Please submit the following electronically through OnCore’s Electronic Protocol Review and Monitoring System (ePRMS) Console. If you have questions or concerns regarding access to this console, please contact email@example.com.
PRC review is only required if amendment to the protocol result in changes to the following:
- Drug (type, dosage, or schedule)
- Methods of response evaluation
- Study Objectives (primary and secondary)
- Statistical/analysis plan (study endpoints; statistical approach and methods; power analysis)
All submissions must include:
- Each research study document being amended with changes noted in track change format (do not submit HIC application)
- Each research study document being amended incorporating all changes (do not submit HIC application)
- Each new research study document being added as a result of the amendment
- If amendment is initiated by the sponsor, include the sponsor's correspondence and the sponsor's summary of changes
- Amendments to National Clinical Trials Network studies
- Amendments to non-therapeutic studies.