Page 54 - PATIENT REGISTRY DATA FOR RESEARCH: A Basic Practical Guide

results are usually regarded as strictly confidential but the SAP should be made available to

the whole study team. This is necessary in order to ensure that all statistical analyses are

made transparent to the stakeholders, which will enable them to understand exactly how all

the statistical analysis procedures have been performed (so that they can pose any queries

whenever necessary).

The SAP is not the same as the section of “statistical analysis” found in a full-text

research paper commonly published in a journal. What is written in the statistical analysis

section will only be a small part of the whole write-up of SAP, since the SAP is a written

document which provides a complete and detailed description of all the specific step-by-step

procedures for managing and conducting statistical analysis. Thus, the SAP can provide

documentary evidence of the adoption of a valid approach for the entire process of both data

preparation and data analysis. This SAP document should be retained for future reference and

in some cases, it may be necessary for it to be made available in the future to various

stakeholders as a documentary evidence of the use of robust statistical methods and

procedures in producing the results (and also that all statistically analyses are conducted in a

scientifically valid manner). This e-book/book has illustrated the importance of a SAP by

providing a checklist which highlights a list of key elements of a properly-prepared and

complete SAP (Please see Table 5.1).

The efficient way of conducting the statistical analysis is to develop a programming

code for each analysis. The codes can be reused many times to produce the updated results

whenever a new data set becomes available. This will increase the efficiency of the analysis.

Another advantage of using the programming software is that the codes can be regarded as a

documentary evidence of whether the selection of the subjects and the analysis were

conducted in a correct manner by referring to each of the lines inside the programming codes.

Therefore, all the steps that are outlined in the programming codes for conducting the study