Trial Summary Domain
from IG 3.1.2 to 3.1.3
Dieter Boß
September 2012
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
2
20-Aug-12
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“
3
20-Aug-12
Changes from 3.1.2
4
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
-
20-Aug-12
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
5
20-Aug-12
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
6
20-Aug-12
Code List Issues
• SNOMED
• Systemized Nomenclature of Medicine
• Used for:
• Trial Indication - INDIC
• Diagnosis Group - TDIGRP
Not licenced in many companies
Can other dictionary or sponsor terms be used?
7
20-Aug-12
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
8
20-Aug-12
Code List Issues
• UNII
• Unique Ingredient Identifier
• Connects to NCI Concept Code
• Used for:
• Investigational Therapy or Treatment – TRT
9
20-Aug-12
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 ?
10
20-Aug-12
UNII is Accessible via SRS
11
20-Aug-12
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 information
Download ?
12
20-Aug-12
Access to NDF-RT and UNII
13
20-Aug-12
Thank You!
Questions?
14
20-Aug-12