Office of Sponsored Programs (OSP)

Institutional Clearance from OSP is necessary prior to beginning any study here at AdventHealth. In order for clearance to be provided the following must be completed:

• Research Review Application signed by PI, Dept Director and/or VP as necessary
• Conflict of Interest and Significant Financial Interest forms on file with ORI
• IRB approval (internal or external) and IRB approved informed consent(s)
• Internal budget approval If any external funding
• Physician Letters of Agreement (if applicable)
• Physician Payment letters for services (e.g. EKG reads, eye exams, etc)
• Fully executed applicable legal documents (CTAs, grant awards (prime/subward), DUAs, MTAs, etc.)
• Local MAC-First Coast Service Options approval (if required) or if Sponsor has National Coverage Determination a copy of the notification to Local MAC is required
• Medicare Coverage Analysis (MCA) signed by the PI*

The Grants Management Team supports campus researchers and their staff with a variety of tasks associated with extramural funding transactions. Our team is responsible for the appropriate and successful processing of grant proposals, as well as interpreting, negotiating, and accepting awards/agreements on behalf of the Hospital in the form of Federal Grants, Cooperative Agreements, State Agreements, Foundation Awards, and Subawards stemming from these prime award mechanisms.

The Grants Management Team offers a wide-range of services including:

PRE-AWARD ADMINISTRATION

The Grants Management Team, as the Authorized Organizational Representative (AOR) of AdventHealth, reviews all grant proposals (including subawards) prior to their submission and negotiates and accepts all grant awards for research activities to ensure that the proposals are compliant with funding agencies’ application instructions, institutional policies, and all relevant regulations.

• Letter of Intent (Pre-application, Pre-proposal, and Concept Paper Submission)
• New Proposal Preparation and Submission (New, Resubmission, and Revision)
• Award Negotiation and Acceptance

POST-AWARD ADMINISTRATION

The Grants Management Team, in collaboration with the PD/PI, Department, and Research Finance, manages the post-award administration of all grant awards including subaward/consortium agreements to ensure that the administration of grant awards is compliant with award documents, institutional policies, and all relevant regulations.

• Award and Account Activation
• Monthly Financials
• Cash Management
• Reporting
• Award Closeout

SUBAWARD ADMINISTRATION

• Subrecipient vs. Contractor Determination
• Subrecipient Risk Assessment
• Subaward Negotiation
• Subrecipient Monitoring

REMINDERS!

• Individual investigators, department directors, or staff members are NOT authorized to submit grant proposals or sign grant awards on behalf of AH.
• FINAL proposal packages should be submitted to AH Grants five (5) business days from due date. The Grants Team makes reasonable efforts to submit grant proposals by the funder’s deadline. However, failure to provide documents by noted deadline(s) for review and submission will require the investigator to directly get written approval in order to proceed with the submission.

If your department is not assigned to an OSP staff, please send an email to ORL[email protected] and someone will connect you to the appropriate team member.

CONTRACT REVIEW MANAGEMENT

Preparation, review, and execution of applicable legal documents in coordination with AdventHealth Legal counsel including but not limited to the following:

• Confidentiality Agreements
• Clinical Trials Agreements
• Master Clinical Trial Agreements
• Material Transfer Agreements
• Data Use Agreements
• Licensing Agreements
• Facilities Use Agreements

*The authorized signatory for AHRI is the Vice President of Research Operations or designee of the same level or higher. If required to sign the PI may not delegate his/her authorized signature to anyone else.

Additional questions could be sent to OSP at Call407-200-9262 or [email protected]

AdventHealth reviews research budgets to ensure that all costs associated with conducting the project are requested (or appropriate Departmental and Institutional approvals are obtained for any cost-sharing or shortfall in the request) and in compliance with funding agency’s guidelines, institutional policies and procedures, and applicable regulations.

The Clinical Trials Management System (CTMS) / Study Builders Team supports researchers and their staff in conducting and implementing projects by leveraging CTMS in order to:

• Increase Compliance
• Increase Patient Safety
• Maximize Research Revenue
• Streamline processes through standardization and automation
• Improve performance through benchmarking

The CTMS/Study Builders Team is responsible for:

• Study creation
• Study calendar build and configuration including budget details for clinical trial data capture in accordance with the protocol, informed consent, and clinical trial agreement
• Study Status updates
• On-site support for CTMS users

AdventHealth Research Institute has adopted Bio-Optronics' Clinical Conductor as its comprehensive web-based CTMS.

The CTMS/Study Builder Team is currently comprised of team members who are assigned specific Hospital departments and serve as the primary contact for that department for any research grants inquiry. Typically, each department is aligned to a primary team member. This structure allows each member to become familiar with the department for which s/he is responsible and builds a collaborative relationship among all parties; however, all team members are cross-trained such that one should be able to assist and keep up with any departmental requests.

To find out the team member assigned to your department, please see our CTMS/SB Responsibility Chart (coming soon). If your department is not assigned to an OSP staff, please send an email to [email protected] and someone will connect you to the appropriate team member.

• Late Certification YY MM Last Name First Namee T-E 23.03.14
• Amendment YY MM Last Name First Name T-E 2023.05.25
• Current Version YY MM Last Name First Name T-E 24.02.27