For both observational and interventional clinical research studies, the NIH requires that a delegation of authority log is created and updated throughout the duration of the protocol. Given the growing need to efficiently activate a protocol, identifying specific tasks for every protocol staff and fetching signatures is often a major pain point that causes delays in the study start up process.
Addressing Delegation of Authority Inefficiencies
One way sites have addressed regulatory inefficiencies during study activation is to implement a Master Delegation of Authority. This allows institutions to standardize tasks to be delegated at the organization level, outside of individual protocols. This standardization acts as a way to ensure the protocol staff roles are consistent across protocols. It also increases efficiency by minimizing the amount of updates needed per individual protocol staff member on a delegation of authority log.
The focus of the Master Delegation of Authority is to:
- Increase regulatory compliance by standardizing delegated tasks by protocol staff roles
- Reduce errors and delays in gathering individual protocol staff signatures for every protocol
Examining the Master Delegation of Authority Process
When setting up the Master Delegation of Authority, institutions will determine the standard protocol staff roles needed, then associate specific tasks to that protocol staff role. This ensures consistency across protocol staff and gives regulatory coordinators a process to easily identify mistakes by referring to this standardized protocol staff role and master template.
Once the standardized protocol staff roles and delegated tasks are created, staff members will have the opportunity to review their specific delegated tasks and acknowledge them prior to study start up. That acknowledgement will carry from protocol to protocol, where only additional protocol-specific tasks or principal investigator modifications need further attention from the protocol staff.
The combination of standardizing delegated tasks by protocol staff role and obtaining signature information by the staff member for their protocol staff role and associated tasks, dramatically reduces the amount of time needed to create the delegation of authority log. The log is sent to the principal investigator for review with fewer manual modifications and less time in administrative updates, resulting in a much more efficient study activation process.
Join Us to See Forte eReg In Action
If you’d like to see how the Master Delegation of Authority can be maintained within an eRegulatory Management System, register for our Forte eReg open demo on Tuesday, March 6 at 1:00pm Central. In addition to introducing our new Master Delegation of Authority functionality, we’ll provide a full product demo. Learn how Forte eReg was built through a collaborative process with our customers, and see how it can provide integrated protocol, staff and institution documentation to streamline your regulatory processes and enhance 21 CFR Part 11 compliance at your institution.