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@@ -3,17 +3,23 @@ Type: Package | |
Title: SDTM Data Transformation Engine | ||
Version: 0.0.0.9001 | ||
Authors@R: c( | ||
person("Omar", "Garcia", email = "[email protected]", role = c("aut", "cre")), | ||
person("Rammprasad", "Ganapathy", role = "aut"), | ||
person("Rammprasad", "Ganapathy", role = c("aut", "cre"), | ||
email = "[email protected]"), | ||
person("Adam", "Forys", role = "aut"), | ||
person("Edgar", "Manukyan", role = "aut"), | ||
person("Rosemary", "Li", role = "aut"), | ||
person("Preetesh", "Parikh", role = "aut"), | ||
person("Lisa", "Houterloot", role = "aut"), | ||
person("Yogesh", "Gupta", role = "aut"), | ||
person("Omar", "Garcia", email = "[email protected]", role = "aut"), | ||
person("Ramiro", "Magno", email = "[email protected]", | ||
role = "aut", comment = c(ORCID = "0000-0001-5226-3441")), | ||
person("Pattern Institute", role = c("cph", "fnd")), | ||
person("F. Hoffmann-La Roche AG", role = c("cph", "fnd")), | ||
person("Pfizer Inc", role = c("cph", "fnd")) | ||
) | ||
Description: An EDC and Data Standard agnostic SDTM data transformation engine | ||
that automates the transformation of raw clinical data in ODM format to SDTM | ||
based on standard mapping algorithms. | ||
Maintainer: Rammprasad Ganapathy <[email protected]> | ||
Description: An EDC and Data Standard-agnostic SDTM data transformation engine designed for SDTM programming in R. Powered by metadata sdtm.oak can automate the conversion of raw clinical data to SDTM through standardized mapping algorithms. SDTM is one of the required standards for data submission to FDA (U.S.) and PMDA (Japan). SDTM standards are implemented in accordance with the SDTM Implemetation guide as defined by CDISC <https://www.cdisc.org/standards/foundational/sdtmig> | ||
Language: en-US | ||
License: Apache License (>= 2) | ||
BugReports: https://github.com/pharmaverse/sdtm.oak/issues | ||
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@@ -26,9 +32,9 @@ Depends: R (>= 4.2) | |
Imports: | ||
admiraldev, | ||
dplyr (>= 1.0.0), | ||
purrr (>= 1.0.0), | ||
rlang (>= 1.0.0), | ||
stringr, | ||
purrr (>= 0.3.3), | ||
rlang (>= 0.4.4), | ||
stringr (>= 1.4.0), | ||
tibble | ||
Suggests: | ||
knitr, | ||
|
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url: ~ | ||
url: https://pharmaverse.github.io/sdtm.oak | ||
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template: | ||
bootstrap: 5 | ||
bootswatch: flatly | ||
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navbar: | ||
title: "sdtm.oak" |
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PATNUM,SUBJSTAT,SITENM,INSTANCE,INSTRN,FOLDER,FOLDERL,FOLDERSQ,FORM,FORML,DATAPGID,PGREPNUM,RECORDDT,RECORDID,RECPOS,RECSTAT,MDNUM,MDNUM_RAW,MDREC,MDRAW,MDIND,MDBDR,MDBDTU,MDBTM,MDBTMU,MDPRIOR,MDEDR,MDEDT,MDETM,MDETMU,MDONG,DOS,DOSU,DOSUV,MDFORM,MDRTE,MDFRQ,MDPROPH,TERMID,SRCLN,RAVRFID,CMMODIFY,CMDRG,CMDRGCD,CMDECOD,CMPNCD,SPLIT,OMIT,ACTTYP,ACTTEXT,CMDICT,CMCLAS,CMCLASCD,CMATC4,CMATC4CD,CMATC3,CMATC3CD,CMATC2,CMATC2CD,CMATC1,CMATC1CD,CLASSNUM | ||
375,Randomized,TEST SITE,Concomitant Medications,0,MD,Concomitant Medications,15,MD1,Concomitant Medications,56379253,0,,111885785,1,N,1,1,No,BABY ASPIRIN,,,1,,1,1,,,,0,1,10,mg,MG,Tablet,PO (Oral),QD (Every Day),0,109576058,20,5652739,BABY ASPIRIN,BABY ASPIRIN,2701701,ACETYLSALICYLIC ACID,2701001,,,,,"WHODRUG GLOBAL B3 MARCH 1, 2021",OTHER AGENTS FOR LOCAL ORAL TREATMENT,A01AD,OTHER AGENTS FOR LOCAL ORAL TREATMENT,A01AD,STOMATOLOGICAL PREPARATIONS,A01A,STOMATOLOGICAL PREPARATIONS,A01,ALIMENTARY TRACT AND METABOLISM,A,1 | ||
375,Randomized,TEST SITE,Concomitant Medications,0,MD,Concomitant Medications,15,MD1,Concomitant Medications,56379253,0,,111969387,2,N,2,2,No,CORTISPORIN,NAUSEA,15-Sep-20,0,,1,0,,,,0,1,50,g,G,Pill,PO (Oral),,0,105820348,28,5533807,CORTISPORIN (UNITED STATES),CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION,90104001001,CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION,90104001001,,,COUNTRY,APPLY SITE COUNTRY TO TERM,"WHODRUG GLOBAL B3 MARCH 1, 2021",CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION,S03CA,CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION,S03CA,CORTICOSTEROIDS AND ANTIINFECTIVES IN COMBINATION,S03C,OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS,S03,SENSORY ORGANS,S,1 | ||
376,Randomized,TEST SITE,Concomitant Medications,0,MD,Concomitant Medications,15,MD1,Concomitant Medications,56407664,0,,111939965,1,N,1,1,No,ASPIRIN,ANEMIA,17-Feb-21,0,8:00,0,0,17-Feb-21,2/17/21,,0,0,,,,,,,0,80619660,8,4297014,ASPIRIN,ASPIRIN [ACETYLSALICYLIC ACID],2701004,ACETYLSALICYLIC ACID,2701001,,,,,"WHODRUG GLOBAL B3 MARCH 1, 2021",OTHER AGENTS FOR LOCAL ORAL TREATMENT,A01AD,OTHER AGENTS FOR LOCAL ORAL TREATMENT,A01AD,STOMATOLOGICAL PREPARATIONS,A01A,STOMATOLOGICAL PREPARATIONS,A01,ALIMENTARY TRACT AND METABOLISM,A,1 | ||
377,Randomized,TEST SITE,Concomitant Medications,0,MD,Concomitant Medications,15,MD1,Concomitant Medications,56408736,0,,111942855,1,N,1,1,No,DIPHENHYDRAMINE HCL,NAUSEA,4-Oct-20,0,9:00,0,0,,,,0,1,50,mg,MG,Capsule,PO (Oral),BID (Twice a Day),0,79751919,3,4240092,DIPHENHYDRAMINE HCL,DIPHENHYDRAMINE HCL,402246,DIPHENHYDRAMINE HYDROCHLORIDE,402001,,,,,"WHODRUG GLOBAL B3 MARCH 1, 2021",AMINOALKYL ETHERS,R06AA,AMINOALKYL ETHERS,R06AA,ANTIHISTAMINES FOR SYSTEMIC USE,R06A,ANTIHISTAMINES FOR SYSTEMIC USE,R06,RESPIRATORY SYSTEM,R,1 | ||
377,Randomized,TEST SITE,Concomitant Medications,0,MD,Concomitant Medications,15,MD1,Concomitant Medications,56408736,0,,129972536,2,N,2,2,No,PARCETEMOL,PYREXIA,20-Jan-20,0,10:00,0,0,20-Jan-20,1/20/20,10:00,0,0,,mg,MG,Capsule,PO (Oral),BID (Twice a Day),1,129972536,2,,,,,,,,,,,,,,,,,,,,,, | ||
377,Randomized,TEST SITE,Concomitant Medications,0,MD,Concomitant Medications,15,MD1,Concomitant Medications,56408736,0,,129972541,3,N,3,3,No,VOMIKIND,VOMITINGS,UN UNK 2019,1,,1,0,UN UNK 2019,6/15/19,,1,0,,Tablet,TABLET,,PO (Oral),PRN (As Needed),1,129972541,3,,,,,,,,,,,,,,,,,,,,,, | ||
377,Randomized,TEST SITE,Concomitant Medications,0,MD,Concomitant Medications,15,MD1,Concomitant Medications,56408736,0,,129972568,4,N,5,5,No,ZENFLOX OZ,DIARHHEA,20 UNK 2019,0,10:00,0,0,20 UNK 2019,6/15/19,,1,0,,mL,ML,Injection,IM (Intramuscular),PRN (As Needed),1,129972568,4,,,,,,,,,,,,,,,,,,,,,, | ||
378,Randomized,TEST SITE,Concomitant Medications,0,MD,Concomitant Medications,15,MD1,Concomitant Medications,63059916,0,,126472439,4,N,4,4,No,AMITRYPTYLINE,COLD,UN UNK 2020,0,,1,1,UN UNK 2020,6/15/20,,1,0,12,g,G,Inhalant,IA (Intra-arterial),QD (Every Day),0,81845879,6,4382628,AMITRIPTYLINE,AMITRIPTYLINE,2201001,AMITRIPTYLINE,2201001,,,SPELLING UPDATE,AMITRIPTYLINE,"WHODRUG GLOBAL B3 MARCH 1, 2021",DRUGS FOR URINARY FREQUENCY AND INCONTINENCE,G04BD,DRUGS FOR URINARY FREQUENCY AND INCONTINENCE,G04BD,UROLOGICALS,G04B,UROLOGICALS,G04,GENITO URINARY SYSTEM AND SEX HORMONES,G,1 | ||
378,Randomized,TEST SITE,Concomitant Medications,0,MD,Concomitant Medications,15,MD1,Concomitant Medications,63059916,0,,126472436,1,N,1,1,No,BENADRYL,FEVER,26-Jan-20,0,9:00,0,0,26-Jan-20,1/26/20,7:00,0,0,100,mg,MG,Capsule,PO (Oral),BID (Twice a Day),1,95547017,4,5211852,BENADRYL (UNITED STATES),BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE],402002,DIPHENHYDRAMINE HYDROCHLORIDE,402001,,,COUNTRY,APPLY SITE COUNTRY TO TERM,"WHODRUG GLOBAL B3 MARCH 1, 2021",AMINOALKYL ETHERS,R06AA,AMINOALKYL ETHERS,R06AA,ANTIHISTAMINES FOR SYSTEMIC USE,R06A,ANTIHISTAMINES FOR SYSTEMIC USE,R06,RESPIRATORY SYSTEM,R,1 | ||
378,Randomized,TEST SITE,Concomitant Medications,0,MD,Concomitant Medications,15,MD1,Concomitant Medications,63059916,0,,126472437,2,N,2,2,Yes,DIPHENHYDRAMINE HYDROCHLORIDE,LEG PAIN,28-Jan-20,1,,1,1,1-Feb-20,2/1/20,,1,1,100,Capsule,CAPSULE,Capsule,Unknown,QD (Every Day),0,94095723,13,5084095,DIPHENHYDRAMINE HYDROCHLORIDE,DIPHENHYDRAMINE HYDROCHLORIDE,402001,DIPHENHYDRAMINE HYDROCHLORIDE,402001,,,,,"WHODRUG GLOBAL B3 MARCH 1, 2021",AMINOALKYL ETHERS,R06AA,AMINOALKYL ETHERS,R06AA,ANTIHISTAMINES FOR SYSTEMIC USE,R06A,ANTIHISTAMINES FOR SYSTEMIC USE,R06,RESPIRATORY SYSTEM,R,1 | ||
378,Randomized,TEST SITE,Concomitant Medications,0,MD,Concomitant Medications,15,MD1,Concomitant Medications,63059916,0,,126472438,3,N,3,3,Yes,TETRACYCLINE,FEVER,12-Feb-20,0,12:12,0,1,18-Feb-20,2/18/20,,0,0,10,mg,MG,Capsule,DE (Transdermal),BID (Twice a Day),1,84246445,6,4537684,TETRACYCLINE,TETRACYCLINE,1701001,TETRACYCLINE,1701001,,,,,"WHODRUG GLOBAL B3 MARCH 1, 2021",ANTIBIOTICS,S01AA,ANTIBIOTICS,S01AA,ANTIINFECTIVES,S01A,OPHTHALMOLOGICALS,S01,SENSORY ORGANS,S,1 | ||
379,Randomized,TEST SITE,Concomitant Medications,0,MD,Concomitant Medications,15,MD1,Concomitant Medications,63059986,0,,126472565,3,N,1,1,No,BENADRYL,COLD,10 UNK 2020,0,,0,0,20 UNK 2020,6/15/20,,0,0,12,IU,IU,Lotion,IJ (Intra-articular), , ,84734661,12,4567194,BENADRYL (UNITED STATES),BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE],402002,DIPHENHYDRAMINE HYDROCHLORIDE,402001,,,COUNTRY,APPLY SITE COUNTRY TO TERM,"WHODRUG GLOBAL B3 MARCH 1, 2021",AMINOALKYL ETHERS,R06AA,AMINOALKYL ETHERS,R06AA,ANTIHISTAMINES FOR SYSTEMIC USE,R06A,ANTIHISTAMINES FOR SYSTEMIC USE,R06,RESPIRATORY SYSTEM,R,1 | ||
379,Randomized,TEST SITE,Concomitant Medications,0,MD,Concomitant Medications,15,MD1,Concomitant Medications,63059986,0,,126472563,1,N,2,2,No,SOMINEX,COLD,,1,,1,0,,,,1,1,,mL,ML,Liquid,EP (Epidural),PRN (As Needed),0,82746644,5,4580551,SOMINEX (UNITED STATES),SOMINEX [DIPHENHYDRAMINE HYDROCHLORIDE],402060,DIPHENHYDRAMINE HYDROCHLORIDE,402001,,,COUNTRY,APPLY SITE COUNTRY TO TERM,"WHODRUG GLOBAL B3 MARCH 1, 2021",AMINOALKYL ETHERS,R06AA,AMINOALKYL ETHERS,R06AA,ANTIHISTAMINES FOR SYSTEMIC USE,R06A,ANTIHISTAMINES FOR SYSTEMIC USE,R06,RESPIRATORY SYSTEM,R,1 | ||
379,Randomized,TEST SITE,Concomitant Medications,0,MD,Concomitant Medications,15,MD1,Concomitant Medications,63059986,0,,126472564,2,N,3,3,No,ZQUILL,PAIN,,1,,1,0,17-Feb-20,2/17/20,,1,0,5,%,%,Aerosol,OP (Ophthalmic),Q2H (Every 2 Hours),0,99707553,22,5330876,ZZZQUIL,ZZZQUIL,402326,DIPHENHYDRAMINE HYDROCHLORIDE,402001,,,SPELLING UPDATE,ZZZQUIL,"WHODRUG GLOBAL B3 MARCH 1, 2021",AMINOALKYL ETHERS,R06AA,AMINOALKYL ETHERS,R06AA,ANTIHISTAMINES FOR SYSTEMIC USE,R06A,ANTIHISTAMINES FOR SYSTEMIC USE,R06,RESPIRATORY SYSTEM,R,1 |
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