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Whether you have decided to create an institutional compliance program or to evaluate and enhance your current program, Research Compliance Consulting can assist you in identifying your risks and implementing the most appropriate options in the context of your specific organizational culture and profile. Research Compliance Consulting embraces the concept that a compliance program is a supportive partner working to enhance quality within research enterprise operations. In this approach audit is an important tool but not a compliance program, and monitoring programs emphasize helping research teams do it right.
- The classic elements of a compliance program
- Oversight responsibility
- Delegations of authority
- Compliance standards and procedures
- Monitoring and auditing systems
- Effective lines of communication
- Enforcement and discipline
- Response and Prevention
- Variations on research compliance program structures
- Centralized and distributed responsibility models
- Accountability metrics
- Anonymous reporting mechanisms
- Presentations to stakeholders
- Risk assessments
- Annual identification of program priorities and midyear status reviews
- Responsible Conduct of Research training programs
- Establishing a “culture of compliance”
- Entry and exit personnel checklists
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