ClinicalTrials.gov is a online resource (also referred to 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, results of the study are submitted after the study ends.
What needs to be registered?
1. Clinical Trials of Drugs and Biologics: Controlled, clinical investigations of a product subject to FDA regulations.
2. Clinical Trials of Devices: Controlled trials with health outcomes, other than small feasibility studies, and pediatric post-market surveillance.
3. 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.
4. “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.
How do I register?
1. Request a user login name and temporary password by sending an email to email@example.com.
a. Place "clinicaltrials.gov registration" in the subject line.
b. Include in the message your name, telephone number, email address, study title and MU HR# (e.g., HR-9999).
2. You will then receive an email with your login name and a temporary password.
3. Go to: https://register.clinicaltrials.gov/ and enter your user name.
a. In the “Organization” field, type “ MarquetteU.”
b. Change your password under "User Account" on the Main Menu page.
4. To register a study, on the Main Menu page, under “Protocol Record,” click "Create" and complete the study description template.
5. When you get to the information about Review Board, the following please complete the fields as follows:
- Unique Protocol ID: Refers to a sponsor-provided number. Otherwise, use grant number or MU IRB number.
- Board Approval Number: Refers to the MU IRB number that begins with "HR-".
- Board Name: Marquette University IRB.
- Board Affiliation: Marquette University
- Board Contact: Benjamin Kennedy; (414) 288-1479, firstname.lastname@example.org; Schroeder Complex 102, PO Box 1881, Milwaukee, WI 53201.
- Oversight Authority: Enter "United States: Institutional Review Board" or if FDA regulated, "United States: Food and Drug Administration."
6. Once complete, submit the study.
7. The Office of Research Compliance will verify the entry and approve it for release to the clinicaltrials.gov registry.
Do I need to do anything once I register my study?
1. Make periodic updates (e.g., study completed) as needed. The “Record Verification Date” field should be updated in conjunction.
2. Submit any adverse events. Submission of adverse events to the IRB separately may be required as well.
3. Submit basic study results.
How do I get more information?