Coverage Analysis Review Submission Form

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, please allow 3-4 weeks 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.

CA submission related to a new study submission or a study amendment?*

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

Select

Original IRB Submission*

Was this study's original submission to the IRB prior to 10/1/2022?

Select or enter value

Study Amendment should be submitted through eCRIS directly.

You do not need to complete this form. If you have questions, please contact CoverAnalysis@ohsu.edu

Requestor Name*

Requestor e-mail*

Protocol Title*

Principal Investigator*

Department*

Select

Is this an Industry-Funded Clinical Trial?*

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.

Select

Will you be using the Fixed Fee Memo?*

The Fixed Fee Memo is required to be used for all industry-sponsored clinical trials/studies submitted to the IRB on or after 10/1/2022. You can find a copy of the FFM on our CRSO O2 Resources Page, under the sub-heading Finance - Budget Negotiation.

Yes

All Services Paid*

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.

Select

Justification*

Please provide a justification as to why you're not using the Fixed Fee Memo.

Is this study funded by a grant?

Select or enter value

Has the grant been awarded?

Select or enter value

Sponsor(s)*

If internally funded, please state "OHSU"

Is this a Cooperative Group (i.e. SWOG/COG) study?*

Select or enter value

Is a National Coverage Analysis Worksheet Available?*

Select

National Coverage Analysis Worksheet Available

Please be sure to include the National CA Worksheet in the documents you upload to help expedite the process.

National Coverage Analysis Worksheet NOT Available

Since the National CA Worksheet is not available, please be sure to include a detailed/internal budget in the documents you upload for this study.

Is this a Consortium (i.e. TACL, PCCC, PCCTC, etc.)?*

Select

Is this an Internal Investigator-Initiated Trial (IIT)?*

Internal IIT - If OHSU investigator wrote the protocol then it's an Internal IIT.

External IIT - If a non-OHSU investigator wrote the protocol (not Industry Sponsor) then it's an External IIT.

Select

What type of study is this?

You've selected No to all the study type questions. Please review your answers to confirm the study type. If you believe the options are not applicable, please let us know what type of study this is using the study team comment box at the bottom of this form.

Internal Investigator-Initiated Trials/Studies (IITs) Note

Given Internal IITs are still going through the IRB approval process at OHSU, it is possible that the reviewers/committees may request changes to the study protocol. Therefore, we'll need to wait until the protocol is at Committee/Non-committee Review status in the eIRB system before we can begin the CA review process.

You will receive an email notification through Smartsheet when this status is achieved and letting you know we will begin the CA review process.

External Investigator-Initiated Trials/Studies (IITs) Note

Given External IITs have already been approved by the external PI's IRB, we are confident the protocol is not going to change so we can begin working on the BG right away.

Protocol Number*

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

Protocol Version and Date*

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

OHSU IRB#*

(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#.

Does the Amendment require an IRB Modification?*

Is there a new version of the protocol that requires a submission of changes (Modification) to the IRB?

Select

OHSU IRB Modification #*

(MOD000#####; enter only last five digits) Please provide respective IRB Modification # for this amendment.

Amendment Summary*

Please provide a Summary of Changes proposed with this amendment.

If sponsor provided this formal document, please upload the file. Otherwise, please list the changes.

You MUST include a redline version of the protocol with changes.

ClinicalTrials.gov # (NCT #)

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

Does the study have any cohorts or sub-studies?*

Select or enter value

Is OHSU participating on all Cohorts/Sub-studies?*

Let us know if you're participating on ALL Cohorts/Sub-studies

Select

Cohort/Sub-study Details*

List which Cohort/Sub-study OHSU is participating in

What type of Expanded Access Study is this?*

Select

Observational Study Type*

Select

CA submission does not seem necessary.

This CA submission does not seem necessary. However, we'll need to verify this by reviewing the protocol and other documents you will be submitting with this form. This form submission is still required.

Coverage Analysis is only required for studies where clinical services may be billed to the patient/insurance or study sponsor. Clinical services could include lab tests, blood draws, x-rays, office visits, etc.

Observational, Retrospective and Prospective Chart Review studies typically do not require a CA review.

Compassionate Use/Humanitarian Use Device projects are not considered research and therefore a Coverage Analysis is not necessary.

Emergency Use INDs are also not considered research, however we track the patient in eCRIS/OnCore for billing purposes. You MUST contact eCRIS or OnCore support and provide the following information once you have patient consented: Patient Name, MRN, and Consent Date.

Please consult with the Coverage Analysis team if you have any questions.

Device/Drug/Biologic Cost

Is Sponsor providing Drug/Biologic/Device at no cost?

Select or enter value

What is the Drug FDA status?

Select

What is the Drug IND number?

Please also upload FDA IND letter in the attachments.

What is the Device FDA status?

Select

What is the Device IDE number?

Please also upload FDA letter with the G code in the attachments.

Documents for Industry-Sponsored Clinical Trials

NEW STUDIES

Required documents:

Sponsor Protocol (must be in final format; no draft protocols accepted)
Draft consent form / ICF (sponsor template acceptable)
Draft sponsor budget
Draft contract
Site Selection Letter/e-mail (written Sponsor/CRO confirmation OHSU's selected)

Documents for Cooperative Group and Consortium Studies

NEW STUDIES

Required documents:

Final Protocol
National Coverage Analysis Worksheet (if available)

Documents for IITs

NEW STUDIES

Required documents:

Final Protocol
Draft budget (If grant, upload copy of Award budget)
Draft/Template consent form / ICF

Expanded Access - CA Review Seems Necessary

The study you're submitting seems to need a CA review. Expanded Access Program for non-emergency use have in the past been requesting specific services to be performed and are not just providing an investigational drug or device to the patient. These often have a schedule of events with procedures/exams/tests to be performed at specific time points.

The CA team will review the protocol and then determine if we need to conduct an analysis.

Please submit all required information including:

NEW STUDIES

Required documents:

Final Protocol
Draft budget (If grant, upload copy of Award budget)
Draft/Template consent form / ICF
Draft Contract (if available)

AMENDMENTS

Required documents:

Protocol Amendment (redline version)
Draft budget amendment
Other documents as revised

Required Documents

NEW STUDIES

Required documents:

Final Protocol
Draft/Template consent form / ICF

AMENDMENTS

Required documents:

Protocol Amendment (redline version)

Upload any study documents available.*

Please include all required documents noted above to minimize delays with the CA review.

There is a file size limit of 30MB per document. If you're having trouble uploading a file, please email it to CoverAnalysis@ohsu .edu and note that on the comment box below.

Drag and drop files here or

Study Team CA Submission Comments

IMPORTANT NOTE:

Please note that any industry-sponsored CA submissions will be charged the CA fee once the BG is completed. We'll be asking OPAM to create the OGA Accounts ahead of time to do this. It's your responsibility to ensure the sponsor is billed at startup or if the sponsor drops OHSU as a site before study activation.

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