1. © CDISC 2014 Stetson Line, Team Lead 2 2014 CDISC Intrachange SDTM Rules Sub-team Update.
17
1
-
Upload
daniella-farmer -
Category
Documents
-
view
221 -
download
0
description
© CDISC 2014 Mission SDTM Rules Sub-team Identify business rules in guidance and surface these in a clear, consistent and consumable manner –Distinct from data validation rules, focused on compliance, conformance to guidance –Coordinate with SHARE, other teams on rule definition metadata and methods 3
Transcript of 1. © CDISC 2014 Stetson Line, Team Lead 2 2014 CDISC Intrachange SDTM Rules Sub-team Update.
1
© CDISC 2014
Stetson Line, Team Lead
2
2014 CDISC IntrachangeSDTM Rules Sub-team Update
© CDISC 2014
Mission• SDTM Rules Sub-team
• Identify business rules in guidance and surface these in a clear, consistent and consumable manner
– Distinct from data validation rules, focused on compliance, conformance to guidance
– Coordinate with SHARE, other teams on rule definition metadata and methods
3
© CDISC 2014
Rules Sub-Team Target Milestones• Q1 2014
Sub-team Kickoff /Member orientation/ assignments SDTM IG v3.2 – DM Rules Pilot
• Q2 2014 SDTM Validation Rules Development Guide SDTM IG v3.2 – Events Observation Class Rules SDTM IG v3.2 – Interventions Observation Class Rules
• Q3 2014 SDTM IG v3.2 – Findings Observation Class Rules SDTM IG v3.2 – Other Special Purpose Domains Rules
• Q4 2014 SDTM IG v3.2 – Trial Design Domains Rules SDTM IG v3.2 Validation Rules (submitted for public comment) SDTM Validation Rule Implementation Guide (submitted for public
comment)
4
© CDISC 2014
SDTM Rules Meeting Support
5
© CDISC 2014
Rule Metadata Elements• Rule ID• Rule• Condition• Comments / Questions / Dispositions• IG Section• IG Item #• IG Text• Class• Domain• Variable
6
© CDISC 2014
21-A
pr-14
26-A
pr-14
1-May
-14
6-May
-14
11-M
ay-14
16-M
ay-14
21-M
ay-14
26-M
ay-14
31-M
ay-14
5-Jun
-14
10-Ju
n-14
15-Ju
n-14
20-Ju
n-14
25-Ju
n-14
30-Ju
n-14
5-Jul-
14
10-Ju
l-14
15-Ju
l-14
20-Ju
l-14
25-Ju
l-14
30-Ju
l-14
4-Aug
-14
9-Aug
-14
14-A
ug-14
19-A
ug-14
24-A
ug-14
29-A
ug-14
3-Sep
-14
8-Sep
-14
13-S
ep-14
0
100
200
300
400
500
600
700
Cumlative HoursRulesParking Lot
Rules Production
Date Rules Parking Lot Domains Cumlative Hours21-Apr-14 55 50 DM 1979-Jun-14 160 108 AE CE DM DS DV MH MO 307.521-Jul-14 146 102 AE CE CM DM DS DV EC EX MH MO HO SU PR 402
27-Aug-14 243 121 AE CE CM DM DS DV EC EG EX IE IS LB MH MI MO HO SU PC PP PR RS TR TU TIMING 55315-Sep-14 236 137 AE CE CM DM DS DV EC EG EX IE IS LB MB MH MI MS MO HO SU PC PP PR RS TR TU TIMING 633.5
7
26 meetings7+ averageattendance
© CDISC 2014
Rules Production by Domain
8
TVTU/TR/RS
TimingTASVSSSEPE
PC_PPParking Lot
MultipleMH
MB/MS/MILBIE
FAEX/EC
DVDSDMCOCMCEAE
0 20 40 60 80 100 120
Sum of RulesSum of Draft Rules
250+ Rules120+ in Draft
© CDISC 2014
• Essential ground rules for authoring consistently formed rules Rule Syntax Standard Operators /Tokens Controlled Terminology
• Document evolution of conventions / best working practices Currently v1.3 – Mostly refinements in definition of rule
scope and hierarchy
Rules Development Guide
9
© CDISC 2014
Rules Hierarchy - Rationale• All rules are stated uniquely at the highest
applicable level of the rule hierarchy possible Minimizes redundancy and maintenance overhead Helps drive clarity around core principles and any
exceptions to those principles Aids rule development and review
10
© CDISC 2014
Rules Examples
Simple Rule – No Hierarchy
11
Rule ID Rule Condition Class Domain VariableEVT_AE_AESER_01 AESER = 'Y' AESCAN = 'Y' or AESCONG = 'Y' or
AEDISAB = 'Y' or AEDTH = 'Y' or AESHOSP = 'Y' or AELIFE = 'Y' or AESOD = 'Y' or AESMIE = 'Y' or AECONTRT = 'Y'
EVT AE AESER
EVT_AE_AESER_02 AESER = 'N' AESCAN ^= 'Y' and AESCONG ^= 'Y' and AEDISAB ^= 'Y' and AEDTH ^= 'Y' and AESHOSP ^= 'Y' and AELIFE ^= 'Y' and AESOD ^= 'Y' and AESMIE ^= 'Y' and AECONTRT ^= 'Y'
EVT AE AESER
© CDISC 2014
Rules Examples
Multiple Domain Rules
Rule ID serves as both unique key and pointer to whether additional fields (Class, Domain, Variable) are needed to further refine scope
12
Rule ID Rule Condition Class Domain VariableFND_ALL_--DRVFL_01 --DRVFL in ('Y', null) FND ALL --DRVFL
FND_ALL_--DRVFL_02 --DRVFL = null --STRESC = null or --STAT = 'NOT DONE'
FND ALL --DRVFL
Rule ID Rule Condition Class Domain VariableINT_MLT_--DOSE_01 --DOSE = null --DOSTXT ^= null INT EX, CM,
EC, PR, SU
--DOSE
INT_MLT_--DOSTXT_01 --DOSTXT = null --DOSE ^= null INT EX, CM, EC, PR, SU
--DOSTXT
© CDISC 2014
Rules Examples
Multiple Observation Class Rules
Notice use of NOT() syntax for excluded domains in last example
13
Rule ID Rule Condition Class Domain VariableMLT_MLT_--OCCUR_01 --OCCUR ^= null --PRESP = 'Y' and --STAT ^= 'NOT
DONE'EVT,INT MH,CE,HO,
CM,EC,PR,SU
--OCCUR
MLT_MLT_--OCCUR_02 --OCCUR = null --PRESP ^= 'Y' EVT,INT MH,CE,HO,CM,EC,PR,SU
--OCCUR
Rule ID Rule Condition Class Domain VariableMLT_MLT_GEN_01 At least one timing
variable must exist FND, EVT,
INTNOT(IE) GEN
© CDISC 2014
SHARE Team Collaboration• SHARE team members on Rules team• Ongoing review of SDTM Rules development
Interest in aligning metadata conventions Preparing for SHARE implementation
• A. Chow invited to Rules meeting Discussed feedback on proposed rules Presented draft CMAP of Rules metadata model
Example conventions – quotes for text values, preceding ‘--’ for domain wildcard in variable naming, categorizing rule types…etc.
14
© CDISC 2014
SHARE Team Draft Rules Model
15
© CDISC 2014
Rules Parking Lot Breakdown
16
Issue/ Observation Class ALL EVT FND INT SPC TotalERRATA 3 2 2 1 8
OTHER TEAMS 3 1 1 5
QUESTION FOR ESCALATION 3 13 3 2 1 22
REVISE GUIDANCE 12 7 9 7 35
RULE METADATA 7 1 8
VAR GENERALLY NOT USED 49 1 8 58
Total 18 81 15 20 2 136
