Study Registration & Initiation ChecklistOCR Log# (OCR Use ONLY)

  • This checklist is for UF Human Subjects and Servicesstudies that require a Research Billing Compliance (RBC) review by the Office of Clinical Research.
  • Click here to see which UFstudies require Research Billing Compliance reviews.
  • Non-Industry Proposals DO NOT need to submit Study Registration documents at the proposal stage.Track your award status and submit this form and all other applicable documents as soon as funding seems likely or IRB approval is needed. Be sure to allow enough time to complete your Study Registration process as needed.

PART A: Study Information
Study Title:
Short Name:
Sponsor Protocol #: / Provide the estimated number of study subjects at this site: / Will any part of this study be conducted at the North Florida /South Georgia VA Health System?
No Yes, STOP: Review VA SRICto see if it may be used instead of this SRIC.
College: (Choose One)DentistryMedicineNursingPharmacyPublic Health and Health ProfessionsOther
Department:
Division: / OnCore # (if applicable):
UFIRST #: OR
N/A for UF internally funded studies / IRB Used: (Choose One)UF IRB-01 (myIRB)*UF IRB-02 (Non-Med)UF IRB-03 (JAX)UF IRB-04 (WIRB)External CIRB Cincinnati (StrokeNet)External CIRB (NCI Cancer)External CIRB NEALS (ALS)External IRB LouisvilleExternal Other (List in Comments)
IRB Study #: OR Study # is Pending
*Note: If you have already submitted electronically to IRB-01 through the myIRB system, you MUST enter the myIRB number assigned to this study.
STUDY FUNDING AND/OR SUPPORT SOURCES / Type in name(s) of all entities providing either Funding or Support (e.g. drugs, devices, equipment, etc. - specify what type of support)
(Choose One) DepartmentalFederal Federal Flow-throughPrivate IndustryFoundationUF CRC (GCRC)Other (explain)
(Choose One) DepartmentalFederal Federal Flow-throughPrivate IndustryFoundationUF CRC (GCRC)Other (explain)
DEPARTMENT CONTACTS / NAMES / EMAILS / As of 01/25/18, signatures are no longer required on this form.
You’re welcome!
Department Chair(s) - REQUIRED for all submissions. Note: Each Chair of a department providing any study support or funding for this study must sign to acknowledge this support or funding and must ensure that the appropriate effort (as applicable) will be captured in the UF Effort Reporting system.
Principal Investigator
Names of person(s) authorized by PI to confirm billable services/charges for this study. Note: If this study will be in Epic, confirmation will include conducting research billing review activities in Epic. / Names only. Last name, First name. Separate by “;”
Email Addresses where study-funded statements should be sent / Email addresses only. 80 character limit. Separate each address with “;” (no spaces)
Study Coordinator
Informed Consent Form Drafter
Person Filling Out This Form
OCR Reviewer (OCR Use Only)
PART B: Services and Budget Questions
Does this human subjects study have a UF Principal Investigator AND activities conducted in a Gainesville UF Health or Health Science Center facility that include at least one of the following:
  • The use of any IND drugs or IDE devices
  • Any services that generate a charge in a UF Health patient billing system (e.g. Epic)
  • Research-only standalone visits in a Shands Facility or UF clinic
  • Research-only activity that prolongs patient encounters that are billed according to time (e.g. surgical procedures, anesthesiology services, etc.)
  • Research services that will performed by Shands personnel, including hospital nurses and other professional/technical staff
  • An outside sponsor who is willing to pay for subject injury?
/ No. This is a human subjects study that has no IND drugs or IDE devices, no Gainesville UF Health technical or professional medical services, and no sponsor willing to pay subject injury.
  • For WIRB & External IRBs, go to Q#7.
  • For all other UF IRBs, go to Q#9.
/ Yes.
  • If your study is (or will be) in UFIRST, make sure you indicate ‘Yes’ on the “Clinical Services” question regarding human subjects.
  • For more information, see UFIRST Guides/Manuals.
  • Go to Q#1.

1)Does study protocol REQUIRE the application, implantation or use of any specifically-named medical device (click for definition of “device”)
OR will Sponsor pay for/provide a device
OR will Shands have to receive/store a study device? / No.
  • Go to Q#2.
/ Yes.
  • Submit Device Table.
  • Go to Q#1a.

1a) Does study involve:
  • IDE Category A
  • IDE Category B
  • Carotid Artery Stenting(510(k) or PMA)
/ No.
  • Go to Q#2.
/ Yes.
  • Submit INITIAL (i.e. first submission) FDA Letter.
  • Read Device Trial information and check this box. to confirm that you agree to adhere to all Shands notification & Medicare pre-approval rules.
  • Go to Q#2.

2)Does protocol REQUIRE administration, ingestion, or use of any specifically named drug or substance (investigational, FDA approved, or other)
OR will Sponsor pay for/provide a drug/substance
OR will Shands Investigational Pharmacy (IDS) be used? / No.
  • Go to Q#3.
/ Yes.
  • Submit Drug Table.
  • Go to Q#3.

3)Is the Sponsor/study paying for all protocol-required activities? / No.
  • Submit FULLY NEGOTIATED sponsor detailed budget or internal Detailed Budget.
  • NCTN studies may submit funding sheets as budget.
  • Go to Q#4.
/ Yes, but this study is solely funded internally by UF, so no budget required.
  • Go to Q#4.
Yes.
  • Submit FULLY NEGOTIATED Sponsor/Grant budget or internal Limited Budget.
  • Go to Q#4.

4)Medicare Coverage Analysis Worksheet
Does the study objective or aim involve:
  • An investigational treatment
  • OR an investigational drug, substance, or device
  • OR a new indication for an FDA-approved drug, substance, or device?
/ No.
  • Go to Q#5.
/ Yes, but PI Medicare Coverage Analysis is not required because:
  • Sponsor is paying for all study services
  • OR this is an IDE or CAS device studyrequiring Medicare pre-approval
  • Go to Q#5.
Yes,SubmitMedicare Coverage Analysis Worksheet.
  • Click here to review requirements. Go to Q#5.

PART C: Billing Plan
5)ALL studies must submit a billing plan using a Billing Grid. / Submit Billing Grid. Note to College of Dentistry: Read Dentistry Billing Grid Instructions.
  • Grid ALL protocol-required services and activities (click here for instructions).
  • Include modifier codes as directed by “Medicare Qualifying” status question at top of the grid (see information on Use of Z00.6 & Q0Q1 Modifiers).
  • For all study-funded ancillary services (“S” on the Billing Grid), submit either service department COS Form.
  • For any study-funded UFHP Eye Clinic visits, a UFHP Clinic COS is REQUIRED.
  • For all other study-funded UFHP clinic visits, it is STRONGLY recommended that you get a UFHP Clinic COS from the clinic manager(s) involved.
  • If the UF CRC will be involved, a UF CRC Confirmation of Services is required.
  • All “S” and “U” must be tracked and reviewed in Epic. Register for RBC805 Tracking class and RBC808 Research Billing in Epic class to learn how!
  • Go to Q#6.

6)Does this study involve any “No Read” Reading Exception?
This refers to a situation where you will be ordering a research-only study-funded UF Health billable service and you are requesting that the service department refrain from performing a professional reading or interpretation because either the study team or the sponsor will be performing the read for research purposes only. / No.
  • Go to Part D.
/ Yes.
  • Make sure to indicate which billable service(s) involve the “No Read” Reading Exception(s) on the Billing Grid above.
  • Follow individual service department procedures/processes to ensure proper billing procedures are implemented.
  • Please note: The study Informed Consent may need to include IRB template language about the reading exception(s). Please contact UF IRB office for more info.
  • Go to Q#7.

PART D: Consent and Agreement Questions
7)Does this study require the use of an Informed Consent Form (ICF) or assent that the participant or their family must sign? / No.
  • Go to Q#9 (skip Q#8).
/ Yes.
  • Indicate # of consent/assent forms total:
  • Submit a copy of the final draft of all consents or assents that you intend to submit to the IRB.
Exception for ICFs already in myIRB for IRB-01 submissions: If you have ALREADY submitted your ICF drafts through the electronic myIRB system, click on this box: and OCR will review the ICF(s) in myIRB.
  • Go to Q#8.

8)A Financial Language Assessment (FLA) is required by the IRBs for this study. The FLA can be issued by OCR at three different time points.
Indicate when you would like OCR to issue the FLA ======
Caution: For studies that require a contract to be negotiated, the timing of the FLA can help reduce the risk of conflict between the fiscal language in the ICF and the final executed contract. In all cases, it is the PI and Study Team’s responsibility to reconcile the ICF and contract language BEFORE the first patient is consented. / Immediately after RBC review is completed (highest risk of language conflict between ICF and contract). Go to Q#9.
When financial language in agreement/contract has been negotiated with sponsor (reduced risk of language conflict between ICF and contract). Go to Q#9.
After the agreement /contract is fully executed (minimal risk of language conflict between ICF and contract). Go to Q#9.
9)Is this study receiving any funding or support
(e.g. drugs, devices, equipment, items, or services) from outside UF? / No.
  • Go to Q#12 (skip Q#10-11).
/ Yes.
  • Go to Q#10.

10) Funding Documentation (e.g. Approval Letter, Award Agreement, Contract, or equivalent) / Submit Sponsor’s or supporting agency’s agreement/contract, approval letter, award notice, etc. (draft, executed or proposed, as appropriate, with FULLY APPROVED/NEGOTIATED budget attached as needed). Go to Q#11.
11)Does this study include an agreement/ contract that will need to be approved or executed by UF? / No.
  • Go to Q#12.
/ Yes. Submit Checklist for Clinical Study Agreements.
  • Go to Q#12.

12) Protocol / All studies must submit a Protocol, Human Subject Plan, or Scope/Statement of Work.
Exception for protocol already in myIRB for IRB-01 submissions: If you have ALREADY submitted your protocol through the electronic myIRB system, click on this box: and OCR will review the protocol in myIRB.

Additional Comments or Information:

UF Office of Clinical Research Page 1 of 4 Version 01/26/18