Clinicaltrials.gov

Does your trial need to be registered on clinicaltrials.gov? Do you currently hold an account to register study protocols on NIH site (clinicaltrials.gov)?

The ClinicalTrials.gov Protocol Registration System (PRS) is a web-based tool developed for submitting clinical trials information to ClinicalTrials.gov.

The sponsor (or for investigator-initiated studies, the Principal Investigator) is required by law to register and submit summary results of clinical trials with ClinicalTrials.gov. The law applies to certain clinical trials of drugs (including biological products) and medical devices.

In addition, the International Committee of Medical Journal Editors (ICJME) has established a requirement that all clinical trials be entered in a public registry before the onset of patient enrollment, as a condition of consideration for publication.

You must have a user ID and password to register your trials on clinicaltrials.gov. Contact Lori Elder in the SOM Clinical Trials Office (lje5u@hscmail.mcc.virginia.edu) to request a user ID.

Click here to register your trial on clinicialtrials.gov
When required by law
ICMJE’s clinical trial registration policy
Journals following the ICMJE’s registration policy