Many data management teams report that their standards initiatives have stalled or failed because executives aren’t bought-in, standards are over-proliferated, or they are stuffed with exploratory variables. In this guide, leaders across pharmaceuticals, biotechnology, generics, and Medtech will learn best practices to build and maintain an effective clinical data collection standards program while driving team adherence. Ami Dudzinski Mehr and Drew Garty at Veeva Systems show a guide that provides recommendations on defining specification and variable tables and when it is appropriate to develop internal standards versus using existing widely accepted standards.
Extract:
A Guide for Establishing and Governing Data Collection Standards
Companies that leverage internal data collection standards can increase efficiency, speed execution, and improve data quality. But establishing standards is hard and maintaining them is even harder. How should you get started? And how do you ensure compliance with standards across your organisation?
Many data management teams report that their standards initiatives have stalled or failed because executives aren’t bought[1]in, standards are over-proliferated, or they are stuffed with exploratory variables. In this guide, leaders across pharmaceuticals, biotechnology, generics, and medtech will learn best practices to build and maintain an effective clinical data collection standards program while driving team adherence.
The guide also provides recommendations on defining specification and variable tables and when it is appropriate to develop internal standards versus using existing widely accepted standards. Best practices are drawn from real-world experiences and case studies to provide leaders with actionable insights and advice for defining their approach to data collection standards.
Establishing Standards for Long-term Success
Beginning your journey toward data collection standards1 requires two essential resources: a team willing to drive the development and improvement over time of proposed templates or standards; and executive buy-in to get started on the right foot and ensure speedy approvals once completed. In addition, internal alignment is critical to the success of your standards, so involve downstream teams such as programming and statistics to incorporate their needs and requirements early on. Here are some tips to get started.
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