Frequently Asked Questions: Amendment Submission Form

NOTE:  For the first action you do with an existing protocol (either CR or amendment), you will need to FIRST “create a revision” to your study application. THEN create the new submission form for your action. Otherwise the CR or amendment form will not carry forward the information correctly.



I have removed a non-NIH collaborator on the amendment form, but it does not show up that I have deleted that person. 

When you delete a non-NIH collaborator in an amendment there is no way for iRIS to show that person has been deleted. Just be sure to include information in your cover memo about the person being removed.


I am changing the eligibility criterion in the amendment to remove a histology that was previously eligible.  How do I answer the question 4.2 “changes in study population”?

Unless you are changing a population of subjects listed with your amendment, you should answer that question as “no.” You would say yes to that question, for example, if you were removing children as a population eligible for this protocol or now adding normal volunteers. Just changing the criterion for a same group of subjects (e.g. adult patients) would not be a change in the population in terms of risk/benefit.


What do I include in my summary of changes to the IRB for an investigator initiated protocol?

These guidelines apply to protocols that are written by NCI investigators. If it is a protocol by an outside sponsor, it is still fine to submit the Summary of Changes (SOC) that the sponsor provides.



FAQs for Routing in iRIS

FAQs for Study Application

FAQs for Continuing Review Submission Form

FAQs for Planned and Cumulative Enrollment Forms

FAQs for Study Closure Form


These pages will continue to be updated as more information becomes available.

Note: If you have a submission procedure question that isn’t answered within these pages, please contact: