Development of Standard Scripts for Analysis and Programming
Notice: Draft white paper on Tables, Flags and Listings associated with central tendency open for comments
Please provide comments in the Discussion Tab of the Working Group wiki by 14 December 2012. Please provide only content-related comments and suggested references, and not formatting, spelling, or typographical error comments. With each comment, please provide the document section number.
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Mission - Original
This working group will identify potential standard scripts for data transformations and analyses across and/or within a therapeutic area and exploratory analysis. The goal will be to begin the process of standardizing analyses across the industry, but also include examples of what can be done with a standardized data set. This will be an interactive session using online wiki to create and add input that can be shared openly between industry and regulatory.
|Mary Nilsson||Eli Lillyemail@example.com|
|Sally Cassells||Next Stepfirstname.lastname@example.org|
|Hanming Tu||Octagon Research||HTu@OCTAGONRESEARCH.com|
|Joy Li||FDA - CDER||Joy.Li@fda.hhs.gov|
|Mat Soukup||FDA - CDERemail@example.com|
Steering Committee Liaison: Scott Getzin firstname.lastname@example.org
Conference Calls and Minutes
Example Scripts: Current and Future State
Script Example - Posted: March 14, 2012:
Progress report on script sharing platform by Mike Carniello Platform for Standard Script Development: Progress as of September 18 2012
Here are the slides from the FDA workshop in march 2012 from subgroup 2, working on defining the process of creating and validating slides:
Similar slides were presented to PSDM (Pharmaceutical Statistics and Data Management), a Dutch network group of statisticians, clinical programmers and data managers working in and for the pharmaceutical industry. The aim of the PSDM is to facilitate professional conduct and development of its members and to provide a platform for the exchange of expertise and ideas by organizing scientific meetings, workshops and courses in the Netherlands. The slides were a personal reflection from Kevin Kane of his experiences at the conference:
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Working drafts and comments provided as part of the FDA/PhUSE Working Group efforts are informal communications and represent the individual's best judgment. They do not necessarily reflect the view and/or policies of their company or institution, the employers of the individuals involved or any of their staff.
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--- Last revision by Kevin Kane,11/6/2012