Optimizing the Use of Data Standards

Working Group & Project Scope

Working Group Leads

Jane Lozano

Janet Low

Over the last decade there has been a significant development and adoption of data standards, showing a promising improvement in the 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 aims to identify and close specific gaps that prevent the FDA and industry from optimising the use of data standards.

CDISC Implementation Primer 

Yvonne Moores

Bess LeRoy

Beate Hientzsch

The FDA and PMDA currently require sponsors to provide study data in a CDISC format for certain types of regulatory submissions. Other global regulators such as the EMA and China FDA endorse standardising clinical trial data in a CDISC format. Additionally, academic institutions are creating or interacting with CDISC datasets during their research activities.This project will identify needs of new CDISC implementers, with an additional focus on academia and technology providers. A "CDISC Primer" (e.g. a Wiki, white paper, slide deck, QuickStart or guide) will be developed that addresses these needs and which will be made freely available to the public.This project is being co-sponsored and co-executed by CDISC.

Data Reviewer's Guide in XML

Mike Hamidi

This project is developing the Data Reviewer's Guide (i.e. SDRG and ADRG) in an XML format for regulatory submissions and, furthermore, is identifying and developing style sheets, elements and semantics capability. It is also assessing a more cohesive cross-documentation data exchange between the Define-XML and Data Reviewer's guides in an XML format. The project intends to use the existing Analysis Data Reviewer's Guide (ADRG) and Study Data Reviewer's Guide (SDRG) as its basis.

Data Standards for Non-interventional Studies

Yuliia Bahatska

Currently, there are no strict standards and guidelines for observational studies. This project studies the challenges that programmers face during creation of the analysis datasets and handling of the data for the observational studies. The plan is to network with the programmers who have experience in observational studies and summarise the most frequent issues they have faced. The next step will be to discuss and optimise the ways they can be resolved from programming and data handling perspectives. Data transparency should be taken into account in the discussion of dataset creation. If possible, CDISC experts should be involved in the project in order to provide guidance. The results are to be presented in the form of a white paper.

Industry Experiences Submitting Standardised Study Data to Regulatory Authorities

Vincent Guo

Todd Case

The FDA and PMDA require standardised study data for certain regulatory submissions. Industry approaches to meeting these requirements vary across companies. This project provides a collaborative, non-competitive forum for industry to share submission planning, interactions with the regulators, test submissions, regulator feedback, etc. Additionally, this project will explore the development of best practices for biometrics departments to engage with regulators. Historically, biometrics departments have not directly interacted with regulators, but relied on internal regulatory affairs departments as an intermediary. The project will examine different communication use cases and make recommendations for ensuring effective exchange of information.

Clinical Integrated Study Data and Analysis Data Reviewer's Guide

Satheesh Avvaru

Kiran Kundarapu

The cSDRG and ADRG apply to a single study. Sponsors have used these templates when creating a reviewer’s guide for integrated Study Data and a reviewer’s guide for integrated Analysis Data. The template has to be changed in order to document the information for multiple studies.  There is an opportunity to create a template for integrated Study Data and integrated Analysis Data. The project team will determine if this can be accomplished in one reviewer’s guide or if there should be two separate reviewer’s guides. Deliverables include a template, completion guidelines, and example documents. 

SDTM ADaM Implementation FAQ

Bhavin Busa

Aatiya Zaidi

Amy Palmer

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, response to, and publishing of common SDTM and ADaM implementation challenges/nuances. This is important for sponsors who 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 FAQ.

Have a query about SDTM/ADaM? Use this form to submit your questions.




Thinking of joining PHUSE?

Already a member but not sure how you can benefit?

PHUSE is an expanding, global society with a global membership of clinical data scientists. It requires a large pool of resources to help with its running, and so there are many opportunities for members to become involved. Whether it's chairing a conference, presenting at an event, leading a working group or contributing to the quarterly online newsletter, we are always keen to hear from volunteers.

Find Out More