an exploration of quality gaps in sdtm implementation activities and ideas on how to address these...
TRANSCRIPT
An exploration of quality gaps in SDTM implementation activities and ideas on how to
address these gaps through appropriate resourcing
Dianne Weatherall: 2013-04-11
GOAL
• Adoption of CDISC standards has led to:– new processes (aCRF, metadata, programming)– new responsibilities
• Goal: to discuss the “best” SDTM team to implement the new process
DEFINE THE PROBLEM
• Define what is wrong with the current setup
ROOT CAUSE OF QUALITY ISSUES
• Poll on the SDTM LinkedIn group:What is the primary cause of quality issues in SDTM?
43%
27%
18%
4%4% 2% 2%
Votes
Not understanding SDTM
Not understanding clinical data
Non-standard data
Not enough time/resource
Inadequate review
Protocol design
Company standards
ROOT CAUSE OF QUALITY ISSUES
• Lack of understanding of SDTM – WHY?1 2 3
Lack of skills Lack of training Expensive
It is complicated Too much room for personal preference
Customer specific implementations
Unclear process Too many cross-functional teams involved
Companies are too silo’ed
Lack of expert support Lack of skills It takes time and effort to become an expert
ROOT CAUSE OF QUALITY ISSUES
• Lack of understanding of clinical data – WHY?1 2 3
Lack of data / clinical skills of teams
Clinical data is complicated Highly un-normalized Database structures are often developed for data entry and clinician preference, not CDASH/SDTM standards
The CRF changes over time Therapeutic areas have complicated study designs (e.g. cohort changes)
Poor planning from the study design stage
ROOT CAUSE OF QUALITY ISSUES
• Non-standard data – WHY?1 2 3
Legacy studies SDTM standards are relatively recent
Customer specific requirements Customer specific implementations
Customer legacy systems are not CDISC-compatible
Therapeutic areas have complicated study designs (e.g. cohort changes)
Poor planning from the study design stage
SUMMARY OF ROOT CAUSES
• Company silo’s • Lack of data skills of Biostats teams • Lack of CDASH / SDTM skills of Data teams • Time and effort to build expertise • Customer-specific • Poor study planning • Expensive - join a user group!
CRITERIA FOR THE BEST SDTM TEAM
• Corporate structure
• Team scenarios
CORPORATE STRUCTURE
Operations
Biometrics
Operations
Biometrics
Data Management
Biostatistics
Operations
Data Management Biostatistics
*** Blur the line between DM and BIOS
BEST TEAM SCENARIO
SDTM experts?Programmers?Biostatisticians?Data genius?Cheap?Available?
ROLES AND SKILLS
Data collection: CRF design
(CDASH / SDTM experts)
SDTM mapping: CRF annotation/
specifications(SDTM experts)
Programming: (SAS experts)
Review: (SDTM +
Biostatistics + Data experts)
Data Management ----------------------------------------Biostatistics
TEAM SCENARIO 1Study CRF / DB Design aCRF Specs Programming
1 A
Reviewer R1
B1 (domain A)B2 (domain B)EtcReviewer R2
B1B2
Reviewer R2
B1B2
Reviewer R2
Advantages Disadvantages
Continuity from aCRF Time consuming
SME on certain domains Pressure (updates)
Small team Inconsistent mapping across domains
Boring
Lack of continuity from CRF design
Inconsistent metadata
TEAM SCENARIO 2Study CRF / DB Design aCRF Specs Programming
1 A
Reviewer R1
B (all domains)
Reviewer R2
C1C2Reviewer R2
C1C2Reviewer R2
Advantages Disadvantages
Consistent mapping across domains
Time consuming
Pressure (updates)
Lack of continuity from CRF design
Inconsistent metadata
TEAM SCENARIO 3Study CRF / DB Design aCRF Specs Programming
1 A
Reviewer R1
Team B (all domains)Reviewer R2
Team B (all domains)Reviewer R2
C1C2Reviewer R2
Advantages Disadvantages
Consistent mapping across domains
Resourcing issue (more people needed), particularly for a submission
Less advanced tasks can be done by cheaper resources, freeing advanced programmers for critical tasks
Lack of continuity from CRF design
Expert group for support
TEAM SCENARIO 4Study CRF / DB Design aCRF Specs Programming
1 A
Reviewer Team
Team B (all domains)Reviewer Team
Team B (all domains)Reviewer Team
C1C2Reviewer Team
Advantages Disadvantages
Consistent mapping across domains
Difficult to develop/find reviewer skills (for design and mapping)
Less advanced tasks can be done by cheaper resources, freeing advanced programmers for critical tasksExpert group for support
Continuity of whole process
Other things to consider
• Submissions– Continuity across studies– Consistency across studies– Change control– Bottle necks (reviewer team)
• ADaM / statistical output resourcing
RESOURCE CRITERIA
FROM• SDTM after design• Just save costs• Allocate availability
TO• SDTM during design• Invest in expert team• Look at continuity
THE BEST SDTM TEAM
Expert Reviewer Team (CDASH / SDTM) Team Leader (Biometrics)
CRF Designer
aCRF / SDTM Mapper Team
Programmer(s)
*** Understand the data*** Understand the purpose
QUESTIONS?????????????????????????????????????