Best Practices for Quality Control and Validation

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Project Overview

We propose to create a subgroup of the Good Programming Practices workgroup to write a white paper on the topic of Best Practices for Quality Control.

Abstract
Quality and accuracy is essential in the health and life sciences industries. Patients and regulators must be able to trust analyses of clinical data. This paper will provide an in-depth review of best practices for robust quality control. The scope of the paper will be quality control of analysis programming of clinical data in health and life sciences organisations. It is applicable to the organisations who produce analyses of clinical data, including Contract Research Organisations. The paper will not discuss oversight of outsourced programming.

Project Leads

Name Role Organization E-mail
Maria Dalton Co-lead GSK maria.y.dalton@gsk.com
Jane Marrer Co-Lead Merck jane_marrer@merck.com
Wendy Dobson PHUSE Project Manager PHUSE Wendy@phuse.eu

Project Members

Name Role Organization E-mail
Daryna Hololovich Participant Intego Darina.Hololovich@gmail.com
Vamshi Mohan Gande Participant Pfizer vamshiMohan.gande@pfizer.com
Gayathri Kolandaivelu Participant JNJ gkrupaka@its.jnj.com
Dawn Edgerton Participant Edgerton Data Consulting dawn@edgerton-data.com
Michael Rimler Participant GSK Michael.S.Rimler@gsk.com
Mark Foxwell Participant PRA Health Sciences FoxwellMark@prahs.com
Eli Miller Participant Covance Eli.Miller@Covance.com
Evgeny Starostin Participant Worldwide Clinical Trials Evgeny.Starostin@worldwide.com
Aadesh Shah Participant GSK Aadesh.x.shah@gsk.com
Sai Bhavaraju Participant Sanofi Sai.Bhavaraju@sanofi.com
Marko Zivkovic Participant Genesis Research marko@genesisrg.com

Project Updates

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

Objectives and Timelines

Objective Timeline
Recruit members for project team through PhUSE Start recruitment after approval of project
Finalize membership of project team By 2 months after launch of project
Organise sub-teams and assign sections of paper 2 weeks after finalisation of project team
Generation of initial draft 3 months after finalization of project team
Review and revisions of paper By beginning of June 2019
Present draft paper at PHUSE CSS June 9 -11, 2019
Launch of approved paper 1 month after PHUSE CSS