View source for Statistical Computing Environment

=Project Title=
Statistical Computing Environments (SCEs)

=Project Leads=

{| class="wikitable"
|-
| 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:
#	Discuss the current state of SCEs, identify common gaps and share best practices 
#	Define ideal future direction of business processes supported by 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)

=Upcoming Deliverables and Dates:=
{| class="wikitable"
| 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:=
{| class="wikitable"
| 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=
'''[[media:State_of_the_SCE_-_Final.docx|'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, [http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM126953.pdf Guidance for Industry - Part 11, Electronic Records; Electronic Signatures - Scope and Application], August 2003

FDA, [http://www.fda.gov/regulatoryinformation/guidances/ucm126402.htm1 Guidance for Industry - Computerized Systems Used in Clinical Trials], April 1999

FDA, [http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070266.pdf Guidance for Industry - Computerized Systems Used in Clinical Investigations], May 2007

==Publications:==

[http://www.lexjansen.com/nesug/nesug03/ph/ph003.pdf 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

[http://www.lexjansen.com/wuss/2013/68_Paper.pdf BUILDING A CONTROLLED STATISTICAL PROGRAMMING ENVIRONMENT], Wayne Woo, Novartis Vaccines & Diagnostics, Cambridge, MA, WUSS 13 Paper

[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

[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

[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

[http://www.d-wise.com/statistical-computing-environment Building a Hosted Statistical Computing Environment: Is it Possible?], d-Wise

[http://www.d-wise.com/blog/bid/312821/d-Wise-s-View-of-Clinical-Data-Repositories-CDRs-2013?Preview=true d-Wise's View of Clinical Data Repositories (CDRs) – 2013], Posted by Keith Ward on Aug 29, 2013

[http://www.d-wise.com/blog/bid/318639/The-Solution-Landscape-Part-3-SCE?Preview=true12%20http://d-wise.com/Statistical-Computing-Environment/ The Solution Landscape Part 3: SCE.], Posted by Keith Ward on Oct 3, 2013

[http://www.lexjansen.com/phuse/2006/ad/AD12.pdf The Submission Data File System - Automating the Creation of CDISC SDTM and ADaM Datasets], Marcus Bloom, Amgen, David Edwards, Amgen, PhUSE 2006

[http://support.sas.com/resources/papers/proceedings13/009-2013.pdf MACUMBA: Modern SAS® GUI Debugging Made Easy], Michael Weiss, Bayer Pharma AG, SAS Global Forum 2013

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[[Category:Emerging Technology]]