Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program

Clinical Trial Registration

Overview

Federal law and journal publication standards require that investigators register their clinical studies in a publicly accessible database. The ClinicalTrials.gov database is a tool to support compliance with these rules and regulations.

The FDA Amendments Act of 2007 (FDAAA) assigns this mandate to a "Responsible Party" and defines a set of "Applicable Clinical Trials" that must be registered. FDAAA stipulates that many prospective clinical trials involving drugs, biological products, and devices must be registered and a subset of these studies also must post results.

The International Committee of Medical Journal Editors (ICMJE) policy (adopted by over 1,000 journals, including JAMA and NEJM) is broader in scope than FDAAA. ICMJE policy requires study registration. The policy applies to research that prospectively assigns human subjects to intervention or comparison groups in order to look at the cause-and-effect relationship between an intervention and a heath outcome.

ClinicalTrials.gov contains information on publicly and privately funded clinical studies on a wide range of diseases and conditions. The registry aims to support improved transparency and to reduce duplication of effort by

  • Improving public access to information about clinical trials
  • Providing information for clinicians, to help their patients find appropriate trials
  • Providing researchers with an overview of a specific field of research, changes in study design, etc.

It is essential to understand which studies must be registered and who is responsible for ensuring this registration (and results reporting, if required) takes place. Noncompliance has serious repercussions for individuals, institutions, and research teams including but not limited to the rejection of manuscript submissions to journals (ICMJE) and withholding of grant funds and civil monetary penalties (up to $10,000 per day) (FDAAA). The resources below provide detailed information to help determine if your research falls within FDAAA and/or ICMJE requirements.

You should register your study under your institution's ClinicalTrials.gov account. For account information and to learn about how to register your study, contact your institution's Protocol Registration System (PRS) administrator. Once you have a ClinicalTrials.gov username and password, you can log in to your institution's account.

Resources

For Investigators
  • ClinicalTrials.gov: Why Does it Affect Me? Should I Be Concerned? [PDF]
    This overview presentation explains what ClinicalTrials.gov is, why you should register your study, who is responsible for registration, and includes practical examples and a list of resources (adapted from the CTSA consortium's Clinical Trials Registration Workgroup).
  • ClinicalTrials.gov: How to Register Your Trial [PDF]
    This presentation walks you through the ClinicalTrials.gov Protocol Registration System and the process for registering a study (adapted from the CTSA consortium's Clinical Trials Registration Workgroup).
  • ClinicalTrials.gov: Results Reporting from the Ground Up [PDF]
    This presentation walks you through the process for reporting study results in ClinicalTrials.gov (adapted from the CTSA consortium's Clinical Trials Registration Workgroup).
  • Top Ten Tips for Results Submission Success [PDF]
    This presentation provides practical, helpful hints on results reporting from Heather Dobbins, PhD, Lead Results Analyst at ClincialTrials.gov.
  • ClinicalTrials.gov: Final Rule - Special Topics [PDF]
    This presentation covers topics related to the requirements for registering and reporting summary results information to ClinicalTrials.gov, including clinical trial determination, expanded access, protocol and statistical analysis planning, certifying initial approval, and implementation. Presented by Rebecca Williams and Deborah Zarin at the October 20, 2016, ClinicalTrails.gov Taskforce.
  • Submitting Results to ClinicalTrials.gov [PDF]
    A guide to results reporting from Heather Dobbins, PhD, Lead Results Analyst at ClincialTrials.gov. (note: for current interface screenshots, see the CTSA presentation above).
  • Request a Consult
    The Biostatistics program at Harvard Catalyst offers assistance with reporting results to ClinicalTrials.gov to investigators within Harvard partnering institutions. To request help with results reporting, submit a consult request and indicate your needs for "ClinicalTrials.gov results reporting."
  • Additional Resources
For Institutions
  • ClinicalTrials.gov: Why Does it Affect Me? Should I Be Concerned? [PPT]
    This overview presentation may be used as a teaching tool to explain what ClinicalTrials.gov is, why investigators should register their studies, who is responsible for registration, and includes practical examples and a list of resources (adapted from the CTSA consortium's Clinical Trials Registration Workgroup).
  • ClinicalTrials.gov: How to Register Your Trial [PPT]
    This presentation may be used as a teaching tool to walk investigators through the ClinicalTrials.gov Protocol Registration System and the process for registering a study (adapted from the CTSA consortium's Clinical Trials Registration Workgroup).
  • ClinicalTrials.gov: Results Reporting from the Ground Up [PPT]
    This presentation walks you through the process for reporting study results in ClinicalTrials.gov (adapted from the CTSA consortium's Clinical Trials Registration Workgroup).
  • Top Ten Tips for Results Submission Success [PDF]
    This presentation provides practical, helpful hints on results reporting from Heather Dobbins, PhD, Lead Results Analyst at ClincialTrials.gov.
  • ClinicalTrials.gov: Final Rule - Special Topics [PDF]
    This presentation covers topics related to the requirements for registering and reporting summary results information to ClinicalTrials.gov, including clinical trial determination, expanded access, protocol and statistical analysis planning, certifying initial approval, and implementation. Presented by Rebecca Williams and Deborah Zarin at the October 20, 2016, ClinicalTrails.gov Taskforce.
  • Submitting Results to ClinicalTrials.gov [PDF]
    A guide to results reporting from Heather Dobbins, PhD, Lead Results Analyst at ClincialTrials.gov. (note: for current interface screenshots, see the CTSA presentation above).
  • Additional Resources

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