ClinicalTrials.Gov

U.S. Public Law 110-85 (Food and Drug Administration Amendments Act of 2007) Title VIII-Section 801 mandates that a broad range of health-related studies register with ClinicalTrials.gov and many health-related journals now require registration prior to accepting a manuscript for review.

You must have an account to register a study with ClinicalTrials.gov. To obtain an account, please contact one of the PR Administrators (see below). To register a new study, login to https://clinicaltrials.gov/ct2/manage-recs/register. The organization will be TexasWU and the unique protocol number should be your TWU IRB Protocol Number. Once you submit this form, the TWU Administrator will receive an email to approve it and will contact you if more information is needed. A Quick Start User Guide for ClinicalTrials.gov  provides more detailed information about this process.

For more information or to obtain an account, contact one of TWU’s Protocol Registration System (PRS) Administrators: Ms. Tracy Lindsay (tlindsay@twu.edu), or Ms. Sandy Owens (sowens6@twu.edu).