The delegation of authority (DoA) log is a key regulatory component of any clinical trial. Most researchers know, to conform to NIH recommendations and good clinical practice (GCP), sites should document any significant study-related duties performed by non-PI staff members. But many sites struggle to create streamlined delegation of authority processes.
Define institution-wide delegation of authority guidelines
One issue prevalent among research institutions is the lack of delegation of authority standardization across teams. The NIH states that all significant study-related duties should be recorded, but leaves it to sites to determine what is actually a “significant” duty. This added level of subjectivity has led to sites recording insignificant tasks to ensure that DoA directives are being met.
By working with a regulatory expert at your institution to establish standard operating procedures for all research teams, you can make your delegation of authority process much more consistent across studies. If your organization needs help making decisions around the delegation of authority process, download our free worksheet to guide you through the DoA process.
Use technology to build better workflows
Once your institution establishes standard delegation of authority processes, it’s important to build efficient workflows for assigning duties to each staff member. Using paper binders or homegrown technology, a regulatory coordinator often has to repeatedly assign tasks to the same individual for each new study. An electronic regulatory management system, such as Forte eReg, can standardize the delegation of duties to specific roles. These systems can also generate and store the actual delegation of authority log, creating additional efficiencies at your organization. This setup streamlines the DoA process in ways that were previously unattainable, and saves time and effort across your institution.
Follow this link to learn how Forte eReg can help you manage your delegation of authority process, as well as boost compliance and efficiency across all regulatory workflows.
You can also join us for our free, upcoming webinar where presenters, Wendy Tate and Mariette Marsh will discuss ethical considerations for delegation of authority, and explain why it’s more important than ever to standardize operating procedures and guidelines. Register today to save your seat.