Multicenter: These forms are to be used by the CRO and/or Sponsor for the submission of a multicenter study and should include the protocol, IB and/or device description and electronic version of the Informed Consent document.
Site Additions: These forms are to be used by the PI/Site that will be conducting a multicenter research study.
Single Site Study: These forms are to be used by the PI/Site that will be conducting a single site research study.
Continuing Review and/or Study Closure: These forms are to be completed for study continuance or in the event you wish to close your study.
Safety Reporting: This form is to be completed for the reporting of Unanticipated Problems, Serious Events, and Serious Protocol Deviations/Violations.