Statistical Computing Environment

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Project Title

Statistical Computing Environments (SCEs)

Project Leads

Name Role Organization E-mail
Shital Desai Project Lead Teradata Shital.Desai@teradata.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 organizations are shifting from a fragmented, "silo-ed" approach preventing them from achieving their full potential to a cross-functional approach eliminating those challenges and taking advantage of new technology. In order to achieve that, the industry shall describe the Ideal Future State for the business process supported by 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 future direction of business processes supported by 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)

Upcoming Deliverables and Dates:

Deliverable Date
Publish draft white paper with SCE ideal "future state" business process TBC
Publish final white paper with SCE on ideal “future state” business process TBC

Objectives and Timelines:

Objective Timeline
Team Members prepare ‘Day in the Life of a Statistical Programmer’ presentations to share with team Sept 2017
Follow up meeting Oct 2017
Discussion club/round-table discussion at PhUSE Annual Conference Oct 2017
Draft white paper titled ‘Best Practices in Next Generation SCE with Real World Datasets’ by October Nov 2017
Publish white paper on the State of the SCE by end of year Nov 2017
Begin working on white paper defining user requirements for optimal SCE Dec 2017

State of the SCE White Paper

'The State of the SCE' published 29Apr2016.

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 Laurenwhite,12/12/2017