Amended Study Registration Form Printed 11/7/2018 11:48 PM

When to use this form: If your study agreement, budget, protocol, or consent is amended in such a manner that the current billinginformationor financial language is altered (adding or deleting services, changes in PI, Study Team or Sponsor, etc.), you must submit this form with supporting documents to the OCR officevia .Allow 5 business days for review.

Date / Study Short Name / Date of Current FLA
NA, No FLA ever issued / R99#
NA, No R99 ever issued
PI Name
Sponsor
RAC/OCR/Institutional# as listed on FLA:
IRB #
UFIRST # OnCore Protocol # / Study Long Title

Which of the followingneeds revision (check all that apply)?

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Amended Study Registration Form Printed 11/7/2018 11:48 PM

StudyTitle

Study Short Name

Principal Investigator

College/Department/Division

Department Contacts

Study Team Contacts

Protocol (revisionaffects billing grid, budget, or FLA)

Billing Grids

OnCore Calendar (revision adds or removes OnCore Calendar timepoints)

OnCore Budget

Financial Language Assessment (FLA)
Funding Sources –Will this

affect Billing Plan? No Yes

Medicare Qualification

Drugs/Biologics/Substances

Device Data

Other (specify below)

UF Office of Clinical Research Page 1 of 1 Version05/08/18

Amended Study Registration Form Printed 11/7/2018 11:48 PM

Provide a brief description of the revision - (add additional pages if needed):

Send a copy of the revised documents as follows:

  • Complete or incomplete pages that include the revised information as a handwritten or typed change (with tracking).Circle or highlight each change. IT MUST BE CLEAR WHAT THE ORIGINAL DATA WAS AND WHAT THE REVISIONS ARE.
  • If you are addingany study-funded ancillary services, a new or revised COSform will be required.
  • If you are deleting study-funded ancillary services, a revised COS is required only if the ancillary provides pre-printed,study-specific research order/encounter forms (e.g. Shands Lab services).
  • If a FLA/FLArevision is requested, includecurrent and/or redlined copies ofbudget, consent, protocol, and contract /agreement/award (as applicable); IT MUST BE CLEAR WHAT IS CHANGING.
  • Note: Additional documents maybe requestedby OCR, as needed for a specific study or revision.

REQUIRED: Confirm Current Study Contacts

List all email addresses to receive final OCR email notification for this amendment:
List names of all current study coordinators and any billingcontacts who perform Epic Charge Reviewfor this study, as applicable:
List the email addressesto receive study Epic services invoices- Separate each address with “;” (80 character limit), as applicable:

If the amendment includes a change to PI, PI’s home department, Sponsor, Funding Source, or Study-funded/Salary-supported Services,then please provide the PI and Chair info below so that they can be copied on the final email relating to this amendment:

List names/department/email address of current PI, previous PI and/or new PI, as applicable:
List names/department/email address of current Chair, previous Chair, and/or new Chair, as applicable:

Name and email address of person to contact if OCR has questions about this ASRF Date

UF Office of Clinical Research Page 1 of 1 Version05/08/18