Main Menu - Harvard Catalyst Main Menu – Harvard Catalyst
Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program

Clinical Trial Registration and Results Reporting

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.

Harvard Catalyst Clinical Trials Registration & Results Reporting (CTR3) Subcommittee

The Clinical Trials Registration and Results Reporting (CTR3) subcommittee has been formed to develop and provide resources to help administrators, investigators, and other research staff involved in registration and results reporting for ClinicalTrials.gov.

CTR3 Resources

  • Registration Tip Sheet [PDF]
  • Results Reporting Data Elements Overview [PDF]
  • Outcome Measure Considerations [PDF]

To request Word documents, email us.

Other Helpful Resources

Contacts

Isabel Chico-Calero
CTR3 Co-Chair
Email

Cynthia Monahan
CTR3 Co-Chair
Email

Aaron Kirby, MSc
Director, Regulatory Affairs Operations
Email

Jacquelyn-My Do
Regulatory Affairs Officer
Email

Footer - Harvard Catalyst Footer – Harvard Catalyst