Transcript Why a TMF Reference Model? - Drug Information Association

DIA Trial Master File
Reference Model
EDM Reference Model
• DIA Document and Records Management
Special Interest Area Community initiative
since 2008
– Standardization effort for the industry with eCTD
backbone
– Version 1 launched in 2008, update in the works
– Extensions of the model are in development
• Interconnects with TMF Reference Model in
trial related submission documentation
– Ensure mapping of taxonomy and alignment of
metadata
Why a TMF Reference Model?
• ICH GCP Section 8.2 – 8.4
• “The minimum list of essential documents
that has been developed.....”
• ICH GCP does NOT provide a
comprehensive contents list for the TMF
– Examples of missing documentation:
• Electronic systems
• Data management and statistical methodology
• Safety monitoring
The Trial Master File
Supporting files e.g.
Minimum list of essential
documents, as defined by ICH
GCP, Chapter 8
Other trial-related
records that “permit
evaluation of the conduct
of the trial and quality of
data produced”
computer SDLC files; GMP
manufacturing files; vendor
selection files
Usually considered
outside the scope
of the TMF
The Trial Master File
Other business records
TMF Reference Model Goals
Standard contents
Standard naming
Industry opinion on what is kept in
a TMF
Based off the ICH E6 Section 8
terminology and industry accepted
terminology
Standard structure
Standard metadata
It doesn’t have to be folder-based
or departmentalized like in a
paper system
If TMF is an EDMS, what would be
the basics – at system and artifact
level?
1.5 years of Accomplishments
Dec08Feb09
Mar09
May09
Aug09
• DIA EDM meetings to recruit team members
• Inaugural meeting and charter created
• TMF split into zones, Leads and members organized
• First pass at TMF contents (artifacts) and naming
• Feedback from TMF reference model members and
Sep09
extended review team
• Artifacts narrowed, definitions added, requirement
Mar10
level and metadata requirements in refinement
Jun10
• Version 1.0 release
How Work on the Model is Organized?
11 Zones and 222 Artifacts
Trial Management
Central Trial Documents
Regulatory
IRB/IEC and other Approvals
Site Management
IP and Trial Supplies
Safety Reporting
Centralized Testing
Third Parties
Data Management
Statistics
Who’s Been Involved?
• 139 members on team
– 55% US, 45% EU
• 98 Companies
– Pharma
– CRO
– Vendor
• Regulatory agency review
– MHRA
– FDA
TMF Reference Model
Version 1.0 Overview
Artifact Definition
Core / Recommended, ICH & EDM
Metadata
Overall Model
Using the TMF Reference Model for paper
Future Plans
• Linked in group (TMF Reference Model)
– Continued connection with industry representatives
• Coordinated feedback on the utilization of the model by
sponsors, CROs, and vendors
– Version 1.1 expected by Dec 2010 / early 2011
• Technical guide to the model
• Version 2.0 of model expected by June 2011 may include:
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Device Studies
Early phase studies
Investigator Initiated Studies
Regional expansive view