Office of Sponsored Programs

OSP's Industry Contracts Team reviews and facilitates the negotiation of the following agreements:

• Clinical Trial Agreements (CTAs)
• Data Transfer/Use Agreements (DTAs/DUAs)
• Incoming and Outgoing Research and Funding Support Agreements
• Licensing Agreements
• Material Transfer Agreements (MTAs)
• Research-Specific Confidential Disclosure Agreements (CDAs)

OSP is responsible for operating and implementing a Clinical Trial Management System. AdventHealth has adopted Bio-Optronics' Clinical Conductor as its comprehensive web-based CTMS.

The CTMS Study Builder Team supports investigators and research staff in conducting and implementing projects to increase compliance, increase patient safety, maximize research revenue, streamline processes through standardization and automation, and improve performance through benchmarking. They work closely with members of the clinical research department, OSP budget specialists and Research Finance to ensure the accuracy of each study build.

The team works collaboratively with research units and is responsible for:

• Onsite support for CTMS users
• 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

OSP's Budget Team facilitates the development and review of coverage analysis if required. This analysis determines the appropriate payors for research-related clinical items and services required by the clinical study. This document should serve as a guide in building and developing an effective study budget.

In addition, the Budget Team reviews and approves 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 the funding agency's guidelines institutional policies and procedures, and applicable regulations.

*The Grants Management Team reviews and approves budgets included in grant applications.

Our OSP's Grants Management Team handles all pre-award and non-financial post-award activities associated with managing external funds.

Pre-award administration includes activities such as processing and submitting grant proposals in compliance with funding agency guidelines, institutional policies and procedures and applicable regulations regarding the receipt, negotiation and acceptance of awards.

Post-award administration (non-financial) includes activities such as interpreting funding agency guidelines and ensuring compliance with the award's terms and conditions.

An institutional clearance is an action required and provided by OSP to ensure that applicable institutional requirements are met before a research project is initiated.

OSP’s review includes, but is not limited to:

• Animal care and use
• Clinical trials billing compliance
• Conflict of interest in research
• Health, safety and environment (e.g., radioactive materials, recombinant DNA, infectious agents/materials and hazardous/toxic chemicals)
• Legal agreements and study documents synchronization
• Protection of human subjects (i.e., IRB-approved)

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

• Research Review Application signed by PI, department director and 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., ECG 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 various 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) before 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 sub-award/consortium agreements, to ensure compliance 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 AdventHealth.
• FINAL proposal packages should be submitted to AdventHealth Grants five (5) business days from the 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 to proceed with the submission.

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.

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

• Clinical trials agreements
• Confidentiality agreements
• Data use agreements
• Facilities use agreements
• Licensing agreements
• Master clinical trial agreements
• Material transfer agreements

*The authorized signatory for the AdventHealth Research Institute is the Vice President of Research Operations or designee of the same level or higher. If required to sign, the PI may not delegate their authorized signature to anyone else.

Additional questions could be sent to OSP at 407-200-9262 or [email protected].

AdventHealth reviews research budgets to ensure that all costs associated with conducting the project are requested (or the appropriate departmental and institutional approvals are obtained for any cost-sharing or shortfall in the request) and in compliance with the 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 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
• Onsite 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 they are 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 assigned to someone other than an OSP staff member, please email [email protected], and someone will connect you to the appropriate team member.

• Late Certification YY MM Last Name First Name 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