Resources

Patient Education

Patient handout (English, French, Spanish)

Research brings hope for cures (English

Trial Protocol

Study Training

Please review slides for this study. Training records are required prior to study activation at your site. Please Sarah.Hardee@utsouthwestern.edu for more information about completing this requirement for study teams.

Complete SIV presentation for participating institutions.

Forms

  • DSMC serious adverse event report form
  • Protocol signature page V2 - Submit a copy of the protocol/amendment signature page. Retain original at site. 
  • Protocol signature page V3 - Submit a copy of the protocol/amendment signature page. Retain original at site. 
  • Quality of life questionnaire - The LCSS questionnaire is the only protocol-required questionnaire. Submit to your IRB if necessary. 
  • REDCap access form - Use this form to request REDCap access for study team members who will be responsiblt for randomizing patients and entering data. 
  • Regulatory transmittal form - Use this form when submitting all regulatory documentation. All IRB documents must be submitted as soon as possible following approval, including initial IRB approvals, IRB-approved consent forms, continuing review approvals, amendment/revision approvals, and protocol-specific regulatory requirements. 
  • RT QA form - To help you evaluate your RT plan. This form should be included in your RT plan dataset. 
  • Site signature and delegation log - Template to document signatures and initials of all individuals authorized to perform study-related activities, as well as functions delegated to each study team member by the principal investigator. You may use your institutional version if preferred.
  • Surgical QA form found in REDCap.
  • Template FDA 1572, statement of investigator - This documents the agreement of the investigator to provide certain information to the sponsor and to assure that he/she will comply with FDA regulations related to the conduct of a clinical investigation. Submit a copy and retain original at site.

External Resources