Clinical Trials Administration Toolkit

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.

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. Hartman.

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.

To Order:

Please call the Association of Academic Health Centers to order the Toolkit: 202-265-9600.

Member price:

  • a. $95.00 for one
  • b. $75.00 each for 2-5 copies
  • c. $50.00 each for 6 or more copies

Non-member price:

  • $500.00

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
Research Clinical Trials Academic Health Center Management Leadership