Trial Summary Domain from IG 3.1.2 to 3.1.3
Dieter Boß
September 2012
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Purpose of Trial Summary Domain
• Submit summary of study in structured format• Characteristics of trial, e.g.,
• Protocol title• Phase• Randomization• Primary and secondary objectives• Actual characteristics like number of subjects, data cut-off dates
• Information is provided in findings structure
20-Aug-12
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Trial Summary Specific Contents
• Standardized parameters – TSPARM • Listed in CDISC Controlled Terminology (CCT)• core concept: required, expected, permissible• Standard code lists or formats assigned to many parameters• Core concept reflects requirements for study protocol disclosure in
publicly available clinical trial registries like CT.GOV
• Values – TSVAL
• Null Flavor Values – TSNVAL• Since Trial Summary Update to 3.1.2• To provide standardized missing codes for not available required
parameters, e.g., “NA“
20-Aug-12
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Changes from 3.1.2
IG 3.1.2 TS Update IG 3.1.3 CCT
No of parameters
20 43 43 47
Required - 28 28 -
Conditionally Required (incl. If Applicable)
- 15 15 -
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Trial Summary Parameters in CCT
• CCT does not contain parameters• AGEU• DESIGN
• Does contain parameters• DOSE• DOSU• DOSFRQ• ROUTE
not listed any more in list of required or expected parameters
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Issues with Parameter List
• Information not always easily retrievable in study protocols•Company standards needed to make TS useful within company and for submissions•Code Lists are available for majority of parameters
Don‘t invent if available
• There are issues with a few special code lists
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Code List Issues
• SNOMED • Systemized Nomenclature of Medicine• Used for:• Trial Indication - INDIC • Diagnosis Group - TDIGRP
Not licenced in many companiesCan other dictionary or sponsor terms be used?
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Code List Issues
•NDF RT• National Drug File – Reference Terminology• Can be found via NCI website• Used for:• Pharmocological Class – PCLAS
Hard/ Impossible for data managers to identify correct term for products in development
20-Aug-12
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Code List Issues•UNII• Unique Ingredient Identifier• Connects to NCI Concept Code• Used for:• Investigational Therapy or Treatment – TRT
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Code List Issues
• SRS Preferred Substance Name• FDA Substance Registration System• Can be found via FDA website • Uses UNII codes and terms• Used for:• Comparative Treatment - COMPTRT• Current Treatment – CURTRT
Only available for approved substances ?
20-Aug-12
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UNII is Accessible via SRS
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Code List Issues
•DUNS• Dun and Bradstreet System to uniquely identify
companies• Recommeded by ISO• Used for:• Clinical Study Sponsor – SPONSOR
Unclear how to retrieve informationDownload ?
20-Aug-12
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Access to NDF-RT and UNII
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Thank You!
Questions?
20-Aug-12
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