Powering your TMF for Inspection Readiness

Paragon Solutions, Inc. Proprietary and Confidential

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Let the Potential of Your Business Emerge

Powering Your TMF for Inspection ReadinessEnsuring complete and accurate records

Chris McSpiritt MAGI West 2016


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Topics

• Why inspection readiness?

• What do inspectors expect?

• How can we ensure readiness?


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WHY INSPECTION READINESS?


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Why TMF Inspection Readiness?

A Trial Master File (TMF) is required for every trial run to ICH Good Clinical Practice(GCP)standards

TMF Inspection Readiness is the state of continual preparedness for a health authority GCP inspection, everywhere, anytime


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Why do we care?

The implications of not being ready are obvious:

1. Rush to prepare for inspections

1. Not doing regular job

2. Extra costs

2. Unsuccessful inspections

1. Health Authority Findings

2. Fines

3. Response costs

4. Risk to product approval


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WHAT DO INSPECTORS EXPECT?


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High-level Inspector Expectations

Each TMF autonomously proves sponsor and site GCP compliance and full story of study execution

• Protocol followed

• Data accurate

• Subjects safe

• Decisions made

TMF management complies with both good record keeping practices (e.g. ALCOA) and all applicable predicate rules(e.g.Part 11)


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Demonstration of Control

Holistic Organization Controls

• Full lifecycle -creation to archive

• Effective structure

• Controlled access

• Investigator’s file oversight

• Availability to all TMF content

Content Management Rigor

• Content robust

• Version control

• Timely filing

• Subject protected

• Decisions documented

Process Controls for Each TMF

• CRO oversight

• Consistency

• Quality assurance

• Location and chain of custody

• Issue remediation

TMF Inspection enables full reconstruction of the trial


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Ability to understand/recreate the study

Duration

• eTMF inspection should not take longer than equivalent paper inspection

• Limited time for inspector training (less than 1 hr)

Access

• Arrange for direct access for inspectors

• Ensure adequate equipment and system performance

• Facility to print content at inspector request

• Location of all TMF source systems clear

Ease of Use

• Inspector is able to self-navigate

• Structure is self evident

• Supportive Search/report functionality

• Able to facilitate access across source systems

Visibility

• Facilitate the presentation of the documents at actual size

• Ideally, side-by-side comparison (dual screen set-up), annotation abilities (bookmarking) to facilitate the review

They want to be able to do it with minimum effort:


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How do electronic systems fit in?

System Controls

• Security

• Training

• Access

• Audit trial

System Processes

• Validation

• Back up

eTMF Content Clarity

• Metadata

• Naming

• Scanning

• Locking

• Workflow approval

System Expectations


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HOW DO WE ENSURE READINESS?


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The bad news for vendors

The system you use will not make you inspection ready!

• A TMF/Regulatory Binder can be made inspection ready using any technology.

However, they can assist you in the journey.


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Components of readiness prep

Create infrastructure

• TMF Quality Management System

•High-level, fits all trials

•Governance

•Structure and Processes

•Metrics

•Standard TMF Architecture

•Standard list for typical trials

•Leverage industry's TMF Reference Model

•Make specific – doc names, definitions, align to SOPs, identify responsible roles

•Tools

•Content management system

•Integration with data source systems

Prepare for each study

•TMF Plan

•Framework for how that study’s TMF will be managed

•Clearly identify exceptions and/or additions to process

•TMF Index

•That study’s adaptation of the organization’s standard TMF architecture

•Ensure all source systems referenced

•Quality Management

•Outline study team’s responsibilities

Manage the study

•Make sure the TMF reflects what is happening

•Ensure communication between study team and those managing content

•Monitor metrics

•Verify timely collection of content

•Execute Quality Oversight activities including remediation activities

•Maintain evidence of execution


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How do metrics fit in?

Per the TMF Reference Model Committee there were three parameters for metrics:1. Quality - so that all parties have confidence in the processes and data

2. Timeliness – so that accurate decisions can be made

3. Completeness – so that authorities can inspect the study

Work to incorporate metrics so that you can continuously improve internal (or service provider) study execution.

Metrics reporting are the key tool to proactively manage the CRO/Sponsor relationship during study execution.


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Who contributes to readiness

• Study Team is TMF responsible• All team adheres to SOPs / TMF Manual

• Each TMF has team Owner

• Records Mgmt is TMF supportive• TMF Q&A, templates, training, archive

• TMF Metrics production

• Clinical Mgmt is TMF accountable• Mandates behaviors and consequences

• TMF Metrics champions

• Quality Mgmt is TMF transformative• Take audits from"old news gotchas" to proactive mock

inspections

Powering your TMF for Inspection Readiness

Health & Medicine

Transcript of Powering your TMF for Inspection Readiness