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Research Administration
Clinical Trials Administration Toolkit: Attaining Optimal Performance
Effective administration is essential to ensure high performance in the research enterprise, and compliance is the key factor to managing the risks of clinical research. Multiple stakeholders engaged in clinical trial activities – from research to billing – need to remain acutely aware of and respond to the complex academic, clinical, and business operations within the ever changing regulatory environment.
Designed to assist academic health center leaders, research administrators, and chief compliance officers optimize clinical research administration and infrastructure, The Clinical Trials Administration Toolkit was developed by the AAHC’s Forum on Regulation comprising chief compliance officers of academic health centers nationwide.
The Clinical Trials Administration Toolkit will provide the answers and solutions to help research administrators:
- Manage financial risk
- Increase transparency and accountability
- Leverage resources for maximum efficiency
- Enhance the management and organization of clinical research, and
- Engage multiple stakeholders to assess and benchmark institutional progress
To order the Clinical Trials Administration Toolkit, click here.
Research Administration: Clinical Trials Offices
Clinical trials offices (CTOs) have emerged within the academic health center research infrastructure to consolidate administrative activities related to clinical trials – from protocol development to billing compliance – and thus enhance institutional research capabilities.
The AAHC study of CTOs revealed:
- The trend towards consolidation or centralization in the administration of clinical trial functions is still ongoing, but far from complete
- Some institutions still lack a clearly defined organization and governance structure for clinical trials administration, but are proactively developing administration infrastructure
- The development of a systems approach strategy is important to planning an operative and effective CTO
- Compliance responsibilities are varied and ranged from contracting and cost analysis to education and training
- CTO leaders often must overcome challenges to institutional cultural change as the research enterprise evolves
- Academic health center leadership at the highest levels is central to a successful CTO
The AAHC recommends that academic health center leaders examine the organization and structure for clinical trials administration and determine what changes are needed to provide:
- A focal point for all billing and compliance activities
- Increased communication and coordination of activities and policies
- Consolidated education and training function
- Decreased redundancy and costs for staffing and infrastructure
- Increased access to information for university and academic health center leadership
For more information about CTOs, read our issue brief (pdf).