University of Colorado Denver

 

ClinicalTrials.gov Assistance

Registration and Maintenance of Studies on ClinicalTrials.gov

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Why list on ClinicalTrials.gov? The FDA is currently citing investigators for noncompliance with clinicaltrials.gov. Federal Law mandates that your clinical trial must be listed no later than 21 days after enrollment of your first patient. The ICMJE member journals will require, as a condition of consideration for publication in their journals, registration in a public trials registry (Guidelines ).   What is an applicable clinical trial? Interventional studies of drugs, biologics, & devices. NOT phase I drugs, NOT small feasibility devices US FDA jurisdiction (e.g. IND/IDE or US site) Clinical trial initiated on or after 9/27/2007 or ongoing as of 12/26/2007 During COMIRB panel review, COMIRB will decide if your trial is an applicable clinical trial (ACT) and therefore will need to be listed on clinicaltrials.gov. For an interactive flowchart to help you determine if your study will need to be registered see ClinicalTrials.gov Interactive Flowchart In 2005, the International Committee of Medical Journal Editors (ICMJE) approved publication guidelines that are different from the Food and Drug Administration Modernization Act (FDAMA) concerning the type of studies that need to be registered with ClinicalTrials.gov. The ICMJE guidelines state that prospective registration is required to be eligible for publication. This includes interventional-ALL phases and ALL intervention types. A number of faculty have had journal articles rejected because their study has not been appropriately registered. For more information on the ICMJE publishing criteria, please visit FAQs What are my responsibilities as an investigator? If you currently have a clinical trial posted, log into your account and verify/update the clinical trial information as soon as possible. Your clinical trial record must be verified or updated every six months. You are responsible for registering your clinical trial, keeping it up to date and submitting your results within one year of primary completion date. You need your OWN individual username and password.