Data Standards for Non-Interventional Studies

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Project Overview

Currently there are no strict standards and guidelines for non-interventional studies. In this project we would like to study the challenges that programmers face during creation of the analysis datasets and handling of the data for the non-interventional studies. The plan is to network with the programmers who have experience in non-interventional studies and summarise the most frequent issues they have faced. The next step would be to discuss and optimise the ways they can be resolved from programming and data handling perspectives. Also 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.

Project Leads

Name Role Organization E-mail
Yuliia Bahatska Project Lead Roche Yuliia.Bahatska@roche.com
Vladlen Ivanushkin Project Lead DataFocus vladlen.ivanushkin@datafocus.de
Wendy Dobson PHUSE Project Manager PHUSE wendy@phuse.eu

Project Team Members

Name Role Organization E-mail
Alex Nasr Participant AbbVie Alex.Nasr@abbvie.com
Bhawna Goel Participant AstraZeneca Bhawna.Goel@astrazeneca.com
Karen Horton Participant Clinical Outcomes Solutions kjturner49@hotmail.com
Renate Kroll Participant Bayer Renate.Kroll@bayer.com
Igor Savostianov Participant Independent igor.savostianov@gmail.com
Jeremy Teoh Participant Independent jeremyyjteoh@gmail.com
Lovi Sandhu Participant Common Inf Lsandhu@commoninf.com
Murali Neela Participant GCESolutions Murali.Neela@gcesolutions.com
Joe Maskell Participant Amgen jmaskell@amgen.com
Sarah Marsall Participant Amgen samarsha@amgen.com
Sanjeev Kommera Participant Blue Bird Bio Skommera@bluebirdbio.com
Pavan Tirunahari Participant Syneoshealth Pavan.Tirunahari@syneoshealth.com
Tomoko Sugihara Participant Syneoshealth tomoko.sugihara@syneoshealth.com
Jon Neville Participant CDISC jneville@cdisc.org
Janet Reich Participant Amgen jroich@amgen.com
Yogesh Pande Participant Merck yogesh.pande@merck.com
Sarad Nepal Participant Merck sarad.nepal@merck.com
Sangeeta Sama Participant Merck Sangeeta.Sama@merck.com
Jorge Abate Participant RDP jabate@rdp.com.ve
Dorothy Diamini Participant Bayer Dorothy.Diamini@bayer.com
Matthew Harrington Participant Pinnacle21 mharrington@pinnacle21.com
Tanvi Gupta Participant Bayer Tanvi.Gupta@bayer.com

Project Updates

Provide project updates in this section.
Date: Description of Update

Objectives and Timelines

In co-operation with other programmers who have experience in non-interventional studies determine potential challenges 01-Oct-2018
Describe most common data handling issues and ways of resolving 01-Aug-2019
Determine whether existing ADaM concept can satisfy the purpose 01-Oct-2019
If not suggest a solution for each of such cases 01-Dec-2019
Determine how data transparency can be maintained 01-Dec-2019
Create a White Paper describing the findings and solutions based on the information collected during the execution of the phases listed above 01-Feb-2020

Project Activities

This section can document project activities or serve as a jumping off point to other pages in the project.

Meeting Minutes

19AUG2018: https://phuse.teamworkpm.net/index.cfm#notebooks/132336
19OCT2018: https://phuse.teamworkpm.net/index.cfm#notebooks/139858

Archived Content