The GWU Office of Clinical Research requires that qualifying studies be entered into the Protocol Registration and Results System (PRS) It is university policy that studies be entered BEFORE subject enrollment- preferably once the study is IRB approved or NO later than 21 days after the subject enrollment. For guidance on agency requirements, registration, updating records and results reporting please review the Standard Operating Procedure (SOP) PRS. The responsible party (RP) as outlined in the policy, is responsible to ensure that the qualifying trial is entered and updated in accordance with federal regulations.
Qualifying Trial
- All applicable clinical trials defined by FDAAA 801.
- Clinical trials funded, either in whole or in part, by the NIH.
- Clinical trials, which will render claims for items and services to the Center for Medicare and Medicaid services.
- Clinical trials that the results of which, the investigator plans to publish in a member journal.
- Clinical trials where it is written in the contract that the PI will register the trial (even in the case that it is considered a Phase I trial)
Policy & SOP
Protocol Registration and Results System Policy
Protocol Registration and Results System SOP