CDISC Implementation Primer

From PHUSE Wiki
Jump to: navigation, search

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 bleroy@cdisc.org
Beate Hientzsch Project Lead PHUSE beate.hientzsch@phuse.eu
Yvonne Moores Project Lead PHUSE yvonne.moores@phuse.eu
Wendy Dobson PHUSE Project Manager PHUSE wendy@phuse.eu

Project Members

Name Role Organization E-mail
Alisa Khomyanina Participant IBM Khomyanina@us.ibm.com
Ashwini Kawtikwar Participant Syneos Health Ashwini Kawtikwar@syneoshealth.com
Caitlin Anderson Participant IBM cmanders@us.ibm.com
Changhong Shi Participant Merck Changhong_Shi@merck.com
Chao Su Participant Merck chao.su@merck.com
Charity Quick Participant RHOWorld charity_quick@rhoworld.com
Eric Crockett Participant Covance escrockett@live.com
Hrushi Samant Participant Syneoshealth hrushikesh.samant@syneoshealth.com
John Bielinski Participant Independent bielinski.john@gmail.com
Jon Neville Participant CDISC jneville@cdisc.org
Julianne Halley Participant Envigo Julianne.Halley@covance.com
Kit Howard Participant CDISC khoward@cdisc.org
Lavjot Sandhu Participant Commonwealth Informatics loviksandhu@gmail.com
Lou Ann Kramer Participant CDISC lkramer@cdisc.org
Meenakshi Thakral Participant JNJ mthakral@its.jnj.com
Nate Freimark Participant The Griesser Group nfreimark@thegriessergroup.com
Nick De Donder Participant BDLS nick.dedonder@businessdecision.com
Parin Shah Participant Cytel shahparin87@gmail.com
Sabine Erbsloeh Participant Clinipace SErbsloeh@clinipace.com
Sanket Sinojia Participant Cytel ssinojia@gmail.com
Shunbing Zhao Participant Merck shunbing.zhao@merck.com
Soumya Rajesh Participant Syneos Health soupy.rajesh@syneoshealth.com
Sruthi Ragavula Participant Syneos Health sruthi.ragavula@syneoshealth.com
Tessa Brown Participant FDA Tessa.Brown@fda.hhs.gov
Uday Patil Participant Syneoshealth uday.patil@syneoshealth.com

Project Updates

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

Agenda:
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