doc_id":78,"user_id":128,"nickname":42,"user_avatar":129,"doc_module":22,"category_id":109,"category_name":29,"doc_title":10,"doc_description":12,"doc_content":130,"file_id":131,"file_url":132,"file_type":133,"file_size":134,"view_count":26,"is_deleted":4,"is_public":22,"is_downloadable":22,"audit_status":22,"page_count":135,"language":136,"language_code":8,"site_id":7,"html_lang":8,"table_of_contents":137,"faqs":138,"seo_title":139,"seo_description":12,"update_tm":140,"read_time":89},1374402524268,"https://ap-avatar.wpscdn.com/davatar_3d24733baf745e90a7e4bdd5f77d97b2","ClinicalTrials.gov Registration and Results Guide\nClinicalTrials.gov (CT.gov) is a publicly available registry and results database of federally and privately supported clinical trials conducted in the United States and around the world.  It is maintained by the National Library of Medicine (NLM) of the National Institutes of Health (NIH).  Clinicaltrials.gov captures significant summary protocol information before and during the trial as well as summary results and adverse event information of a completed trial.  The website helps patients find trials, enhances the design of clinical trials and prevents duplication of unsuccessful or unsafe trials, improves the evidence base that informs clinical care, increases the efficiency of drug and device development processes, improves clinical research practice, and builds public trust in clinical research.  Federal laws and regulations as well as editors of prominent medical journals require registration of a clinical trial, as described below.\nImportant Notices:\nRegistration and Results Reporting Timelines\nIf you plan on publishing your study results, it is highly recommended that you register prior to the first subject enrollment (study must have an NCT number) due to ICMJE policy (see page 9 for more information).\nNo “Delayed Results Extension” After 1 Year Due Date\nAs of January 25, 2022, the PRS no longer permits Responsible Parties to submit Good Cause Extension requests late for ACTs with a primary completion date on or after January 18, 2017.\nA Responsible Party may request to delay the submission of results information for an ACT by submitting a good cause extension request via the ClinicalTrials.gov Protocol Registration and Results System (PRS) prior to the date (i.e., the day before) that results information would otherwise be due.  The standard submission deadline for results information is no later than 1 year after the ACT's primary completion date.\nThe extension request must include a description of the reasons that the responsible party believes constitute good cause to justify an extension and an estimated date on which the results information will be submitted, with sufficient detail to allow for evaluation of the request.\nConsequences for Noncompliance\nAs of August 2021, the FDA started issuing notices of noncompliance to individual investigators for failing to report study results. In addition to receipt of a letter from the FDA that outlines the details and time frame for remedying the violation and potential penalties for continued noncompliance, information regarding the violation will be publicly available on the noncompliant study record in ClinicalTrial.gov (see example below).\nAs of July 21, 2022, noncompliance with ClinicalTrials.gov registration and results reporting may result in fines of $14,262 per study/per day for PIs and institutions.  In addition to civil monetary penalties, violations of section 301(jj) of the FD&C Act (21 U.S.C. 331(jj)) could result in other regulatory action, such as injunction and/or criminal prosecution.\nFor an NIH funded study for which a grantee is the responsible party, failure to submit required results information could result in NIH not releasing remaining funding for a grant or funding for a future grant.\nPolicy for Responsible Party (RP) when leaving the University at Buffalo\nOnce your study is made public on ClinicalTrials.gov, it will remain on the website permanently.  If you leave the University at Buffalo, you must provide your future contact information to the UB CT.gov administrator before you leave UB so that the change can be made in the CT.gov study record.  If another PI is taking over the study responsibilities for you, you must provide the new information of the new Responsible Party to the UB CT.gov administrator before you leave UB.\n\u000f\nTable of Contents\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc127340641\" \u0014What is required?\t\u0013 PAGEREF _Toc127340641 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc127340642\" \u0014Which studie","cbCaiarxISP3AdVH","https://ap.wps.com/l/cbCaiarxISP3AdVH","docx",640905,33,"English","# What is required?\n## Which studies need to be registered in ClinicalTrials.gov?\n# Registration requirements by policy and law\n## Registration is Required by Law for Applicable Clinical Trials (ACT) (FDAAA Law)\n## Registration is Required for NIH-funded Clinical Trials (NIH Policy)\n## Registration is Required for Publication (ICMJE Policy)\n## Registration is Required When Billing Centers for Medicare and Medicaid Services (CMS)\n## Registration is Required for National Cancer Institute (NCI) Supported Clinical Trials\n## Registration is Required for Patient-Centered Outcomes Research Institute (PCORI)\n# How to get started\n## How do I get started with registering my study?\n## Protocol Registration and Results System (PRS)\n## How to Register a Study\n## Maintaining the Record\n## Entering Results Data\n## Consent Form Posting\n## Tips for Success\n## Frequently Asked Questions\n## Websites\n## Additional Resources\n## Sample Cover Page for Protocol, Statistical Plan and ICF","[{\"question\":\"When should registration and results reporting happen for a clinical study?\",\"answer\":\"The guide recommends registering before the first subject enrollment and obtaining an NCT number if results will be published. Standard results submission is due no later than 1 year after the ACT primary completion date.\"},{\"question\":\"What restrictions exist on requesting delayed results submissions?\",\"answer\":\"As of January 25, 2022, PRS no longer permits late “Good Cause Extension” requests for ACTs with primary completion dates on or after January 18, 2017. A good cause extension must be requested via the PRS before the results due date.\"},{\"question\":\"What are the consequences of failing to comply with registration and results reporting?\",\"answer\":\"The FDA issues notices of noncompliance and the violation becomes publicly available on the noncompliant study record. As of July 21, 2022, noncompliance may result in fines per study per day for investigators and institutions, and NIH-funded studies may lose remaining or future funding.\"}]","ClinicalTrials.gov Registration and Results Guide - Instructions | DOCX",1788154868]