How the biotech Galapagos have looked at risk-based quality review when regarding all components of a TMF, collaborating with vendors and aiming for adequate quality at all times.

-        Identifying study specific critical data and processes to define scope and timing of TMF Quality review

-        Adapting strategy based on vendor collaboration, changing risks and QR findings

-        Including all stakeholders in the QR process

Katrien Clinckx

Senior Director, Head of TMF Operations & Clinical Support
Galapagos

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Jolien Baele

Clinical Study Associate
Galapagos

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PANEL DISCUSSION: FORWARD THINKING SOLUTIONS TO BE DEFENSIBLE

Adopting a risk-based approach to TMF by inculcating forward thinking solutions that encourage reasonable rationale for operations, actions and approaches

-        How risk-based approaches to TMF management can simplify and modernise operations without compromising inspection readiness

-        Highlight what a risk-based approach actually entails, the benefits that can be gained and how it impacts, time, cost and process

-        Enable better delegation of responsibility by effectively prioritising to truly understand risks involved in operations

-        Is it always possible to set framework ahead of time?

Manogna Valluru

Senior Clinical Data Manager
GRAIL

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Mihaela Nosca

Director Clinical Compliance and Inspection Readiness
Seqirus - A CSL Company

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Anne-Noelle Charles

Director, Clinical Documentation Operations
GlaxoSmithKline

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In Worldwide Clinical Trials we are focused to have the TMF Inspection ready at all times.

In order to achieve this, we are creating, monitoring and reporting on the 7 TMF KPIs that are related to Timelines, Quality and Completeness:

·       Submission Timeliness – % of documents submitted within the timelines agreed in the TMF Management Plan

·       Approval Timeliness - % of documents approved within the timelines agreed in the TMF Management Plan

·       Submission Quality - % of documents submitted without errors

·       Query Response Timeliness - % of queries responded within the timelines agreed in the TMF Management Plan

·       Risk Score – Risk impact of missing/queried documents per different document types

·       Completeness by Milestone - % of present documents vs. expected documents in accordance with the applicable milestone

·       Completeness by Milestone Provisional – progress in the completeness for the applicable milestone

Tatjana Jevtovic

Associate Director, TMF Operations Quality
Worldwide Clinical Trials

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- EU CTR key changes and us of the CTIS for submissions

- Complexity of CTA packages for CTIS upload – tracking is key

- Handling of requests for information – improving collaboration and managing critical timelines

- Management of CTR submissions preparations in the eTMF

Martina Duevel

Systems Excellence Project Leader
Bayer

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-        Explore the moral and ethical standards most commonly missed that can be identified through an effective audit

-        How data integrity differs in an internal to external context, and gauge what steps can be taken to ensure vendors deliver at a required standard

-        Realise how the validation process is crucial to audits by understanding what processes are under your responsibility, whether these standards match with your chosen vendors, all whilst in-keeping with required regulatory standards.

-        Look at processes on sites, documentation is there, information is included, document can be easily located

-        What can you do as a person or group to ensure the integrity of data. Learn how to manage these steps with a risk-based approach

Tatjana Jevtovic

Associate Director, TMF Operations Quality
Worldwide Clinical Trials

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Dora Endreffy

Director Data Privacy and Data Governance, Juvenescence and Chairperson, HSRAA
HSRAA

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George Noşca

Associate Director, GCP Compliance EU/ROW
Seagen International GmBH

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• Outline how the sponsor can initiate conversations with the CRO to understand existing systems, reports, metrics and TMF expectation to establish an oversight process
• Discuss how sponsors with an established oversight process can adapt this for a successful relationship
• Look at how to ensure oversight aligns to the process carried out by the CRO

With assistance from our vendor partners, attendees will be split into groups and given a problem scenario aimed at simulating real-life challenges during inspections, while focusing on tasks such as Mock Inspections, Study specific TMF Storyboards, TMF Process Storyboards, eTMF System Storyboards. After which, groups will be required to present their strategies and findings to the panel of judges.

This session is aimed at giving all attendees a chance to put their skills and knowledge

to the test while working on small task collaboratively with other attendees from across several different

organisations. Not only can you hear strategies and ideas of others outside of your network, but the group with the best action plan will be awarded a prize!