DATA STANDARDIZATION PLANNING FOR CLINICAL DEVELOPMENT PROGRAMS

Data Standardization within and across clinical development programs is now a requirement as Regulatory Authorities worldwide are all requesting that clinical data, and metadata, be made available in a structured and standardized CDISC compliant architecture. The development and evolution of a Clinical Development Plan (CDP) is a critical document and process for cost effective and efficient drug development programs. The CDP is now more important than ever with the integration of a data standardization into the CDP architecture. Recent FDA Guidance (February 2014) on Providing Regulatory Submissions in Electronic Format ‐ Standardized Study Data and corresponding Technical Conformance Guidelines identified that a Study Data Standardization Plan (SDSP) should be submitted with an IND to outline standards to be followed throughout the course of the development program. In this paper we present a high level model for an SDSP with a specific focus on endpoints. The relationship of the SDSP to the CDP will be discussed and show that (1) it is an evolving document that should be developed during the pre-IND phase of a program and updated frequently to ensure consistency, transparency, and interoperability of all data in a program and (2) implementation will significantly aid in the maintenance and updating of important regulatory required documents like the Investigator’s Brochure and Annual Safety reports.