Optimizing the Use of Data Standards

Working Group Scope

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.

Current Projects

Bioresearch Monitoring (BIMO) Frequently Asked Questions Forum

Building a Better MDR

Clinical Integrated Study Data & Analysis Data Reviewer's Guide

Management of ODS Regulatory Referenced Deliverables

SDTM ADaM Implementation FAQ

PHUSE Collaborative Projects
Electronic Data Submission in Japan

janet_low@merck.com

Janet Low is a Statistical Programmer at Merck where she is focused on study data standards and ensuring that electronic submission deliverables are high-quality and aligned with regulatory submission requirements. Nearly 20 years at Merck, Janet has worked in data management and statistical programming, but she is most passionate about leveraging her M.S. in Quality Assurance and Regulatory Affairs from Temple University to guide teams to submission and audit readiness.

She has provided operational excellence with training, consultation and mentorship to teams in a broad array of therapeutic areas covering drugs and vaccines; early to late stage clinical development; and partnership and collaborations.

In 2019, Janet joined as a co-lead to PHUSE Optimizing the Use of Data Standards Working Group. Prior to her role, she was an active volunteer in PHUSE projects and publications since 2015, including Standardising Data within the Inspection Site Selection Process, SDSP, Industry Experiences Submitting Standardised Study Data to Regulatory Authorities and Clinical Integrated Study Data and Analysis Data Reviewers Guides.

When Janet is not behind a computer, you’ll find her volunteering in her community and cooking international dishes.

Sandra.VanPeltNguyen@pfizer.com

Sandra (Sandy) VanPelt Nguyen has been working in clinical research for over 20 years in roles in data management, clinical/statistical programming, and data standards across multiple therapeutic areas. She has been involved in data standards implementation and governance in many of those roles, and has about 20 years’ experience working with CDISC standards.

Sandy has been involved with PHUSE since 2015, leading and supporting PHUSE projects under the Optimizing the Use of Data Standards and Real World Evidence Working Groups. As a life-long learner, Sandy enjoys these types of collaborative projects along with other opportunities to share and learn. She regularly presents at conferences such as the PHUSE CSS, the PHUSE Connects and PharmaSUG.

Sandy currently works at Pfizer as a Director in the Submissions and Standards team, focused on end-to-end data standards implementation, governance, and optimisation.