Clinical trial registration frequently asked questions
The information found here is adapted from TheNIH U.S. National Library of Medicine, clinicaltrials.gov.
ClinicalTrials.govis 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 (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
| Registry Purpose | Groups that Benefit |
|---|---|
| Fulfill ethical obligations to participants and the w88 sports betting community | Patients, the general public, the w88 sports betting 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 w88 sports betting funds | Granting agencies, the w88 sports betting community |
| Help institutional review boards (IRBs) determine the appropriateness of a w88 sports betting 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]
| 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 w88 sports betting results to medical knowledge | Patients, the general public, the w88 sports betting community |
| Reduce publication and outcome reporting biases | Users of the medical literature |
| Facilitate systematic reviews and other analyses of the w88 sports betting literature | Researchers, policymakers |
Source: Tse T, Williams RJ, Zarin DA.Reporting "Basic Results" in ClinicalTrials.gov.Chest. 2009;136(1):295-303. [Full text found in Chest Journal]
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 w88 sports betting award, w88 sports betting Integrity & Security staff will register the trial in consultation with researchers. w88 sports betting Integrity & Security staff will also assign user accounts to researchers for access to the study record.
w88 sports betting, Reno researchers and clinical research coordinators shouldcontact w88 sports betting Integrity & Securityto request a University-associated user account.
w88 sports betting 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.