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Project Scope

  • Access to study data with the ability to aggregate various sources of data enabling oversight of the clinical data and operational data in near real time. This includes frequency of data transfers, audit trail, and facilitating PI oversight of medical care of patients.
  • Ideal technology requirements (very broad – patients, sites, CRO-Sponsor connection) and new vendor qualification expectations.
  • Data review plan (medical review, statistics, data cleaning activities, operational, etc.), with clear defined purpose of what each role is reviewing, what, when and why.
  • Definition of robust “monitoring” strategy as required by ICH.
  • Connection to on-site monitoring, using centralised monitoring to determine on-site monitoring needs,
    site trends allowing for early, targeted site feedback for CRA to have more focused site engagement.
  • Discuss different data oversight strategies and methodologies and when to consider use of
    visualisations related to types of data reviewed ( visualisations focused on critical data only,
    visualisation that could contribute to a significant deviation vs. all deviations).
  • Facilitate risk mitigation through the trial, ensuring risk linkage to Central Monitoring oversight.
Project LeadsEmail
Nicole Stansbury (Syneos Health)nicole.stansbury@syneoshealth.com
Anne Lawrence (AbbVie)anne.lawrence@abbvie.com
Objectives and DeliverablesTimelines
White PaperQ32022
White PaperQ42022

CURRENT STATUS Q1/2022

Project approved Q1 2022
Project MembersOrganisations
Andy Lawton Independent
Catherine SinclairGSK
Crupa KurienPfizer
Georgina WoodCyntegrity
Gregory LongRoche
Jean MulindeFDA
Lynne CesarioPfizer
Marion Wolfs

JNJ

Priti Gupta
Samantha HewlettAmgen


Project Statement

Central Monitoring is an emerging field with an unclear scope, goals and roles. Central Monitoring, if executed appropriately, can have a positive impact on data quality, patient safety and clinical trial efficiencies. This project will work to define Central Monitoring (including differentiating from data management and other forms of data surveillance), suggest success measures and best practices to ensure a well-connected end-to-end component of quality risk management.


Project Impact

The project will provide insight and guidance to address understanding as well as the current and future needs of holistic Central Monitoring process and capabilities. Strong Central Monitoring practices can support risk reduction and through important trend analysis and mitigation, decrease preventable errors that can have an impact on patient safety or clinical trial conclusions. Our approach will encourage exploration of different approaches versus recommendations as not deter sponsor innovation (e.g - points to consider).

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