Submitting to ORA

Please select your submission type below to view where, what and when to submit:

Advance Account Request

Request to open an account in advance of the award/contract OR to extend an existing account beyond award period.

Include the following	When	Where
Advance Account Request Form Sponsor documentation, if available DRAFT agreement, if applicable If proposal was not previously submitted through ORA, provide Proposal Contract Routing Form – Long (PCRF-L), scope, budget, justification, deliverables, etc.	Upon identification of need	mra@med.miami.edu

Agreements (UM Not Receiving Funds)

Agreements which do not involve UM receiving funds from an external entity, and their associated amendments.

Collaboration Agreement

Include the following	When	Where	Note
Proposal Contract Routing Form – Short (PCRF-S) Draft Agreement Scope of Work Collaborator’s contact information	Upon receipt of Agreement draft	mra@med.miami.edu	Also referred to as a Memorandum of Understandings and follows the same process.

Confidentiality Disclosure Agreement (CDA)

Include the following	When	Where	Note
Word Format of DRAFT Agreement Contact information for the external party to the agreement	Upon receipt of CDA draft	cris@med.miami.edu	A Non-Disclosure Agreement is similar and follows the same process.

Inbound Material Transfer Agreement (MTA)

Include the following	When	Where	Note
Proposal Contract Routing Form – Short (PCRF-S) Word Format of DRAFT Agreement	Upon receipt of MTA draft from provider	cris@med.miami.edu	1) ORA processes inbound MTAs where material is being provided at NO COST TO UM. If your MTA involves the purchase of, or payment for, the materials, it should be reviewed and processed by Supply Chain Services/Procurement and not ORA. Please submit directly to SupplyChain Services-Procurement to avoid delay. 2) OUTBOUND Material Transfer Agreements are handled by the Office of Technology Transfer.

Master Agreement

Include the following	When	Where
Proposal Contract Routing Form – Short (PCRF-S) Word Format of DRAFT Agreement	Upon receipt of Master Agreement	cris@med.miami.edu

Memorandum of Understanding Agreement (MOU)

Include the following	When	Where	Note
Proposal Contract Routing Form – Short (PCRF-S) Draft Agreement Scope of Work Collaborator’s contact information	Upon receipt of Agreement draft	mra@med.miami.edu	Also referred to as a Collaboration Agreement and follows the same process.

Non-Disclosure Agreement (NDA)

Include the following	When	Where	Note
Word Format of DRAFT Agreement Contact information for the external party to the agreement	Upon receipt of NDA draft	cris@med.miami.edu	A Confidentiality Agreement is similar and follows the same process.

Teaming Agreement

Include the following	When	Where
Proposal Contract Routing Form – Short (PCRF-S) Prime Agency’s RFP/Solicitation/BAA Word Format of DRAFT Agreement Contact information for the external party to the agreement	Upon receipt of Teaming Agreement	mra@med.miami.edu

Agreements (UM Receiving Funds)

Agreements which involve UM receiving funds from an external entity and their associated Amendments.

Governmentally Funded – federal, state, city, county, etc

Include the following

When

Where

Note

InfoEd/Proposal Identifiers
If applicable, include IRB, IACUC and/or IBC approval documentation
If contract is for less than the requested amount shown on the previously submitted Proposal Contract Routing Form – Long (PCRF-L), revised scope, budget, justification must be attached
For state/county contracts which require Level 2 Background Screening for personnel on the project, provide proof of screening, if applicable.
If proposal was not previously submitted through ORA, provide Proposal Contract Routing Form – Long (PCRF-L), scope, budget, justification, deliverables, etc.

If the study anticipates the use of JHS’ facilities, resources or services, include:

Outbound Subaward / Jackson Work Order Request
If an amendment, provide draft with associated supporting documents as applicable
JHS Clinical Trials Office (CTO) Application (completely filled and signed by PI) and Study Calendar (in Draft Excel format, not signed) documents (which can be found at: https://jacksonhealth.org/clinical/submission/.)

If an Inter Personnel Action (IPA), include Agency Contact information

Upon receipt of the contract. If ORA receives the contract before the PI/Dept then ORA will request these documents from PI/Dept.

mra@med.miami.edu

For Governmental contracts, generally, a proposal has already been submitted through ORA, so ORA would need to review and negotiate the contract.

Industry, Association, Foundation Funded

Include the following

When

Where

Note

Proposal Contract Routing Form – Long (PCRF-L)
Word Format of DRAFT Agreement
Sponsor DRAFT budget
Protocol/Scope of Work
Informed Consent (as applicable)
eProst identifier

If the study involves the anticipation of JHS’ facilities, resources or services, include:

Outbound Subaward / Jackson Work Order Request
If an amendment, provide draft with associated supporting documents as applicable
JHS Clinical Trials Office (CTO) Application (completely filled and signed by PI) and Study Calendar (in Draft Excel format, not signed) documents (which can be found at: https://jacksonhealth.org/clinical/submission/.)

After all documents have been received from the sponsor/CRO and the PI/Department have reviewed, conducted feasibility assessment, and approved the project.

cris@med.miami.edu

Association and Foundation agreements follow the same process.

Applications (also known as Proposal) which UM submits to an external sponsor in the hopes of receiving funding. In most cases, UM is following the sponsor’s requirements associated with how the application is built, submitted and will be funded, if funded.

Include the following

When

Where

Note

Proposal Contract Routing Form – Long (PCRF-L)
Complete/Final Application (If not submitted through InfoEd PD) – including but not limited to:

Budget
Justification
Abstract/Scope
Higher Approval Requests, if applicable

Funding Announcement

If the study involves the anticipation of JHS’ facilities, resources or services, include:

Budget that includes JHS costs and expenses.

Two options as per Application Deadline Policy:

Option 1: Single Review 5 days prior to agency deadline
Option 2: Two-Tiered Review 10 days- Preliminary 3 days- Final Review

mra@med.miami.edu

For private foundations and corporate foundations/giving programs, the Office of Corporate and Foundation Relations must also review and approve proposals to ensure guidelines are met and accurate supporting documentation is included. Please see PCRF-L for Foundation Relations contact information.

The following F & A Moratorium message is effective 8-2-2017. It does not impact proposals/contracts utilizing:

Sponsor-pubished rates
UM federally negotiated rates
Industry funded clinical trials - 29% F&A

F&A Waiver Requests must be submitted to ORA at least 15 days prior to the deadline.

Award Documents

Include the following	When	Where
Send email with the award documentation.	Upon receipt of notice of award.	ORA-SI@miami.edu

Closeout Documents

Include the following	When	Where
As required by sponsor, but typically includes: Invention Statement Final Progress Report Property Report Other as required by sponsor	When project is closed and sponsor requires final reports. Documents must be sent prior to reporting due date.	ORA team lead assigned to your department/center Please see Who is my ORA contact Person.

Equipment Acquisition not included in Original Budget

Include the following	When	Where
Internal Prior Approval Request (IPAR)
Letter/Email Request addressed to Sponsor and IPAR	Upon identification of need.	ORAAwardAdmin@miami.edu

Export Control Forms and Questions

Include the following	When	Where
Completed Export Control Compliance forms Product Classification forms End User Disclosure forms Any export control compliance questions	As applicable	Exportcontrol@miami.edu

Financial Reporting Requests

Include the following	When	Where
Email with request	Based on Terms and Conditions of Award. ORA does not require rebudgeting when agency allows flexibility.	ORAAwardAdmin@miami.edu

Jackson Health System (JHS) Work Order

Jackson Health System (JHS) Work Order under the UM / JHS Master Research Collaboration Agreement) and funded from a Sponsored Project/Activity.

Include the following	When	Where
Outbound Subaward / Jackson Work Order Request If project is under an award (not Agreement) provide the following: JHS Clinical Trials Office (CTO) Application (completely filled and signed by PI) and Study Calendar (in Draft Excel format, not signed) documents, which can be found at: https://jacksonhealth.org/clinical/submission/.	Upon receipt of the Notice of Award from ORA.	cris@med.miami.edu

Just In Time

Post-Application and Pre-Award Submission

After UM submits an application to our external sponsors, the sponsor may request additional documentation from UM (including but not limited to Just In Time Information)

Include the following	When	Where
InfoEd/Proposal Numbers Sponsor requested information (e.g., IRB/IACUC/IBC Approval, Current & Pending, etc.) Sponsor's communication which shows what documents were requested and when these documents must be provided to the sponsor	Based on sponsor request	mra@med.miami.edu

No Cost Extensions

Include the following	When	Where
Internal Prior Approval Request (IPAR)	When PI has identified a scientific need to extend the project and UM has delegated authority to approve the NCE.	ORAAwardAdmin@miami.edu

Include the following	When	Where
Letter/Email Request addressed to Sponsor	Prior Written Approval Required	MRA@med.miami.edu

Outbound Subaward Requests

Outbound Subaward requests which UM is contracting with an external entity to perform a portion of UM’s overall scope/science.

Include the following	When	Where
For each external entity, please submit the following as a complete package: Outbound Subaward / Jackson Work Order Request Scope Budget Justification Deliverables	Upon receipt of the Notice of Award from ORA.	mra@med.miami.edu

Pre-Award Costs up to 90 Days

Include the following	When	Where
Internal Prior Approval Request (IPAR)	When terms and conditions of the sponsor allow.	ORAAwardAdmin@miami.edu

Rebudgeting

Include the following	When	Where
Internal Prior Approval Request (IPAR)	Based on Terms and Conditions of Award. ORA does not require rebudgeting when agency allows flexibility.	ORAAwardAdmin@miami.edu

Include the following	When	Where
Internal Prior Approval Request (IPAR) Letter/Email Request addressed to Sponsor and IPAR	Prior Written Approval Required	ORAAwardAdmin@miami.edu

Relinquish to Another Institution

Include the following	When	Where
Send email.	As needed.	ORAAwardAdmin@miami.edu

Request InfoEd Subaward Entity

Include the following	When	Where
InfoEd New Subaward/Consultant Request Form	When subaward is not in InfoEd Proposal Development	ORA-SI@miami.edu

Requests for Clinical Procedure Pricing

Include the following	When	Where
Detailed description of procedures, where services will be rendered, and associated CPT Codes Identification of sponsor (i.e. Federal, Industry, Foundation).	Requested prior to proposal budget preparation	cris@med.miami.edu

Requests for Medicare Coverage Analysis Revisions

Include the following	When	Where
Copy of prior Medicare Coverage Analysis eProst Number Reason for revision request Documents associated with the reason for the revision (updated protocol, etc.)	When needed	cris@med.miami.edu

RRS/PI Portal Access Requests

Include the following	When	Where
Research Reporting System Access Request Form	When access to RRS/PI Portal system is needed	ORA-SI@miami.edu

Salary Cap/Cost Sharing

Include the following	When	Where
Request for salary cap or cost sharing account	Based on Terms and Conditions of Award. ORA does not require rebudgeting when agency allows flexibility.	ORAAwardAdmin@miami.edu

Service Center Rates

Include the following	When	Where
All matters related to service/recharge center accounting and billing Submitting billing rate sheets to ORA for review and approval Any questions regarding what function should be assigned to space during the annual space survey/certification process	As applicable	Costanalysis.ORA@miami.edu

Submission to UM's Sponsors (including Just In Time)

Post-Application and Pre-Award Submission (Just In Time)

After UM submits an application to our external sponsors, the sponsor may request additional documentation from UM (including but not limited to Just In Time Information)

Include the following	When	Where
InfoEd/Proposal Numbers Sponsor's communication which shows what documents were requested and when these documents must be provided to the sponsor Sponsor requested information (e.g., IRB/IACUC/IBC Approval, Current & Pending, etc.)	Based on sponsor request	mra@med.miami.edu

Sponsor Required Progress Report

Include the following	When	Where	Note
Proposal Contract Routing Form – Short (PCRF-S) Supporting documentation, if applicable	Based upon sponsor requirements	mra@med.miami.edu	All FINAL reports and interim financial reports are handled by Post Award; therefore, please contact them via oraawardadmin@miami.edu

Agency Requests

(Carry Forward, Scope Revision, Change of PI/CO-I/Key Personnel)

Include the following	When	Where	Note
Word format of DRAFT agency request Supporting documentation, if applicable	Upon identification of need	mra@med.miami.edu	Please see Rebudgeting and No Cost Extension sections contained above for instructions on How to Submit.

Systems, Web, Training, Reporting Questions

Include the following	When	Where
Send email with specific questions.	As applicable.	ORA-SI@miami.edu

Submitting to ORA

Please select your submission type below to view where, what and when to submit:

Advance Account Request

Agreements (UM Not Receiving Funds)

Agreements (UM Receiving Funds)

Applications/Proposal

Award Documents

Closeout Documents

Equipment Acquisition not included in Original Budget

Export Control Forms and Questions

Financial Reporting Requests

Jackson Health System (JHS) Work Order

Just In Time

No Cost Extensions

Outbound Subaward Requests

Pre-Award Costs up to 90 Days

Rebudgeting

Relinquish to Another Institution

Request InfoEd Subaward Entity

Requests for Clinical Procedure Pricing

Requests for Medicare Coverage Analysis Revisions

RRS/PI Portal Access Requests

Salary Cap/Cost Sharing

Service Center Rates

Submission to UM's Sponsors (including Just In Time)

Systems, Web, Training, Reporting Questions

Office of Research Administration

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