Digital Data Flow from Protocol to Report: TransCelerate’s Common Protocol Template and the Art of the Possible
Robert A. DiCicco, PharmD
Vice President, Clinical Innovation and Digital Platforms
GlaxoSmithKline, United States
TransCelerate BioPharma common protocol template (CPT) was first released in December 2015. It was updated in 2017 based on collaboration with NIH-FDA to align templates from both organizations. Since the initial release CPT has been downloaded over 3,700 times by several hundred unique clinical research organizations including Pharma, CROs, academic institutions and health authorities. In 2016 the project initiated proof of concept programs, using the technology enhanced CPT, with the aim of demonstrating automated reuse of protocol information for critical activities such as eCRF generation and registry posting. The session will focus on the development of prototypes which deliver high value applications of a machine readable protocol. In addition, a model which describes traceability from protocol to report will be described. Current applications of the technology enabled edition of the CPT will also be presented.
Learning Objective : Discuss the benefits of digital data flow, including accelerating time to study start up; Describe how TransCelerate’s technology enabled edition delivers automated traceability; Discuss future opportunities for implementation.