Compliance
Improving compliance with new and existing regulations is one of the many ways in which CFS helps sponsors manage clinical trials. Our expert teams and automated processes work in conjunction to remove the burden from your compliance team and ensure that all organizational and regulatory requirements are met for every investigator in every trial you undertake.
Physician Payment Sunshine Provisions
A Physician Payment Sunshine Provision has been included in the Patient Protection and Affordable Care Act (PPACA). This provision requires companies to begin recording any physician payments, including research grants, in January 2012 and to report them by March 31, 2013. Grant payments for investigative work are usually made to investigative sites rather than to the physicians themselves, making it difficult for sponsors to accurately measure and report this vital information. In addition, many sponsors work with multiple CROs, adding further complexity to data gathering and reporting in accordance with Sunshine Act requirements.
Global Payment Management Services from CFS make it easier for your organization to manage business intelligence and remain in compliance with federal aggregate spend requirements because we track and report investigator payments across all of your clinical trials. What’s more, we construct our reports around both investigative sites and individual investigators, making federal compliance even more accurate.
Maintaining Contractual and Financial Compliance
Maintaining strong financial controls and compliance when managing payments to investigative sites begins with execution of the trial contracts. By ensuring that what a sponsor pays out is actually captured in the contract, CFS enables standard and Sarbanes-Oxley financial audit compliance. Our database is used not only to make investigator payments but can also ensure the accuracy of the payment process by flagging any payment requests that fall outside the scope of the contract.
CFS provides services in several key areas that assist you with financial compliance are:
- Investigator contract management
- Consultant agreement management
- Financial disclosure management
- Amendment management
- Payment management
- Detailed compliance reporting
Adhering to Federal Regulations
21 CFR Part 54
Before any clinical trial can commence, all regulatory documentation must be accurate and complete. With the signing of the Patient Protection and Affordable Care Act in March 2010, the Physician Payment Sunshine Provision (“Sunshine Act”) has become law. While the Sunshine Act places a large emphasis on physician payment tracking and reporting, it has also heightened the importance of the financial disclosure compliance process, which is governed by 21CFR Part 54. Sponsor companies must now ensure that physician self-report data from financial disclosure questionnaires are aligned with the payment data being reported through the Sunshine Act, so having a robust 21CFR Part 54 compliance strategy is a must.
The CFS Site Activation Services division has a dedicated Financial Disclosure Compliance Team comprised of experts in this area. Our team will collect financial disclosure forms from your investigator sites and audit them to ensure that the forms are properly completed and compliant with 21CFR Part 54. Potential conflicts of interest are quickly identified and documented, and data consistency and integrity are ensured by cross-referencing data back to Form FDA 1572. Our financial disclosure management services include:
- Automated, near-time forms tracking via our online project dashboard
- Quality control review by our experienced staff
- Complete reporting, including form status and operational metrics
- Resolution of potential conflicts and discrepant or incomplete data
