Coverage Analysis Review Submission Form

 

Purpose

Please use this form to submit your study for Coverage Analysis (CA) Review.


  • For Industry studies, you may submit this form once the sponsor has selected OHSU as a study site and when you have received the required study documents.


  • For IITs, you may submit this form once you have a finalized protocol and draft budget.


Once a complete request has been submitted, the CRBO CA team will begin the CA process after the study has been submitted to the IRB (no longer in Pre-Submission status in the IRB). Please allow 3-4 weeks after IRB submission to develop the Billing Grid.


You will receive detailed instructions via email on next steps once the Billing Grid is created.


NOTE: We are asking for all projects that render clinical services to a patient, regardless if it's a Clinical Trial or Compassionate Use (Expanded Access/Emergency Use), to be submitted through this form. If a Coverage Analysis is not needed, we will make that determination within 3 business days if not sooner and give you direction to move forward.


More information about the CA process can be found on our O2 page.

 

Amendments for studies where the initial CA was approved after 10/1/2022.

 
 
 
 
 
 
 

We consider the study to be industry-funded if the industry partner developed the protocol and are looking to add OHSU as a study site. Investigator-Initiated studies with some industry funding are not required to use the Fixed Fee Memo.

 

Will the study account be paying/charged for all services in the study? This would mean that no study-related charges will be billed to the subject/subject's coverage or insurance.

 

If internally funded, please state "OHSU"

 

If IIT and no protocol number listed, enter N/A

 

e.g. Version 1 dated 1/15/2022

 

(STUDY000#####; enter only last five digits) You only need to create and save the first page on the IRB application to have system generate an IRB#. This number allows you to submit the study for CA review.


However, please remember that once you submit the study for CA review, the CA process will not be initiated until the study is past the Pre-Submission state in the IRB.

 

If NCT is not yet available, you may skip this but please know NCT is required before you may begin subject enrollment.