Difference between revisions of "Standard Analyses & Code Sharing"

From PHUSE Wiki
Jump to: navigation, search
(Working Group Meeting Minutes)
m (Disclaimer for Others)
 
(51 intermediate revisions by 5 users not shown)
Line 28: Line 28:
 
= Leadership Team =
 
= Leadership Team =
  
{| class="wikitable"
+
{| class="wikitable" style="width:100%"
 
|-
 
|-
| Name || Role || Organization|| E-mail
+
| '''Name''' || '''Role''' || '''Organization'''|| '''E-mail'''
 
|-
 
|-
 
|Mary Nilsson || Industry Co-lead and Steering Committee Liaison ||Lilly || [mailto:nilsson_mary_e@lilly.com nilsson_mary_e (at) lilly.com]
 
|Mary Nilsson || Industry Co-lead and Steering Committee Liaison ||Lilly || [mailto:nilsson_mary_e@lilly.com nilsson_mary_e (at) lilly.com]
 
|-
 
|-
| Hanming Tu || Project Manager ||Frontage ||[mailto:htu@frontagelab.com htu (at) frontagelab.com]
+
| Hanming Tu || Industry Co-lead and Steering Committee Liaison ||Frontage ||[mailto:htu@frontagelab.com htu (at) frontagelab.com]
 
|-
 
|-
| Mat Soukup|| FDA Liaison || FDA ||[mailto:mat.soukup@fda.hhs.gov mat.soukup (at) fda.hhs.gov]
+
| Wendy Dobson || PHUSE Project Manager || PHUSE || Wendy@phuse.eu
 
|}
 
|}
  
 
= Current Projects =
 
= Current Projects =
  
* [ [[Standard_Script_Index]] ]  [[https://github.com/phuse-org/phuse-scripts/wiki/Simple-Index Simple Index In Github]] - Frond-end User Interface (Hanming Tu)
 
* Github: [https://github.com/phuse-org/phuse-scripts Script Repository]
 
* [[WG5 Project 01|P01 - SDA]]: Script discovery and acquisition (Rebeka M Revis; Looking for a co-lead)
 
* [[WG5 Project 02|P02 - RCD]]: Repository content and delivery (Gustav Bernard; Andrew Miskell; FDA Liaison: Mat Soukup)
 
* [[WG5 Project 03|P03 - RGI]]: Repository governance and infrastructure: (Hanming Tu and Mike Carniello)
 
* [[WG5 Project 07|P07 - CPE]]: Communication, Promotion and Education  (Jared Slain and Wendy Dobson)
 
* [[WG5 Project 08|P08 - ADW]]: Analysis and Display White papers (Mary Nilsson)
 
* [[WG5 Project 09|P09 - TDF]]: Test Data Factory (Peter Schaefer)
 
*[[Script_Metadata_for_Sharing|Script Metadata for Sharing]]
 
  
= News =
+
{| class="wikitable"
# 02 May 2017: Mary and Hanming gave a webinar to ASA: [[http://www.phusewiki.org/wiki/images/6/62/PhUSE_20170502_ASAWebinar_v2.pdf ASA presentation]] and [[http://amstat.commpartners.com/se/Meetings/Playback.aspx?meeting.id=779247 Recording]]
+
|-
#February 2017:  The Adverse Events White Paper was finalized. The final copy is in the PhUSE Deliverables Catalog
+
| '''Project || Scope || Recruiting'''
# 25 August 2016: Draft 2 of the Adverse Events white paper is available for review until 14 October 2016. See[[http://www.phusewiki.org/wiki/index.php?title=SS_P08_Adverse_Events_White_Paper white paper wiki page]] for instructions on how to participate in the review.
+
|-
# 11 May 2016: We renamed this working group from <b>Development of Standard Scripts for Analysis and Programming</b> to <b>Standard Analyses and Code Sharing</b>.
+
|[[WG5_Project_08|Analysis and Display White papers]] (Mary Nilsson) || This project includes the development of white papers that provide recommended Tables, Figures, and Listings for clinical trial study reports and submission documents. The intent is to begin the process of developing industry standards with respect to analysis and reporting for measurements that are common across clinical trials and across therapeutic areas. Script developers could then create scripts consistent with the recommendations for all to use, improving efficiency and safety signal detection. || Yes
#10 Sep 2015: Final white paper version 1.0 of white paper on Outliers or Shifts from Normal to Abnormal: [[File:CS WhitePaper OutliersShifts v1.0.pdf]]
+
|-
#27 Aug 2015: All-hands meeting [[http://www.phusewiki.org/wiki/images/5/5d/Standard_Script_All-Hands_meeting2015_v3.pdf slides]]  
+
| [[Code_Sharing_(Repository)|Code Sharing (Repository)]] (Hanming Tu, Bob Friedman, Gustav Bernard) || Establish and maintain a collaboration platform for leveraging crowd-sourcing to improve the content and implementation of analyses for medical research and leading to better data interpretations and increased efficiency in the clinical drug development and review processes. || Yes
#09 Oct 2014: Draft 1 of the Adverse Events white paper is available for review until 01 December 2014.  This review is a partial draft intended to get initial feedback on the proposed tables and figures. See the [[http://www.phusewiki.org/wiki/index.php?title=SS_P08_Adverse_Events_White_Paper white paper wiki page]] for instructions on how to participate in the review.
+
|-
#07 Oct 2014: Version 1 of the Demographics/Disposition/Medications white paper has been finalized and available on www.phuse.eu (Publications section).  The white paper is also available from the [[http://www.phuse.eu/CSS-deliverables.aspx CSS Catalog of Deliverables]].
+
| [[WG5_Project_07|Communication, Promotion and Education]]  (Jared Slain and Wendy Dobson) || The success of working group “Standard Analyses and Code Sharing” relies on the acceptance, input, feedback and further development from/by the user community. A main priority will be to develop a Communication Plan that conceptualizes efficient ways to communicate working group progress and results, e.g. white papers, and the call for scripts. It will define target groups, timing, communication channels, and the presentation. || Yes
#29 Sep 2014: All Hands Meeting slides [[file:Standard_Script_All-Hands_meeting2014.pptx]]
+
|-
#26 June 2014: Draft White Paper [[media:CSS_WhitePaper_DemoDispMed_draft3.docx|Analyses and Displays Associated with Demographics, Disposition, and Medication in Phase 2-4 Clinical Trials and Integrated Submission Documents]] is available for review until 8 August 2014.  
+
| [[Best Practices for Quality Control and Validation]] (Maria Dalton and Jane Marrer) || Quality and accuracy is essential in the health and life sciences industries. Patients and regulators must be able to trust analyses of clinical data. This paper will provide an in-depth review of best practices for robust quality control. The scope of the paper will be quality control of analysis programming of clinical data in health and life sciences organisations. It is applicable to the organisations who produce analyses of clinical data, including Contract Research Organisations. The paper will not discuss oversight of outsourced programming || Yes
#25 March 2014: Version 1 of PK white paper is available [[media:PhUSE_CSS_WhitePaper_PK_final_25March2014.pdf|Analyses and Displays Associated to Non-Compartmental Pharmacokinetics – with a Focus on Clinical Trials]].
+
|-
#18 November 2013: As part of the CSS conference we will host the first ever PhUSE "Script-athon". Find more info here: [http://www.phuse.eu/css CSS conference]
+
| [[Good_Programming_Practice_in_Macro_Development|GPP in Macro Development]] (Ninan Luke) || Macros provide an effective way to automate and reuse code in a standard and consistent manner across SAS programs. This ability to reuse code means that the use of GPP is particularly important in macro code and we think that there is a need to develop a consensus and document good programming prairies specifically for macro programming. || Yes
#10 October 2013: The [http://www.phusewiki.org/wiki/images/4/48/CSS_WhitePaper_CentralTendency_v1.0.pdf Central Tendency White Paper] has been finalized!
+
|-
#26 June 2013: [[Hackathon_notes_20130626]] are posted
+
| [[WG5_Project_09|Test Data Factory]] (Peter Schaefer) || Several CS Projects develop and specify medical research methods, features, or processes, and some even create software components or subsystems for common tasks in drug development. As part of these efforts, a variety of SDTM or ADaM test datasets are required. The typical fallback position of project teams is to use data from the CDISC pilot project and/or anonymized study data that are provided by project team members. The Test Data Factory project aims at providing test data formatted in SDTM and ADaM that support a more systematic and comprehensive testing of these concepts and scripts. || Yes
#01 May 2013: [[SS_15591982_1_UKGROUPS_Harmony Individual Contributor License AgreementDOC|Individual Contributor License Agreement (Draft)]]
+
|-
# [[Phuse_SS_Agenda20130318|FDA/PhUSE Standard Scripts Agenda]] (Date Published: March 13, 2013)
+
| [https://www.phusewiki.org/wiki/index.php?title=Standard_Analyses_%27Deliverables_%26_Key_Links%27 Key Links] || Previously published deliverables & News || FYI
# The final draft of [[PhUSE_SS_Update20130318|PhUSE Standard Scripts Update]] (Date Published: March 1, 2013)
+
|}
# [[User Guide for Standard Script Repository]] has been drafted.  (Date Published: February 28, 2013)
+
 
# The [[First Call For Scripts|first Call for Scripts]] has been issued and a [[Press Release for Call for Scripts 1|press release]] issued.
+
== Small tasks that Working Group members can help with ==
# [https://github.com/phuse-org/phuse-scripts/ GitHub] has been chosen for our repository.
+
*CPE project - Help with entering conferences and due dates for abstract submissions
 +
*CPE project - After a presentation is given, add the ppt and pdf versions to the wiki
  
 
=Working Group Meeting Minutes=
 
=Working Group Meeting Minutes=
{| border="1" class="wikitable"
+
Starting in 2019, meeting minutes are kept in [https://phuse.teamworkpm.net/#projects/336388/notebooks Teamwork] instead of the Wiki which is accessible to Project Members only<br>
|+ Working Group Meeting Minutes
+
<br>
| Year 2013
+
Previous minutes can be found [[Archived_Meeting_Minutes|here]]
| Year 2014
 
| Year 2015
 
| Year 2016
 
| Year 2017
 
| Year 2018
 
|-
 
|[[WG5_08Jan2013|08Jan2013]]<br>
 
[[WG5_16Jan2013|16Jan2013]]<br>
 
[[WG5_22Jan2013|22Jan2013]]<br>
 
[[WG5_30Jan2013|30Jan2013]]<br>
 
[[WG5_06Feb2013|06Feb2013]]<br>
 
[[WG5_13Feb2013|13Feb2013]]  <br>
 
[[Media:20Feb2013.docx|20Feb2013]]<br>
 
[[WG5_27Feb2013|27Feb2013]]<br>
 
[[WG5_13Mar2013|13Mar2013]]<br>
 
[[SS_19Mar2013|19Mar2013]]<br>
 
[[19Mar2013 White Paper Breakout Session|19Mar2013]]<br>
 
[[SS_03Apr2013|03Apr2013]]<br>
 
[[SS_17Apr2013|17Apr2013]]<br>
 
[[SS_01May2013|01May2013]]<br>
 
[[SS_15May2013|15May2013]]<br>
 
[[SS_12Jun2013|12Jun2013]]<br>
 
[[SS_26Jun2013|26Jun2013]]<br>
 
[[SS_10Jul2013|10Jul2013]]<br>
 
[[SS_24Jul2013|24Jul2013]]<br>
 
[[SS_07Aug2013|07Aug2013]]<br>
 
[[SS_21Aug2013|21Aug2013]]<br>
 
[[SS_28Aug2013|28Aug2013]]<br>
 
[[SS_04Sep2013|04Sep2013]]<br>
 
[[SS_18Sep2013|18Sep2013]]<br>
 
[[SS_02Oct2013|02Oct2013]]<br>
 
[[SS_16Oct2013|16Oct2013]]<br>
 
[[SS_30Oct2013|30Oct2013]]<br>
 
[[SS_13Nov2013|13Nov2013]]<br>
 
[[SS_04Dec2013|04Dec2013]]<br>
 
[[SS_18Dec2013|18Dec2013]]<br>
 
|
 
[[SS_08Jan2014|08Jan2014]]<br>
 
[[SS_22Jan2014|22Jan2014]]<br>
 
[[SS_05Feb2014|05Feb2014]]<br>
 
[[SS_19Feb2014|19Feb2014]]<br>
 
[[SS_07Mar2014|07Mar2014]]<br>
 
[[SS_17Mar2014Phuse|17Mar2014Phuse]]<br>
 
[[SS_02Apr2014|07Apr2014]]<br>
 
[[SS_16Apr2014|16Apr2014]]<br>
 
[[SS_30Apr2014|30Apr2014]]<br>
 
[[SS_14May2014|14May2014]]<br>
 
[[SS_28May2014|28May2014]]<br>
 
[[SS_11Jun2014|11Jun2014]]<br>
 
[[SS_23Jul2014|23Jul2014]]<br>
 
[[SS_06AUG2014|06Aug2014]]<br>
 
[[SS_02SEP2014|03Sep2014]]<br>
 
[[SS_17SEP2014|17Sep2014]]<br>
 
|
 
[[SS_21JAN2015|21Jan2015]]<br>
 
[[SS_19FEB2015|19Feb2015]]<br>
 
[[SS_17Mar2015|17Mar2015]]<br>
 
[[SS_01Apr2015|01Apr2015]]<br>
 
[[SS_29Apr2015|29Apr2015]]<br>
 
[[SS_27May2015|27May2015]]<br>
 
[[SS_15Jul2015|15Jul2015]]<br>
 
[[SS_05Aug2015|05Aug2015]]<br>
 
[[SS_19Aug2015|19Aug2015]]<br>
 
[[SS_16Sep2015|16Sep2015]]<br>
 
[[SS_14Oct2015|14Oct2015]]<br>
 
[[SS_11Nov2015|11Nov2015]]<br>
 
[[SS_09Dec2015|09Dec2015]]<br>
 
|
 
[[SS_06Jan2016|06Jan2016]]<br>
 
[[SS_20Jan2016|20Jan2016]]<br>
 
[[SS_27Jan2016|27Jan2016]]<br>
 
[[SS_17Feb2016|17Feb2016]]<br>
 
[[SS_02Mar2016|02Mar2016]]<br>
 
[[SS_13Mar2016|13Mar2016 Agenda]]<br>
 
[[SS_06Apr2016|06Apr2016]]<br>
 
[[SS_11May2016|11May2016]]<br>
 
[[SS_01Jun2016|01Jun2016]]<br>
 
[[SS_06Jul2016|06Jul2016]]<br>
 
[[SS_03Aug2016|03Aug2016]]<br>
 
[[SS_07Sep2016|07Sep2016]]<br>
 
[[SS_05Oct2016|05Oct2016]]<br>
 
[[SS_02Nov2016|02Nov2016]]<br>
 
[[SS_07Dec2016|07Dec2016]]<br>
 
|
 
[[SS_04Jan2017|04Jan2017]]<br>
 
[[SS_01Feb2017|01Feb2017 CSS Agenda]]<br>
 
[[SS_09Feb2017|09Feb2017]]<br>
 
[[SS_01Mar2017|01Mar2017]]<br>
 
[[SS_15Mar2017|15Mar2017]]<br>
 
[[SS_05Apr2017|05Apr2017]]<br>
 
[[SS_03May2017|03May2017]]<br>
 
[[SS 07June2017|07June2017]]<br>
 
[[SS 05Jul2017|05Jul2017]]<br>
 
[[SS 06Sep2017|06Sep2017]]<br>
 
[[SS 04Oct2017|04Oct2017]]<br>
 
[[SS 01Nov2017|01Nov2017]]<br>
 
[[SS 06Dec2017|06Dec2017]]<br>
 
|
 
[[SS 03Jan2018|03Jan2018]]<br>
 
[[SS 17Jan2018|17Jan2018]]<br>
 
[[SS 07Feb2018|07Feb2018]]<br>
 
[[SS 21Feb2018|21Feb2018]]<br>
 
[[SS 04Apr2018|04Apr2018]]<br>
 
[[SS 02May2018|02May2018]]<br>
 
|}
 
 
 
<inputbox>
 
type=create
 
buttonlabel=Create new Minutes
 
preload=Template:WG5Minutes
 
</inputbox>
 
  
 
= Conference Records =
 
= Conference Records =
==PhUSE/CSS 2018==
+
[http://www.phusewiki.org/wiki/index.php?title=Standard_Analyses_%26_Code_Sharing_Conference_Materials PhUSE CSS Conferences]
* [http://www.phusewiki.org/wiki/images/f/ff/PhUSE_Working_Group_PP_Template_Dec_2017_.pptx PhUSE CS Power Point Template]
 
* [http://www.phusewiki.org/wiki/images/1/14/PhUSE_CSS2018_SACS_ProjectUpdates_v1.pptx Project Update from PhUSE CSS 2017]
 
; SACS Presentation
 
* [http://www.phusewiki.org/wiki/images/e/ec/PhUSE_CSS20180304_SACS_WG_Overview.pdf Session Overview]
 
* [http://www.phusewiki.org/wiki/images/9/9b/PhUSE_CSS20180305_01_Intro_Soukup.pdf WG Introduction by Mat Soukup]
 
* [http://www.phusewiki.org/wiki/images/a/ad/PhUSE_CSS20180305_02_WGOverview.pdf WG Overview by Hanming Tu]
 
* [http://www.phusewiki.org/wiki/images/c/c3/PhUSE_CSS20180305_03_WhitepaperGverview.pdf Whitepaper Overview by Mary Nilsson]
 
* [http://www.phusewiki.org/wiki/images/a/a2/PhUSE_CSS20180305_04_TDF.pdf Test Data Factory by Peter Schaefer]
 
* [http://www.phusewiki.org/wiki/images/7/78/PhUSE_CSS20180305_05_SMS.pdf Script Metadata for Sharing by Hanming Tu]
 
* [http://www.phusewiki.org/wiki/images/d/df/PhUSE_CSS20180305_06_CPE.pdf Communication, Promotion and Education by Jared Slain]
 
; Workshop: Github Enironment
 
* [https://drive.google.com/open?id=1AGc9eU2PtWQZ01QyN2BYGjv_i8GHkAzU workshop - from whitepapers to shareable scripts by Hanming Tu]
 
* [https://drive.google.com/open?id=1kNE0XuAchHr4SnCVrZpkqO_wroXKioY9 Workshop: script development process by Valerie Williams]
 
; Reach-out and Brainstorm sessions
 
* [http://www.phusewiki.org/wiki/images/a/a4/PhUSE_CSS20180305_workshop.pdf Meet with Data Visualization Project team]
 
* [http://www.phusewiki.org/wiki/images/0/0c/PhUSE_CSS20180306_02_Brainstorm.pdf Brainstorm session]
 
* [http://www.phusewiki.org/wiki/images/2/22/PhUSE_CSS20180306_03_wrapup.pdf Wrap-up session]
 
 
 
==PhUSE/CSS 2017==
 
* [http://www.phusewiki.org/wiki/images/b/b8/CSS_2017_Schedule_SACS_draft_v7.pdf PhUSE CSS 2017 Agenda]
 
*  [http://www.phuse.eu/annual-conference.aspx Annual Conference 2017]
 
* Presentations
 
** [http://www.phusewiki.org/wiki/images/2/2d/PhUSE_CSS2017_StandardAnalysesAndCodeSharing_Intro.pdf Background and Vision - Mat Soukup]
 
** [http://www.phusewiki.org/wiki/images/d/d6/PhUSE_CSS2017_StandardAnalysesAndCodeSharing_SundayNight_v3.pdf Working Group Overview - Mary Nilsson/Hanming Tu]
 
** [http://www.phusewiki.org/wiki/images/a/a1/PhUSE_CSS2017_StandardAnalysesAndCodeSharing_ProjectUpdates_v2.pdf Project Updates - All Project Co-leads]
 
** [http://www.phusewiki.org/wiki/images/d/dc/PhUSE_CSS2017_StandardAnalysesAndCodeSharing_ScriptDev.pdf Script Development - Gustav Bernard/Andrew Miskell ]
 
** [http://www.phusewiki.org/wiki/images/8/87/PhUSE_CSS2017_StandardAnalysesAndCodeSharing_JumpStart.pdf JumpStart Scripts - Rebeka Revis]
 
** [http://www.phusewiki.org/wiki/images/8/8b/PhUSE_CSS2017_StandardAnalysesAndCodeSharing_Spotfire.pdf Inter Active Display using Spoffire - Rebeka Revis]
 
** [http://www.phusewiki.org/wiki/images/2/23/PhUSE_CSS2017_ADWandVisualizationsJointMeeting.pptx ADW and Data Visualizations Joint Meeting - Mary Nilsson]
 
** [http://www.phusewiki.org/wiki/images/7/77/PhUSE_CSS2017_ADWandCollectionInstructionsJointMeeting.pptx ADW and Collection Instructions Joint Meeting - Mary Nilsson]
 
** [http://www.phusewiki.org/wiki/images/f/fd/PhUSE_CSS2017_StandardAnalysesAndCodeSharing_Wrapup.pdf Breakup and Wrap-up Sessions]
 
* Posters
 
** [http://www.phusewiki.org/docs/2017_CSS_US/PP14_Final.pdf Standard Analyses and Displays for Common Data in Clinical Trials – The Journey Continues]
 
** [http://www.phusewiki.org/docs/2017_CSS_US/PP17_Final.pdf A User Guide for the PhUSE GitHub Repository]
 
** [http://www.phusewiki.org/docs/2017_CSS_US/PP16_Final.pdf A Contribution to Better Systems – The Test Data Factory (TDF) Project]
 
** [http://www.phusewiki.org/docs/2017_CSS_US/PP18_Final.pdf Reducing Duplicated Effort on Standard Analyses through Collaboration]
 
 
 
==PhUSE/CSS 2016==
 
 
 
;[http://www.phuse.eu/Single-Day-Events.aspx PhUSE SDE 2016]
 
; PhUSE/CSS 2016 WG Agenda
 
 
 
[[SS_13Mar2016|13Mar2016 Agenda]]<br>
 
 
 
;PhUSE/CSS 2016 Meeting Slides
 
* [http://www.phusewiki.org/wiki/images/2/28/PhUSE_CSS2016SS_Agenda.pdf PhUSE/CSS 2016 Agenda]
 
* [http://www.phusewiki.org/wiki/images/e/ee/PhUSE_CSS2016SS_Motivation.pdf PhUSE/CSS 2016 Motivation]
 
* [http://www.phusewiki.org/wiki/images/b/b7/PhUSE_CSS2016SS_Projects.pdf PhUSE/CSS 2016 Project Updates]
 
* [http://www.phusewiki.org/wiki/images/8/84/PhUSE_CSS2016Git_and_Github.pdf PhUSE/CSS 2016 Git and Github]
 
== [https://www.cdisc.org/events/interchanges CDISC Interchange] ==
 
== [http://www.diaglobal.org/ DIA Global] ==
 
  
 
= Closed Projects =
 
= Closed Projects =
Line 260: Line 90:
  
 
= Disclaimer for Others =
 
= Disclaimer for Others =
Documents and comments provided as part of the PhUSE CSS Working Group efforts 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.  
+
Documents and comments provided as part of the PHUSE CSS Working Group efforts 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 PhUSE CSS 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.
+
Note:  Individuals participating in PHUSE CSS 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.

Latest revision as of 09:32, 5 September 2019


Working Group Overview

Name/Vision/Goals Presentation
Name
  • Standard Analyses and Code Sharing (formerly Development of Standard Scripts for Analysis and Programming)
Vision
  • Leverage crowd-sourcing to improve the content and implementation of analyses for medical research, leading to better data interpretations and increased efficiency in the clinical drug development and review processes.
Goals
  1. Establish and maintain a publicly available repository for storing program code to be used as analytical tools for medical research.
  2. Where gaps exist, develop recommendations for analyses and displays in areas that could benefit from crowd-sourcing.
  3. Where gaps exist, develop code for recommended analyses and displays that could benefit from crowd-sourcing (to reside in the repository).


Leadership Team

Name Role Organization E-mail
Mary Nilsson Industry Co-lead and Steering Committee Liaison Lilly nilsson_mary_e (at) lilly.com
Hanming Tu Industry Co-lead and Steering Committee Liaison Frontage htu (at) frontagelab.com
Wendy Dobson PHUSE Project Manager PHUSE Wendy@phuse.eu

Current Projects

Project Scope Recruiting
Analysis and Display White papers (Mary Nilsson) This project includes the development of white papers that provide recommended Tables, Figures, and Listings for clinical trial study reports and submission documents. The intent is to begin the process of developing industry standards with respect to analysis and reporting for measurements that are common across clinical trials and across therapeutic areas. Script developers could then create scripts consistent with the recommendations for all to use, improving efficiency and safety signal detection. Yes
Code Sharing (Repository) (Hanming Tu, Bob Friedman, Gustav Bernard) Establish and maintain a collaboration platform for leveraging crowd-sourcing to improve the content and implementation of analyses for medical research and leading to better data interpretations and increased efficiency in the clinical drug development and review processes. Yes
Communication, Promotion and Education (Jared Slain and Wendy Dobson) The success of working group “Standard Analyses and Code Sharing” relies on the acceptance, input, feedback and further development from/by the user community. A main priority will be to develop a Communication Plan that conceptualizes efficient ways to communicate working group progress and results, e.g. white papers, and the call for scripts. It will define target groups, timing, communication channels, and the presentation. Yes
Best Practices for Quality Control and Validation (Maria Dalton and Jane Marrer) Quality and accuracy is essential in the health and life sciences industries. Patients and regulators must be able to trust analyses of clinical data. This paper will provide an in-depth review of best practices for robust quality control. The scope of the paper will be quality control of analysis programming of clinical data in health and life sciences organisations. It is applicable to the organisations who produce analyses of clinical data, including Contract Research Organisations. The paper will not discuss oversight of outsourced programming Yes
GPP in Macro Development (Ninan Luke) Macros provide an effective way to automate and reuse code in a standard and consistent manner across SAS programs. This ability to reuse code means that the use of GPP is particularly important in macro code and we think that there is a need to develop a consensus and document good programming prairies specifically for macro programming. Yes
Test Data Factory (Peter Schaefer) Several CS Projects develop and specify medical research methods, features, or processes, and some even create software components or subsystems for common tasks in drug development. As part of these efforts, a variety of SDTM or ADaM test datasets are required. The typical fallback position of project teams is to use data from the CDISC pilot project and/or anonymized study data that are provided by project team members. The Test Data Factory project aims at providing test data formatted in SDTM and ADaM that support a more systematic and comprehensive testing of these concepts and scripts. Yes
Key Links Previously published deliverables & News FYI

Small tasks that Working Group members can help with

  • CPE project - Help with entering conferences and due dates for abstract submissions
  • CPE project - After a presentation is given, add the ppt and pdf versions to the wiki

Working Group Meeting Minutes

Starting in 2019, meeting minutes are kept in Teamwork instead of the Wiki which is accessible to Project Members only

Previous minutes can be found here

Conference Records

PhUSE CSS Conferences

Closed Projects

  • P04: Legal ownership and issues in open source repository (Sally Cassells)
    • Task completed, creating a summary is planned
  • P05: Create templates and metadata for documenting scripts and coding practices (Jean-Marc Ferran and Eric Sun)
    • Closed, remaining tasks are folded into RGI project.
  • P06: Refine process for creating and editing scripts in Google Code (Kevin Kane)
    • Closed, any remaining tasks moved to Project 03

Legacy Projects/Information

Development_of_Standard_Scripts_for_Analysis_and_Programming - This contains the legacy working group information.

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

Documents and comments provided as part of the PHUSE CSS Working Group efforts 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 PHUSE CSS 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.