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Background: ICH Guidelines for Good Clinical Practice (GCP) states, “Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).” Systemizing and documenting staff training for multi-disciplinary trials is challenging.
Purpose: Prior to 2018, documentation of training at Children’s Mercy was not captured in a systematic manner. The COG team wanted to identify a platform for distributing and tracking completion of training materials for study team members. REDCap is a secure web application that can be used to build and manage online surveys. The purpose of this effort was to determine if REDCap could effectively document training.
Methods: In 2017, COG regulatory effort was consolidated into one position. The Regulatory Coordinator (RC) is responsible for maintaining documentation of protocol training. Prior methods in achieving this were inconsistent. In 2018, after discussion and trials, training for new protocols and amendments were forwarded as a REDCap survey to study team members. Recipients are asked to review the modules and attest to understanding with a date and signature stamp. The REDCap dashboard provides the PI and RC a tool to view completion. The system allows automatic email reminders to be sent to any delinquent team members.
Results: REDCap provides a platform for protocol training, communication and real-time tracking.
Conclusions: Attributes for good documentation as described by US-FDA are attributable, legible, contemporaneous, original and accurate (Bargaje, 2011). REDCap creates an audit trail of documentation reflecting compliance with GCP.
Claro, Carol; Ryan, Robin E.; and August, Keith, "Documenting Training Using REDCap" (2019). Research at Children's Mercy Month 2019. 19.