Decentralized Clinical Trials: Being Audit Ready and Avoiding Pitfalls

By Sandra Orset, PhD, Applied Clinical Trials

As the modernization of clinical research through digital and decentralized solutions continues to take research into local communities, reduce patient and site burden, and increase diversity, it will lead to new ways of working for project delivery teams. The integration of decentralized clinical trials (DCTs) to add more flexibility within traditional trial design also means thinking about audit readiness differently to maintain strong quality systems to support operations. This article will review trends in audit findings specific to DCTs and provide guidance on how to develop a new project delivery framework that will support audit readiness by focusing on decentralized solutions such as home health care (HHC), mobile health clinics (MHC), virtual sites (VS), and direct to patient (DTP).

Common audit findings and audit readiness shortfalls

The audit output presented here has been compiled across a number of studies in the US and Europe to which a variety of DCT services were applied, including HHC, MHC, VS, and DTP. It also includes recurrent shortfalls identified during the review of project and vendor documentation. Common findings identified in decentralized clinical trials documentation and processes include the following. Read more…