Clinical Trials Registration

Registering clinical trials when they begin, providing timely updates, submitting summary results, and making this information publicly available fulfills a number of purposes and benefits a variety of people.

Source: Zarin DA, Keselman A.  Registering a clinical trial in ClinicalTrials.gov. Chest. 2007;131(3):909-12. [ Full Text]

ClinicalTrials.gov is an online resource (also referred to as a "registry") that provides the public, researchers, patients and their family members, and health care professionals access to information on publicly and privately supported clinical studies. The website is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).

Information on ClinicalTrials.gov is provided and updated by the sponsor or principal investigator of the clinical study. Studies are generally submitted/registered to ClinicalTrials.gov when they begin, and the information is updated throughout the study. In some cases, the results of the study are submitted after the study ends. All clinical trials receiving federal grant support must be registered to meet compliance with the law.

Clinical trials receiving federal grant support.

Clinical Trials of Drugs and Biologics: Controlled, clinical investigations of a product subject to FDA regulations.

Clinical Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric post-market surveillance.

The International Committee of Medical Journal Editors (ICMJE) requires certain research studies to be registered at ClinicalTrials.gov in order to be considered for publication in ICMJE member journals and other publications that adhere to ICMJE Uniform Requirements for Manuscripts Submitted to Biomedical Journals: “Any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.” This definition includes Phase I trials. Interventions include “any intervention used to modify a biomedical or health-related outcome (for example, drugs, surgical procedures, devices, behavioral treatments, dietary interventions, and process-of-care changes).” Health outcomes include “any biomedical or health-related measures obtained in patients or participants, including pharmacokinetic measures and adverse events. Purely observational studies (those in which the assignment of the medical intervention is not at the discretion of the investigator) will not require registration. The ICMJE accepts registration in any registry that is a primary register of the WHO International Clinical Trials Registry Platform (ICTRP) or in gov, ICMJE endorses these registries because they meet several criteria. They are accessible to the public at no charge, open to all prospective registrants, managed by a not-for-profit organization, have a mechanism to ensure the validity of the registration data, and are electronically searchable. An acceptable registry must include the minimum 20-item trial registration dataset here.

• Request a user login name and temporary password, by sending an email to bilicek@uiwtx.edu. Place "clinicaltrials.gov registration" in the subject line.
• Include in the message your name, telephone number, and email address
• You will then receive an email with your login name and a temporary password.
• Go to: Clinicaltrials.gov and follow the instructions to log in.
• In the “Organization” field, type “UniversityIW”
• Change your password under "User Account" on the Main Menu page
• To register a study, on the Main Menu page, under “Protocol Record”, click "Create" and complete the study description template.
• Once complete, submit the study.
• The UIW PRS Administrator will verify the entry and approve it for release to the clinicaltrials.gov registry.

• Make periodic updates (e.g., a study completed) as needed.
• Submit any adverse events. Submission of adverse events to the IRB separately may be required as well.
• Submit basic study results and periodic updates during and at the end of the trial.