Today’s Clinical Research Imperatives
- Clinical research infrastructure must change to respond to today’s complex business operations and regulatory environment.
- Compliance is key to managing the financial risk of clinical research
- Effective administration is essential to high performance.
The Clinical Trials Administration Toolkit is designed to assist academic health center leaders, research administrators, and chief compliance officers in establishing, strengthening, and improving the administrative infrastructure for the research enterprise, particularly to manage and support compliance functions for clinical trials.
Please call the Association of Academic Health Centers to order the Toolkit: 202-265-9600.
AAHC members can purchase the Toolkit for $150. The non-member price is $2500 per Toolkit.
The toolkit is divided into 10 easy-to-follow steps that lead the user from self-assessment of current administrative processes and operations to examination of integral organizational structures for optimal institutional practices and policies.
Academic health center leaders as well as the multiple stakeholders engaged in clinical trial activities—from research to billing—can identify critical information, tackle major hot spots, and strengthen institutional policies to achieve a high-performing research enterprise.
“This valuable toolkit will help all users assess and leverage resources to maximize and align organizational strengths and manage effective operations for this critically important research area,” according to AAHC President and CEO Dr. Steven A. Wartman.
The toolkit is the culmination of groundbreaking work of the AAHC’s Forum on Regulation, the executive leadership group comprising chief compliance officers of academic health centers nationwide, which is dedicated to fostering the development of appropriate regulatory compliance frameworks for universities and the nation.
Table of contents:
Step 1 Profile Your Institution
Step 2 Navigate the Transformational Curve
Step 3 Examine Organization, Governance, and Leadership
Step 4 Chart Your Institution on the Clinical Trials Functional Process Map
Step 5 Tackle Major Hot Spots
Step 6 Strengthen Institutional Policies
Step 7 Focus on People
Step 8 Enhance Communications
Step 9 Evaluate IT Needs
Step 10 Use Additional Resources