54 - Bringing Visibility and Efficiency to Compliance Management

Background: The Massachusetts General Hospital is a large academic hospital. Animal welfare concerns and noncompliance reports were received in a non-standardized manner with information entered on an Excel spreadsheet, incident report document, and emails to the investigator. This process was cumbersome and involved redundant data entry, increasing risk of error. Trend analysis was time consuming.

Program

Description: Using REDCap, a free, secure web platform, we created a comprehensive database for receiving, managing, and tracking animal welfare and noncompliance reports. Our system allows any individual to submit animal welfare concerns to the IACUC office, anonymously or identified. Preliminary reports are received in a standardized manner, with questions to guide the process and solicit the information needed to start an investigation.

The database eliminates duplicative data entry to reduce errors and time burden for staff; facilitates communication with principal investigators and tracking of key events, including IACUC decisions/incident outcomes, external reporting dates, for-cause audit outcomes, and completion of corrective actions; and the creation of repeatable, customized reports to improve data usability. Automated notifications alert stakeholders when their attention is required, remind Principal Investigators about outstanding corrective actions, and notify the principal investigator when an incident is resolved.

Program

Assessment: The response to the database has been overwhelmingly positive, and it has functioned as anticipated. Principal Investigators have emphasized the system is easy to use and helps them stay on track. IACUC staff have found the database to improve efficiency. Some processes resulted in a >90% reduction in time and effort. Management greatly appreciates the quick, transparent visual for tracking workload and output.

After launch, we did identify a few unanticipated issues, which we were easily able to accommodate by modifying the database. The ability to modify the database ourselves after the initial learning curve is a strength of the system.

Limitations: The main limitation we encountered was in the development phase. REDCap requires the end user (i.e., IACUC staff) to create and modify the project. A staff spent several months learning to use the development aspects of the platform and building the complex database. The self-development allowed for customization to our needs, but required a great deal of discussion and testing. Other institutions could mitigate this effort by starting with an existing REDCap project.

Discussion: This database will continue to be used to document and manage the investigation of animal welfare and compliance concerns. The use of this database has improved our efficiency and enables us to easily keep track of the status of investigations and corrective actions. We look forward to leveraging the reporting capabilities to analyze noncompliance trends in order to improve our animal care and use program, as well as to assess the success of training and postapproval monitoring initiatives.

We feel this database could be useful for managing compliance incidents at any institution. The system streamlines the workflow and improves efficiency.