# Difference between revisions of "Statistical Computing Environments"

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[http://www.phuse.eu/download.aspx?type=cms&docID=2437 Standards-based, Metadata-driven Statistical Computing Environments], Sue Dubman, September 28, 2010, PhUSE, Cambridge, MA | [http://www.phuse.eu/download.aspx?type=cms&docID=2437 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 | + | [https://wiki.nci.nih.gov/download/attachments/91797216/04-DIJ44(1)%2B2459%2Bqxd.pdf] 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 | + | [http://cdn2.hubspot.net/hub/188561/file-2076515304-pdf/New_Papers/2013-Statistical_Computing_Environment_Implementation_%E2%80%93_An_Agile_Approach.pdf?t=1415806249172&t=1426777303120] 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 | + | [http://www.d-wise.com/statistical-computing-environment] 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 | d-Wise's View of Clinical Data Repositories (CDRs) – 2013, Posted by Keith Ward on Aug 29, 2013 |

## Revision as of 13:39, 28 April 2015

## Contents

# Project Title

Statistical Computing Environments (SCEs)

# Project Team Members

Project Lead: Art Collins

Project Co-leads: Stephen Matteson, Olivier Leconte, Mark Matthews

# 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:

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

# 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

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

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

[3] 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

# Deliverables and Dates:

Deliverable | Date |
---|---|

Follow-up meeting | 29 April, 2015 |

Round-table discussion at PharmaSUG | May, 2015 |

Third meeting | July, 2015 |

Draft white paper titled ‘The State of the SCE’ by | October, 2015 |

Discussion club/round-table discussion at PhUSE Annual Conference | October, 2015 |

Publish white paper 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 |

Last revision by Collinsa,04/28/2015