Clinical trial registration frequently asked questions
The information found here is adapted from The NIH U.S. National Library of Medicine, clinicaltrials.gov.
This page contains links to 3rd party online content. If you experience any issues accessing this content, please contact Research Integrity.
What is ClinicalTrials.gov?
ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
Why do clinical trials need to be registered at ClinicalTrials.gov?
Section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) requires registration of all clinical trials and reporting of results.
The International Committee of Medical Journal Editors (ICMJE) requires registration of clinical trials.
What trials are considered applicable clinical trials that must be registered in ClinicalTrials.gov?
Applicable Clinical Trials include the following:
- Trials of drugs and biologics: Controlled clinical investigations, other than phase 1 clinical investigations, of drugs or biological products subject to Food and Drug Administration (FDA) regulation
- Trials of devices (see note): 1) Controlled trials with health outcomes of devices subject to FDA regulation, other than small feasibility studies, and 2) pediatric postmarket surveillance required by FDA
What is the purpose of clinical trial registration?
Purposes of clinical trial registration and the groups that benefit Registry Purpose Groups that Benefit Fulfill ethical obligations to participants and the research community Patients, the general public, the research community Provide information to potential participants and referring clinicians Patients, clinicians Reduce publication bias Users of the medical literature Help editors and others understand the context of study results Journal editors, users of the medical literature Promote more efficient allocation of research funds Granting agencies, the research community Help institutional review boards (IRBs) determine the appropriateness of a research study IRBs, ethicists
Source: Zarin DA, Keselman A. Registering a clinical trial in ClinicalTrials.gov. Chest. 2007;131(3):909-12. [ Full text found in Chest Journal]
What is the purpose of clinical trial results dissemination?
Purposes of clinical trial results dissemination Results Database Purpose Groups that Benefit Provide a public record of basic study results in a standardized format Researchers, journal editors, IRBs, ethicists Promote the fulfillment of ethical obligations to participants and the overall contribution of research results to medical knowledge Patients, the general public, the research community Reduce publication and outcome reporting biases Users of the medical literature Facilitate systematic reviews and other analyses of the research literature Researchers, policymakers
Who registers clinical trials in ClinicalTrials.gov?
Sponsor-initiated trials and multicenter trials will have designated Responsible Parties designated to registrer trials in Clinical Trials.gov.
For investigator-initiated studies, generally internally sponsored or where the PI is the primary awardee of a federal research award, RIO staff will register the trial in consultation with researchers. Research Integrity staff will also assign user accounts to researchers for access to the study record.
University of Nevada, Reno researchers and clinical research coordinators should contact Research Integrity to request a University-associated user account.
Research Integrity has a Clinical Trials Registry Data Form available in IRBNet to collect needed data elements for initial data entry on the researchers’ behalf.