A collaborative clinical trial protocol writing system.

Increasing complexity in medicine has caused clinical trial experts with disparate backgrounds from multiple organizations to collaborate when developing clinical trial protocols. Although many protocol-authoring tools provide computer-based decision support to assist protocol writing, few of them provide sufficient collaboration support for a group of protocol writers. The iterative group writing activities among interdisciplinary clinical trial experts call for advanced tool support. Here we present a web-based protocol writing system with integrated support for collaborative reviewing and collaborative editing. The system uses a shared database to store threaded review comments and version information for electronic protocols. It also captures rich group event information to provide cross-activity awareness and to facilitate self-coordination within the collaborative writing team. We believe that our system can help streamline collaborative clinical trial protocol writing processes.