Guidelines for Amendment Submission

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 ycc.ycci.committees@yale.edu

PRC review is only required if amendment to the protocol result in changes to the following:

  1. Drug (type, dosage, or schedule)
  2. Methods of response evaluation
  3. Study Objectives (primary and secondary)
  4. 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
The YCC PRC does not need to review the following amendment types: 
  • Amendments to National Clinical Trials Network studies
  • Amendments to non-therapeutic studies.

For information contact:
Niece Hanna, MSW
Research Oversight Committee Regulatory Analyst 
Yale Center for Clinical Investigation 
2 Church Street South, Suite 112 
203.785.7408   
niece.hanna@yale.edu