25th Aug 2016, 07:23 PM
Statistical Analysis Plans
I have come across a number of statistical analysis plans which have not been updated using the most recent protocol + amendment/s. Standard text in a SAP is usually something along the lines of ''This analysis plan is based on the
trial protocol plus amendment, version 3.0 dated 25Aug2016 ''(for example)
However there are often more recent protocols plus amendments, often with substantial changes, which leaves the SAP with outdated information.
What is the industry guidance on updating SAPs? Any help greatly appreciated.