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SDS ELT Rules Team Update
Stetson Line
08 Dec 2014
© CDISC 2014
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SDS ELT Nov 24 2014 Discussion
Decisions from last meeting
• SDTM 1.4 / SDTMIG 3.2 Rules Publication
 Supplement (Excel)
 Target Date by EOQ1 2015
• Rules Development Guide
 Target Date for Internal Review by Jan 2015
 Independent of rules publication
• SDTM 1.5 / SDTMIG 3.3 Rules
 Target Date – Summer 2015
© CDISC 2014
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FDA SDTM Rules vs. SDS SDTM Rules
• FDA published 315 rules 11/18
 Based on OpenCDISC Validator 1.x with updates
• New TS domain rules
• CT rules simplification
• Deprecated concept of ‘Notice’ type rules
• Versioned for SDTMIG 3.1.1-3.1.3
 Approved and maintained by FDA Change Control Board (CCB)
• Pinnacle 21/OpenCDISC implement these in Validator 2.0
 Publisher ID column used to reference FDA Rule ID
• FDA CCB to evaluate SDS SDTMIG v3.2 Rules (Q1 2015)
© CDISC 2014
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FDA SDTM Rules vs. SDS SDTM Rules
There are gaps/overlaps between FDA/SDS SDTM rules




Similar rules with differences in scope
Conflicts / differences in interpretation
FDA intends regular (semi-annual) updates asynchronous to SDS updates
FDA rules parameterized without benefit of parameter datasets
• Apparent ties to Pinnacle 21 OpenCDISC implementation
© CDISC 2014
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Sample FDA CT Rules
FDA Rule
MESSAGE
ID
FDAC340 Value for <Variable Name> not found in
(<Codelist ID>) CT codelist
FDAC341 Value for <Variable Name> not found in
(<Codelist ID>) CT codelist
FDAC343 Value for <Variable Name> not found in
(<Codelist ID>) CT codelist
FDAC344 Value for <Variable Name> not found in
(<Codelist ID>) CT codelist
© CDISC 2014
DESCRIPTION
DOMAINS
<Variable Label> (<Variable Name>) variable values should
be populated with terms found in '<Codelist Name>' (<NCI
Code>) CDISC controlled terminology codelist. New values
cannot be added into the CDISC CT non-extensible codelist.
<Variable Label> (<Variable Name>) variable values should
be populated with terms found in '<Codelist Name>' (<NCI
Code>) CDISC controlled terminology codelist. New terms
can be added as long as they are not duplicates, synonyms
or subsets of existing standard terms.
<Variable Label> (<Variable Name>) variable values must be
populated with terms found in '<Codelist Name>' (<NCI
Code>) CDISC controlled terminology codelist, when
<Variable Label (from WhereClause)> (<Variable Name (from
WhereClause)>) <Comparator> '<Value (from
WhereClause)>'. New values cannot be added into the CDISC
CT non-extensible codelist.
<Variable Label> (<Variable Name>) variable values must be
populated with terms found in '<Codelist Name>' (<NCI
Code>) CDISC controlled terminology codelist, when
<Variable Label (from WhereClause)> (<Variable Name (from
WhereClause)>) <Comparator> '<Value (from
WhereClause)>'. New terms can be added as long as they
are not duplicates, synonyms or subsets of existing standard
terms.
ALL
Error
X
3.1.3
(3.1.2 A1)
X
ALL
Warning
X
X
ALL
Error
X
X
ALL
Warning
X
X
SEVERITY 3.1.1 3.1.2
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SDS Sub-Team Proposed CT Rules
Rule ID
Rule
Condition
Item #
Text
Class
Domain
Variable
ALL_ALL_GEN_05 Value in assigned
controlled terms or
'MULTIPLE'
Assigned nonextensible controlled
terms
3.2Conformance with the SDTMIG Domain
ALL
Models is minimally indicated by following
SDTM-specified controlled terminology and
format guidelines for variables, when
provided
ALL
GENERAL
ALL_ALL_GEN_06 Value in assigned
controlled terms or in
('MULTIPLE','OTHER')
Assigned extensible
controlled terms
3.2Conformance with the SDTMIG Domain
ALL
Models is minimally indicated by following
SDTM-specified controlled terminology and
format guidelines for variables, when
provided
ALL
GENERAL
© CDISC 2014
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Questions for SDS ELT
• Should we be concerned about referencing or with harmonizing SDS
rules with FDA rules sets?
 Option – reference FDA Rule ID as additional metadata?
• What about rules not approved by FDA CCB or un-implementable?
(How will they be viewed by industry?)
• What is our purview when compliance rules are wrong or misstated?
 Feedback edata@fda.hhs.gov
 Would it be advisable for CDISC to have representation on the FDA CCB?
© CDISC 2014
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