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![[CB1]Note
to ADaM team: We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S
Example 1 : Time to Event Analysis
Variable Metadata including Analysis
Parameter Value-Level Metadata (1)
Dataset Parameter Variable Variable Label Variable Display
Name Identifier Name
Type
Format
Codelist /
Controlled
Terms
Source / Derivation
ADTTEOS *ALL*
STUDYID Study Identifier
text
$20
ADSL.STUDYID
ADTTEOS *ALL*
USUBJID Unique Subject
Identifier
text
$20
ADSL.USUBJID
ADTTEOS *ALL*
ITTFL
Intent-To-Treat
Population Flag
text
$1
Y, null
ADSL.ITTFL
ADTTEOS *ALL*
TRTP
Planned
Treatment
text
$40
Drug 1, Drug 2
ADSL.TRT01P
ADTTEOS *ALL*
TRTPN
Planned
Treatment (N)
integer
1.0
1 = Drug 1,
2 = Drug 2
ADSL.TRT01PN
ADTTEOS PARAMCD
PARAM
Parameter
text
$50
Days to Death
ADTTEOS *ALL*
PARAMCD Parameter Code text
$8
DEATH
www.cytel.com
Š2012 Cytel Statistical Software & Services Pvt. Ltd.
10](https://image.slidesharecdn.com/metadataandadam-131126224913-phpapp01/85/Metadata-and-ADaM-10-320.jpg)
![[CB1]Note
to ADaM team: We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S
Example 1 : Time to Event Analysis
Variable Metadata including Analysis
Parameter Value-Level Metadata (2)
Dataset Parameter Variable
Name Identifier
Name
Variable
Label
Variable Display
Type Format
Codelist /
Controlled Terms
Source / Derivation
ADTTEOS *ALL*
AVAL
Analysis Value float
8.2
ADT â STARTDT + 1
ADTTEOS *ALL*
STARTDT
YYYYMM
DD10.
ADSL.RANDDT
ADTTEOS *ALL*
ADT
Time to Event integer
Origin Date for
Subject
Analysis Date integer
YYYYMM
DD10.
SAS Date of DS.DSDTC
ADTTEOS *ALL*
CNSR
Censor
integer
1.0
ADTTEOS *ALL*
EVNTDESC Event or
Censoring
Description
text
$40
www.cytel.com
0 for DS.DSDECOD =
âDEATHâ, 1 for any other
study completion
DEATH, COMPLETED DS.DSDECOD
THE STUDY, LOST TO
FOLLOW-UP, AE, PD
0, 1
Š2012 Cytel Statistical Software & Services Pvt. Ltd.
11](https://image.slidesharecdn.com/metadataandadam-131126224913-phpapp01/85/Metadata-and-ADaM-11-320.jpg)
![[CB1]Note
to ADaM team: We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S
Example 1 : Time to Event ADaM Dataset
USUBJID
TRTP
PARAM
AVAL
STARTDT
001-01-001 Study Drug 1
Days to
Death
157
001-01-002 Study Drug 2
Days to
Death
001-01-003 Study Drug 2
001-01-004 Study Drug 1
www.cytel.com
ADT
CNSR
EVNTDESC
2011-01-04 2011-06-10
1
COMPLETED
THE STUDY
116
2011-02-01 2011-05-28
1
AE
Days to
Death
88
2011-02-05 2011-05-04
0
DEATH
Days to
Death
102
2011-03-20 2011-06-30
1
PD
Š2012 Cytel Statistical Software & Services Pvt. Ltd.
12](https://image.slidesharecdn.com/metadataandadam-131126224913-phpapp01/85/Metadata-and-ADaM-12-320.jpg)
![[CB1]Note
to ADaM team: We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S
Example 2 : Time to Event Analysis
Variable Metadata including Analysis
Parameter Value-Level Metadata (1)
Dataset Parameter Variable Variable Label Variable Display
Name Identifier Name
Type
Format
Source / Derivation
Codelist /
Controlled Terms
ADTTEOS *ALL*
STUDYID Study Identifier
text
$20
ADSL.STUDYID
ADTTEOS *ALL*
USUBJID Unique Subject
Identifier
text
$20
ADSL.USUBJID
ADTTEOS *ALL*
ADTTEOS *ALL*
ADTTEOS *ALL*
AGE
SEX
ITTFL
Age
Sex
Intent-To-Treat
Population Flag
integer
text
text
3.0
$1
$1
Y, null
ADSL.AGE
ADSL.SEX
ADSL.ITTFL
ADTTEOS *ALL*
TRTP
Planned
Treatment
text
$40
Drug 1, Drug 2
ADSL.TRT01P
ADTTEOS *ALL*
TRTPN
Planned
Treatment (N)
integer
1.0
1 = Drug 1,
2 = Drug 2
ADSL.TRT01PN
ADTTEOS PARAMCD
PARAM
Parameter
text
$50
ADTTEOS *ALL*
PARAMCD Parameter Code text
Days to Death
Days to Progression
Free Survival
DEATH
PFS
www.cytel.com
$8
Š2012 Cytel Statistical Software & Services Pvt. Ltd.
15](https://image.slidesharecdn.com/metadataandadam-131126224913-phpapp01/85/Metadata-and-ADaM-15-320.jpg)
![[CB1]Note
to ADaM team: We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S
Example 2 : Time to Event ADaM Dataset
USUBJ AGE SEX TRTP
ID
PARAM
AVA STAR
L
TDT
ADT
CNSR
EVNTDESC
001-01001
43
M
Study
Drug 1
Days to Death
157
201101-04
201106-10
1
COMPLETED
THE STUDY
001-01002
57
F
Study
Drug 2
Days to Death
116
201102-01
201105-28
1
AE
001-01003
71
M
Study
Drug 2
Days to Death
88
201102-05
201105-04
0
DEATH
001-01004
55
F
Study
Drug 1
Days to Death
102
201103-20
201106-30
1
PD
001-01001
43
M
Study
Drug 1
Days to Progression 157
Free Survival
201101-04
201106-10
1
COMPLETED
THE STUDY
001-01002
57
F
Study
Drug 2
Days to Progression 116
Free Survival
201102-01
201105-28
1
AE
001-01003
71
M
Study
Drug 2
Days to Progression 88
Free Survival
201102-05
201105-04
0
DEATH
001-01004
55
F
Study
Drug 1
Days to Progression 102
Free Survival
201103-20
201106-30
0
PD
www.cytel.com
Š2012 Cytel Statistical Software & Services Pvt. Ltd.
17](https://image.slidesharecdn.com/metadataandadam-131126224913-phpapp01/85/Metadata-and-ADaM-17-320.jpg)
Uploaded byKevin Lee
Metadata and ADaM
This document discusses ADaM metadata, which provides information about Analysis Data Model (ADaM) datasets. It presents examples of metadata for time to event analyses, including analysis dataset, variable, parameter value-level, and results metadata. The goal of metadata is to specify how to create ADaM and TFL datasets, define information for sponsors, and promote consistency between sites. Benefits include reduced communication needs, easier estimation and planning, and help for inexperienced users. Challenges include initial time/resource investment and determining who maintains the metadata.
![Getting Started with Apache Spark: Big Data Made Simple [Free Meetup]](https://cdn.slidesharecdn.com/ss_thumbnails/apachesparkgettingstarted-260203175547-8361bcc3-thumbnail.jpg?width=640&height=640&fit=bounds)
Metadata and ADaM
- 1.
- 2. Disclaimer Any views oropinions presented in this presentation are solely those of the author and do not necessarily represent those of the company. www.cytel.com Š2012 Cytel Statistical Software & Services Pvt. Ltd. 2
- 3. Agenda ⢠Introduction of ADaMMetadata ⢠Clincial Trial Process ⢠Examples of how to create Metadata ⢠Goal of ADaM Metadata ⢠Pros and Cons ⢠Conclusion ⢠Questions & Answers www.cytel.com Š2012 Cytel Statistical Software & Services Pvt. Ltd. 3
- 4. ADaM Metadata ⢠Definitionâ Information of ADaM(Analysis Data Model) datasets ⢠Types â â â â Analysis Dataset Metadata Analysis Variable Metadata Analysis Parameter Value-Level Metadata Analysis Results Metadata www.cytel.com Š2012 Cytel Statistical Software & Services Pvt. Ltd. 4
- 5. Normal Clinical TrialProcess Protocol SAP Mock Up Tables CRF DMDB www.cytel.com Raw Derived Š2012 Cytel Statistical Software & Services Pvt. Ltd. TFL 5
- 6. CDISC Clinical TrialProcess Protocol SAP Mock Up Tables ADaM Metadata eCRF EDC SDTM ADaM TFL ADaM Related Process www.cytel.com Š2012 Cytel Statistical Software & Services Pvt. Ltd. 6
- 7. ADaM Related Process ADaMMetadata Analysis Dataset Metadata Analysis Variable Metadata Analysis Parameter value-level Metadata ADaM www.cytel.com Š2012 Cytel Statistical Software & Services Pvt. Ltd. Analysis Results Metadata TFL 7
- 8. Example 1 -Time to Event Mock Up table Table 14.2.1 Time to Death by Treatment PARAM = âDays to Deathâ, TRTP Analysis Population: Intent to Treat ITTFL=âYâ Drug 1 Drug 2 p-value __________________________________________________________________________________________ N xxx xxx Median xx xx x.xx Q1, Q3 xx, xx xx, xx __________________________________________________________________________________________ AVAL(Days to Event), CNSR(Censor information) proc lifetest data=ADTTEOS; where PARAM=âDays to Deathâ and ITTFL=âYâ; time AVAL*CNSR(1); strata TRTP; run; www.cytel.com Š2012 Cytel Statistical Software & Services Pvt. Ltd. 8
- 9. Time to EventAnalysis Dataset Metadata Dataset Dataset Dataset Name Description Location ADTTEOS Overall Survival Analysis Dataset www.cytel.com Dataset Structure Key Class of Documentation Variables Dataset of Dataset adtteos.xpt One record STUDYID, BDS per subject USUBJID, PARAM per parameter Š2012 Cytel Statistical Software & Services Pvt. Ltd. adtteos.txt 9
- 10. [CB1]Note to ADaM team:We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S Example 1 : Time to Event Analysis Variable Metadata including Analysis Parameter Value-Level Metadata (1) Dataset Parameter Variable Variable Label Variable Display Name Identifier Name Type Format Codelist / Controlled Terms Source / Derivation ADTTEOS *ALL* STUDYID Study Identifier text $20 ADSL.STUDYID ADTTEOS *ALL* USUBJID Unique Subject Identifier text $20 ADSL.USUBJID ADTTEOS *ALL* ITTFL Intent-To-Treat Population Flag text $1 Y, null ADSL.ITTFL ADTTEOS *ALL* TRTP Planned Treatment text $40 Drug 1, Drug 2 ADSL.TRT01P ADTTEOS *ALL* TRTPN Planned Treatment (N) integer 1.0 1 = Drug 1, 2 = Drug 2 ADSL.TRT01PN ADTTEOS PARAMCD PARAM Parameter text $50 Days to Death ADTTEOS *ALL* PARAMCD Parameter Code text $8 DEATH www.cytel.com Š2012 Cytel Statistical Software & Services Pvt. Ltd. 10
- 11. [CB1]Note to ADaM team:We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S Example 1 : Time to Event Analysis Variable Metadata including Analysis Parameter Value-Level Metadata (2) Dataset Parameter Variable Name Identifier Name Variable Label Variable Display Type Format Codelist / Controlled Terms Source / Derivation ADTTEOS *ALL* AVAL Analysis Value float 8.2 ADT â STARTDT + 1 ADTTEOS *ALL* STARTDT YYYYMM DD10. ADSL.RANDDT ADTTEOS *ALL* ADT Time to Event integer Origin Date for Subject Analysis Date integer YYYYMM DD10. SAS Date of DS.DSDTC ADTTEOS *ALL* CNSR Censor integer 1.0 ADTTEOS *ALL* EVNTDESC Event or Censoring Description text $40 www.cytel.com 0 for DS.DSDECOD = âDEATHâ, 1 for any other study completion DEATH, COMPLETED DS.DSDECOD THE STUDY, LOST TO FOLLOW-UP, AE, PD 0, 1 Š2012 Cytel Statistical Software & Services Pvt. Ltd. 11
- 12. [CB1]Note to ADaM team:We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S Example 1 : Time to Event ADaM Dataset USUBJID TRTP PARAM AVAL STARTDT 001-01-001 Study Drug 1 Days to Death 157 001-01-002 Study Drug 2 Days to Death 001-01-003 Study Drug 2 001-01-004 Study Drug 1 www.cytel.com ADT CNSR EVNTDESC 2011-01-04 2011-06-10 1 COMPLETED THE STUDY 116 2011-02-01 2011-05-28 1 AE Days to Death 88 2011-02-05 2011-05-04 0 DEATH Days to Death 102 2011-03-20 2011-06-30 1 PD Š2012 Cytel Statistical Software & Services Pvt. Ltd. 12
- 13. Example 1 :Time to Event Analysis Results Metadata Metadata Field Metadata DISPLAY IDENTIFIER DISPLAY NAME Table 14.2.1 RESULT IDENTIFIER PARAM Days to Death PARAMCD DEATH ANALYSIS VARIABLE REASON AVAL DATASET ADTTEOS Time to Death by Treatment, Analysis Population: Intent to Treat Days to Death Primary efficacy analysis ITTFL=âYâ and PARAM = âDays to Deathâ SELECTION CRITERIA DOCUMENTATION See SAP Section XX for details. Program: t-14-012-001-death.txt PROGRAMMING STATEMENTS www.cytel.com proc lifetest data= ADTTEOS; where ITTFL=âYâ and PARAM = âDays to Deathâ; time AVAL*CNSR(1); strata TRTP; run; Š2012 Cytel Statistical Software & Services Pvt. Ltd. 13
- 14. Example 2 :Time to Event Mock Up table Table 14.2.2 Time to Progression Free Survival : Cox Proportional Hazard Model PARAM = âDays to Progression Free Survivalâ, TRTP Analysis Population: Intent to Treat ITTFL=âYâ Drug 1 Drug 2 p-value __________________________________________________________________________________________ N xxx xxx Median xx xx x.xx Q1, Q3 xx, xx xx, xx __________________________________________________________________________________________ AVAL(Days to Event), CNSR(Censor information) proc phreg data=ADTTEOS; where PARAM=âDays to Progression Free Survivalâ and ITTFL=âYâ; model AVAL*CNSR(1) = TRTP AGE SEX ; run; www.cytel.com Š2012 Cytel Statistical Software & Services Pvt. Ltd. 14
- 15. [CB1]Note to ADaM team:We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S Example 2 : Time to Event Analysis Variable Metadata including Analysis Parameter Value-Level Metadata (1) Dataset Parameter Variable Variable Label Variable Display Name Identifier Name Type Format Source / Derivation Codelist / Controlled Terms ADTTEOS *ALL* STUDYID Study Identifier text $20 ADSL.STUDYID ADTTEOS *ALL* USUBJID Unique Subject Identifier text $20 ADSL.USUBJID ADTTEOS *ALL* ADTTEOS *ALL* ADTTEOS *ALL* AGE SEX ITTFL Age Sex Intent-To-Treat Population Flag integer text text 3.0 $1 $1 Y, null ADSL.AGE ADSL.SEX ADSL.ITTFL ADTTEOS *ALL* TRTP Planned Treatment text $40 Drug 1, Drug 2 ADSL.TRT01P ADTTEOS *ALL* TRTPN Planned Treatment (N) integer 1.0 1 = Drug 1, 2 = Drug 2 ADSL.TRT01PN ADTTEOS PARAMCD PARAM Parameter text $50 ADTTEOS *ALL* PARAMCD Parameter Code text Days to Death Days to Progression Free Survival DEATH PFS www.cytel.com $8 Š2012 Cytel Statistical Software & Services Pvt. Ltd. 15
- 16. Example 2 :Time to Event Analysis Variable Metadata including Analysis Parameter Value-Level Metadata (2) Dataset Parameter Variable Name Identifier Name Variable Label Variable Display Type Format Codelist / Controlled Terms Source / Derivation ADTTEOS *ALL* AVAL Analysis Value float 8.2 ADT â STARTDT + 1 ADTTEOS *ALL* STARTDT YYYYMM DD10. ADSL.RANDDT ADTTEOS *ALL* ADT Time to Event integer Origin Date for Subject Analysis Date integer YYYYMM DD10. SAS Date of DS.DSDTC ADTTEOS DEATH CNSR Censor integer 1.0 ADTTEOS PFS CNSR Censor integer 1.0 ADTTEOS *ALL* EVNTDESC Event or Censoring Description text $40 www.cytel.com 0 for DS.DSDECOD = âDEATHâ, 1 for any other study completion 0, 1 0 for DS.DSDECOD in(âDEATHâ , âPDâ), 1 for any other study completion DEATH, COMPLETED DS.DSDECOD THE STUDY, LOST TO FOLLOW-UP, AE, PD 0, 1 Š2012 Cytel Statistical Software & Services Pvt. Ltd. 16
- 17. [CB1]Note to ADaM team:We have elected to use this format for the program names. According to the Study Data Specifications, since the programs created by S Example 2 : Time to Event ADaM Dataset USUBJ AGE SEX TRTP ID PARAM AVA STAR L TDT ADT CNSR EVNTDESC 001-01001 43 M Study Drug 1 Days to Death 157 201101-04 201106-10 1 COMPLETED THE STUDY 001-01002 57 F Study Drug 2 Days to Death 116 201102-01 201105-28 1 AE 001-01003 71 M Study Drug 2 Days to Death 88 201102-05 201105-04 0 DEATH 001-01004 55 F Study Drug 1 Days to Death 102 201103-20 201106-30 1 PD 001-01001 43 M Study Drug 1 Days to Progression 157 Free Survival 201101-04 201106-10 1 COMPLETED THE STUDY 001-01002 57 F Study Drug 2 Days to Progression 116 Free Survival 201102-01 201105-28 1 AE 001-01003 71 M Study Drug 2 Days to Progression 88 Free Survival 201102-05 201105-04 0 DEATH 001-01004 55 F Study Drug 1 Days to Progression 102 Free Survival 201103-20 201106-30 0 PD www.cytel.com Š2012 Cytel Statistical Software & Services Pvt. Ltd. 17
- 18. Example 2 :Time to Event Analysis Results Metadata Metadata Field Metadata DISPLAY IDENTIFIER DISPLAY NAME Table 14.2.2 RESULT IDENTIFIER PARAM Days to Progression Free Survival PARAMCD PFS ANALYSIS VARIABLE REASON AVAL DATASET ADTTEOS Time to Progression Free Survival : Cox Proportional Hazard Model Days to Progression Free Survival Secondary efficacy analysis ITTFL=âYâ and PARAM=âDays to Progression Free Survivalâ SELECTION CRITERIA DOCUMENTATION See SAP Section XX for details. Program: t-14-002-002-pfs.txt PROGRAMMING STATEMENTS www.cytel.com proc phreg data= ADTTEOS; where ITTFL=âYâ and PARAM = âDays to Progression Free Survivalâ; model AVAL*CNSR(1) = TRTP AGE SEX; run; Š2012 Cytel Statistical Software & Services Pvt. Ltd. 18
- 19. Summary of Examples MockUp Tables ADaM Metadata 14.2.1 14.2.2 Dataset ADTTEOS Variables STUDYDI, USUBJID ITTFL TRTP, TRTPN PARAM, PARAMCD AVAL STARTDT, ADT CNSR EVNTDESC AGE SEX Parameter DEATH Results Days to Death www.cytel.com Š2012 Cytel Statistical Software & Services Pvt. Ltd. PFS Days to Progression Free Survival 19
- 20. Goal of Metadata â˘Serve as Spec and Define â Spec : provide the programmers how ADaM and some TFL can be created â Define : datasets information for sponsors ⢠Central document for all programmers and statisticians www.cytel.com Š2012 Cytel Statistical Software & Services Pvt. Ltd. 20
- 21. Goal of Metadata(2) ⢠Minimize the communication traffic in virtual office setting â â â â Philadelphia Office Boston Office India Office Remote Programming ⢠Reconciliation between ADaM datasets and Metadata â use macros to check wether ADaM datasets follow ADaM Metadata. www.cytel.com Š2012 Cytel Statistical Software & Services Pvt. Ltd. 21
- 22. Cons ⢠Who willprepare and maintain the metadata ⢠CDISC expert(SDTM, ADaM and so on) ⢠Programmer Lead ⢠Statistician ⢠The initial investment on resource and time at the early stage of the study ⢠Two many metadata? www.cytel.com Š2012 Cytel Statistical Software & Services Pvt. Ltd. 22
- 23. Pros (1) ⢠Consistencyin ADaM datasets â â â â Label Name Format # of variables ⢠Help the inexperience personnel â ADaM is new ⢠The central document between developers and validators â especially for the virtual office setting ⢠Helps the programmers on efficacy analysis. www.cytel.com Š2012 Cytel Statistical Software & Services Pvt. Ltd. 23
- 24. Pros (2) ⢠Betterestimate on the number of ADaM datasets â help the planning and resourcing. ⢠Review on Mock Up tables and SAP www.cytel.com Š2012 Cytel Statistical Software & Services Pvt. Ltd. 24
- 25. Conclusion ⢠The conceptof Metadata is âPlan your work and work your planâ ⢠ADaM Metadata is ongoing until all are done. www.cytel.com Š2012 Cytel Statistical Software & Services Pvt. Ltd. 25
- 26. Questions? www.cytel.com Š2012 Cytel StatisticalSoftware & Services Pvt. Ltd. 26