Validation & Derivation Procedures

Mission Statement

The mission of the Validation & Derivation Procedures Focus Group is:

  • To share experience with regard to features, techniques and solutions
  • To suggest technical enhancements
  • To prepare concepts for an efficient programming environment, e.g. concepts for development and maintenance of procedure libraries
  • To openly discuss workflows to create and validate study-specific procedures in the context of the clinical development process
  • To collaborate among the members in solving problems via the on-line discussion board
  • To encourage and facilitate presentations on relevant V&DP topics at annual conferences.

Targeted Membership

  • OC ProcedureWriters / programmers
  • Data Managers
  • OC Global Librarians
  • Any individual involved in any part of the process of study design, development of a data quality plan, documentation of procedures required based on standard and study-specific needs, and programming, testing and validating of these procedures for UAT and implementation against clinical trial data