Statistical Computing Environments

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Project Title

Statistical Computing Environments (SCEs)

Project Leads

Name Role Organization E-mail
Art Collins Lead Biogen arthur.collins@biogen.com
Stephen Matteson Co-lead Pfizer stephen.p.matteson@pfizer.com
Olivier Leconte Co-lead Novartis olivier.leconte@novartis.com
Mark Matthews Co-lead GCE Solutions mark.matthews@gcesolutions.com

Affected Stakeholders

Could include statisticians, clinical reviewers, nonclinical reviewers, software developers, SDO, etc.

Definition(s) of Problem/Issue/Challenge

This project came about because of a common set of challenges facing organizations across the industry around Statistical Computing Environments (SCEs). The group has four objectives:

  1. Discuss the current state of SCEs, identify common gaps and share best practices
  2. Define ideal case user requirements for an SCE
  3. Clarify expectations for an SCE within industry and regulatory agencies regarding implementation and compliance
  4. Explore SCE relationship to the Metadata Repository (MDR) and the Clinical Data Repository (CDR)

Deliverables and Dates:

Deliverable Date
Follow-up meeting 29 April, 2015
Round-table discussion at PharmaSUG May, 2015
Third meeting July, 2015
Conduct survey based on common SCE elements identified by the team September, 2015
Discussion club/round-table discussion at PhUSE Annual Conference October, 2015
Publish draft white paper for open comment/review on the State of the SCE by end of year December, 2015
Begin working on white paper defining user requirements for optimal SCE March, 2016

SCE Survey

The survey has closed, thank you to the 70 respondents. The information collected is being summarized for our first white paper entitled 'The State of the SCE' which should be out for public comment in early January 2016.

Recommended Reading

Regulatory Guidance:

FDA, 21 CFR Part 11, Electronic Records; Electronic Signatures; Final Rule. Federal Register Vol. 62, No. 54, 13429, March 20, 1997

FDA, Guidance for Industry - Part 11, Electronic Records; Electronic Signatures - Scope and Application, August 2003

FDA, Guidance for Industry - Computerized Systems Used in Clinical Trials, April 1999

FDA, Guidance for Industry - Computerized Systems Used in Clinical Investigations, May 2007

Publications:

Date/Time Stamped Files and Audit Trails: What Part 11 Compliant SAS® Systems are Made of, Carolyn Dougherty, ViroPharma Incorporated, Exton, PA, NESUG 16 Paper

BUILDING A CONTROLLED STATISTICAL PROGRAMMING ENVIRONMENT, Wayne Woo, Novartis Vaccines & Diagnostics, Cambridge, MA, WUSS 13 Paper

Standards-based, Metadata-driven Statistical Computing Environments, Sue Dubman, September 28, 2010, PhUSE, Cambridge, MA

Hopkins, Duke, Dubman, "Statistical Computing Environments and the Practice of Statistics in the Biopharmaceutical Industry", Drug Information Journal, Vol. 44, 2010

Statistical Computing Environment Implementation – An Agile Approach, Gary Cozzolino, d-Wise Technologies, Morrisville, NC, PharmaSUG 2013 - Paper MS12

Building a Hosted Statistical Computing Environment: Is it Possible?, d-Wise

d-Wise's View of Clinical Data Repositories (CDRs) – 2013, Posted by Keith Ward on Aug 29, 2013

The Solution Landscape Part 3: SCE., Posted by Keith Ward on Oct 3, 2013

The Submission Data File System - Automating the Creation of CDISC SDTM and ADaM Datasets, Marcus Bloom, Amgen, David Edwards, Amgen, PhUSE 2006

MACUMBA: Modern SAS® GUI Debugging Made Easy, Michael Weiss, Bayer Pharma AG, SAS Global Forum 2013


Last revision by Collinsa,12/17/2015