About CTD

The Clinical Trial Disclosure (CTD) group at the University of Miami was established in 2013.  While CTD has several compliance components, it also provides support and assistance to our research community. These are our services: 

  • One-on-One assistance with protocol registration and/or result reporting on ClinicalTrials.gov 
  • QC review of records on ClinicalTrials.gov (registration or results) 
  • Facilitate development of processes, procedures and/or workflows to support adherence to the regulations 
  • Development of resources and tools to facilitate compliance 

As the functions of the CTD group continue to evolve, the University of Miami research teams are valuable contributors to this evolution.  In our effort to maintain a collaborative relationship, we encourage you to submit questions and/or feedback by using our contact us form:  https://umiami.qualtrics.com/jfe/form/SV_9TrDAMDFkVIn2NU  'U' Matter! 

Accordion Group

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  • What is Clinical Trial Disclosure (CTD)?

    The act of making clinical trial information (protocol registration and protocol results) known and/or available to the public. 

    The University of Miami requires registration on ClinicalTrials.gov for all Clinical Trials (as defined by NIH), is under FDA Oversight with the use of a drug, device, or biologic, meets the ICMJE definition, and for all Clinical Studies/Registries with Medicare billing implications, prior to enrollment of the first participant. This is applicable to studies where the University of Miami Principal Investigator has initiated, sponsored or been designated the Responsible Party for registering such Clinical Trials. See UM Policy https://umhs-ummg.policystat.com/policy/token_access/628beb33-c8ef-422e-b7f2-f79acb2dbe1e/ 

     

    Below is a figure that depicts the regulations and requirements included in the University of Miami Policy on Clinical Trial Registration:  

     

    ctd

  • Why should we comply?

    The Food and Drug Administration (FDA), the National Institutes of Health (NIH), Centers for Medicaid and Medicare Services (CMS), and the International Committee of Medical Journal Editors (ICMJE), all have adopted regulations and/or requirements surrounding the registration and result reporting of clinical trials on the ClinicalTrials.gov website. 

    Not complying with any of these regulations and/or the University of Miami policy may result in the following: inability to publish; civil monetary penalties levied against the University; suspension of protocol approval from the IRB; loss of additional or continued funding from federal agencies and other entities or inadequate reimbursement. 

    Notice of Non-Compliance 

    Please contact the Clinical Trial Disclosure group at ctgovum@miami.edu or (305) 243-1107 if you are contacted by any agency, institution or group regarding lack of registration or result reporting. 

  • Does your study meet the requirements for CT.gov registration?

     

    UM Clinical Trial Tool: An online survey that facilitates determination if your study meets the requirements for registration on ClinicalTrials.gov per UM Policy. 

    CTD Determination: https://umiami.qualtrics.com/jfe/form/SV_8GlHlJm91F0vAJU 

     

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