{"id":9208,"date":"2017-02-21T14:44:13","date_gmt":"2017-02-21T22:44:13","guid":{"rendered":"https:\/\/www.washington.edu\/research\/?page_id=9208"},"modified":"2025-11-24T12:38:38","modified_gmt":"2025-11-24T20:38:38","slug":"how-to-report-clinical-trial-results","status":"publish","type":"page","link":"https:\/\/www.washington.edu\/research\/hsd\/clinical-trials\/how-to-report-clinical-trial-results\/","title":{"rendered":"How to Update a Record or Report Results on ClinicalTrials.gov"},"content":{"rendered":"
All updates to study records occur in the CT.gov Protocol Registration and Results System (PRS). After initial registration, a record in PRS can be modified or updated at any time (except when the record is locked for PRS review). A list of all your records can be found on the Record List on the home page in PRS.<\/p>\n
For more detailed instructions on updating and maintaining records, see section\u00a07.1-Modifying a Record<\/strong> of the PRS User’s Guide<\/a>.<\/p>\n For active study records in PRS, there are specific deadlines and requirements for updating study information and some data elements must be updated sooner than others. The key updates and deadlines are outlined below. All deadlines are in calendar days<\/span>, not business days.<\/p>\n Failure to respond within the expected timeframe can lead to restrictions and penalties (Consequences and Penalties for Late Registration\/Results Reporting<\/a>).<\/li>\n Tip<\/strong>: Anytime a record is reviewed or changed, update the Record Verification date<\/strong> (in the \u2018Protocol\u2019 section, \u2018Study Status\u2019 module) to the current month and year before releasing it for review (see example below). This confirms that the record has been reviewed and when it was reviewed to ensure deadlines are met.<\/em><\/p>\n If a UW PI leaves the UW for another institution (which may require transferring the clinical trial to that institution), or there is a change in PI for a clinical trial, or there is a change to the study\u2019s PI Proxy or Primary Contact in Zipline, the study team should contact Regulatory Affairs team at hsdreprt@uw.edu as soon as possible. These changes affect who is responsible for maintaining the CT.gov record and ensuring compliance. Include \u2018CT.gov<\/strong>\u2019 in the subject line of your email to help triage your message efficiently.<\/p>\n Results for ACTs and NIH-funded clinical trials are required to report results on ClinicalTrials.gov. Results are entered into the trial record in PRS and are due within one year of the primary completion date<\/a>. Once data is entered into PRS, results are submitted to PRS staff for quality control review. Once accepted by quality control, the results are published on ClinicalTrials.gov.<\/p>\n TIP<\/strong>: Preparing data for the Results Section should involve individuals who are familiar with the study design and analysis (such as an investigator or statistician).<\/p>\n Results are reported by completing topic-specific sections (called modules) in PRS which include: Participant Flow, Baseline Characteristics, Outcome Measures, Adverse Events, Limits and Caveats and more information. Almost all information must be entered in tabular format.<\/p>\n A copy of the protocol and statistical analysis plan (SAP), if not included in the protocol, is required to be submitted as part of clinical trial results information for ACTs with a Primary Completion Date on or after January 18, 2017 (see ClinicalTrials.gov FAQ<\/a>). The responsible party may redact names, addresses, and other personally identifiable information, as well as any trade secret and\/or confidential commercial information contained in the protocol or statistical analysis plan prior to submission. The protocol and SAP can be uploaded to the \u2018Document Section\u2019 in the \u2018Record Summary\u2019 page.<\/p>\n Note: Results cannot be reported by uploading publications.<\/strong><\/em><\/p>\n Results should be posted no later than one year after the trial\u2019s primary completion date<\/a>. This requirement applies even if no participants were enrolled, or the study ended early or was terminated.<\/p>\n Section 8 of the PRS User\u2019s Guide<\/a> describes how to identify and resolve records with problems.<\/p>\n For specific questions related to updating your record or entering results, we recommend contacting register@clinicaltrials.gov for assistance.<\/p>\n For general questions, contact HSD at hsdreprt@uw.edu for assistance. Include \u2018CT.gov<\/strong>\u2019 in the subject line of your email to help triage your message efficiently.<\/p>\n For assistance with studies managed by the Cancer Consortium\u2019s Clinical Research Support (CRS) Office, contact CRS at CTgov@fredhutch.org. More information can also be found on the CRS webpage<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":" Contents How to Update a Record Deadlines for Updating Records Change of PI or PI’s institution, or changes to the PRS Access List How to Report…<\/p>\n","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-9208","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nDeadlines for Updating Records<\/h3>\n
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\nSee a detailed listing of the data elements and deadlines for updating the information at the CT.gov FAQ, When must I update clinical trial registration information?<\/a><\/li>\n<\/ol>\n
<\/p>\nChange of PI, PI’s institution, or changes to the PRS Access List<\/h3>\n
How to Report Results<\/h2>\n
Steps to enter results:<\/h4>\n
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What results must be reported<\/h3>\n
Results reporting resources<\/h3>\n
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Deadlines for reporting results<\/h3>\n
Possible exceptions:<\/h4>\n
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Resolving Problems<\/h2>\n