GWU Office of Clinical Research (GW OCR) requires that qualifying studies be entered into ClinicalTrials.gov once the IRB approves the study or NO later than 21 days after the first subject is enrolled. For guidance on agency requirements, registration, updating records, and results reporting, please review the ClinicalTrials.gov guidance document. This policy defines the responsible party (RP) of the clinical trial as the principle investigator. It is the responsibility of the RP to ensure that their qualifying trial is entered and updated in accordance with federal regulations.
The following new or ongoing clinical trials shall be registered at http://www.clinicaltrials.gov by the RP:
- All Applicable clinical trials defined by Title VIII of the Food and Drug Administration Amendment Act of 2007 (FDAAA);
- Clinical trials funded, either in whole or in part, by the National Institutes of Health (NIH);
- Qualifying clinical trials which will render claims for items and services to the Center for Medicare and Medicaid Services (CMS)
- Clinical trials that meet the clinical trial definition of the International Committee of Medical Journal Editors (ICMJE) and, the results of which, the investigator plans to publish in a member journal. NOTE: ICMJE accepts registration at registries other than ClinicalTrials.gov to meet their publication requirements.
- Clinical Trials where it is written in the contract that the Principal Investigator will register the trial (even in the case that it is considered a Phase I trial)