ACRO’s DCT Toolkit includes five resources: (1) a detailed QbD Manual for DCTs; (2) an accessible, quick-reference QbD Manual; (3) a Risk Assessment Considerations template; (4) DCT Data Flow Maps; and (5) a Change Management Question-and-Answer resource. In addition to the DCT Toolkit, ACRO’s White Paper provides an overview of key issues in the decentralization of clinical trials.
Stakeholders are experiencing a paradigm shift in the clinical trial enterprise from conventional trials to studies where at least one or more DCT components are utilized (e.g., direct-to-patient shipment and home health visits). The use of DCT components is here to stay, and stakeholders need the tools to successfully embrace this change. While the Quality-by-Design (QbD) Manual, Risk Considerations Tool, and Data Flow Maps focus on providing educational resources to build confidence and trust in DCTs, this new ACRO resource focuses on the final hurdle to greater DCT adoption – which is the change management needed to address risk aversion and the difficulty in adopting brand new ways of working. Access the latest toolkit resource here.
ACRO members are dedicated to helping bring quality-based principles, risk-assessment tools, and patient-centricity to the decentralized trials process.
Explore some of ACRO’s additional DCT resources: