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Registration of Clinical Research Trials

This guidance is intended to offer support to researchers at Dartmouth who must register and report clinical research trials to ClinicalTrials.gov, a database of clinical research trials conducted in the United States and around the world.

What is ClinicalTrials.gov?

ClinicalTrials.gov is a registry of federally and privately supported research studies conducted in the United States and around the world. Each entry is provided by the study sponsor and includes a summary of the trial, including the purpose, recruitment status, and criteria for patient participation. Study site locations and specific contact information are provided to assist enrollment. Some entries provide summary study results, including number of participants starting and completing the trial, baseline characteristics of participants, outcome measures, and adverse events information.

Over the past ten years, government agencies and the International Committee of Medical Journal Editors have issued laws and directives on the subject of trial registration. All parties have consistently agreed that the purpose of trial registration is to promote the public good by ensuring that the existence and design of clinically directive trials are publicly available. The registration effort began with the development of a publicly available Web site, ClinicalTrials.gov. ClinicalTrials.gov is a service of the NIH, developed by the National Library of Congress.

Why Register?

Required by law. Section 801 of the Food and Drug Administration (FDA) Amendments Act mandates the registration with ClinicalTrials.gov of certain clinical trials of drugs (including biological products) and medical devices subject to FDA regulations for any disease or condition.

For details, see http://prsinfo.clinicaltrials.gov/.

Required for journal publication. The International Committee of Medical Journal Editors (ICMJE) requires trial registration as a condition for publication of research results generated by a clinical trial.

For further information, please see http://www.icmje.org

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