Governing And Maintaining Standards For Collecting Clinical Data

As your company grows and runs more trials, reusing case report form (CRF) designs and edit checks can deliver benefits at scale. The increase in efficiency, speed, and quality motivate organizations to develop internal data collection standards1 for their clinical data collection instruments. Yet, these benefits are only possible with consistent enforcement and governance processes in place.

Many data management teams report that their standards initiatives have stalled or failed due to a lack of executive buy-in, an over-proliferation of standards, or standards stuffed with exploratory variables. It is possible to successfully establish internal data collection standards if the right stakeholders are involved, governance is established, and change management is prioritized.

Here is a How-to Guide with best practices and advice for establishing and maintaining a successful clinical data collection standards program.