Submitter Name:
* must provide value
Submitter Email:
* must provide value
enter uabmc.edu email if applicable
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
Name and Email
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
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
(e.g., CAR-I300000000-TEST-STUDY, XUAB1234, etc.)
PI Name:
* must provide value
PI Email:
* must provide value
enter uabmc.edu email if applicable
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
enter uabmc.edu email if applicable
Billing/Financial Contact Name:
* must provide value
Billing/Financial Contact Email:
* must provide value
enter uabmc.edu email if applicable
Regulatory Coordinator Name:
* must provide value
Regulatory Coordinator Email:
* must provide value
enter uabmc.edu email if applicable
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
O'Neal Comprehensive Cancer Center Anesthesiology Clinical Nutrition Dermatology Emergency Medicine Epidemiology Family and Community Medicine Genetics Health Behavior Human Studies Medicine Microbiology Neurobiology Neurology Neurosurgery OB/GYN Occupational Therapy Oncology (includes Neuro-Oncology and RadOnc) Optometry Oral and Maxillofacial Surgery (OMFS) Orthopedic Surgery Otolaryngology (OTOL) Pathology Pediatrics Physical Medicine and Rehabilitation (PM&R) Physical Therapy Psychiatry Psychology Radiology School of Nursing Surgery Urology
What is the name of your location (hospital/institution):
* must provide value
Department:
* must provide value
Management Group:
* must provide value
(ANE) Anesthesiology
Management Group:
* must provide value
(CLN) Clinical Nutrition
Management Group:
* must provide value
(DCR) Dermatology-Clinical Research (DGR) Dermatology-Grants
Management Group:
* must provide value
(ERM) Emergency Medicine
Management Group:
* must provide value
(EPI) Epidemiology
Management Group:
* must provide value
(FCM) Family and Community Medicine
Management Group:
* must provide value
(GEN) Genetics
Management Group:
* must provide value
(PHA) Public Health-Addiction
Management Group:
* must provide value
Kinesiology Other
Management Group:
* must provide value
(CAR) Cardiology (END) Endocrinology (GIH) Gastroenterology and Hepatology (GIM) General and Internal Medicine (GER) Gerontology (HEM) Hematology/Oncology (IDC) ID-CTG (IDH) ID-HIV (IDS) ID-STI (NEC) NephrologyCTG (NET) NephrologyTrans (PRM) Preventive Medicine (PUL) Pulmonology (RHU) Rheumatology
Is this a CRE-managed study?
* must provide value
Yes No
Department of Medicine Clinical Research Enterprise
Management Group:
* must provide value
Neurobiology
Management Group:
* must provide value
Microbiology
Management Group:
* must provide value
(NEP) Epilepsy (NMD) Movement Disorder (NME) Memory Disorders (NMS) Multiple Sclerosis (NMU) Neuro-Muscular (NPA) Neuropathology (NPS) Neuropsychology (NSD) Sleep/Wake Disorders (NST) Stroke
To find Neuro-Oncology, update the Department to Oncology
Management Group:
* must provide value
(NSU) Neurosurgery
Management Group:
* must provide value
Acute, Chronic, and Continuing Care
Management Group:
* must provide value
(MFM) OB/GYN - MFM (URG) URO/GYN (GCC) GYNECOLOGIC-ONCOLOGY
Management Group:
* must provide value
(OPT) Optometry
Management Group:
* must provide value
(OMS) Oral and Maxillofacial Surgery
Management Group:
* must provide value
(OSU) Orthopedic Surgery
Management Group:
* must provide value
(OTO) Otolaryngology
Management Group:
* must provide value
(PLM) Laboratory Medicine
Management Group:
* must provide value
(PAI) PEDS: Allergy and Immunology (PCA) PEDS: Cardiology (PCC) PEDS: Critical Care (PED) PEDS: Endocrinology/Diabetes (PGH) PEDS: Gastroenterology, Hepatology, and Nutrition (PHO) PEDS: Hem/Onc (PID) PEDS: ID (PNE) PEDS: Neo (PNP) PEDS: Nephrology (PNU) PEDS: Neurology (PPU) PEDS: Pulmonary
Management Group:
* must provide value
(PMR) Physical Medicine and Rehabilitation (PM&R)
Management Group:
* must provide value
(PHT) Physical Therapy
Management Group:
* must provide value
(PHI) Psychiatry
Management Group:
* must provide value
(PSH) Psychology-HIV (PSP) Psychology-Pain (PST) Psychology-Therapy (PAS) Psychology-CAS (College of Arts and Sciences)
Management Group:
* must provide value
Neuro-Oncology RadiationOncology (RadOnc)
Management Group:
* must provide value
(RBI) Breast Imaging (RDI) Diagnostic Radiology (RIN) Interventional Radiology (RIT) Molecular Imaging, Therapeutics, and Advanced Medical Imaging Research
Management Group:
* must provide value
(SAC) Surgery - Acute Care (SCT) Surgery - Cardio Thoracic (SGI) Surgery - Gastro Intestinal (SPE) Surgery - Pediatric (SPL) Surgery - Plastic (SON) Surgical Oncology (STR) Surgery - Transplantation (SVE) Surgery - Vascular & Endovascular
Management Group:
* must provide value
(URO) Urology
(OCT) Occupational Therapy
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
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
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
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
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
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
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
just the PI
PI and Additional Providers
PI and the entire Division
Please specify the Additional Providers who will receive effort:
* must provide value
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
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) 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)
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)
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:
enter uabmc.edu email if applicable
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)
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 I 300001234 format )
* must provide value
if available
Protocol Title:
* must provide value
Protocol Short Title:
* must provide value
Sponsor Protocol Number:
* must provide value
If Investigator-Initiated (or no protocol number), enter 'N/A'
Phase:
* must provide value
Early Phase I
I
I/II
I/II/III
II
II/III
III
III/IV
IV
N/A
Pilot
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
If pending, enter 'pending'. If not applicable, enter 'NA'.
What type of study is this?
(Select all that apply.)
* must provide value
If other, please specify:
* must provide value
What is the funding source?
(Select all that apply.)
* must provide value
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
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
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
If there is a range, enter both numbers (e.g., 5 - 10)
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
MM/DD/YYYY
Study's anticipated primary completion date:
* must provide value
MM/DD/YYYY
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
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
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.
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
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 pending, enter "pending"
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
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)
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 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
For CBR Use Only: Modified CCC submission
T his 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:
Submit
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