As of August 18, 2011, ClinicalTrials.gov has changed their requirements for Sponsor Investigators. Designated staff may continue to update and edit protocol records. However, Clinicaltrials.gov is now requiring sponsor investigators deemed as the “Responsible Party” to review the final protocol record and release it into the system. This will require all PIs of investigator initiated protocols registered to clinicaltrials.gov to establish an account and be listed as the Responsible Party.
Please note that protocol records should be updated every 6 months and final results should be entered within 1 year of the conclusion of the trial if the protocol qualifies per U.S. Public Law 110-85 FDAAA requirements.
About Responsible Party Change
Please contact Vanessa Hill with any questions or to create a ClinicalTrials.gov account.