Spring 2019
From the editor
Working Groups
Working Groups Quarterly

Info on our Working Groups

Info on our Working Groups

In 2019, the Working Groups will launch their 150th project and finalise their 75th work package. The Working Groups have traditionally been effective at addressing current challenges as well as exploring future opportunities. In 2018, the Educating for the Future Working Group launched with a remit to develop frameworks to educate the PhUSE Community about new mindsets, methodologies, and technologies. I am personally excited about this Working Group as it challenges PhUSE as an organisation to think differently and be better; it challenges the PhUSE Community to think differently and be better; it challenges me to think differently and be better; and it challenges YOU to think differently and be better. I know the PhUSE Working Groups are up to the challenge. Are you?


The final charter for the Projects has now been finalised and published here under Useful Information on the Wiki. It highlights the roles and responsibilities from Working Groups BoDs to project members. We encourage you all to take the time to review and familiarise yourself with the expectations of being part of a PhUSE project.

Since the beginning of 2019, we have already had 25 new members join one of our many active projects. Here is an overview of the PhUSE Working Groups projects. If you are interested in joining one, please email workinggroups@phuse.eu.

Standard Analyses & Code Sharing Working Group:

The Script Metadata for Sharing project finalised its White Paper, which has now been published on the PhUSE website. The project presented its finding during a PhUSE Webinar on 23rd January. You can find their presentation here.

The Communication, Promotion & Education project is currently developing a platform where members are able to easily navigate GitHub. Educational materials, hints and tips, and links to useful information will be housed on the PhUSE Education website, which is a subsidiary of Squarespace. This project is currently working towards presenting a Workshop on Safety Analytics during the CSS conference, which will be taking place in Silver Spring, Maryland 9–11th June. Registration for the CSS is open. In addition, we are currently working on multiple presentations and posters which will be presented at the DIA annual meeting in June.

The Code Sharing (Repository) project is currently re-structuring and is looking for volunteers to join the team to help establish and maintain a collaboration platform for leveraging crowd-sourcing to improve the content and implementation of analyses for medical research. The aim is to develop guidance on managing repositories and script metadata for sharing scripts, review contributed scripts from the FDA, and develop scripts based on White Papers. If you are willing to contribute, please email workinggroups@phuse.eu.

The Analyses & Displays White Paper project this year will focus on developing and producing the following White Papers:

Events of Special Interest

General Output Tips and Considerations


• Labs

• Treatment-Emergent Definitions

If you would like to join one of these sub-teams, please contact workinggroups@phuse.eu.

The Test Data Factory project has now published deliverables on the following:

TDF ADaM: ADaMIG v1.1 Test Datasets

TDF SDTM: SDTMIC v3.2 Test Datasets

The project recently presented its findings during a PhUSE Webinar and is now looking to kick-start Phase 2. The aim is to have a web-based system that creates test datasets based on study metadata specified by users. If you can contribute, please contact workinggroups@phuse.eu.

The Best Practices for Quality Control and Validation project is working towards a White Paper that will provide an in-depth review of best practices for robust control. It will focus on the quality control of analysis programming of clinical data in health and life sciences. The project recently formed four sub-teams to focus on Tools, Process, Introductions and Metrics and each of these sub-teams will curate its findings and work towards a consolidated White Paper. This paper is expected to be made available to the public in Q32019.

The Good Programming Practice in Macro Development project, which has recently launched, will focus its efforts on:

• Coding Style of Macro

• Best Practices while Writing Macro

• Structured Documentation of Macro

• Optimisation and Saving Compiling Time while Using Macro

• Refactoring in Macro.

If you would like to contribute towards this project, please email workinggroups@phuse.eu.

Optimizing the Use of Data Standards Working Group:

In collaboration with the Standard Analyses & Code Sharing White Papers project, the Best Practices for Data Collection Instructions team will be combining a White Paper which will simplify the current variations in Adverse Events collections and analysis and why such variations exists. The project would be keen to welcome new members, so if you are interested in participating, please reach out to workinggroups@phuse.eu.

Data Standards for Non-interventional Studies addresses the challenges that programmers face during creation of the analysis datasets and handling of the data for the observational studies. The project hopes to present its draft findings at the upcoming CSS conference in June, with a view to finalising its White Paper by the end of Q32019.

Working in partnership with CDISC, the CDISC Implementation Primer project has recently formed four sub-teams to focus on the following:

• Getting Started with CDISC

• Linking of Models

• CDISC-compliant

• Traceability

This project will identify needs of new CDISC implementers, with an additional focus on academia and technology providers. A "CDISC Primer" (e.g. Wiki, white paper, slide deck, QuickStart, guide, etc.) will be developed that addresses these needs and be made freely available to the public. We are looking for volunteers to join this team. If you are interested, please email workinggroups@phuse.eu.

The SDTM ADaM Implementation FAQ project continues to provide clarification to questions received from industry. Responses can be found here. In addition, if you have a question you wish to ask the team, please complete this form. In parallel, there are two active sub-teams both looking to produce a White Paper on best practices for ISS/ISE and Event Adjudication. They hope to share their findings during the CSS event in Silver Spring, in June.

The Define-XML Stylesheet Recommendations project has now published its final deliverable, which can be viewed here: Define-XML Stylesheet Recommendations.

Over the next few weeks, the following projects will publish their final deliverables on the PhUSE website:

• Define-XML Completion Guidelines


• Define-XML vs Reviewer’s Guide

The Data Reviewer’s Guide in XML project recently sort feedback on its White Paper from the PhUSE Community and is now looking to do a Proof of Concept in collaboration with the FDA. Further details will follow in due course.

Educating for the Future Working Group:

Upon review of the current topics being researched by the Machine Learning and Artificial Intelligence project, it was agreed that they would better fit under the Emerging Trends & Technologies Working Group. This restructure has now taken place.

The Data Engineering project explores how established data engineering techniques successfully deployed in other industries could be utilised in our industry. From traditional data warehousing to the arrival of the big data lake, with data marketplaces, ePRO and IoT, the challenge is on to identify analytical value from all of these disparate data sources. This team continues to build upon its findings by publishing them to our Educational website (Squarespace). Here, you will find some use cases in the data engineering industry as well as some useful tools and software packages. Finally, the Project Leads presented at both the EU Connect 2018 in Frankfurt and the US Connect 2019 in Baltimore in February. Here is the link to their abstract from Frankfurt. They always welcome new members, so if you are interested in this project and can contribute, please email workinggroups@phuse.eu.

The Design Thinking team ran a very successful workshop at the EU Connect in Frankfurt last year during the CRO Summit, and will be presenting at the US Connect in Baltimore in both the Leadership Stream and once again, at the CRO Summit. This project is looking at ways to identify and collate resources in the field of design thinking to share amongst the PhUSE Community. Materials curated to date can be found here.

A new Data Science project has been launched by this Working Group, and is currently seeking support from the PhUSE Community. If you are interested in joining this team, please email workinggroups@phuse.eu.

Emerging Trends & Technologies Working Group:

The PhUSE Key Performance Indicators & Metrics project has been working to establish a set of common data reporting metrics which are more detailed than industry-wide metrics, therefore allowing a greater level of granularity in our project reporting, and business process management. The team has recently created a report based on the findings of last year’s survey and is now using the feedback to create another survey, which it is looking to send to over 200 companies. The 2019 survey will remove KPIs that do not seem to have value, in the hope of establishing a core set of benchmarking metrics in support of statistical programming operations for general use.

The Clinical Trials Data as RDF team recently published a White Paper which describes the motivation and utility of data as a graph, as demonstrated by the PhUSE Computational Science Symposium Emerging Trends & Technologies Working Group project "Clinical Trials Data as RDF". The project was formed to investigate the feasibility of using Linked Data as a future-proof technology for clinical trial results. This project has now closed and has initiated a new venture broadening into nonclinical concepts, thus extending the impact of the project further along the data lifecycle. The new project 'Going Translational with Linked Data' is seeking members and welcomes support from the PhUSE Community. If you would like to join this new and exciting project, please email workinggroups@phuse.eu.

Blockchain Technology Phase 2 is a follow-up from the Phase 1 project presented in the White Paper to show how a blockchain-powered health wallet could support greater efficiencies across the clinical trial process through design and implementation of faster, less onerous user identification processes and through permissioned access to a federated database pointing to a variety of traditionally siloed sources (including EMR, wearables, IoT, etc.). The team has split into five sub-teams and will come together to develop a user interface and a White Paper.

Nonclinical Topics Working Group:

The Nonclinical Scripts project has completed a safety pharma dataset summarisation for Latin square design, which was presented at a Safety Pharma conference and at the CDISC Interchange. The team continues to work on the development of a SEND quality check script, a SEND test data factory script, and scripts to convert from xpt to txt and back to xpt, enabling manual edits and creation of SEND datasets. It is also working on improving the Repository Index to make it easier to find scripts and help users understand what each script can do.

The Nonclinical Study Data Reviewer’s Guide team has decided that, based on the Technical Conformance Guide, it is no longer necessary to include a section for "Legacy Data Conversion". Therefore, section 6.4 will be removed with the next update of the nSDRG, expected for the CSS in June 2019.

The Define-XML Codelist project has provided best practice recommendations on the SEND Implementation FAQ Wiki, addressing questions about Define-XML codelists. The team has one remaining question to address. The clinical Define-XML completion guidelines document (under public review) is also being evaluated by the team to determine if any of the information is relevant to nonclinical.

The Data Consistency: SEND Datasets and the Study Report project has an interactive Wiki page listing the identified potential inconsistencies between SEND datasets and study reports. The associated recommendations will be made public this summer. The team is presently refreshing its project page and seeking ways to socialise the interactive Wiki.

Industry SEND Progress Survey: The team has recently produced a survey to gather data on industry SEND. The results will be presented at the PhUSE CSS in June 2019.

Data Transparency Working Group:  

The GDPR Impact on Data Collection Practices project is to share experiences and approaches for collecting date of birth and other personal information in compliance with regulations. The team recently separated into three sub-teams to explore Data Collection and PII, Safeguard and Processes and Data Breaches. Two of the teams sent out surveys to investigate the collection of data and the application of GDPR within the industry. Using the data collected through the surveys, the team is looking to produce a White Paper consolidating opinions and providing recommendations.

The Clinical Trials Data Transparency Toolkit project recently published a White Paper which looks to highlight the evolving global landscape of clinical trial transparency and disclosure, with special focus on individual study and submission-related requirements. The team is now developing a best practices guide.

The Policy 0070 Interpretations project has been reviewing very closely Policy 0070 and its External Guidance. The project is looking further into different aspects of the Policy and aims to provide further guidance and interpretations where needed. The team has recently been working on the "Handling of Narratives" White Paper, which is soon to be published here.