Congratulations, You’ve Been Funded!
Research Operations is here to support you as you transition from award acceptance to award management. Sponsored Programs Administration (SPA) has been collaborating since proposal submission and will continue to serve you in managing your award administratively. Sponsored Programs Finance will now take the larger role as it supports your SP finances, including salary allocations and effort reporting.
If your award includes clinical services, and you did not contact the Clinical Trial Office at the time of proposal development for billing compliance review and budgeting recommendations, please hesitate no longer. The CTO is known for financial support of industry clinical trials, but it also has a vital role when your federal, state, city, or foundation award involves or more prospective clinical services for either interventional, diagnostic, or observational research.
Last, but not least, if your study team could use temporary or part-time augmentation, the Clinical Research Network offers a range of services, e.g., coordination or regulatory support, and supports investigators in community engagement initiatives.
Below, the SPA team offers guidance for launching your awarded program.
Tips for Award Management Success
Careful planning and preparation are essential to the success of any complex endeavor, from pulling off a grand vacation to – changing the future of health care. A kick-off meeting, formal or informal, sets the tone for various collaborators, saves time, and mitigates frustration. It may even promote a good night's sleep
Sponsor requirements and award details may not seem high priority: patient care and/or the science toward transforming it are the goals. We agree and thus counsel: early due diligence eases back-end complications, allowing SP teams to focus on what is ultimately important:
TIP 1: Review the award carefully, consulting related sponsor policies to ensure you know what is required. Document your questions/concerns as you go and review them with your assigned SPA contact.
TIP 2: Cultivate that relationship. Early, respectful connections pay enormous dividends.
TIP 3: Because sponsor approval must be received before making significant changes to the SP, assess the costs and benefits of such changes, and plan accordingly. Perhaps some desired changes are not worth the complications. Perhaps they are.
TIP 4: If your award involves clinical data or services, do you have sufficient experienced staff support to meet your needs? If not, consider the Clinical Research Network's menu of services.
Guiding Questions for SP Commencement
In planning the award management phase of your SP, consider the following questions:
- What are the allowable expenses? Unallowable?
- What are my obligations and how much leeway do I have to deviate from the approved budget?
- What’s my financial status and how long will the funds last?
- What are the reporting requirements?
- Are we sharing data? If so, to whom do we turn to ensure compliance?
- Are we engaging foreign partners? Do we need to consider export controls?
- Do we need to hire staff or transfer existing staff to the new SP?
- Do team members understand research conflict of interest and conflict of commitment requirements?
- Does everyone on the team know their role and whom to contact whenever questions arise?
- As applicable (see section just below):
- Are we set on IRB, IACUC, Biosafety requirements?
- Have we met billing and finance requirements related to clinical services?
- How shall we track for conflict of interest disclosure updates within 30 days of change?
Identifying Compliance Collaborators to Meet Requirements
See Shared Services and Ancillary Services for webpages and contact information. See the Systems, as applicable, for these offices' required applications: IRB, IACUC, IBC, and CTO's clinical trial management and participant reimbursement systems.
Compliance collaborators and related requirements may include but are not limited to:
- Institutional Review Board (IRB) for review and approval or exemption from oversight of research studies involving human participants
- Investigational Pharmacy Services (IPS) for clinical trials requiring use of drugs
- IACUC and associated requirements
- Institutional Biosafety Committee (IBC) for oversight of cell-lines and certain compounds
- Supply Chain Operations for procurement of goods and services consultants; also Sponsored Programs Finance, if equipment >5K is to be purchased
- Clinical Data Warehouse (CDW) for clinical data, privacy and security
- Collaborative Research Core (CoRE) for pathology research laboratory and biorepository
- Clinical Trial Office (CTO) for studies including clinical data and/or services
- Clinical Research Network (CRN) study staff augmentation with a specialty in community engagement, and the
- Research Compliance Officer (RCO) for questions related to Conflict of Interest, Conflict of Commitment, Export Controls, Privacy and Security.
Best Practice: Hold a Formal Kick-off Meeting
Design the meeting to:
- Inculcate an appreciation of why this work is important
- Demonstrate the importance of meeting ethics of engagement, when applicable (e.g., human and animal participants, conflicts of interest, export controls)
- Include PI/PD, DA, assigned SPA, SPFA, and, when applicable, CTO collaborators.
- Invite everyone involved to the meeting: study and lab staff, key personnel, other related work units:
- Aim for two weeks after award receipt
- Summarize the research plan
- Confirm collaborators and budget.
- Align the full team toward a common goal, spell out responsibilities, identify all compliance requirements (e.g., human subjects protections, animal protections, bio-safety and -security needs, billing and finance, effort reporting)
- Invite and encourage the team to discuss issues, opportunities, and obligations outlined in the agreement
- Prepare all for unanticipated issues; form a communication plan to address them
- Review, discuss, allow debate, and finalize roles and responsibilities
- Delineate roles of SP team and central support teams (eg, SPA, SPFA, CTO)
- Facilitate the transition from pre-award to post-award
- Plan for effort allocations on new project and adjustments to existing allocations.