[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"doc-detail-199604-en":3,"doc-seo-199604-105":29,"detail-sidebar-cat-0-en-105":90},{"code":4,"msg":5,"data":6},0,"success",{"doc_id":7,"user_id":8,"nickname":9,"user_avatar":10,"doc_module":4,"category_id":11,"category_name":12,"doc_title":13,"doc_description":14,"doc_content":15,"file_id":16,"file_url":17,"file_type":18,"file_size":19,"view_count":20,"is_deleted":4,"is_public":20,"is_downloadable":20,"audit_status":20,"page_count":20,"language":21,"language_code":22,"site_id":23,"html_lang":22,"table_of_contents":24,"faqs":25,"seo_title":26,"seo_description":14,"update_tm":27,"read_time":28},199604,5909877438554,"Maeve","https://ap-avatar.wpscdn.com/avatar/5600025385ad2bf12a7?_k=1778553567797529272",8,"Research & Report","Public Health Service, HHS § 11.44 - Submission Deadlines for Clinical Trial Results Information","This section defines when and who must submit clinical trial results information under HHS Public Health Service regulations. It requires the responsible party for applicable device clinical trials to post results within a standard deadline tied to the primary completion date, generally within one year, unless specific conditions support delayed submission. It also explains how submission timing can differ when seeking approval, licensure, or clearance for a new use, including certification-based triggers.","Public Health Service, HHS § 11 .44  \ntrial results information is required tobe posted, as specified in § 11 .52.  \n(2) For an applicable device clinical trial of a device product that has not been previously approved or cleared:  \n(i) The Director will post publicly on [ClinicalTrials.gov](ClinicalTrials.gov) the clinical trial registration information, except for certain administrative data, not earlier than the date of FDA approval or clearance of the device product and not later than 30 calendar days after the date of such approval or clearance, except as otherwise provided in paragraph (b)(2)(ii) of this section.  \n(ii) If, prior to the date of approval or clearance of the device product, the responsible party for an applicable clinical trial that is initiated on or after January 18, 2017, indicates to the Director, by submitting the Post Prior to U. S. FDA Approval or Clearance data element under § 11 .28(a)(2)(i)(Q), that it is authorizing the Director to publicly post its clinical trial registration information, which would otherwise be subject to delayed posting as specified in paragraph (b)(2)(i) of this section, prior to the date of FDA approval or clearance of its device product, the Director will publicly post the registration information, except for certain administrative data, as soon as practicable.  \nSubpart C—Results Information  \nSubmission  \n§ 11.40 Who must submit clinical trial results information?  \nThe responsible party for an applicable clinical trial specified in § 11 .42 must submit clinical trial results information for that clinical trial.  \n§ 11.42 For which applicable clinical trials must clinical trial results information be submitted?  \n(a) Applicable clinical trials for which the studied product is approved, licensed, or cleared by FDA. Unless a waiver of the requirement to submit clinical trial results information is granted in accordance with § 11 .54, clinical trial results information must be submitted for any applicable clinical trial for which the studied product is approved, licensed, or cleared by FDA for which submission of clinical trial registration  \ninformation is required in accordance with the following:  \n(1) If the primary completion date is before January 18, 2017, the responsible party must submit the clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U. S. C. 282(j)(3)(C) and 42 U. S. C. 282(j)(3)(I)); or  \n(2) If the primary completion date is on or after January 18, 2017, the responsible party must submit the clinical trial results information specified in § 11 .48.  \n(b) Applicable clinical trials for which the studied product is not approved, licensed, or cleared by FDA. Unless a waiver of the requirement to submit clinical trial results information is granted in accordance with § 11 .54, clinical trial results information specified in § 11 .48 must be submitted for any applicable clinical trial with a primary completion date on or after January 18, 2017 for which clinical trial registration information is required to be submitted and for which the studied product is not approved, licensed, or cleared by FDA.  \n§ 11.44 When must clinical trial results information be submitted for applicable clinical trials subject to § 11.42?  \n(a) Standard submission deadline. In general, for applicable clinical trials subject to § 11 .42, clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U. S.C. 282(j)(3)(C) and 42 U. S.C. 282(j)(3)(I)) orin § 11 .48, as applicable, must be submitted no later than 1 year after the primary completion date of the applicable clinical trial.  \n(b) Delayed submission of results information with certification if seeking approval, licensure, or clearance of a new use—(1) General requirements. If, prior to the results information submission deadline specified under paragraph (a) of this section, the responsible pa","cbCaigKieNaUOI5S","https://ap.wps.com/l/cbCaigKieNaUOI5S","pdf",196048,1,"English","en",105,"# § 11.40 Who must submit clinical trial results information?\n## § 11.42 For which applicable clinical trials must clinical trial results information be submitted?\n# § 11.44 When must clinical trial results information be submitted for applicable clinical trials subject to § 11.42?\n## Standard submission deadline\n## Delayed submission of results information with certification if seeking approval, licensure, or clearance of a new use","[{\"question\":\"Who is required to submit clinical trial results information?\",\"answer\":\"The responsible party for an applicable clinical trial specified in § 11.42 must submit the clinical trial results information for that trial.\"},{\"question\":\"Which clinical trials must have results information submitted under § 11.42?\",\"answer\":\"Results must be submitted for applicable clinical trials where the studied product is approved, licensed, or cleared by FDA, and also for certain trials with a primary completion date on or after January 18, 2017 where the studied product is not approved, licensed, or cleared, subject to waiver rules.\"},{\"question\":\"What is the standard deadline for submitting clinical trial results information?\",\"answer\":\"In general, results information must be submitted no later than 1 year after the primary completion date of the applicable clinical trial.\"}]","Public Health Service, HHS § 11.44 - Submission Deadlines for Clinical Trial Results Information | PDF",1788506467,3,{"code":4,"msg":30,"data":31},"ok",{"site_id":23,"language":22,"slug":32,"title":13,"keywords":33,"description":14,"schema_data":34,"social_meta":85,"head_meta":87,"extra_data":89,"updated_unix":27},"public-health-service-hhs-1144-submission-deadlines-for-clinical-trial-results-information","",{"@graph":35,"@context":84},[36,52,67],{"@type":37,"itemListElement":38},"BreadcrumbList",[39,43,47,49],{"item":40,"name":41,"@type":42,"position":20},"https://docshare.wps.com","Home","ListItem",{"item":44,"name":45,"@type":42,"position":46},"https://docshare.wps.com/document/","Document",2,{"item":48,"name":12,"@type":42,"position":28},"https://docshare.wps.com/document/research-report/",{"item":50,"name":13,"@type":42,"position":51},"https://docshare.wps.com/document/public-health-service-hhs-1144-submission-deadlines-for-clinical-trial-results-information/199604/",4,{"url":50,"name":13,"@type":53,"author":54,"headline":13,"publisher":56,"fileFormat":59,"inLanguage":22,"description":14,"dateModified":60,"datePublished":61,"encodingFormat":59,"isAccessibleForFree":62,"interactionStatistic":63},"DigitalDocument",{"name":9,"@type":55},"Person",{"url":40,"name":57,"@type":58},"DocShare","Organization","application/pdf","2026-09-05","2026-09-04",true,{"@type":64,"interactionType":65,"userInteractionCount":20},"InteractionCounter",{"@type":66},"ViewAction",{"@type":68,"mainEntity":69},"FAQPage",[70,76,80],{"name":71,"@type":72,"acceptedAnswer":73},"Who is required to submit clinical trial results information?","Question",{"text":74,"@type":75},"The responsible party for an applicable clinical trial specified in § 11.42 must submit the clinical trial results information for that trial.","Answer",{"name":77,"@type":72,"acceptedAnswer":78},"Which clinical trials must have results information submitted under § 11.42?",{"text":79,"@type":75},"Results must be submitted for applicable clinical trials where the studied product is approved, licensed, or cleared by FDA, and also for certain trials with a primary completion date on or after January 18, 2017 where the studied product is not approved, licensed, or cleared, subject to waiver rules.",{"name":81,"@type":72,"acceptedAnswer":82},"What is the standard deadline for submitting clinical trial results information?",{"text":83,"@type":75},"In general, results information must be submitted no later than 1 year after the primary completion date of the applicable clinical trial.","https://schema.org",{"og:url":50,"og:type":86,"og:title":13,"og:site_name":57,"og:description":14},"article",{"robots":88,"canonical":50},"index,follow",{"doc_id":7,"site_id":23},{"code":4,"msg":5,"data":91},[92,96,100,104,109,114,119,122,127,130,134],{"id":20,"doc_module":4,"doc_module_name":45,"category_name":93,"show_sort_weight":94,"slug":95},"Story & Novel",90,"story-novel",{"id":46,"doc_module":4,"doc_module_name":45,"category_name":97,"show_sort_weight":98,"slug":99},"Literature",80,"literature",{"id":51,"doc_module":4,"doc_module_name":45,"category_name":101,"show_sort_weight":102,"slug":103},"Exam",70,"exam",{"id":105,"doc_module":4,"doc_module_name":45,"category_name":106,"show_sort_weight":107,"slug":108},5,"Comic",60,"comic",{"id":110,"doc_module":4,"doc_module_name":45,"category_name":111,"show_sort_weight":112,"slug":113},6,"Technology",50,"technology",{"id":115,"doc_module":4,"doc_module_name":45,"category_name":116,"show_sort_weight":117,"slug":118},7,"Healthcare",40,"healthcare",{"id":11,"doc_module":4,"doc_module_name":45,"category_name":12,"show_sort_weight":120,"slug":121},30,"research-report",{"id":123,"doc_module":4,"doc_module_name":45,"category_name":124,"show_sort_weight":125,"slug":126},9,"Religion & Spirituality",20,"religion-spirituality",{"id":125,"doc_module":4,"doc_module_name":45,"category_name":128,"show_sort_weight":125,"slug":129},"World Cup","world-cup",{"id":131,"doc_module":4,"doc_module_name":45,"category_name":132,"show_sort_weight":131,"slug":133},10,"Lifestyle","lifestyle",{"id":135,"doc_module":4,"doc_module_name":45,"category_name":136,"show_sort_weight":105,"slug":137},19,"General","general"]