Difference between revisions of "Standard Analyses & Code Sharing"
From PHUSE Wiki
| Line 26: | Line 26: | ||
* Update from each projects (Project Leads) | * Update from each projects (Project Leads) | ||
| − | ; Monday 11 am - 12 pm - the whole group | + | ; Monday Morning: 11 am - 12 pm - the whole group |
* Background and Trends (Mat) | * Background and Trends (Mat) | ||
* Overview of WG and Tour of the WG Wiki Pages (Mary) | * Overview of WG and Tour of the WG Wiki Pages (Mary) | ||
| Line 40: | Line 40: | ||
** Overview of the qualification process | ** Overview of the qualification process | ||
** Exercise the qualification process on a pre-selected script | ** Exercise the qualification process on a pre-selected script | ||
| + | ** Goals of the qualification/scriptathon | ||
| + | *** Clearly define what is qualification process and what means to be qualified. | ||
| + | *** Exercise the qualification process on a selected script | ||
| + | *** Develop other scripts into new phases | ||
| + | *** Qualification is on-going process and the qualified script could be re-qualified for its new version (expanded feature or coverage). | ||
| + | ; Scriptathon: Monday 6:30 pm ~ 11:30 pm | ||
| + | * Every person will choose one or two scripts to move from its current stage to next stage such as from “D” to “T” | ||
| + | * At least one or two persons to exercise the whole qualification process on additional script (moving from “C” or “D” to “Q”) | ||
| + | * Track the progress on a matrix for the status and traceability | ||
| − | + | ;Tuesday Sessions: 8:30 am -12:00 pm | |
| + | * 8:30 – 9:00 am: Group Meet | ||
| + | * 9:00 – 10:00 am: Meet with Therapeutic Area User Guide (TAUG) group on eSHARE | ||
| + | * 10:00 – 12:00 breakout | ||
| + | ** White paper will work on Hepatotoxicity, TQT, and Questionnaire white papers | ||
| + | ** Platform will work on creating documentation including tracking matrix | ||
| + | ; Tuesday Group Meet: Tuesday 1:00 pm - 2:00 pm | ||
| + | * wrap up together | ||
= Current Projects = | = Current Projects = | ||
Revision as of 09:28, 20 February 2015
Working Group Overview
This working group will identify potential standard scripts for data transformations and analyses across and/or within a therapeutic area and exploratory analysis. The goal will be to begin the process of standardizing analyses across the industry, but also include examples of what can be done with a standardized data set. This will be an interactive session using online wiki to create and add input that can be shared openly between industry and regulatory.
Leadership Team
| Name | Role | Organization | |
|---|---|---|---|
| Mary Nilsson | Industry Co-lead and Steering Committee Liaison | Lilly | nilsson_mary_e (at) lilly.com |
| Hanming Tu | Project Manager | Accenture | hanming.h.tu (at) accenture.com |
| Steve Wilson | FDA Liaison | FDA | Stephen.Wilson (at) fda.hhs.gov |
| Mat Soukup | FDA Liaison | FDA | mat.soukup (at) fda.hhs.gov |
Agenda for Group Sessions in PhUSE/CSS 2015
- Sunday Night Working Group Meet & Greet (5 pm - 7 pm)
- Overview of working group (Mary)
- Overview about Google Code (Hanming)
- Update on scriptathons (Mike)
- Update from each projects (Project Leads)
- Monday Morning
- 11 am - 12 pm - the whole group
- Background and Trends (Mat)
- Overview of WG and Tour of the WG Wiki Pages (Mary)
- Tour of Repository: structure and Index page (Hanming)
- Updates for each projects within the working group (Project leads)
- Breakout sessions
- Monday 1:30 - 4:30 pm
- White papers
- Outlier/shift displays
- Cumulative or adjusted percentages
- Adverse event displays
- Platform: qualification process
- Overview of the qualification process
- Exercise the qualification process on a pre-selected script
- Goals of the qualification/scriptathon
- Clearly define what is qualification process and what means to be qualified.
- Exercise the qualification process on a selected script
- Develop other scripts into new phases
- Qualification is on-going process and the qualified script could be re-qualified for its new version (expanded feature or coverage).
- Scriptathon
- Monday 6:30 pm ~ 11:30 pm
- Every person will choose one or two scripts to move from its current stage to next stage such as from “D” to “T”
- At least one or two persons to exercise the whole qualification process on additional script (moving from “C” or “D” to “Q”)
- Track the progress on a matrix for the status and traceability
- Tuesday Sessions
- 8:30 am -12:00 pm
- 8:30 – 9:00 am: Group Meet
- 9:00 – 10:00 am: Meet with Therapeutic Area User Guide (TAUG) group on eSHARE
- 10:00 – 12:00 breakout
- White paper will work on Hepatotoxicity, TQT, and Questionnaire white papers
- Platform will work on creating documentation including tracking matrix
- Tuesday Group Meet
- Tuesday 1:00 pm - 2:00 pm
- wrap up together
Current Projects
- P01: Look for existing scripts and store them in the repository (Adie Bonwick and Aiyu Li)
- Ongoing
- P02: Qualification of scripts in the repository (Dante Di Tommaso; Lina Jørgensen through 2013)
- Ongoing.
- P03: Maintain and enhance platform (repository) for sharing scripts (Mike Carniello/Hanming Tu)
- Ongoing [ Standard_Script_Index ]
- 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)
- Ongoing
- P07: Implement and further develop communication plan for standard scripts (Dirk Spruck)
- Ongoing
- P08: Create white papers providing recommended display and analysis including Table, List and Figure shells (Mary Nilsson)
- Ongoing
Closed Projects
- P06: Refine process for creating and editing scripts in Google Code (Kevin Kane)
- Closed, any remaining tasks moved to Project 03
News
- 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 [white paper wiki page] for instructions on how to participate in the review.
- 09 Oct 2014: Draft 3 of the Outliers/Shifts white paper is available for review until 01 December 2014. This will likely be the last draft sent for review. See the [white paper wiki page] for instructions on how to particpate in the review.
- 09 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 [CSS Catalog of Deliverables].
- 29 Sep 2014: All Hands Meeting slides File:Standard Script All-Hands meeting2014.pptx
- 26 June 2014: Draft White Paper 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.
- 25 March 2014: Version 1 of PK white paper is available 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: CSS conference
- 10 October 2013: The Central Tendency White Paper has been finalized!
- 26 June 2013: Hackathon_notes_20130626 are posted
- 01 May 2013: Individual Contributor License Agreement (Draft)
- FDA/PhUSE Standard Scripts Agenda (Date Published: March 13, 2013)
- The final draft of 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 has been issued and a press release issued.
- Google Code has been chosen for our repository.
Group Meetings
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.
