Clinical trial registration frequently asked questions
The information found here is adapted from The .
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
| 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. [ ]
| 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.
推荐杏吧原创 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.