How to ensure your topline results are correct has become more challenging when the analysis is prepared in a CDISC environment. This is a good thing since CDISC provides a standard and uniform framework for clinical data sharing and reviewing. However, many data manipulations are often involved in creating these CDISC data sets which inevitably leads to a natural but critical question: how to make sure all these intermediate steps that deal with data changes/formatting won’t unintentionally introduce any errors/bias into the analysis results?

Approach 1. Double Programming to Make Sure CDISC Conversions Are Accurate

This might be the common and conventional way to alleviate the concern and ensure quality of analysis results. Of course this means extra time and resources. In particular, double programming for CDISC data sets then comparing and reconciling all differences might take a lot of time and require a good process and team in place to accomplish. More importantly the analysis result itself still has to be verified following the completion of this CDISC double programming process.

Approach 2. Raw Data Approach

This is the approach to verify the analysis results directly from the raw data sets. First of all it can be performed in parallel to the CDISC approach since it doesn’t depend on CDISC conventions – this would potentially save BIG on turn-around time. It is also an entirely independent process since it is independent from the CDISC conventions. Moreover, it not only verifies the analysis results but also verifies CDSIC conversions.  

Topline results usually requires a fast turnaround for good business causes. The raw data-based approach is worthy of consideration due to its efficiency and independency.