If raw data are transcribed and sent to the sponsor for (a) preparing the data in computer format or (b) performing a statistical analysis, what are the responsibilities of the QAU?

For (a) the QAU should assure that the computer-formatted data accurately reflect the raw
data. For (b) the statistical analyses would comprise a report from a participating scientist,
therefore it should be checked by QAU and appended to the final report.