Clinical trials gov login

Penalties include civil monetary penalties and, for federally funded studies, the withholding of grant funds. Does my study require registration on ClinicalTrials. Health-related interventions are those used to modify a biomedical or health-related outcome; examples include drugs, surgical procedures, devices, behavioral treatments, educational programs, dietary interventions, quality improvement interventions, and process-of-care changes.

Applicable Clinical Trials generally include interventional studies with one or more arms of FDA-regulated drugs, biological products, or devices that meet one of the following conditions: The trial has one or more sites in the United States The trial is conducted under an FDA investigational new drug application or investigational device exemption The trial involves a drug, biologic, or device that is manufactured in the United States or its territories and is exported for research ClinicalTrials.

For purposes of this policy, the NIH defines "clinical trial" as "a research study in which one or more human subjects are prospectively assigned to one or more interventions which may include placebo or other control to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. There are several differing registration requirements. ICJME Requirements Registration is required at or before the time of first patient enrollment as a condition of consideration for publication.

FDA Requirements A research protocol must be registered no later than 21 days after enrollment of the first participant. NIH Requirements A research protocol must be registered no later than 21 days after enrollment of the first participant. Your account information and temporary password will be sent to the email address you provided. Then follow the prompts to enter your protocol information. You will automatically become the Record Owner for this protocol if you are the initial person to register the study.

What is an NCT number and when will I get one? PRS has published a detailed guide for how to complete each module. Pay attention to these notes and details to help expedite authorization of the public release of your record. As you complete the section, errors, warnings, or notes may appear. Find a study all fields optional Saved Studies. Recruiting and not yet recruiting studies All studies.

Condition or disease For example: breast cancer x. Other terms For example: NCT number, drug name, investigator name x. Yemen Zambia Zimbabwe x. Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Phase 1 Study of SQ in Patients With Advanced Solid Tumors The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Last Update Posted : November 19, See Contacts and Locations. Study Description. The purpose of this study is to evaluate the safety, tolerability, and preliminary activity of SQ in patients with advanced solid tumors. See About the Results Database for more information.

See the For Study Record Managers page for more information. Please check the site frequently for new information. The Find Studies section of the site includes different options for finding studies, along with instructions on how to find the studies you are looking for and how to read study records. In this section, you can:. The Resources section of the site includes scholarly publications by ClinicalTrials.