Study and Protocol Design

The study design of a clinical trial is the scientific road-map for the study. An important element of the study design is the protocol, which contains a high-level description of the reasoning behind and the schedule for every activity that will occur during a study in support of its stated aims. It incorporates input from various stakeholders and is used as a guidepost throughout the study. The protocol must be approved by the FDA in the US—and other regulatory bodies elsewhere as local regulations require—prior to the start of any trial.

As a practical document, the protocol serves as the origin for all data generated during the study and therefore for all knowledge resulting from such data. All of the clinical technology that can touch data during a modern trial—data collection systems such as electronic data capture (EDC) and interactive voice response systems (IVRS), trial management systems, data analysis and reporting systems—must be configured according to the elements defined by the protocol.

The opportunity to bring automation to facilitate and enrich the study design process is realized through Medidata Designer®, a tool used by innovative life science organizations to:

  • Facilitate line of sight linkage between and among trial objectives, endpoints and procedures, enabling study designers to reduce non-core procedures which save cost and time. This allows clinical researchers to focus on the clinical procedures and data that have the most impact on the trial.
  • Provide guidance and input during the design process based on previous studies, company standards and input from the PICAS® database in order to streamline the process and develop and share an organization's knowledge base.
  • Automate the population of downstream systems—such as the EDC database and the data analysis system—with study elements as originally defined by the protocol, reducing manual system development that can lead to data conflicts, errors and discontinuities.
  • Produce a read-only MS Word output synopsis document following CDISC PRM Standards.