Numerical Reasoning: In the form of multiple-choice this test requires data interpretation and mathematical calculations. Using information presented through tables and graphs, you will be required to draw conclusions and calculate changes within these data sets. Basic mathematical skills such as percentages, arithmetic operations, and ratios must be reviewed prior to taking the test. There are 10 numerical reasoning questions in a competition, and the allocated time is 20 minutes.
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SDTM (Study Data Tabulation Model) defines a standard structure for human clinical trial (study) data tabulations and for nonclinical study data tabulations that are to be submitted as part of a product application to a regulatory authority such as the United States Food and Drug Administration (FDA).
DB TechShowcase Tokyo - Intelligent Data PlatformDaiyu Hatakeyama
AI (Artificial Intelligence) が様々なアプリケーション/サービスに組み込まれ始めて、それをうみだす原動力ともいえるデータプラットフォームもその立ち位置を変えてきています。次期SQL Server 2017には、Machine Learning Servicesが同梱され、まさに次世代のデータプラットフォームの一つの形といえるでしょう。このセッションでは、System of Record から、System of Insight へとその価値を変えていく最新のData Platformの世界をご紹介します。
10. ODMConverter
•メタデータ部分(ODMのStudy要素, AdminData要素)をデータフレームの各列のattributeとし
て変換できている。
•Define-xmlの読み込みには使える? → Define-xml 2.0のサンプルは読み込めなかった…
•ClinicalData要素は無視されているようだ
•sink()でRコードを出しているようで、処理に失敗すると出力が持って行かれたままになるので、
sink(NULL)を何回か呼ぶ必要がある
•今年論文が出ていた: Dugas M, Dugas-Breit S. Integrated data management for
clinical studies: automatic transformation of data models with semantic
annotations for principal investigators, data managers and statisticians.
PLoS One. 2014 Feb 28;9(2):e90492
11. compareODM
• 2つのODMファイルを入力すると、 list of identical,
matching, similar and differing data items を出力する、と
いうものらしいけれども…
• ほぼ同じ2つのODMを渡しても1項目しかidenticalと
出さないなど、若干挙動が不明瞭
• やはりClinicalData要素は見ない
12. R4CDISC
• Define-XML 2.0を読み込ませて、Dataset Level Metadataを抽出
> str(getDLMD("define2-0-0-example-sdtm.xml"))
$ IGD_OID : chr "IG.TA" "IG.TE" "IG.TI" "IG.TS" ...
$ IGD_Domain : chr "TA" "TE" "TI" "TS" ...
$ IGD_Name : chr "TA" "TE" "TI" "TS" ...
$ IGD_Repeating : chr "No" "No" "No" "No" ...
$ IGD_IsReferenceData : chr "Yes" "Yes" "Yes" "Yes" ...
$ IGD_SASDatasetName : chr "TA" "TE" "TI" "TS" ...
$ IGD_Purpose : chr "Tabulation" "Tabulation" "Tabulation" "Tabulation" ...
p$l aInGnDe_d SEtlreucmetnurt"e " O n e r e:c ocrdh r p e"r OIn/e E rcecriortde ripeonr " p"lOannen edr eEcloerdm enpet r petrr iAalr m"s u"mOmaner y repacorardm epteerr value" ...
D$E SIIGGDN"_ C.l.a.ss : chr "TRIAL DESIGN" "TRIAL DESIGN" "TRIAL DESIGN" "TRIAL
$ IGD_ArchiveLocationID: chr "LF.TA" "LF.TE" "LF.TI" "LF.TS" ...
C$r iItGeDr_iDa"e s"cTriripatil oSn u m m a r y": .c.h.r "Trial Arms" "Trial Elements" "Trial Inclusion/Exclusion
C$r iItGeDr_iat"i t"lTe r i a l S u m m a r y": .c.h.r "Trial Arms" "Trial Elements" "Trial Inclusion/Exclusion
13. R4CDISC
• Define-XML 2.0を読み込ませて、Variable Level Metadataを抽出
> str(getVarMD("define2-0-0-example-sdtm.xml"))
'data.frame': 414 obs. of 10 variables:
"$I T.IARE_.IAtEeSmEOIQ"D . . . : chr "IT.STUDYID" "IT.AE.DOMAIN" "IT.USUBJID"
$ IGD_Name : chr "AE" "AE" "AE" "AE" ...
$ IR_OrderNumber : int 1 2 3 4 5 6 7 8 9 10 ...
$ IR_Mandatory : chr "Yes" "Yes" "Yes" "Yes" ...
$ IR_KeySequence : int 1 NA 2 NA NA NA NA 3 NA NA ...
$ ID_Name : chr "STUDYID" "DOMAIN" "USUBJID" "AESEQ" ...
$ ID_Length : chr "7" "2" "14" "1" ...
$ ID_DataType : chr "text" "text" "text" "integer" ...
S$u bIjDe_cLt aIbdeel n t i f i e r": "cSher q u"eSncteu dNy uImbdeenr"t i.f.i.er" "Domain Abbreviation" "Unique
$ ID_SASFieldName: chr "STUDYID" "DOMAIN" "USUBJID" "AESEQ" ...
14. R4CDISC
• Define-XML 2.0を読み込ませて、Value Level Metadata(ある列のデータの値によって、別の列のメタデー
タが決まるような場合)を抽出
> str(getValMD("define2-0-0-example-sdtm.xml"))
'data.frame': 121 obs. of 9 variables:
"$I T.IERG_.IEtGeOmORIRDE S . I N T:P " c"hIr T ."EGI.T.EDGAO.RDRAEOS.RPRERMS.EADIN"S P.A.M.T" "IT.DA.DAORRES.RETAMT"
"$V L.VEaGl.uEeGLOiRsRtEOIS"D . ..: chr "VL.DA.DAORRES" "VL.DA.DAORRES" "VL.EG.EGORRES"
$ IR_OrderNumber : int 1 2 1 2 3 4 5 1 2 1 ...
$ IR_Mandatory : chr "Yes" "No" "No" "No" ...
.$. .ID_Name : chr "DA.DISPAMT" "DA.RETAMT" "EG.INTP.ORRES" "EG.PRMEAN.ORRES"
$ ID_Length : chr "2" "2" "8" "3" ...
$ ID_DataType : chr "integer" "integer" "text" "integer" ...
O$r iIgDi_nLaal bReel s u l t s " ": Scuhmmr a r"y D(iMsepaenn)s ePd R ADmouruantt"i o"n R(eOtruirgn eUd )"A m.o.u.nt" "Interpretation:
$ ID_SASFieldName: chr "DISPAMT" "RETAMT" "INTPOR" "PRMEANOR" ...
15. R4CDISC
• Dataset-XMLを読み込ませて、データフレームにする
> read.dataset.xml(dataset_xml=”da.xml", define_xml=”define2-0-0-
example-sdtm(2013-11-09).xml")
STUDYID DOMAIN USUBJID DASEQ DATESTCD DATEST DAORRES
1 CDISC01 DA CDISC01.100008 1 DISPAMT Dispensed Amount 40
2 CDISC01 DA CDISC01.100008 2 DISPAMT Dispensed Amount 80
3 CDISC01 DA CDISC01.100008 3 RETAMT Returned Amount 22
4 CDISC01 DA CDISC01.100008 4 RETAMT Returned Amount 35
5 CDISC01 DA CDISC01.100014 1 DISPAMT Dispensed Amount 80
6 CDISC01 DA CDISC01.100014 2 DISPAMT Dispensed Amount 80
7 CDISC01 DA CDISC01.100014 3 RETAMT Returned Amount 44
8 CDISC01 DA CDISC01.100014 4 RETAMT Returned Amount 44
9 CDISC01 DA CDISC01.200001 1 DISPAMT Dispensed Amount 40