Yale validates research readiness in P.R. post-Hurricane María
The Yale Center for Clinical Investigation (YCCI) recently visited Puerto Rico Consortium for Clinical Investigation member clinical research sites to assess research-readiness post-Hurricane María, confirming the island is ready to continue its operations.
Results provided by YCCI reveal continuity in research operations, both during and after the historic storm, largely due to careful planning, solid procedures, and the unifying support of PRCCI programs and initiatives, PRCCI officials said.
During the visit to seven research sites, YCCI members found that:
- Only a single physical document was damaged by the storm. This document was backed up electronically, so no source data was lost as a direct result of the hurricane.
- Emergency preparations were evident, minimizing protocol deviations. As some deviations were not avoidable, sites are actively reviewing SOPs (Standard Operating Procedures) to address lessons learned for continuous improvement.
- Power was continuously maintained both during and after the storm with the strategic use of generators. No temperature excursions for investigational product were reported.
- Communication with research participants was especially challenging after the storm. Sites narrowed this communication gap by advance planning, home visits, and utilization of courier services. Communication systems including telephone, internet, and mobile services are all fully functional.
- Arrival and departure to/from San Juan’s Luis Muñoz Marín International Airport were without delay, hotel accommodations were acceptable and comparable to visits prior to the hurricane, and transportation on the island via taxi and Uber remained available.
“YCCI’s objective, external perspective provides clinical trial sponsors and Clinical Research Organizations with the bold assurance that Puerto Rico is not only open for business post-Hurricane Maria, but also that PRCCI member sites continue to conduct clinical trials with the highest commitment to quality,” local organization officials said.
Additional PRCCI member sites are scheduled to receive similar visits to validate research-readiness as 2018 progresses. PRCCI is a nonprofit cooperative of top research sites on the island.