Optimizing the Use of Data Standards

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Working Group Overview

The development and adoption of data standards over the last decade has shown significant promise in improving efficient delivery of data to support drug product and device submissions as well as the review process. However, there have also been gaps, issues and challenges in the interpretation and use of data standards. This working group will identify specific gaps that prevent FDA and industry from optimizing the use of data standards. This working group will collaborate to close those gaps. On this page you will find information on Current and Completed projects.

Leadership Team

Name Role Organization E-mail
Lisa Brooks Working Group Leader Iris Statistical Computing lisa (at) irisstatcomp.com
Jane Lozano Working Group Leader Eli Lilly lozano_jane_a (at) lilly.com

Completed Projects

Reviewer's Guide Work Packages referenced in FDA Study Data Technical Conformance Guide

(2014-05-13) Analysis Data Reviewer's Guide (ADRG) - ADaM provides a framework that enables analysis of the data, while at the same time allowing reviewers and other recipients of the data to have a clear understanding of the data’s lineage from collection to analysis to results. Although ADaM provides a robust metadata framework, FDA Reviewers benefit from additional, human-readable, documentation of analysis methods, data sets, and programs that cannot be fully explained within the ADaM metadata. The Final ADRG package contains a template to be used in submissions with completion guidelines and examples. The ADRG template provides an orientation to the submitted data in a consistent and usable format.
(2013-05-13) Study Data Reviewers Guide (SDRG) - The define.xml document does not adequately document mapping decisions, sponsor-defined domains, and other key study components and a SDRG would help to address this documentation gap. The goal of this project is to develop a SDRG template jointly between CDER, Industry, and CDISC to be used for submissions.
(2016-03-03) Nonclinical SDRG Package - The Nonclinical Study Data Reviewers Guide extends the SDRG to SEND datasets for nonclinical study submissions.

Version Release Date Downloadable Work Package Changes from Previous Version
v1.1 26-Jan-2015 ADRG Package v1.1 2015-01-26
  • Added ADSL Header to Section 5.2
  • Improved ADRG Template usability
  • Minor revisions to instructions in ADRG Completion Guidelines
  • ADRG Examples updated to match revised SDRG Template
v1.01 13-May-2014 ADRG Package v1.01 2014-05-13 Initial Version
v1.2 26-Jan-2015 SDRG Package v1.2 2015-01-26
  • Removed Trial Design Dataset navigation table from Section 2.3
  • Improved SDRG Template usability
  • Minor revisions to instructions in SDRG Completion Guidelines
  • SDRG Examples updated to match revised SDRG Template
v1.1 03-May-2013 SDRG Package v1.1 2013-05-13 Initial Version
V1.0 03-Mar-2016 Nonclinical SDRG Package v1.0 2016-03-03 Version for FR Notice Public Review

Traceability and Data Flow Deliverables

Traceability: Current State Analysis Released August 2013

Preliminary Recommendations for Traceability Documentation using Define-XML 2.0 Released December 2013

Traceability: Best Practices for Basic Linear Data Flow Released October 2014

White Paper: Study Level Traceability in a Non Linear Data Flow Released October 2014

Current Projects

Best Practices for Data Collection Instructions - This project will create a white paper documenting challenges and gaps with the CDASH CRF completion as well as recommendations for a future version of CDASH. The white paper will be provided to CDISC for their consideration. The project team will focus on the following domains: Adverse Events, Medical History, Concomitant Medications, Pregnancy, and Reasons for Treatment and Study Discontinuation. The team will assess the opportunity to address other domains after the white paper is completed.

Best Practices for Metadata Documentation (define.xml versus reviewer's guide) - This project is aimed at looking at use of the reviewer's guide in conjunction with the define.xml. The objective is to define best practices for documenting and describing dataset structures and contents within standard submission deliverables such as define.xml and the data reviewer’s guide, addressing common challenges, differences between reviewing agencies and divisions, and recommending quality assurance activities. The team plans on delivering at least one white paper on this subject.

Clinical Legacy Data Conversion Plan & Report - This team will work on a standardized approach to the development of a single traceability document to address conversions from non-standardized data (i.e. legacy) to standardized data (SEND, SDTM, ADAM). Although the Technical Conformance Guide indicates this should be added to the SDRG, FDA has agreed that a separate document is acceptable since the conversion could be related to SDTM and ADaM. There are also other traceability situations that occur within the life cycle of a compound that could be relevant and should be shared with FDA. The goals of the team are to provide a template, completion guidelines, and some examples that may be utilized by sponsors to develop the LDCP. It is expected that the LDCP will be created when non-standardized data is converted to standardized data (e.g. CDISC, SDTM, SEND, and ADaM).

Data Reviewer's Guide in XML - This project will develop the Data Reviewer's Guide (i.e., SDRG and ADRG) in an XML format for regulatory submissions. Furthermore, this project will identify and develop style sheets, elements and semantics capability. This project will also assess a more cohesive cross-documentation data exchange between the define.xml and data reviewer's guide as an XML format. The project intends to use the existing Analysis Data Reviewer's Guide (ADRG) and Study Data Reviewers Guide (SDRG) as its basis.

Define-XML V2.0 Completion Guidelines & Style Sheet Recommendations - This project addresses documenting the best practices in the implementation of define 2.0 and the existing style sheet. Two CDISC Define-XML liaisons are involved in this project.
Two projects have been identified:
1) Define-XML 2.0 Implementation, The deliverable is a Completion Guidelines document, focusing on best practices for content and granularity.
2) Define-XML 2.0 Stylesheet Recomendations. There are 2 phases to this project:

  • 1) Development of a Define-XML v2 stylesheet for regulatory submissions, by reviewing and updating the existing CDISC stylesheet.
  • 2) Demonstrate other uses of a stylesheet, and utilizing libraries and frameworks to make the display more interactive.

GDPR Impact on Data Collection Practices - In May 2016, the new EU General Data Protection Regulation (GDPR) was released and will become applicable in all member states two years after publication on May 25th, 2018. The GDPR was designed to harmonise data privacy laws across Europe, to protect and empower all EU citizens' data privacy and to reshape the way organisations across the region approach data privacy. This project will create a best practices white paper to summarize experiences and recommendations for collecting personal information in compliance with the regulations.

Pooling WHO Drug B3 Format - The FDA Data Standards Catalog requires the use of WHODrug dictionary codes for coded medications in March 2018. The WHODrug B3 format is different than the previous formats. Codes should include the drug product trade name (where available), the active ingredient(s) and the Anatomical Therapeutic Chemical (ATC) Class. This project team will create a white paper outlining best practices for creating an integrated database with medication data collected in different formats (B3 format and whatever format was applied previously).

SDTM ADaM Implementation FAQ - Standard implementation nuances exist across the multiple available versions of SDTM and ADaM. The project team will establish a framework for the collection, compilation, assessment, responding to, and publishing common SDTM and ADaM implementation challenges/nuances. This is important for Sponsors that are still transitioning to newer versions of standards (e.g. SDTM), as well as the vast majority who have to govern multiple versions, even for a single product or application. This is a joint project between PhUSE and CDISC. Five primary categorical areas will be used for the FAQs:
I) Data Submission (SDTM and ADaM)
II) Validation/Conformance Rules
III) IG Nuances
IV) Legacy Mapping to SDTM
V) Trial Design Domains

(Re-Launched) Standardizing Data within the Inspection Site Selection Process - This group is a revival of a previous project team from a few years ago which focused on FDA's still draft guidance document on inspection site selection datasets. The group has completed a CDISC gap analysis document to understand from where elements can be pulled from CDISC datasets in order for organizations to more easily and efficiently create these requested datasets. FDA has read the gap analysis and will work with CDISC and PhUSE with the path moving forward. The Standard Scripts Working Group has indicated they will consider standard specs and code.

Study Data Standardization Plan (SDSP) - Development of a required study data standardization plan early in the development cycle to optimize implementation of CDISC SEND, SDTM, ADaM data standards is the focus of this project. The template has been created and FDA has issued a FR Notice for Intent to Review with comments due by January 9th, 2017. Deliverables include the following: template, sponsor implementation plan, example documents, and completion guidelines.

Industry Experiences Submitting Standardised Study Data to Regulatory Authorities:

Projects on Hold

CDRH Pilot for the Electronic Submission of Medical Device Data in an SDTM-Based Format - This project has been put on hold until further notice (2014-01-07).

Evaluation of SDTM Elements - Sponsors collect data elements to support operational activities such as data cleaning or data reconciliation. Although these data elements are not analyzed, sponsors frequently tabulate them in SDTM. As a result, both sponsor analysts and FDA Reviewers spend time differentiating analyzable observations from operational noise. Documenting data elements of limited utility to data analysis and/or FDA Reviewers provides sponsors and the agency with a common baseline for pre-submission data standards discussions. This project has been put on hold until further notice (2014-05-13).

Working Group Meeting Materials

Teleconference: Conference Info: 888-706-6468 Participant Code: 2210463
Adobe Connect Session: https://connect.vrtx.com/jeff

The following file contains the introduction slides for the CSS Meetings introduction to Optimizing Data Standards Working Group. Optimizing Data Standards Introduction for CSS Meetings - 20140315

Working Group Meeting Minutes

2017 CSS Roundtable Discussion

Legacy Projects/Information

Legacy Projects

Standardizing Site Selection

2017 CSS Agenda

There will be an opening session Sunday night from 5 - 7 pm. Each working group co-lead will give an overview and the projects that will be covered in the CSS. Please attend and get to know the folks you'll be working with for the next 2 days, and hopefully 12 months!

We will be discussing project topics according to the breakout schedule below.

Note that there will be an opening session for this working group Monday morning. The slides from Sunday night will be presented and this also offer a chance for you to meet with members of a project you are a part or to speak with a project lead if you are interested in getting involved.

We will also have a working group wrap-up and round-table breakout session after lunch on Tuesday. Each of the working group leads will communicate the accomplishments during the conference and the path moving forward. This is also an opportunity to discuss ideas for new projects and communicate that with the working group co-leads.

If you have any questions or concerns, please reach out to Jane Lozano or Susan Kenny.

Webinar Presentations