The code block below illustrates how one might use # and // as comments in your logic and calculations.

# Text can be put here to explain what the logic/calculation does and why.
if ([field1] = '1' and [field2] > 7,

	// This comment can explain what the next line does.
	[score] * [factor],

	// Return '0' if the condition is False.
	0
)

Working...

Working...

This value you provided is not a number. Please try again.

This value you provided is not an integer. Please try again.

The value entered is not a valid Vanderbilt Medical Record Number (i.e. 4- to 9-digit number, excluding leading zeros). Please try again.

The value you provided must be within the suggested range

The value you provided is outside the suggested range

This value is admissible, but you may wish to double check it.

The value entered must be a time value in the following format HH:MM within the range 00:00-23:59 (e.g., 04:32 or 23:19).

This field must be a 5 or 9 digit U.S. ZIP Code (like 94043). Please re-enter it now.

This field must be a 10 digit U.S. phone number (like 415 555 1212). Please re-enter it now.

This field must be a valid email address (like joe@user.com). Please re-enter it now.

The value you provided could not be validated because it does not follow the expected format. Please try again.

Required format:

CBR-CCTS-OCS Submission Form

Returning?

A A A

This form is to be used for all new and revision submissions for any of the below:

CBR (Clinical Billing Review): for protocols that contain UAB health system clinical billable procedures which require CBR review for the Fiscal Approval Process (FAP)
CCTS (Center for Clinical and Translational Science): for protocols that will utilize CCTS services, including Bionutrition, Biorepository, CRSP, CRU, or SPAN
OCS (OnCore Calendar Services): for protocols that will be built by OCS and managed in OnCore by a non-O'Neal Comprehensive Cancer Center team, (including all protocols with UAB Health System clinical billable procedures, protocols with CCTS services that require a calendar, industry-sponsored clinical trials, and protocols the study team wishes to enter into OnCore for financial management or for the management, tracking, or reporting of its research portfolio).

This request form contains questions that were formerly submitted via the CBR workbook, the OCS REDCap request form, and the CCTS Clinical Support Registration form. Before you begin completing this submission form, please have your protocol documents and information ready. A checklist to help gather the required information can be found here along with the Outreach Lab Requisition form ("Green sheet") linked here, and a list of commonly used labs with CPT codes linked here that can help determine which local labs are needed (if you are not directed to these documents immediately, log in using your uab.edu email.)

Not ready to submit this form and just need pricing/coding from CBR for feasibility? Complete the CBR Feasibility Request here. When ready to move forward with the study, return to the current form for your submission.

If you have questions about this form, please contact OncoreCalendars@uabmc.edu.

REMINDER - NO PHI should be entered in this form.

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Submitter Name:

* must provide value

Submitter Email:

* must provide value

Submitter Telephone Number:

* must provide value

If there are questions regarding this form, are you the person CBR/CCTS/OCS should contact?

* must provide value

Yes

No

If no, then provide correct contact's name and email address:

* must provide value

Who is managing this study?

(**if study is managed within Department of Pediatrics/Children's of Alabama, or Radiation Oncology, or Neuro-Oncology, enter 'Non-Cancer Center study team.')

* must provide value

O'Neal Comprehensive Cancer Center

Non-Cancer Center study team

EXTERNAL USERS (outside of UAB, e.g., St. Vincent's or other institutions) applying only for CCTS-CRSP services

NON-ONCORE USERS applying only for CCTS specimen processing and/or Biorepository services

Have you confirmed with CCTS staff that the services for this study will not require an OnCore calendar?

* must provide value

Yes

No

Please contact CCTSclinical@uab.edu to determine if this study will require an OnCore calendar before moving forward with this request.

Please exit this form and return once confirmed.

(If CCTS staff determines it will require an OnCore calendar, when you return to this form, please complete the question above as a "Non-Cancer Center Study Team" rather than "Non-OnCore Users".)

Is this a New submission or a Revision/ Amendment to a previous submission?

* must provide value

New

Revision/ Amendment

Is this revision due to a protocol amendment?

* must provide value

Yes

No

Has this study been previously FAP-approved by CBR?

* must provide value

Yes

No

Was this study ever assigned a FAP# from a CBR feasibility review?

* must provide value

Yes

No

Provide the FAP#:

* must provide value

Has this study ever utilized CCTS services (Bionutrition, Biorepository, CRSP, CRU, SPAN)?

* must provide value

Yes

No

Provide the OnCore Protocol Number:
If the study is not yet in OnCore, enter 'pending'.

* must provide value

PI Name:

* must provide value

PI Email:

* must provide value

Has this study ever been listed under a different PI?

* must provide value

Yes

No

If yes, please provide previous PI's name:

* must provide value

Study Coordinator Name:

* must provide value

Study Coordinator Email:

* must provide value

Billing/Financial Contact Name:

* must provide value

Billing/Financial Contact Email:

* must provide value

Regulatory Coordinator Name:

* must provide value

Regulatory Coordinator Email:

* must provide value

Department:

Note - If you do not find your Department in this list: Please reach out to OncoreCalendars@uabmc.edu to request your Department and Management Group be added to this form.

In order to continue with the submission, you may select an incorrect Department and Management Group, but please leave a Comment at the bottom of this form with the correct Department and Management Group. We can correct this at a later time.

* must provide value

What is the name of your location (hospital/institution):

* must provide value

Department:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

If other, specify:

Management Group:

* must provide value

Is this a CRE-managed study?

* must provide value

Yes

No

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

* must provide value

Management Group:

Have you reached out to Melissa McBrayer (Pediatric Research Office) to determine logistics and assist with identification of UAB Health System clinical billable procedures?

* must provide value

Yes

No

If not, please hold submission. Please contact Melissa McBrayer at mmcbrayer@uabmc.edu.

Will this revision add, remove, or change UAB Health System clinical billable procedures?

This could include:

Procedures conducted within the UAB Health System (MRIs, CT scans, ECGs, biopsies, etc.)
Labs drawn, processed, resulted, shipped, or stored by the UAB Hospital Lab/Outreach, TKC, Whitaker lab, etc. (note - blood drawn by CRU staff is sent to Hospital lab for results)
Standard of care (SOC) procedures that are billed to insurance
Office Visit or Physical Exam where the PI is receiving effort.

Additional information may be found on CBR's Education and Training Page https://www.uab.edu/medicine/ctao/investigators/clinical-billing-review/education-training

* must provide value

Yes

No

Do these changes affect any UAB Health System billable items/services that are Billed to Insurance?

* must provide value

Yes

No

Do you need pricing and coding information for Health System billable services?

* must provide value

Yes

No

This amendment does not require CBR review. However, please still upload the Revised Billing Plan below for CBR's records.

Will UAB Hospital Lab/Outreach Lab (including TKC, Whitaker, Highlands, etc.) perform any of the following:

draw blood
process labs
result labs (note: blood drawn by CRU staff is sent to Hospital Lab for results)
prepare labs for shipment/ship to central lab
store labs

If yes to any of the above, answer YES.

* must provide value

Yes

No

Does this study include any clinical billable procedures performed within the UAB Health System (e.g., MRI scans, CT scans, biopsies, ECGs, etc.)?

Additional information may be found on CBR's Education and Training Page https://www.uab.edu/medicine/ctao/investigators/clinical-billing-review/education-training

* must provide value

Yes

No

Does this study involve UAB Radiology procedures/services?

* must provide value

Yes

No

Does this study include a PET scan?

* must provide value

Yes

No

Is the contrast for the PET scan provided by the sponsor at no cost?

* must provide value

Yes, contrast is provided by the sponsor at no cost

No, contrast is not provided by the sponsor at no cost

NA, no contrast

Are the Radiology procedures billed through the UAB Health System?

If unsure, please contact Radiology Research at radresearch@uabmc.edu.

* must provide value

Yes

No

Radiology Research
If your trial includes UAB radiology procedures, after you complete this form, you will need to also submit the study directly to Radiology Research. You may receive bills from both Radiology Research and the UAB Health System Billing Offices. Please see the link below for the application.

Link for Rad Research RedCap Application: https://redcap.dom.uab.edu/surveys/?s=PJPANNA439

Please contact Radiology Research directly for any questions or concerns: (205) 975-4559 / radresearch@uabmc.edu

Additional Notes Regarding Submission:
**The Tumor Metrics request is ONLY for exams not ordered in IMPACT for Metrics, we are NOT requiring this to be entered for all metrics studies
**The oracle account number is a required field on multiple documents, for CCC studies please enter 999999

Does this study involve standard of care (SOC) procedures billed through the UAB Health System?

Additional information may be found on CBR's Education and Training Page https://www.uab.edu/medicine/ctao/investigators/clinical-billing-review/education-training

* must provide value

Yes

No

Are any of the SOC procedures related to the study?
Or are the SOC procedures considered conventional care (not related to study)?

* must provide value

Related to Study

Not Related to Study (only conventional care)

Some Related to Study, and some Not Related to Study (conventional care)

Unsure

Will this study use the UAB Flow Cytometry lab?

* must provide value

Yes

No

If there is a Physical Exam being performed in a UAB Health System billable location (TKC, UAB Hospital, etc.), is the physician/PI receiving effort for the exam?

* must provide value

There is no Physical Exam

There is a Physical Exam but it is not in a UAB billable location

There is a Physical Exam in a UAB billable location and the physician/PI IS NOT receiving effort

There is a Physical Exam in a UAB billable location and the physician/PI IS receiving effort

If yes, is the PI receiving effort at some visits or all the visits (where a Physical Exam occurs)?

* must provide value

SOME visits

ALL visits

Who is receiving effort?

* must provide value

just the PI

PI and Additional Providers

PI and the entire Division

Please specify the Additional Providers who will receive effort:

* must provide value

Expand

Is there a Physical Exam/Office Visit (E&M) performed as a Telehealth Visit?

(A billable office visit code will apply.)

* must provide value

Yes

No

Will any of the visits include an RPE (Research Practice Expense)?

Additional information may be found on CBR's Education and Training Page https://www.uab.edu/medicine/ctao/investigators/clinical-billing-review/education-training

* must provide value

Yes

No

You have indicated you have UAB Health System clinical billable services. This study information will be automatically submitted to CBR/FAP after the request has been submitted. Please select the type of FAP submission:

* must provide value

Device Trial Submission

All Other Submissions (Full)

This study will require additional review by Hospital Administration. Ensure you complete the subsequent mandatory Device Form.

If the Device Form is not completed, the study will be marked as incomplete and review cannot be initiated. This will extend your overall review time.

For Pediatric Studies:
Are you requesting an individualized Peds submission (calendar with only the UAB HS billables), or a full OnCore calendar?

* must provide value

Individualized PEDS Submission (OnCore calendar will only contain UAB HS billables)

OnCore full calendar (OnCore calendar will contain all protocol procedures including UAB HS billables)

For Pediatric Studies:
You have indicated there are no UAB Health System billables for this study. Are you requesting an OnCore protocol shell only, or a full OnCore calendar?

* must provide value

OnCore protocol shell only

OnCore full calendar (calendar will contain all protocol procedures)

You have indicated there are no UAB Health System clinical billable procedures for this study. CBR will NOT review this study and will not provide a separate acknowledgment email.

You may move forward with managing the study without this FAP acknowledgment email.

(If you believe this is an error, review the questions above in this section and update as needed.)

Will this study have all the below:

at least 3 UAB Health System clinical billable procedures
at least 3 subjects to be enrolled
at least 3 visits?

(UAB Health System clinical billable procedures may include labs, rad, echo, research prescriptions, dexa scan, mammograms, infusion.)

If you have any questions about PowerTrials, please contact HSISPowertrials@uabmc.edu

* must provide value

Yes

No

PowerPlan Validation Contact Name:

PowerPlan Validation Contact Email:

Are you requesting to add, remove, or change CCTS services for this study (Bionutrition, Biorepository, CRSP, CRU, SPAN)?

This includes amendments that add new visits that will include CCTS services.

* must provide value

Yes

No

Will CCTS perform any of the following:

draw blood
process labs
prepare labs for shipment/ship to central lab
store labs

If yes to any of the above, answer YES.

* must provide value

Yes

No

Will this study be using any other CCTS services?
(e.g., Bionutrition, Biorepository, CRSP, CRU, SPAN)

* must provide value

Yes

No

Is this a request for an OnCore protocol shell only (no calendar)?

* must provide value

Yes - please enter the protocol in OnCore but no calendar is needed (protocol shell only)

No - please build the calendar in OnCore (there will be FAP-approved UAB Health System billable procedures or CCTS-CRU, Bionutrition, Biorepository, or SPAN lab services)

IRB Number:

(enter in I300001234 format)

* must provide value

OSP number:

Protocol Title:

* must provide value

Expand

Protocol Short Title:

* must provide value

Sponsor Protocol Number:

* must provide value

Phase:

* must provide value

Early Phase I

I

I/II

I/II/III

II

II/III

III

III/IV

IV

N/A

Pilot

NCT Number:
(Clinicaltrials.gov number)

* must provide value

What type of study is this?

(Select all that apply.)

* must provide value

Investigator-Initiated

Academic Collaboration

Cooperative Group

Clinical Trial

Multi-site

HIV/AIDS-related

COVID-19- related

Rare Disease

Other

If other, please specify:

* must provide value

What is the funding source?

(Select all that apply.)

* must provide value

Industry

Federal / National

Departmental

Investigator Initiated with Industry funding

Other

If other, please specify:

* must provide value

Protocol Type:

* must provide value

Device Feasibility

Diagnostic

Epidemiologic / Observational

Intervention: Non-Treatment

Prevention

Screening

Supportive Care

Treatment

Protocol Type:

* must provide value

Basic Science

Device Feasibility

Diagnostic

Epidemiologic/Observational

Health Services Research

Other

Prevention

Screening

Supportive Care

Treatment

Age of subjects:

* must provide value

Adults

Children

Both

Estimated number of participants to be enrolled at UAB:

* must provide value

Estimated number of participants to be enrolled at your study site:

* must provide value

Does this study involve cancer patients or screening for cancer in a healthy population?

* must provide value

Yes

No

Has the Letter of Intent been approved through PRMC (Disease Working Group and Protocol Review Committee) as part of the O'Neal Comprehensive Cancer Center CTRC Approval?

* must provide value

Yes

No

If No, send Letter of Intent and all protocol documents to the PRMC Team Manager (Denise McKenzie, at dhmckenzie@uabmc.edu ). The calendar cannot be built until this PRMC approval is in place.

Date of study activation:

(If study is not open yet, this is the anticipated date of study activation. If study is already open, this is the date the study was initiated/opened for enrollment.)

* must provide value

Study's anticipated primary completion date:

* must provide value

Number of months you plan to recruit participants on this study:

* must provide value

Will subjects ever be consented for the study while they are inpatient (hospital, ER, ICU, etc.)?

* must provide value

Yes

No

Clinical trial/research activities will be provided in what setting(s)?

(Select all that apply.)

* must provide value

Hospital Inpatient

Outpatient

Home Health

Clinical Research Unit (CRU) Outpatient

Child Health Research Unit (CHRU)

Children's Hospital

Other

Is the reason for the hospital inpatient stay only for study reasons or entirely due to their clinical care?

(Why are study subjects being admitted to the hospital?)

* must provide value

For study reasons only (protocol-driven inpatient stay)

For clinical care reasons only

Both study and clinical care reasons

If both, please specify circumstances of hospital admission:

(For example: patient admitted to the hospital due to clinical reasons but inpatient stay may be extended due to study reasons)

* must provide value

If other, please specify:

* must provide value

Please contact Melissa McBrayer (Pediatric Research Office) at mmcbrayer@uabmc.edu to determine logistics and assist with identification of UAB Health System clinical billable procedures.

To utilize the CHRU, including the centrifuge located in the lab, complete the CHRU application found at www.uab.edu/medicine/peds/research/chru

Is this study conducted under an IND or Device application reviewed by the FDA?

* must provide value

Yes, Drug (IND)

Yes, Device (IDE)

Yes, both drug and device (IND and IDE)

No, it has been granted an exemption from being required to have an FDA IND

No, other

N/A, the study does not involve a drug or a device

If yes, provide the IND#, etc.

* must provide value

If yes, provide the IDE#, etc.

* must provide value

If yes, please provide the IND#, IDE#, etc.

* must provide value

Please upload the FDA letter:

* must provide value

If it is exempt, upload the documentation confirming this exemption here.

* must provide value

If other, please explain:

* must provide value

This study will require additional review by Hospital Administration. Ensure you complete the subsequent mandatory Device Form.

If the Device Form is not completed, the study will be marked as incomplete and review cannot be initiated. This will extend your overall review time.

Will this study use Investigational Drug Services (UAB's Research Pharmacy)?

* must provide value

Yes

No

Will this study involve an infusion?

* must provide value

Yes

No

Where will the infusion take place?

(Select all that apply.)

* must provide value

Phase 1

CRU

TKC

UAB Hospital

Other

If other, please specify:

* must provide value

Would you like the Financial Analyst on the OnCore team to enter your budget in the OnCore Financials Console?

There is no additional fee for this service.

* must provide value

Yes

No

Unsure, please have the OnCore Financial Analyst email me to discuss (and the Billing Contact listed at the top of this form)

Billing Plan: The OCS Calendar Builder will send the Billing Plan for your completion.

Calendar Revision: The OCS Calendar Builder will send the Calendar for you to document the specific changes.

Upload the Billing Plan for CBR:

* must provide value

Upload the Final Protocol:

(If study protocol is not available, upload the exported IRB submission.)

* must provide value

Upload the Informed Consent form:

* must provide value

Upload Sponsor Draft Clinical Trial Agreement:

* must provide value

Upload Sponsor Budget:

* must provide value

Upload Pharmacy Manual, if available:

Upload the Lab Manual, if available:

Upload Manual of Procedures (MOP), if available:

Upload the amended protocol, if applicable:

(If study protocol is not available, upload the IRB amendment or revised HSP submitted to the IRB.)

Upload the revised Informed Consent form, if applicable:

Upload the Summary of Changes (not the full redlined protocol), if available:

Upload the amended Pharmacy Manual, if available:

Upload the amended Lab Manual, if applicable:

Are there any additional document(s) to upload?

* must provide value

Yes

No

Upload additional document

Upload additional document

Upload additional document

Upload additional document

Upload additional document

Additional Comments:
(For example, if you will only be participating in a specific arm, or if you want the calendar built a certain way. )

Expand

For CBR Use Only: Modified CCC submission

This is a CCC request for a NEW study that does NOT contain any SOC procedures.

For CBR Use Only: Modified Medical Center submission
This is a Medical Center request for a NEW study that does NOT contain any SOC procedures.

FAP Number (CBR USE ONLY):

Date the request was submitted:

You have selected an option that triggers this survey to end right now.

To save your responses and end the survey, click the 'End Survey' button below. If you have selected the wrong option by accident and/or wish to return to the survey, click the 'Return and Edit Response' button.