Genentech
Hands On Clinical Reporting Using R
Genentech

Hands On Clinical Reporting Using R

Taught in English

Course

Gain insight into a topic and learn the fundamentals

Adrian Chan
Tatiana Alonso Amor
Stefan Pascal Thoma

Instructors: Adrian Chan

Intermediate level

Recommended experience

20 hours to complete
3 weeks at 6 hours a week
Flexible schedule
Learn at your own pace

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July 2024

Assessments

20 assignments

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There are 8 modules in this course

In this module, we will introduce this course and provide a brief outline of what you will be learning. We will provide context on clinical reporting in R and the motivation for the recent shift in industry trends for the support of open-source tools. We will describe the challenges in current statistical programming practices and the benefits of applying open-source tools, as well as provide additional resources to learn more.

What's included

1 video1 reading1 discussion prompt

In this module, we will cover several important topics related to Phase 3 clinical trials and clinical data. We will start with a brief introduction to Phase 3 trials and discuss the type of data that is collected during these trials. Following that, we will provide an overview of two data models that are commonly used to handle clinical trial data, namely SDTM and ADaM. Next, we will delve into the process of preparing a data submission package for health authorities, with a specific focus on the Food and Drug Administration (FDA) in the United States. We will explore the requirements and guidelines for submitting clinical trial data to the FDA. Lastly, we will wrap up this module by summarizing our understanding of the clinical data flow, highlighting the key points we have covered throughout the course.

What's included

6 videos1 reading1 assignment

In this module, we will provide an introduction to Study Data Tabulation Model (or SDTM) by giving context and highlighting the importance of such data models on clinical trials. We will explore different SDTM data mappings for CRF and non-CRF data. Finally, we will provide an outlook on the programming of SDTMs on R.

What's included

4 videos1 assignment

In this module, we explore what are analysis data model (ADaM) datasets, the 3 structures of ADaM, and how to create ADaM in R using Pharmaverse packages.

What's included

16 videos4 readings4 assignments

In this module, we explore ADaM and R using Pharmaverse packages, one step further. We will focus on the ADaM Occurence Data Structure known as OCCDS using the example Analysis Dataset Adverse Events (ADAE). We'll go over what an OCCDS is, Adverse Events, and how to create ADAE using {admiral} and other R Pharmaverse packages.

What's included

36 videos2 readings8 assignments

In this module, we introduce the concepts of generating outputs used for regulatory purposes, and the NEST packages in particular. We show how you can use NEST effectively to create and customize your tables, listings, and graphs (TLGs) during clinical reporting and introduce the TLG-Catalog to aid output generation using our packages. We will explain the benefits of open-source and the industry collaboration efforts on clinical reporting.

What's included

36 videos2 assignments

In this module we will discuss benefits of of using interactive data displays for clinical reporting. We will introduce the teal family of R packages and become familiar with the key features this framework offers. Finally, we will learn how to develop a production level interactive application using teal modules for data review, safety and efficacy analyses.

What's included

26 videos1 reading4 assignments

In this final module we will briefly review the course and suggest next steps in your learning journey.

What's included

1 video

Instructors

Adrian Chan
Genentech
1 Course363 learners
Tatiana Alonso Amor
Genentech
1 Course363 learners
Stefan Pascal Thoma
Genentech
1 Course363 learners

Offered by

Genentech

Recommended if you're interested in Data Analysis

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