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.
To register a clinical trial, complete the PRS Administrator Contact Request Form at https://clinicaltrials.gov/ct2/contact-org-admin. 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, contact TWU’s Protocol Registration System (PRS) Administrator, Dr. Donna Scott Tilley firstname.lastname@example.org or by phone (940) 898-3401.