FEDgrant Solutions
Introduction
Clinical trials are pivotal in advancing medical research, yet the path from proposal to results is fraught with challenges. Managing federally funded clinical trials, especially those that span multiple sites, and often more than one collaborator (aka cooperatives), presents unique compliance hurdles. Research administrators and finance teams often grapple with managing allowable costs, ensuring accurate time and effort reporting, and adhering to federal regulations. In this article, I will share strategies for effective grant management, emphasizing the importance of centralized systems and proactive compliance measures.
Understand the differences
The difference between a multi-site research project and one that involves multiple collaborators primarily lies in the structure and management of the research activities.
Multi-Site Research Project
Definition: A multi-site research project involves multiple research sites that are part of a single study, often with a central coordinating institution overseeing the entire project.
Management: The primary institution typically manages all sites under a unified protocol, ensuring consistency in procedures, data collection, and reporting.
Collaboration: The sites may share resources and data but follow a common set of guidelines and objectives established by the lead institution.
Research with Multiple Subrecipients/Collaborators
Definition: This type of project also involves multiple research entities, but each may be operating independently under their own agreements, potentially with different objectives or methods.
Management: Each collaborator or subrecipient may have its own administrative and research framework, which requires a more complex management structure to ensure compliance and coordination among different entities.
Collaboration: While there may be shared goals, each entity may pursue specific research agendas, necessitating detailed agreements outlining roles, responsibilities, and funding allocation.
Key Differences
Oversight Structure: Multi-site projects are usually more centralized in terms of oversight, while projects with subrecipients may have distributed management responsibilities.
Protocols and Objectives: Multi-site projects typically follow a single protocol, whereas subrecipient projects may have varied methodologies or goals.
Compliance and Reporting: Managing compliance and reporting can be more straightforward in multi-site projects due to uniformity, while subrecipient projects require careful coordination to ensure that all parties meet their individual compliance obligations.
Understanding these differences is crucial for effective project planning and management, especially regarding compliance and oversight requirements. It's helpful to keep these in mind as you move through this blog.
The Real Challenges of Multi-Site Trials
Anyone who has worked on a multi-site clinical trial understands the complexities of maintaining consistent reporting across locations. Same can be said about working within a coalition of several institutions, with each research site may employ its own methods for handling financial data, leading to discrepancies that complicate data aggregation. Without a robust centralized system to track costs and personnel effort, issues can escalate quickly. Mistakes in this area can trigger audit findings that jeopardize the entire project.
A notable instance of this was highlighted in a 2024 audit by the HHS Office of Inspector General (OIG), which reviewed a multi-site clinical trial funded by the NIH. The audit uncovered over $1.2 million in questioned costs due to inconsistencies in time and effort reporting across sites. The core problem? A lack of a uniform system to accurately track personnel effort. Site coordinators often lacked the necessary tools and training to document the time spent by key personnel on the project. Additionally, weak internal controls failed to catch reporting errors before they resulted in significant audit findings(1).
Cost Allowability: A Common Stumbling Block
One of the primary challenges in clinical trial management is ensuring that costs are allowable under federal regulations. Federal guidelines dictate that costs must be reasonable, allocable, and necessary for the performance of the grant. However, misunderstanding these criteria can lead to unallowable costs that could jeopardize funding.
For instance, common pitfalls include improper classification of expenses and failure to document cost-sharing arrangements. A clear and comprehensive understanding of cost allowability is essential. This can include regular training sessions on federal cost principles for staff at all sites as a means to mitigate these issues along with establishing a centralized repository for cost guidance and documentation. This is a simple solution with great impact as it helps to ensure that all team members are on the same page, reducing the likelihood of costly mistakes, particularly in high-risk areas such as time and effort reporting. An example of not getting this right is exemplified In the Columbia University audit, also conducted in 2024, where inadequate documentation contributed to questioned costs, resulting in findings of non-compliance related to cost-sharing and unallowable costs (2).
Staying Audit-Ready
To enhance compliance and stay ahead of potential audit findings, institutions must adopt proactive measures. Centralizing your financial management system is one effective strategy. A centralized approach enables close monitoring of expenditures at each site, ensuring consistency in reporting and minimizing the risk of questioned costs.
Time and effort reporting is another critical area where clinical trials often falter. Federal regulations, such as OMB’s 2 CFR Part 200, require institutions to maintain detailed records of personnel time on federally funded projects (3). When sites are left to track time independently, discrepancies are common. Implementing a centralized process for tracking and certifying time and effort is vital. Automated systems can streamline this process, ensuring adherence to uniform standards across all sites.
Moreover, conducting regular audits and reviews of time and effort reporting practices can identify weaknesses and offer opportunities for improvement. Creating a culture of transparency and accountability within research teams can also help maintain compliance and audit readiness.
How to Strengthen Compliance and Stay Ahead of the Curve
To effectively navigate the complexities of multi-site trials, consider the following strategies:
Centralize Financial Management: Implementing a centralized financial management system is essential for real-time tracking of expenditures and ensuring consistent reporting across all sites. This often necessitates the appointment of a dedicated individual to manage and coordinate these efforts—enter FEDgrant Solutions! We specialize in supporting and enhancing compliance efforts for large, multi-site collaborations. Importantly, consulting costs like ours are allowable expenditures under federal grant budgets, offering an efficient solution without the need to tie down specific staff to long-term (12–60 month) appointments.
Standardize Time and Effort Reporting: While it may seem straightforward to “develop a unified process for time and effort tracking with automated tools,” the reality is far more complex. Each institution has its own internal processes and controls that cannot easily be bypassed. This is why a thorough pre-award weighted assessment of subrecipients is crucial. It ensures that 1) their processes and controls are audit-ready, and 2) any areas requiring additional scrutiny and monitoring are flagged early on, setting the project up for long-term success.
Enhance Training Programs: Regular training and ongoing support for personnel across institutions involved in the trial are both necessary and effective for maintaining compliance. At FEDgrant Solutions, we’ve been pivotal in ensuring compliance by providing tailored support to multi-institutional research projects. Our training programs focus on translating OMB Uniform Guidance into actionable processes, covering topics such as cost allowability, and empowering staff to confidently meet compliance requirements.
Engage with Experts: As highlighted in the previous steps, partnering with consulting firms specializing in federal grant management, such as FEDgrant Solutions, can offer essential support and resources for compliance and oversight. Importantly, while costs are always a consideration, it’s worth reiterating that these consulting fees are allowable expenses within the grant budget. This strategic investment can help ensure the success and compliance of your projects.
The Path Forward: Partnering for Success
Navigating the complexities of grant management in clinical trials especially across multiple sites requires diligence and expertise. At FEDgrant Solutions, we offer tailored consulting services focused on federal grant compliance and management. Whether you need assistance with the challenges highlighted above to prevent audit issues or with implementing corrective action plans to address findings, we’re here to support you.
Conclusion
Don’t let the complexities of grant management hold you back. Reach out today to discover how we can help you enhance your grant administration processes and ensure compliance. Together, we can pave the way for the success of your clinical trials and research initiatives.
