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Nonclinical Study Data Reviewer's Guide – Started Q1 2019

Project Scope:

This project is to evolve the Nonclinical Study Data Reviewer's Guide (nSDRG), based on comments from a public PHUSE review, plus to adapt it to updates of the FDA Technical Conformance Guide. The project continues to check and align with the SDRG template and guide developed by the Optimizing the Use of Data Standards Working Group for clinical studies.

Preparation of a Study Data Reviewer’s Guide (SDRG) is recommended as an integral part of a CDISC standards-compliant study data submission. The challenge is to operationalise this new documentation requirement efficiently and effectively.

Challenges we seek to answer with this project:

  • Provide a practical template for easy access and use

  • Provide guidance document which describes expected content and options to guide nonclinical SDRG authors.

  • Provide authors with examples, describing how to handle different data situations with SDRG content.

Things we expect to learn along the way:

  • Exploration of ways to generate the nonclinical SDRG and who should do the job.

  • The SDRG is expected to be useful by FDA reviewers. Can it also be useful for other nonclinical study stakeholders?

  • Will the SDRG evolve as systems and processes gain expertise in the new SEND requirements for submission of nonclinical data?

Current Status:

  • FDA review of next version nSDRG – draft pending.

Regular Project Meeting Day/Time:

  • Monthly: Last Thursday of the month 4-5pm GMT

Key Skills:

  • Experience with the SDRG

  • Knowledge on the FDA's Technical Conformance Guide

Investigating the Use of FHIR in Clinical Research SEND Industry Feedback Survey – Started Q Q1 2016

Project Scope:

Increasing interest in eSource keeps the issue of data integration between Research Systems (EDC, CTMS, CDMS, etc) and healthcare systems (EHR, etc) as a consistent want for Sponsors of Clinical Investigators and Regulators. Previous efforts to make this a repeatable, scalable solution have not met with wide-scale adoption, for a variety of reasons.

Some common historical points of view have included:

  • That the quality of the data that can be retrieved from the Healthcare sites is insufficient to meet research needs.

  • That uptake of electronic systems at investigative sites has been slow, expensive, and not delivering real value to healthcare practises.

  • Types of data captured in healthcare have been more operational rather than clinical.

  • Enabling the Necessary interfaces is an expensive and process-heavy undertaking.

  • There is not a suitable, generally supported electronic exchange format, with a number of standard representations being supported in recent memory.

Many of these issues are on the path to being resolved; government programs have pushed the adoption and accessibility of electronic health records. In addition, there are a number of stakeholders in the Research Industry that are making the use of healthcare resources a priority for the future; examples include Transcelerate eSource initiative and HL7 Vulcan Accelerator.

Current Status:

Jan 25 Connectathon PoC with SDC.

Execute an annual survey process to objectively collect data that enables detection of impactful issues and trends (both good and bad) that can be acted upon by the PHUSE community

The survey will:

  • provide SDOs with actionable information regarding improvements to their standards.

  • enable CROs, software developers and data service providers, with extensive data management experience, an opportunity to provide actionable recommendations

  • provide Sponsors with information on how they can better leverage their SEND investments.

Results of the survey will be presented at the PHUSE/FDA CSS. 

Current Status:

Regular Project Meeting Day/Time:

  • Bi-weekly: Thursdays 2-3pm GMT

Key Skills:

SEND Coding Bootcamp – Started Q1 2025

Project Scope:

The 4-day SEND Coding Bootcamp aims to help those working with SEND datasets become more productive by teaching basic coding and plotting skills. Over the course of a series of separate hands-on coding sessions, participants will learn the basics of programming and plotting using the R programming language. The course will be oriented around SEND datasets and will include reading, writing, plotting, and manipulating SEND datasets stored in .xptformat. Basic knowledge of the SEND standard is expected. No previous knowledge about programming or the R programming language is needed.

Current Status:

  • New project accepted

  • Currently calling for volunteers 

Regular Project Meeting Day/Time:

  • ?

Key Skills:

  • Experience with HL7 Vulcan

  • Experience with FHIR

    • Experience in writing Use Cases