Protocol Design

The protocol is the design document of the clinical trial, detailing the scientific road-map for the study. It 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 body 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 eClinical technology that can touch data during a modern trial—data collection systems such as EDC and 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 protocol development process is realized through Medidata Designer^®, a tool used today by technology-savvy companies to:

• Provide guidance and input during protocol authoring, based on previous studies or company standards, in order to streamline the writing 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.