2  Syllabus

Published

July 13, 2025

This site provides some further information on the objectives and syllabus/organization of the course.

Course Date: August 25, 2024 (9am-12:30pm, Berlin)

Course Objectives

Attendees of this advanced methods couse will learn how to implement transparent and reproducible workflows across the real-world evidence study lifecycle.

flowchart TB
A(Design stage) --> B
B(Analysis execution stage) --> C
C(Reporting stage)
Figure 2.1: RWE study liefcycle.

  • Design stage: Incorporate reproducible reporting of key study parameters at a study design and planning stage using the HARPER protocol

  • Analysis stage: Version control and share analytic code at the analysis and execution stage of the study using git and Github

  • Reporting stage: Use literate programming by combining narrative language, analytic code and study results for transparent and reproducible study reporting

Syllabus

In this practical hands-on course, we introduce resources and tools needed for the transparent and reproducible conduct of RWE studies following FAIR (Findable, Accessible, Interoperable and Reproducible) principles.

Table 2.1: Detailed course timetable
Time Topic Instructor Description
14:30 - 14:40 Welcome and introduction Janick Weberpals Welcome, housekeeping, and introduction to the topic
14:40 - 15:00 DESIGN STAGE: HARPER template Shirley V. Wang A harmonized protocol template to enhance reproducibility of hypothesis evaluating real-world evidence studies on treatment effects (HARPER protocol)
15:00 - 16:10 ANALYSIS STAGE: Git and GitHub Anna Schultze, John Tazare Introduction to the Git distributed version control system and remote repositories (e.g., GitHub) to track changes, collaborate, disseminate and archive analytic source code through dedicated project repositories that maintain a complete audit trail of all relevant study documents including code lists. This will be followed by interactive case study for part in which every course participant can try git hands-on.
16:10 - 16:40 COFFEE BREAK - Take a break and enjoy a tasty coffee
16:40 - 17:20 ANALYSIS STAGE: Github Copilot Janick Weberpals, Anna Schultze, John Tazare Introduction to AI-based tools to support and augment code development, quality control, transparency and reproducibility
17:20 - 17:50 REPORTING STAGE: Quarto introduction Janick Weberpals Introduction and examples of literate programming using the Quarto technical reporting system
17:50 - 18:00 COURSE CONCLUSION Janick Weberpals Future direction and trends & resources for where to go to learn more