Development of Standard Scripts for Analysis and Programming

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Revision as of 05:40, 16 January 2013 by Kevin Kane (talk | contribs) (Conference Calls and Minutes)
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This is the wiki home of the working group that is developing tools to support development and contributions of analysis scripts and programs.

White Paper

Notice: Draft white paper on Tables, Flags and Listings associated with central tendency open for comments

Click Here! Central tendency TFLs white paper draft (2nd draft)

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.

We realize the Discussion tab might not be an ideal method for providing and receiving comments. Alternative methods are being assessed and may be available for future reviews.

Script Development Platform

Working group 5 are pleased to announce that the initial platform for sharing and developing scripts (SAS, R, S+, STATA etc) is up and running at the following location:

Some team members have set up Tortoise SVN which provides a GUI for working with GoogleCode in a windows environment. The GoogleCode site is configured to use the MIT License.

Progress report on script sharing platform by Mike Carniello Platform for Standard Script Development: Progress as of September 18 2012

Script Documentation

We are working on creating templates for specification and user guide documentation. Initial draft documents ready for review are here:

File:User Guide template.docx
File:Requirements Specifications template.doc

We are hoping to use the Good Programming Practice processes being developed by a seperate PhUSE group.

Validating Scripts

Here are the slides from the FDA workshop in march 2012 from subgroup 2, working on defining the process of creating and validating slides:

File:WG5 Subgroup 2 slides v2.pptx

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:

File:FDA CSS PhUSE initiative.pptx

The subgroup have started working on adding more details to the process of validating scripts. Here is the initial document for review:

File:FDA Scrips.ppt


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.


Leadership: Co-Leads

Mary Nilsson Eli Lilly
Sally Cassells Next Step
Hanming Tu Octagon Research
Kevin Kane Phastar
Mat Soukup FDA - CDER

Steering Committee Liaison: Scott Getzin


Conference Calls and Minutes

WG5 11JAN2012
WG5 22FEB2012
WG5 14MAR2012
WG5 Subgroup1 F2F March 19-20 2012
File:WG5 subgroup 2 TC 7 Nov 12.docx
WG5 Subgroup3 F2F March 19-20
WG5 Subgroup3 TC June 7
Discussion Club: FDA/PhUSE CSS Working Group 5 Update Budapest 2012
WG5 8th Jan 2013

WG5 DDMONYYYY(template)


FDA/PhUSE WG5 Subgroup1B


WG5 Charter


Example Scripts: Current and Future State

Script Example - Posted: March 14, 2012:

Example Overview Presentation

Current State Example Files

Future State Example Files


Call for Scripts

Here is a draft Call for Scripts, which we hope to send out to the statistical computing community before the March 2013 conference:

FDA Disclaimer

FDA comments are an informal communication and represent the individual's best judgment. These comments do not bind or obligate FDA. The contents of this wiki are from the individual contributors and do not necessarily reflect the view and/or policies of the Food and Drug Administration, the employers of the individuals involved or any of their staff.

Disclaimer for Others

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.

Note: Individuals participating in FDA/PhUSE Working Group discussions on the wiki are responsible for determining whether this disclaimer is sufficient for complying with any relevant procedures from their company or institution.

--- Last revision by Kevin Kane,01/16/2013