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Publication Date

5-2021

Abstract

Introduction:

Accuracy with Delegation of Authority Logs (DOAs) is essential to ensure correct assignment of tasks for research staff. An error can lead to reportable deviations and impact participant safety. Delegation templates are not universal and use different terminology. Lack of uniformity can lead to errors when assigning delegated tasks. Tasks can also overlap among the study members, furthering confusion. As a study evolves, or new staff are added, delegation of responsibilities can be missed. The fluidity of DOAs can lead to reportable errors. We designed a quality improvement project to promptly identify and prevent DOA errors.

Methods:

Bi-weekly meetings including a Principle Investigator (PI) and Research Coordinator (RC) were held to develop a process to examine accuracy of DOAs for each study. Considering DOAs fluctuate based on amendments, and change of study members, a plan was developed for continual monitoring throughout the life of the study. Activity included a three-pronged approach: 1) create universal tool with standardized definitions and assignments for a guide in absence of a DOA template; 2) develop process verifying DOAs for accuracy at study start-up by having a second RC review DOA; and 3) develop process to ensure accuracy of DOAs throughout the study with twice yearly DOA reviews for active studies. A template DOA form was drafted and accepted by the team which provides consistency among defined roles. Next, all RCs were asked to review DOAs of active studies and report errors to the QI team. Finally, a goal was established to decrease the amount of errors found by 50% each year.

Results:

The initial review of DOAs showed 7 (44%) of the 16 studies examined had errors. Examples included missing end dates for staff or lack of updated tasks based on recent certifications. Interestingly, there were also errors related to tasks assigned at study initiation. After a Plan-Do-Study-Act (PDSA) cycle to review the initial data, it was determined DOAs should be verified at the time of study start-up by backup RC. This added step was presented and accepted by the research team. At the next bi-annual review, the error rate was noted to be 18%. The team commitment to this project helped achieve a decrease of 26% in error rate after just one review.

Conclusion

DOAs are fluid documents requiring updates throughout the life of the study. Lack of continuous monitoring and confusing tasks can lead to untimely updates and errors. With standardization of definitions and research roles, combined with the implementation of a periodic review system of active DOAs, we are able to decrease reported errors.

Document Type

Poster

Plan To Prevent Delegation Of Authority Log Errors

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