CDISC Implementation Primer

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Project Overview

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 standardizing clinical trial data in a CDISC format. Additionally, academic institutions are creating or interacting with CDISC datasets during their research activities.

As the CDISC implementation community expands, new implementers, especially those not directly connected to the industry and regulators, lack a starting point for their implementation journey. The goal of this project is to provide new CDISC implementers a primer to start their journey. In addition, the project will identify how to effectively guide newcomers and stakeholders to this resource.

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, guides, etc.) will be developed that addresses these needs and made freely available to the public.

This project will be co-sponsored and co-executed with CDISC.

Project Deliverables

Project Leadership Team

Name Role Organization E-mail
Bess LeRoy Project Lead CDISC
Beate Hientzsch Project Lead PHUSE
Yvonne Moores Project Lead PHUSE
Wendy Dobson PHUSE Project Manager PHUSE

Project Members

Name Role Organization E-mail
Alisa Khomyanina Participant IBM
Ashwini Kawtikwar Participant Syneos Health Ashwini
Changhong Shi Participant Merck
Chao Su Participant Merck
Charity Quick Participant RHOWorld
Eric Crockett Participant Covance
Hrushi Samant Participant Syneoshealth
Jon Neville Participant CDISC
Julianne Halley Participant Envigo
Kit Howard Participant CDISC
Lavjot Sandhu Participant Commonwealth Informatics
Lou Ann Kramer Participant CDISC
Meenakshi Thakral Participant JNJ
Nate Freimark Participant The Griesser Group
Nick De Donder Participant BDLS
Parin Shah Participant Cytel
Sabine Erbsloeh Participant Clinipace
Sanket Sinojia Participant IQVIA
Shunbing Zhao Participant Merck
Soumya Rajesh Participant Amgen
Sruthi Ragavula Participant Syneos Health
Uday Patil Participant Syneoshealth

Project Updates

All team meeting scheduled for 29th March 14:00 GMT. If you would like to join this project / meeting please contact

Project introduction for new team members
Wrap-up of the kick-off meeting at the PHUSE CSS meeting
Categorization of notes
Start organizing topics in deliverables
Discuss Visualisation
Start creating the 'out of industry' survey
Form working teams

Objectives and Timelines

Objective Timeline
Project Kick off US CSS 2018
Identify needs for new implementers/survey June 2019
1st draft of materials September 2019
Finalize materials October 2019

Project Content and Activities

Meeting Minutes