FDA/Industry/Academic Safety Graphics Working Group Information

Welcome! Thanks for visiting the FDA/Industry/Academia Safety Graphics Wiki site. This site was prepared by a joint working group of 20+ statistician and clinical members from many areas of clinical research at the FDA, pharmaceutical companies, and academia (support from NIH CTSA UL1 RR024150). You can find more details in our charter.

The goal of the working group is to develop a palette of graphs for visualizations of clinical trial safety data, along with the programming code needed to create the graphs. The working group has divided into four smaller subgroups to define and develop safety graphics to four separate topics areas.

General Adverse Events

The General Adverse Event Subgroup was responsible for identifying ways to views general adverse event data, such as data collected using the MedDRA dictionary. This subgroup was led by Stephine Keeton, Qi Jiang, and Liping Huang.

ECG

The ECG Subgroup was responsible for identifying visualizations of data related to ECG data. This subgroup was lead by Richard Anziano.

Labs and Liver

The Labs/Liver Subgroup is responsible for developing graphical visualizations of laboratory data collected in clinical trials as well as data related to assessing liver function. This subgroup was lead by Robert "Mac" Gordon.

General Principles

The General Principles Subgroup was responsible for several tasks. Some of these are related to identifying good graphical principles and identifying templates for graphic presentation in a public domain. This subgroup was led by Susan Duke.

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Topic revision: 24 Oct 2013, MatSoukup

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