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is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.

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.

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 (): 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

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. Chest. 2007;131(3):909-12. [ ]

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

Source: Tse T, Williams RJ, Zarin DA. Chest. 2009;136(1):295-303. [ ]

Sponsor-initiated trials and multicenter trials will have designated Responsible Parties designated to register 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, Research Integrity & Security staff will register the trial in consultation with researchers. Research Integrity & Security staff will also assign user accounts to researchers for access to the study record.

Â鶹´«Ã½AV researchers and clinical research coordinators should contact Research Integrity & Security to request a University-associated user account.

Research Integrity & Security has a Clinical Trials Registry Data Form available in IRBNet to collect needed data elements for initial data entry on the researchers’ behalf.