Carilion Clinic Research Application Form

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Required format:

Please complete and receive the department approval prior to IRB PRISM application. If you have any questions, please contact research@carilionclinic.org. If you need Epic data extract, biostatistics support, data management (REDCap), Epic research builds, Epic research access, or feasibility volume, please contact HART@carilionclinic.org.

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Carilion Clinic Principal Investigator Name

* must provide value

Is the PI a Carilion Clinic employee?

Yes No

Position at Carilion

* must provide value

Email

* must provide value

Phone number

* must provide value

Estimated percent effort expended on project from the Principal Investigator. For an investigator, 1-2 percent is typical.

* must provide value

Contact Person (if other than PI)

Contact Email

Contact Phone Number

Is this submission a Primary Research Domain Project to fulfill a VTCSOM medical student graduation requirement?

* must provide value

Yes No

Project Title

* must provide value

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Primary Project Type

Basic Research (in vitro/tissue culture/cell biology)

Clinical Trial (e.g., interventional study such as drug or device)

Clinical Research (prospective study without intervention, observational or registries)

Clinical Research (retrospective study)

Expanded Access, Compassionate Use, or Humanitarian Use

Instructional

Social/Behavioral Research

Other (e.g., community outreach)

Other research type

Study Feasibility FAQs

If you are doing a prospective study, please review these FAQs to prepare for a Feasibility meeting.

FAQ Link

Attachment:Feasibility Checklist - Investigators and Key Research Personnel.pptx

Because you have selected "Clinical Trial", Carilion Clinic must verify that the study meets a specific set of research billing regulations from Centers for Medicare and Medicaid Services (CMS).

Studies involving drugs, biologics, and diagnostic interventions are subject to CMS Policy 310.1 "Qualifying Clinical Trial Policy". Device studies are subject to Medicare Coverage IDE Study Criteria (42 CFR 405 Subpart B).

You will be asked a series of questions to determine if your study meets the applicable CMS criteria. If your study meets the criteria, then you may bill routine services to CMS. Many private insurers follow CMS guidelines, but a pre-authorization is still recommended for study participants with private insurance.

Which of the following describes your study?

Drug/Biologic or Diagnostic Intervention

Device

Registry

Survey

Upload CMS IDE Letter (Category A or B Determination)

If you don't have this, request it from your study sponsor or research study coordinator.

IDE studies are regulated under Medicare Coverage IDE Study Criteria (42 CFR 405 Subpart B).

CMS classifies devices as Category A (Experimental) or Category B (Nonexperimental/Investigational). An approval for a Category A IDE study will allow coverage of routine care items and services furnished in the study, but not of the Category A device, which is statutorily excluded from coverage. An approval for a Category B (Nonexperimental/Investigational) IDE study will allow coverage of the Category B device and the routine care items and services in the trial.

Because you selected "Device", you will be asked a series of questions to determine if your device trial meets the Medicare Coverage IDE Study Criteria (42 CFR 405 Subpart B). If you select "yes" for the following 10 questions, your trial qualifies for billing of routine services to CMS. Many private insurers follow CMS guidelines, but a pre-authorization is still recommended for study participants with private insurance.

CMS classifies devices as Category A (Experimental) or Category B (Nonexperimental/Investigational). An approval for a Category A IDE study will allow coverage of routine care items and services furnished in the study, but not of the Category A device, which is statutorily excluded from coverage. An approval for a Category B (Nonexperimental/Investigational) IDE study will allow coverage of the Category B device and the routine care items and services in the trial.

Yes

No

1

The principal purpose of the study is to test whether the device improves health outcomes of appropriately selected patients.

* must provide value

2

The rationale for the study is well supported by available scientific and medical information, or it is intended to clarify or establish the health outcomes of interventions already in common clinical use.

* must provide value

3

The study results are not anticipated to unjustifiably duplicate existing knowledge.

* must provide value

4

The study design is methodologically appropriate and the anticipated number of enrolled subjects is adequate to confidently answer the research question(s) being asked in the study.

* must provide value

5

The study is sponsored by an organization or individual capable of successfully completing the study.

* must provide value

6

The study is in compliance with all applicable Federal regulations concerning the protection of human subjects found at 21 CFR parts 50, 56, and 812 and 45 CFR part 46.

* must provide value

7

Where appropriate, the study is not designed to exclusively test toxicity or disease pathophysiology in healthy individuals. �Studies of all medical technologies measuring therapeutic outcomes as one of the objectives may be exempt from this criterion only if the disease or condition being studied is life threatening and the patient has no other viable treatment option.

* must provide value

8

The study is registered with the National Institutes of Health's National Library of Medicine ClinicalTrials.gov. (NCT#)

* must provide value

9

The study protocol describes the method and timing of release of results on all pre-specified outcomes, including release of negative outcomes and that the release should be hastened if the study is terminated early.

* must provide value

10

The study protocol must describe how Medicare beneficiaries may be affected by the device under investigation, and how the study results are or are not expected to be generalizable to the Medicare beneficiary population. Generalizability to populations eligible for Medicare due to age, disability, or other eligibility status must be explicitly described.

* must provide value

Because you answered NO to the above question, this trial does not meet the CMS billing criteria for IDE studies.

Because you selected "Drug/Biologic or Diagnostic Intervention", you will be asked a series of questions to determine if your drug/biologic trial meets the CMS Qualifying Clinical Trial Criteria.

Some trials are automatically "Deemed" as Qualifying Trials. These include studies with federal funding (NIH, CDC, DOD, AHRQ, etc). Further, studies that are conducted by cooperative groups or centers that receive federal funding are automatically "Deemed". IND and IND exempt studies are also automatically "Deemed".

If your study does not fall under the automatically deemed categories, you will need to confirm that it has the other required characteristics listed below to be considered a Qualifying Clinical Trial. Many private insurers follow CMS guidelines, but it is recommended that pre-authorization for clinical trial participation is obtained for study participants with private insurance.

Yes

No

1

Will the trial evaluate an item or service that falls within a Medicare benefit category and not statutorily excluded from coverage? Common benefit categories include Physician Services, Drugs and Biologics, Diagnostic Laboratory Tests, and Inpatient Hospital Services. Examples of excluded items are cosmetic surgery and dental care. For a complete list, please refer to the Medicare Coverage Database: https://www.cms.gov/medicare-coverage-database/details/ncd-details.aspx?NCDId=1

* must provide value

2

Does the trial have therapeutic intent, i.e., not designed exclusively to test the toxicity or disease pathophysiology?

* must provide value

3

Will the trial enroll patients with the diagnosed disease, i.e., not a Phase I study enrolling only healthy volunteers?

Because you answered NO to the above question, this trial is does NOT meet the Qualifying Clinical Trial criteria.

B. Qualification Process for Clinical Trials:

The three requirements above are insufficient by themselves to qualify a clinical trial for Medicare coverage of routine costs. Some trials are determined to be automatically DEEMED Qualifying Clinical Trials. A "Yes" answer to any of the following 4 criteria automatically deems the trial a Qualifying Clinical Trial. If you answer "No" to all of the following 4 questions, you will be given a list of desirable characteristics that may also qualify your trial.

Yes

No

1

Is the trial funded by NIH, CDC, AHRQ, CMS, DOD or VA?

* must provide value

2

Is the trial supported by centers or cooperative groups that are funded by the NIH, CDC, AHRQ, CMS, DOD or VA?

* must provide value

3

Is the trial being conducted under an Investigational New Drug application (IND) reviewed by the FDA?

* must provide value

4

Is the trial a drug trial that is exempt from having an IND under 21 CFR 312.2(b)(1)**?

* must provide value

**See Appendix A for IND exempt criteria.

Attachment:Appendix A.pdf

Because you answered YES to the above question, the trial is automatically deemed to be a Medicare Qualifying Clinical Trial.

Because you answered NO to all four of the above questions, the study is not a qualifying Clinical Trial.

C. Desirable Characteristics:

If your study is not considered an automatically "Deemed" trial, it must also have the following 7 desirable characteristics for Medicare coverage of routine costs.

Yes

No

1

Is the purpose of the trial to test whether the intervention potentially improves the participants' health outcomes?

* must provide value

2

Is the trial well-supported by available scientific and medical information or intended to clarify or establish the health outcomes of interventions already in common clinical use?

* must provide value

3

The study does NOT unjustifiably duplicate existing studies, (i.e., the study concept is novel or is justified in reproducing an existing study).

* must provide value

4

Is the trial designed to answer the research question being asked?

* must provide value

5

Is the trial sponsored by a credible organization or individual capable of executing the proposed trial successfully?

* must provide value

6

Is the trial in compliance with the Federal regulations relating to the protection of human subjects?

* must provide value

7

Will all aspects of the trial be conducted according to the appropriate standards of scientific integrity?

* must provide value

Because you answered NO to the above question, this trial is does NOT meet the Qualifying Clinical Trial criteria.

Items not billable to Medicare/Insurance:

Although the study has met the Qualifying Clinical Trial Criteria, there are still some items that are not billable to Medicare/Insurance. These are referred to as carve-outs.

1. Anything that is paid for by the study sponsor, even if it would fall under routine care.

Ex: A CT scan is considered routine care when performed every year to determine cancer progression, however, the study sponsor has offered to pay for all CT scans for study participants. In this example, no CT scans would be billed to the patient and/or their insurance as the study sponsor would cover all costs.

2. Anything that is conducted solely for research purposes.

Ex: A study participant has pharmacokinetic labs collected at each study drug dosing visit. These labs would not be done as routine care outside of a research study and cannot be billed to the patient and/or their insurance.

3. Any items that do not have CMS coverage under a national coverage determination (NCD) or a local coverage determination (LCD).

Ex: Services that are not considered medically necessary or excluded services. Cosmetic procedures are an example of a service that is not covered by Medicare (unless there is a medically necessary reason).

R&D will assist study teams with research billing compliance processes and study budget builds.

FINAL DEPOSITION:
Based on the above documented coverage analysis, the study meets the CMS coverage criteria for payment of routine costs (See Appendix B for Routine Cost definitions).

R&D will assist you with preparing your study budget and negotiating with the study sponsor.

Attachment:Appendix B.pdf

FINAL DEPOSITION:Based on the above documented coverage analysis, the study meets the CMS coverage criteria for payment of routine costs (See Appendix B for Routine Cost definitions).

R&D will assist you with preparing your study budget and negotiating with the study sponsor.

Attachment:Appendix B.pdf

Funding Source

Industry

Federal or Federal Flow Through

Foundation / Non-profit

Other University / Institution

Investigator Self-Funded (e.g., discretionary; start-up funds)

Internally Funded (e.g., RAP grant)

I do not yet have this information available

Other

Other funding source

Industry Sponsor Name

* must provide value

Do you have an interest in securing clinical research coordinator support with your study?

*Please Note: R & D research coordinators are assigned on a first-come first-serve basis.

Yes No

Department: (Chair/Officer/Dean)

* must provide value

Emergency Medicine

Family and Community Medicine

Radford University Carilion

Medicine

Neurosurgery

Nursing

Obstetrics/Gynecology

Orthopaedic Surgery

Pediatrics

Surgery

Radiology

Psychiatry

Other

If other please specify Department/Functional Area

* must provide value

Project Approver

* must provide value

Additional Carilion Clinic Research Team Member?

Yes No

Additional Carilion Clinic Research Team Member Name

Estimated percent effort expended on project.
For an investigator, 1-2 percent is typical.
For supporting staff, 5-25 percent is typical.

Additional Carilion Clinic Research Team Member?

Yes No

Additional Carilion Clinic Research Team Member Name

Estimated percent effort expended on project.
For an investigator, 1-2 percent is typical.
For supporting staff, 5-25 percent is typical.

Additional Carilion Clinic Research Team Member?

Yes No

Additional Carilion Clinic Research Team Member Name

Estimated percent effort expended on project.
For an investigator, 1-2 percent is typical.
For supporting staff, 5-25 percent is typical.

Additional Carilion Clinic Research Team Member?

Yes No

Additional Carilion Clinic Research Team Member Name

Estimated percent effort expended on project.
For an investigator, 1-2 percent is typical.
For supporting staff, 5-25 percent is typical.

Additional Carilion Clinic Research Team Member?

Yes No

Additional Carilion Clinic Research Team Member Name

Estimated percent effort expended on project.
For an investigator, 1-2 percent is typical.
For supporting staff, 5-25 percent is typical.

Additional Carilion Clinic Research Team Member?

Yes No

Additional Carilion Clinic Research Team Member Name

Estimated percent effort expended on project.
For an investigator, 1-2 percent is typical.
For supporting staff, 5-25 percent is typical.

Additional Carilion Clinic Research Team Member?

Yes No

Additional Carilion Clinic Research Team Member Name

Estimated percent effort expended on project.
For an investigator, 1-2 percent is typical.
For supporting staff, 5-25 percent is typical.

Additional Carilion Clinic Research Team Member?

Yes No

Additional Carilion Clinic Research Team Member Name

Estimated percent effort expended on project.
For an investigator, 1-2 percent is typical.
For supporting staff, 5-25 percent is typical.

Additional Carilion Clinic Research Team Member?

Yes No

Additional Carilion Clinic Research Team Member Name

Estimated percent effort expended on project.
For an investigator, 1-2 percent is typical.
For supporting staff, 5-25 percent is typical.

Additional Carilion Clinic Research Team Member?

Yes No

Additional Carilion Clinic Research Team Member Name

Estimated percent effort expended on project.
For an investigator, 1-2 percent is typical.
For supporting staff, 5-25 percent is typical.

Non-Carilion Clinic Research Team Member

Yes No

Non-Carilion Clinic Research Team Member Name

Non-Carilion Clinic Research Team Member Email

Role and Responsibility

External Institution

Non-Carilion Clinic Research Team Member

Yes No

Non-Carilion Clinic Research Team Member Name

Non-Carilion Clinic Research Team Member Email

Role and Responsibility

External Institution

Non-Carilion Clinic Research Team Member

Yes No

Non-Carilion Clinic Research Team Member Name

Non-Carilion Clinic Research Team Member Email

Role and Responsibility

External Institution

Non-Carilion Clinic Research Team Member

Yes No

Non-Carilion Clinic Research Team Member Name

Non-Carilion Clinic Research Team Member Email

Role and Responsibility

External Institution

Non-Carilion Clinic Research Team Member

Yes No

Non-Carilion Clinic Research Team Member Name

Non-Carilion Clinic Research Team Member Email

Role and Responsibility

External Institution

Non-Carilion Clinic Research Team Member

Yes No

Non-Carilion Clinic Research Team Member Name

Non-Carilion Clinic Research Team Member Email

Role and Responsibility

External Institution

Non-Carilion Clinic Research Team Member

Yes No

Non-Carilion Clinic Research Team Member Name

Non-Carilion Clinic Research Team Member Email

Role and Responsibility

External Institution

Non-Carilion Clinic Research Team Member

Yes No

Non-Carilion Clinic Research Team Member Name

Non-Carilion Clinic Research Team Member Email

Role and Responsibility

External Institution

Non-Carilion Clinic Research Team Member

Yes No

Non-Carilion Clinic Research Team Member Name

Non-Carilion Clinic Research Team Member Email

Role and Responsibility

External Institution

Non-Carilion Clinic Research Team Member

Yes No

Non-Carilion Clinic Research Team Member Name

Non-Carilion Clinic Research Team Member Email

Role and Responsibility

External Institution

Additional Services: Check all that are requested

Health Analytics data extraction

Health Analytics statistics support

Carilion REDCap

Carilion's SPARC Secure Research Environment

EPIC research access for chart review

EPIC research study build (e.g., research drug build, BPA, ordersets)

Pharmacy

Clinical laboratories

Basic science laboratory support

Pathology

Simulation laboratory

Imaging

Radiation Safety (non-standard of care imaging/administration of radioactive materials)

Other service (Please note - any service that will be required for research purposes outside of your home department should be listed. i.e., ECGs, Pulmonary functions tests, etc.)

Other additional service

Does the study have research-specific imaging requirements?
(Imaging is different from standard of care imaging protocols and may require Radiology to create a study specific build.)

* must provide value

Yes No

Does the study require specific parameters for image collection (imaging manual or imaging protocol)?

Yes No

Please provide specific language for imaging requirements and/or attach the imaging manual.

Enter "Not Applicable/No attachments" if this does not apply.

Expand

Please attach the imaging manual, if available.

Include specific aim(s), scope, time frame, number of subjects/population, methodology, or type in "attached" if uploaded.

* must provide value

Expand

Protocol: Please upload a protocol in this link if appropriate

Budget: Please upload a budget in this link if appropriate

Principal Investigator

Clinical section chief (not required of all departments/functional areas)

Authorized department chair/ officer/ dean or vice president (Required per Carilion Clinic policy)

Second clinical section chief (not required of all departments/functional areas)

Second Authorized department chair/ officer/ dean or vice president (Required per Carilion Clinic policy)

R&D Letter generated

Yes No

R&D Letter Date

M-D-Y

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