{"id":594,"date":"2016-10-31T14:05:35","date_gmt":"2016-10-31T18:05:35","guid":{"rendered":"https:\/\/www.bumc.bu.edu\/ohra\/?page_id=594"},"modified":"2026-06-14T16:30:04","modified_gmt":"2026-06-14T20:30:04","slug":"helpful-clinicaltrials-gov-guidance","status":"publish","type":"page","link":"https:\/\/www.bumc.bu.edu\/ohra\/clinicaltrials-gov\/helpful-clinicaltrials-gov-guidance\/","title":{"rendered":"Guidance and Helpful Tips"},"content":{"rendered":"

Guidance and Helpful Tips for Registering, Updating and Reporting Results on ClinicalTrials.gov<\/strong><\/h3>\n\n\n\n
For CTgov assistance<\/strong>, such as: accessing\/becoming a ClinicalTrials.gov user, registration of a clinical study to obtain the NCT identifier, resetting a forgotten password, posting results for registered studies, posting required documents, and scheduling an individual or group CTgov zoom training session\/s for PIs\/researchers and research team members<\/span><\/span><\/span> at the <\/span><\/span><\/strong>BU Medical Campus and <\/span><\/span><\/strong>BMC<\/span><\/span>, contact the BMC\/BUMC PRS Administrator (Karla Damus, damusk@bu.edu<\/a>,<\/span> 617 358 5337).<\/strong><\/p>\n

For CTgov assistance at the BU Charles River Campus<\/span><\/strong><\/span> contact the IRB Director and Clinical Trials Registration (<\/a>LaNeia Thomas, laneia@bu.edu<\/a>, 617 358 6346)<\/a>.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n

Classic ClinicalTrials.gov website was retired on June 25, 2024- <\/strong>The ClinicalTrials.gov Modernization Initiative (2019-2027)<\/a> is near completion and on June 25, 2024, the NLM’s modernized ClinicalTrials.gov website<\/a> became the singular public website experience for all users. On August 28, 2024 the Modernized beta PRS ClinicalTrials.gov website became the primary website for the institutional\/sponsor specific PRS. And beginning in July 2026, record registration will only be possible using the Modernized PRS<\/strong>. However, some PRS features can still only be done on the classic PRS so currently both the classic and the modernized PRS sites are available. For any questions or challenges navigating the modernized sites, contact the CTgov Administrator, damusk@bu.edu.<\/span><\/p>\n

BUMC\/BMC HRPP policies related to clnicaltrials.gov<\/strong> [Section 6.6.9 Registering, Updating, and Posting Requirements for Clinical Trials<\/a>]<\/p>\n

FAQs-<\/strong> ClinicalTrials.gov <\/a>provides a regularly updated, comprehensive list of frequently asked questions (FAQs) that provide the latest information about most topics and for additional questions, contact the PRS Administrator [damusk@vu.edu] or email ClinicalTrials.gov at register@clinicaltrials.gov<\/a><\/p>\n

CTgov updates<\/strong> to access the latest updates and news about clinicaltrials.gov go to this site\u00a0<\/a><\/span><\/p>\n

‘Getting to Know ClinicalTrials.gov’ section in the Clinical Research Times <\/strong>This section has articles with tips and information about ClinicalTrials.gov related to federal regulations, BMC\/BUMC HRPP policies, record registration, outcome measures, posting results, the modernization initiative and much more. To review the articles go to CR Times<\/a> and select ‘Archives’ in the banner. Then scroll down to: ‘To list articles sorted by date, select a category and click submit<\/em>‘ and from the drop down menu select\u00a0 ‘Getting to Know ClinicalTrials.gov’. All the articles will be listed.<\/span><\/p>\n

Please note:<\/span> <\/em>Published<\/strong>\u00a0results on CTgov<\/span> <\/b>[which is required for all Applicable Clinical Trials\/ACTs and for any clinical trial that receives NIH funding after Jan 17, 2017]<\/span>\u00a0<\/span><\/span><\/span>is\u00a0<\/span><\/span><\/span><\/span>NOT considered to be prior publication<\/span>.<\/span><\/strong>\u00a0 <\/span>http:\/\/www.icmje.org\/recommendations\/browse\/publishing-and-editorial-issu<\/a>es\/clinical-trial-registration.html\u00a0<\/a>(<\/a>paragraph 3 in Section 1). In addition, published results can be edited at any time<\/em> if needed (eg due to\u00a0<\/span>\u00a0<\/span>journal requests, <\/span>additional or re-analyses, or to correct identified errors).<\/span><\/p>\n

Data sharing required by ICMJE<\/strong><\/p>\n

    \n
  1. As of 1 July 2018 manuscripts submitted to ICMJE journals that report the results of clinical trials must contain a data sharing statement<\/span>.<\/li>\n
  2. Clinical trials that begin enrolling participants on or after 1 January 2019 must include a data sharing plan in the trial’s registration. If the data sharing plan changes after registration this should be reflected in the statement submitted and published with the manuscript, and updated in the registry record.<\/li>\n<\/ol>\n

    Data sharing statements must indicate the following: whether individual de-identified participant data (including data dictionaries) will be shared (\u201cundecided\u201d is not an acceptable answer); what data in particular will be shared; whether additional, related documents will be available (e.g., study protocol, statistical analysis plan, etc.); when the data will become available and for how long; by what access criteria data will be shared (including with whom, for what types of analyses, and by what mechanism).<\/p>\n

    Data sharing plan examples – http:\/\/www.icmje.org\/news-and-editorials\/data_sharing_june_2017.pdf<\/em><\/p>\n

    NIH Data Sharing Plans<\/strong><\/a><\/div>\n

     <\/p>\n

    CTgov Related Articles\u00a0\u00a0<\/strong>Links to scholarly publications about ClinicalTrials.gov and clinical research, written by ClinicalTrials.gov staff and others by year of the publications can be accessed through this link<\/a>.<\/strong> Titles of journal articles link to the PubMed\u00ae<\/a>\u00a0abstract for the publication, when available. Links to full-text versions of articles that are available for free are also provided.<\/p>\n

    CTgov informational podcast<\/strong><\/a>\u00a0 presented by Anna M. Fine, PharmD, MS, Acting Director CTgov on 6\/15\/2023 about ‘What Researchers and Recipients Should Know about ClinicalTrials.gov<\/em>‘<\/span><\/p>\n

    FDA ClinicalTrials.gov webinar<\/a>\u00a0<\/span><\/strong> In this webinar the FDA provides a general overview of ClinicalTrials.gov and relevant definitions, laws, and regulations for complying with ClinicalTrials.gov registration and results information submission requirements.<\/p>\n

    Related Websites<\/strong><\/p>\n

    ClinicalTrials.gov<\/strong><\/a><\/span><\/p>\n

    Register.clinicaltrials.gov<\/strong><\/a><\/span><\/p>\n

    FDAAA TrialsTracker<\/strong><\/a><\/p>\n

    \u00a0<\/span><\/p>\n","protected":false},"excerpt":{"rendered":"

    Guidance and Helpful Tips for Registering, Updating and Reporting Results on ClinicalTrials.gov For CTgov assistance, such as: accessing\/becoming a ClinicalTrials.gov user, registration of a clinical study to obtain the NCT identifier, resetting a forgotten password, posting results for registered studies, posting required documents, and scheduling an individual or group CTgov zoom training session\/s for PIs\/researchers […]<\/p>\n","protected":false},"author":1250,"featured_media":0,"parent":535,"menu_order":3,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/www.bumc.bu.edu\/ohra\/wp-json\/wp\/v2\/pages\/594"}],"collection":[{"href":"https:\/\/www.bumc.bu.edu\/ohra\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/www.bumc.bu.edu\/ohra\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/ohra\/wp-json\/wp\/v2\/users\/1250"}],"replies":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/ohra\/wp-json\/wp\/v2\/comments?post=594"}],"version-history":[{"count":41,"href":"https:\/\/www.bumc.bu.edu\/ohra\/wp-json\/wp\/v2\/pages\/594\/revisions"}],"predecessor-version":[{"id":3132,"href":"https:\/\/www.bumc.bu.edu\/ohra\/wp-json\/wp\/v2\/pages\/594\/revisions\/3132"}],"up":[{"embeddable":true,"href":"https:\/\/www.bumc.bu.edu\/ohra\/wp-json\/wp\/v2\/pages\/535"}],"wp:attachment":[{"href":"https:\/\/www.bumc.bu.edu\/ohra\/wp-json\/wp\/v2\/media?parent=594"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}