Good Programming Practice for Clinical Trials - …：临床试验的良好的编程实践—….docx

Table of ContentsIntroduction2Getting Started With a New Project2Language3Program header3Revision history4Comments4Naming conventions4Coding conventions4Log File Checking5Portability6Hard coding6Defensive programming7APPENDIX8IntroductionThis document provides guidance for good programming practices (GPP) for analysis, reporting and data manipulation of clinical data in health and life sciences organizations. This guidance is primarily aimed at SAS programmers however the principles of GPP also apply to other languages such as R and Stata. In addition, although this is not produced with SAS macros in mind, the same principles apply to macros too. We often have to update existing programs to add new rules, copy programs from one study to another, and take over programs written by others. The guidance aims to show how to produce well structured and well documented programs so that they are easy to read and maintain over time. It is meant to be applicable to all programs, and hence all programmers regardless of experience. Specific rules may be of more use to novice programmers, but applying the principles should be in mind for experienced programmers and mentors.Getting Started With a New ProjectWhen starting work on any new study, it is important to familiarize yourself with the study. Review the study documents and try to understand the following:The objectives of the study.How many patients will be enrolled, randomized, and treated.Schedule of events, i.e. screening, run-in, treatment periods, washouts, how many treatments and when they are taken.What is the primary endpoint and how, when and where is this data collected.Timelines for the trial, when is the database lock, when should the top line results be ready, and when should all the reporting be finalized.The current status of the project.Study documents include:Clinical Study Protocol (CSP) - study outline and statistical sections are usually of relevance.Case Report Forms (CRF) /annotated CRF (annotated