CDISC Releases New Protocol Representation Toolkit

The Clinical Data Interchange Standards Consortium (CDISC) is pleased to announce the release of the first iteration of a Protocol Representation “Toolkit” for clinical research. The purpose is to make it easy for authors of the research plan or protocol to reap the benefits of the Protocol Representation Model (PRM), which has been developed over the past decade by global clinical research experts from academia, industry and government. Using such a model can save time and resources for research studies by enabling electronic re-use of protocol information for other purposes such as clinical trial registration, study tracking, regulatory information and study reports. The current release of the “Toolkit” includes a standard Study Outline Template in MS Word format, a standard list of Study Outline Concepts, and a complete mapping of the Study Outline Concepts to both the Biomedical Research Integrated Domain Group (BRIDG) model and the CDISC Study Data Tabulation Model (SDTM) Trial Summary (TS) Domain.

"Initiating the study design and protocol process in a structured manner while incorporating CDISC standards use drives efficiency throughout the entire study life,” said David Gemzik, Chair of the Protocol Representation Group. “The Toolkit creates a foundation upon which a standards-driven approach can be implemented."

The next release of the Toolkit, coming later in 2012, will include the PRM Protocol Wizard. The Wizard will allow the end user to simply “plug and play” different protocol elements into a simple-to-use web-based form. What once took hours to reengineer into different formats will require only a few ‘button clicks.’ The underlying technology for the PRM Protocol Wizard is being contributed by Medidata Solutions, a longtime CDISC Member Organization and Registered Solutions Provider. “Support for industry standards is a crucial part of Medidata’s vision for optimizing clinical research,” said Michelle Marlborough, Director of Product Management at Medidata.

“We are very excited that with the PRM Protocol Wizard, the final frontier for clinical research standards has been breached.” “We are extremely pleased that Medidata has offered this Toolkit openly to CDISC members to streamline their research, from protocol development throughout the study process to reporting,” said Rebecca Kush, President and CEO of CDISC. “This is what has been missing from the PRM since Version 1.0 was released in 2010; it provides a means for protocol authors to use the model without having to be technology experts.”

The CDISC Protocol Representation Toolkit has been released on the CDISC website. To access the toolkit, please visit the Members Only area.