Creating and Submitting a New Therapeutic Protocol


Creating and Preparing Study Documents

When preparing study documents for submission, use the applicable templates and guidance to ensure DF/HCC requirements are met.

Note that some of the resources on this page are for Investigator-Sponsored research only, meaning that the DF/HCC investigator is writing and developing the study and will hold the IND/IDE. You can skip over these resources if your study has an external sponsor providing you with the protocol document.


Additional Resources for Sponsor-Investigators 

Developing your own study?

Use these additional resources for studies where a DF/HCC investigator is sponsoring their own research project.


Submitting a New Protocol

Most submissions, including the New Project Application, can be made directly in iRIS.

In order to submit a new research project in iRIS, you will need to complete training on use of the iRIS system and obtain the appropriate access. Please follow the instructions on the New Research Staff Checklist to obtain access.

Please see below for guidance on making a new submission.


New Protocol Review Process

Once the NPA has been submitted in iRIS, your study will be routed for any required scientific, feasibility, operational and/or ancillary reviews in addition to IRB review.

Investigators and study teams can help ensure a timely and smooth review process by tracking their submission and responding promptly to conditions and questions from the reviewers. 


Activating a New Protocol

Research activities cannot begin until you have received both IRB approval and a notification of protocol activation. These are system-generated notifications from iRIS. 

Many new protocols require an Operational Readiness Checklist in iRIS to confirm all operational pieces are in place for when the study is activated.