{ "cells": [ { "cell_type": "markdown", "metadata": { "id": "view-in-github", "colab_type": "text" }, "source": [ "\"Open" ] }, { "cell_type": "markdown", "id": "84462ebf-12f3-4b6a-abb9-9a6b508fc8a5", "metadata": { "id": "84462ebf-12f3-4b6a-abb9-9a6b508fc8a5" }, "source": [ "**Author:** Alpha Traore, Sr Data Scientist, Biostat Consultants Inc. \n", "**πŸ“ Project:** CDISC Dataset Preparation \n", "**πŸ“ Domain:** DM (Demographics) \n", "**🎯 Purpose:** Generate a synthetic raw dataset to simulate DM domain input for SDTM mapping and validation. \n", " \n", "---\n", "\n", "**πŸ“ŒOverview**\n", "\n", "This notebook demonstrates the creation of dummy raw data for the **Demographics (DM)** domain following CDISC standards. The goal is to simulate realistic input data for testing SDTM transformations and downstream programming tasks." ] }, { "cell_type": "markdown", "id": "a0aa6e4d-a6eb-404e-be6b-cede9c6d56f7", "metadata": { "id": "a0aa6e4d-a6eb-404e-be6b-cede9c6d56f7" }, "source": [ "**Set Up Folders to Store Final Datasets**" ] }, { "cell_type": "code", "execution_count": null, "id": "6808ff60-fdbd-4479-ab00-dde575c02d07", "metadata": { "id": "6808ff60-fdbd-4479-ab00-dde575c02d07" }, "outputs": [], "source": [ "# setwd('C:/Users/Waraba/Desktop/R in CDISC _ Jupyter Lab')\n", "# setwd('/Users/SDTM')\n", "# setwd('/Users/ADAM')" ] }, { "cell_type": "code", "execution_count": null, "id": "0204318c-2525-4365-a7d9-f3dd30174cc7", "metadata": { "id": "0204318c-2525-4365-a7d9-f3dd30174cc7" }, "outputs": [], "source": [ "# getwd()" ] }, { "cell_type": "markdown", "id": "9f53d8bf-c6dc-43d4-b5e7-ad1fdb840a35", "metadata": { "id": "9f53d8bf-c6dc-43d4-b5e7-ad1fdb840a35" }, "source": [ " " ] }, { "cell_type": "markdown", "id": "35df260d-4548-44d3-924a-87b38368daa6", "metadata": { "id": "35df260d-4548-44d3-924a-87b38368daa6" }, "source": [ "**Package Installation** \n", "Install all required software packages, libraries, or dependencies needed to create, validate, and submit CDISC-compliant datasets." ] }, { "cell_type": "code", "execution_count": null, "id": "a2c5b574-ba78-47f5-8076-786cc51cecb1", "metadata": { "id": "a2c5b574-ba78-47f5-8076-786cc51cecb1" }, "outputs": [], "source": [ "# install.packages(\"tidyverse\")\n", "# install.packages(\"glue\")\n", "# install.packages(\"assertthat\")\n", "# install.packages(\"huxtable\")\n", "# install.packages(\"data.table\")\n", "# install.packages(\"hms\")\n", "# install.packages(\"lubridate\")\n", "# install.packages(\"pharmaRTF\")\n", "# install.packages(\"Hmisc\")\n", "\n", "# install.packages(\"pacman\")" ] }, { "cell_type": "markdown", "id": "81054109-4c78-4045-b89e-a00df3f8f4ce", "metadata": { "id": "81054109-4c78-4045-b89e-a00df3f8f4ce" }, "source": [ "Install Multiples packages" ] }, { "cell_type": "code", "execution_count": null, "id": "2858eb3f-58d8-4738-87e5-d33128510e8e", "metadata": { "id": "2858eb3f-58d8-4738-87e5-d33128510e8e" }, "outputs": [], "source": [ "# install.packages(c(\"tidyverse\", \"glue\", \"assertthat\", \"huxtable\", \"data.table\", \"hms\", \"lubridate\", \"pharmaRTF\", \"Hmisc\"))" ] }, { "cell_type": "code", "execution_count": null, "id": "5ae581d8-717b-4162-bc4f-e0687e432303", "metadata": { "id": "5ae581d8-717b-4162-bc4f-e0687e432303" }, "outputs": [], "source": [] }, { "cell_type": "markdown", "id": "3d9337bb-0eea-4676-8a62-ae278849908a", "metadata": { "id": "3d9337bb-0eea-4676-8a62-ae278849908a" }, "source": [ "**Loading Packages**" ] }, { "cell_type": "code", "execution_count": null, "id": "ffc34d63-f0bd-4a17-aa88-2abf9d9b435b", "metadata": { "tags": [], "id": "ffc34d63-f0bd-4a17-aa88-2abf9d9b435b" }, "outputs": [], "source": [ "library(tidyverse)\n", "library(lubridate)" ] }, { "cell_type": "markdown", "id": "c66d00c8-be3b-47a6-8e95-8dfddb8d5475", "metadata": { "id": "c66d00c8-be3b-47a6-8e95-8dfddb8d5475" }, "source": [ "Load Multiples packages" ] }, { "cell_type": "code", "execution_count": null, "id": "1cafb084-43f2-460e-a115-ce6bd955ce84", "metadata": { "id": "1cafb084-43f2-460e-a115-ce6bd955ce84" }, "outputs": [], "source": [ "pacman::p_load(tidyverse, glue, assertthat, huxtable, lubridate)" ] }, { "cell_type": "markdown", "id": "d5f612d1-20ad-48cd-b975-7ac635c9b63d", "metadata": { "id": "d5f612d1-20ad-48cd-b975-7ac635c9b63d" }, "source": [ "**R packages available**" ] }, { "cell_type": "code", "execution_count": null, "id": "e975cab5-bcdc-4a0b-bc3e-9497462039b0", "metadata": { "id": "e975cab5-bcdc-4a0b-bc3e-9497462039b0" }, "outputs": [], "source": [ "library()" ] }, { "cell_type": "code", "execution_count": null, "id": "d3350124-40fd-424b-8c17-41c8397b099b", "metadata": { "id": "d3350124-40fd-424b-8c17-41c8397b099b" }, "outputs": [], "source": [] }, { "cell_type": "markdown", "id": "0a1392c2-ab3f-4ded-81a9-e328d6933d37", "metadata": { "id": "0a1392c2-ab3f-4ded-81a9-e328d6933d37" }, "source": [ "**Building Mock Raw Dataset for Demographics (DM)**" ] }, { "cell_type": "code", "execution_count": null, "id": "d71299da-7d29-4283-9500-22489265146d", "metadata": { "id": "d71299da-7d29-4283-9500-22489265146d" }, "outputs": [], "source": [ "demog<-tribble(\n", "~study,~pt,~sex,~ethnic,~race,~race2,~race3,~race4,~racesp,~age_raw,~age_rawu,~brthdt_raw,~country,\n", "\"STU001\",\"1001\",\"Male\",\"Hispanic or Latino\",\"White\",\"\",\"\",\"\",\"\",\"35\",\"Years\",\"\",\"USA\",\n", "\"STU001\",\"1002\",\"Female\",\"Not Hispanic or Latino\",\"Asian\",\"American Indian or Alaska Native\",\"\",\"\",\"\",\"40\",\"Years\",\"\",\"USA\",\n", "\"STU001\",\"1003\",\"Male\",\"Hispanic or Latino\",\"Other\",\"\",\"\",\"\",\"BRAZILIAN\",\"40\",\"Years\",\"\",\"USA\",\n", "\"STU001\",\"1004\",\"Male\",\"Hispanic or Latino\",\"White\",\"\",\"\",\"\",\"\",\"38\",\"Years\",\"\",\"USA\",\n", "\"STU001\",\"1005\",\"Male\",\"Not Hispanic or Latino\",\"American Indian or Alaska Native\",\"\",\"\",\"\",\"\",\"64\",\"Years\",\"\",\"USA\",\n", "\"STU001\",\"1006\",\"Female\",\"Not Hispanic or Latino\",\"Native Hawaiian or Other Pacific Islander\",\"\",\"\",\"\",\"\",\"75\",\"Years\",\"\",\"USA\",\n", "\"STU001\",\"1007\",\"Male\",\"Not Hispanic or Latino\",\"Unknown\",\"\",\"\",\"\",\"\",\"32\",\"Years\",\"\",\"USA\",\n", "\"STU001\",\"1008\",\"Female\",\"Not Hispanic or Latino\",\"Not Reported\",\"\",\"\",\"\",\"\",\"83\",\"Years\",\"\",\"USA\",\n", ")\n", "\n", "ipadmin<-tribble(\n", "~study,~pt,~folder,~ipconc,~ipstdt_raw,~ipsttm_raw,~ipqty_raw,~ipqtyu,~ipadj,~ipboxid,\n", "\"STU001\",\"1004\",\"WEEK 1\",\"500\",\"05/JAN/2010\",\"8:35\",\"2\",\"mL\",\"\",\"13434371\",\n", "\"STU001\",\"1004\",\"WEEK 2\",\"500\",\"12/JAN/2010\",\"8:35\",\"2\",\"mL\",\"\",\"52970539\",\n", "\"STU001\",\"1004\",\"WEEK 3\",\"500\",\"18/JAN/2010\",\"9:30\",\"1\",\"mL\",\"Adverse Event\",\"52120567\",\n", "\"STU001\",\"1004\",\"WEEK 4\",\"500\",\"25/JAN/2010\",\"8:45\",\"2\",\"mL\",\"\",\"59305202\",\n", "\"STU001\",\"1005\",\"WEEK 1\",\"500\",\"05/FEB/2010\",\"8:46\",\"2\",\"mL\",\"\",\"13787377\",\n", "\"STU001\",\"1005\",\"WEEK 2\",\"500\",\"12/FEB/2010\",\"8:30\",\"2\",\"mL\",\"\",\"65580239\",\n", "\"STU001\",\"1005\",\"WEEK 3\",\"500\",\"19/FEB/2010\",\"8:15\",\"0\",\"mL\",\"Adverse Event\",\"45377264\",\n", "\"STU001\",\"1006\",\"WEEK 1\",\"500\",\"2/MAR/2010\",\"8:30\",\"1.9\",\"mL\",\"\",\"39024101\",\n", "\"STU001\",\"1006\",\"WEEK 2\",\"500\",\"10/MAR/2010\",\"8:30\",\"2\",\"mL\",\"\",\"65845489\",\n", "\"STU001\",\"1007\",\"WEEK 1\",\"500\",\"15/APR/2010\",\"8:23\",\"2\",\"mL\",\"\",\"66223983\",\n", "\"STU001\",\"1007\",\"WEEK 2\",\"500\",\"22/APR/2010\",\"9:00\",\"2\",\"mL\",\"\",\"71763169\",\n", "\"STU001\",\"1007\",\"WEEK 3\",\"500\",\"29/APR/2010\",\"9:03\",\"2\",\"mL\",\"\",\"60038358\",\n", "\"STU001\",\"1007\",\"WEEK 4\",\"500\",\"6/MAY/2010\",\"8:12\",\"2\",\"mL\",\"\",\"68706162\",\n", "\"STU001\",\"1008\",\"WEEK 1\",\"500\",\"27/JUN/2010\",\"8:45\",\"2\",\"mL\",\"\",\"68891589\",\n", "\"STU001\",\"1008\",\"WEEK 2\",\"500\",\"4/JUL/2010\",\"8:17\",\"2\",\"mL\",\"\",\"2311359\",\n", "\"STU001\",\"1008\",\"WEEK 3\",\"500\",\"11/JUL/2010\",\"9:20\",\"2\",\"mL\",\"\",\"3199027\",\n", ")\n", "\n", "eos<-tribble(\n", "~study,~pt,~eoscat,~eotype,~eostdt_raw,~eoterm,\n", "\"STU001\",\"1002\",\"End of Study\",\"\",\"5/JAN/2010\",\"Withdrawl of consent\",\n", "\"STU001\",\"1003\",\"End of Study\",\"\",\"5/JAN/2010\",\"Death\",\n", "\"STU001\",\"1004\",\"End of Study\",\"\",\"28/FEB/2010\",\"Completed\",\n", "\"STU001\",\"1006\",\"End of Study\",\"\",\"25/MAR/2010\",\"Adverse Event\",\n", "\"STU001\",\"1007\",\"End of Study\",\"\",\"12/JUN/2010\",\"Completed\",\n", "\"STU001\",\"1008\",\"End of Study\",\"\",\"18/AUG/2010\",\"Subject Request\",\n", ")\n", "\n", "eoip<-tribble(\n", "~study,~pt,~eoscat,~eotype,~eostdt_raw,~eoterm,\n", "\"STU001\",\"1004\",\"End of Treatment\",\"\",\"25/JAN/2010\",\"Completed\",\n", "\"STU001\",\"1006\",\"End of Treatment\",\"\",\"25/MAR/2010\",\"Adverse Event\",\n", "\"STU001\",\"1007\",\"End of Treatment\",\"\",\"6/MAY/2010\",\"Completed\",\n", "\"STU001\",\"1008\",\"End of Treatment\",\"\",\"15/JUL/2010\",\"Subject Request\",\n", ")\n", "\n", "enrlment<-tribble(\n", "~study,~pt,~folder,~icdt_raw,~icvers,~prtvers,~enrldt_raw,~randdt_raw,~randno,\n", "\"STU001\",\"1001\",\"SCR\",\"1/JAN/2010\",\"1\",\"1\",\"\",\"\",\"\",\n", "\"STU001\",\"1002\",\"SCR\",\"1/JAN/2010\",\"1\",\"1\",\"4/JAN/2010\",\"\",\"\",\n", "\"STU001\",\"1003\",\"SCR\",\"1/JAN/2010\",\"1\",\"1\",\"3/JAN/2010\",\"3/JAN/2010\",\"514876\",\n", "\"STU001\",\"1004\",\"SCR\",\"1/JAN/2010\",\"1\",\"1\",\"4/JAN/2010\",\"5/JAN/2010\",\"101415\",\n", "\"STU001\",\"1005\",\"SCR\",\"15/JAN/2010\",\"1\",\"1\",\"1/FEB/2010\",\"5/FEB/2010\",\"306185\",\n", "\"STU001\",\"1006\",\"SCR\",\"18/FEB/2010\",\"1\",\"1\",\"1/MAR/2010\",\"1/MAR/2010\",\"987435\",\n", "\"STU001\",\"1007\",\"SCR\",\"4/APR/2010\",\"2\",\"2\",\"14/APR/2010\",\"14/APR/2010\",\"098745\",\n", "\"STU001\",\"1008\",\"SCR\",\"20/JUN/2010\",\"2\",\"3\",\"26/JUN/2010\",\"27/JUN/2010\",\"123098\",\n", ")\n", "\n", "rand<-tribble(\n", "~rand_id,~tx_cd,~cohort,~strata,\n", "\"514876\",\"PBO\",\"1\",\"Dummy strata1\",\n", "\"101415\",\"ACTIVE\",\"1\",\"Dummy strata1\",\n", "\"306185\",\"ACTIVE\",\"1\",\"Dummy strata1\",\n", "\"987435\",\"PBO\",\"2\",\"Dummy strata2\",\n", "\"098745\",\"PBO\",\"2\",\"Dummy strata2\",\n", "\"123098\",\"ACTIVE\",\"2\",\"Dummy strata2\",\n", ")\n", "\n", "box<-tribble(\n", "~kitid,~content,\n", "\"13434371\",\"ACTIVE\",\n", "\"52970539\",\"ACTIVE\",\n", "\"52120567\",\"ACTIVE\",\n", "\"59305202\",\"ACTIVE\",\n", "\"13787377\",\"PBO\",\n", "\"65580239\",\"ACTIVE\",\n", "\"45377264\",\"ACTIVE\",\n", "\"39024101\",\"PBO\",\n", "\"65845489\",\"PBO\",\n", "\"66223983\",\"PBO\",\n", "\"71763169\",\"PBO\",\n", "\"60038358\",\"PBO\",\n", "\"68706162\",\"PBO\",\n", "\"68891589\",\"ACTIVE\",\n", "\"2311359\",\"ACTIVE\",\n", "\"3199027\",\"ACTIVE\",\n", ")\n", "\n", "ecg<-tribble(\n", "~study,~pt,~folder,~egdt_raw,~egscat,~egmethod,~egloc,~pr_raw,~qrs_raw,~qt_raw,~qtc_raw,~hr_raw,~egintp,~egintpsp,\n", "\"STU001\",\"1004\",\"SCR\",\"4/JAN/2010\",\"SOC\",\"12 Lead\",\"Heart\",\"80\",\"88\",\"409\",\"385\",\"59\",\"Normal\",\"\",\n", "\"STU001\",\"1005\",\"SCR\",\"5/FEB/2010\",\"SOC\",\"12 Lead\",\"Heart\",\"180\",\"80\",\"360\",\"392\",\"76\",\"Normal\",\"\",\n", "\"STU001\",\"1005\",\"UNS_ECG\",\"22/FEB/2010\",\"SOC\",\"12 Lead\",\"Heart\",\"190\",\"90\",\"376\",\"408\",\"81\",\"Normal\",\"\",\n", "\"STU001\",\"1006\",\"SCR\",\"1/MAR/2010\",\"SOC\",\"12 Lead\",\"Heart\",\"142\",\"76\",\"389\",\"411\",\"71\",\"Normal\",\"\",\n", "\"STU001\",\"1007\",\"SCR\",\"13/APR/2010\",\"SOC\",\"12 Lead\",\"Heart\",\"152\",\"108\",\"396\",\"441\",\"74\",\"Abnormal Not Clinically Significant\",\n", "\"AV BLOCK Grade 1\",\n", ")\n", "\n", "physmeas<-tribble(\n", "~study,~pt,~folder,~pmdt_raw,~height_raw,~heightu,~weight_raw,~weightu,\n", "\"STU001\",\"1004\",\"SCR\",\"4/JAN/2010\",\"177\",\"Centimeters\",\"87.3\",\"Kilogram\",\n", "\"STU001\",\"1005\",\"SCR\",\"5/FEB/2010\",\"66.14\",\"Centimeters\",\"76.1\",\"Kilogram\",\n", "\"STU001\",\"1006\",\"SCR\",\"1/MAR/2010\",\"160\",\"Centimeters\",\"60.9\",\"Kilogram\",\n", "\"STU001\",\"1007\",\"SCR\",\"13/APR/2010\",\"178\",\"Centimeters\",\"85.4\",\"Kilogram\",\n", ")\n", "\n", "vitals<-tribble(\n", "~study,~pt,~folder,~vsdt_raw,~sysbp_raw,~diabp_raw,~pos,~hr_raw,~resp_raw,~temp_raw,~tempu,~temploc,\n", "\"STU001\",\"1004\",\"SCR\",\"02/JAN/2010\",\"122\",\"72\",\"Supine\",\"79\",\"24\",\"34.8\",\"Celsius\",\"Axilla\",\n", "\"STU001\",\"1004\",\"WEEK 2\",\"12/JAN/2010\",\"120\",\"82\",\"Supine\",\"87\",\"20\",\"35.3\",\"Celsius\",\"Axilla\",\n", "\"STU001\",\"1005\",\"SCR\",\"5/FEB/2010\",\"120\",\"85\",\"Sitting\",\"68\",\"14\",\"98.06\",\"Fahrenheit\",\"Axilla\",\n", "\"STU001\",\"1005\",\"WEEK 2\",\"12/FEB/2010\",\"125\",\"87\",\"Sitting\",\"69\",\"15\",\"36.6\",\"Celsius\",\"Axilla\",\n", "\"STU001\",\"1005\",\"UNS_VIT\",\"22/FEB/2010\",\"130\",\"90\",\"Sitting\",\"75\",\"18\",\"37.0\",\"Celsius\",\"Axilla\",\n", "\"STU001\",\"1006\",\"SCR\",\"01/MAR/2010\",\"133\",\"87\",\"Sitting\",\"74\",\"20\",\"36.2\",\"Celsius\",\"Ear\",\n", "\"STU001\",\"1006\",\"WEEK 2\",\"11/MAR/2010\",\"115\",\"68\",\"Sitting\",\"65\",\"21\",\"35.1\",\"Celsius\",\"Ear\",\n", "\"STU001\",\"1007\",\"SCR\",\"15/APR/2010\",\"120\",\"80\",\"Sitting\",\"75\",\"21\",\"36.9\",\"Celsius\",\"Axilla\",\n", "\"STU001\",\"1007\",\"WEEK 2\",\"29/APR/2010\",\"140\",\"80\",\"Sitting\",\"80\",\"\",\"37.4\",\"Celsius\",\"Axilla\",\n", ")\n", "\n", "lab_hema<-tribble(\n", "~study,~pt,~folder,~lbdt_raw,~test,~specimen,~coll_rslt,~coll_unit,~lower,~upper,\n", "\"STU001\",\"1004\",\"SCR\",\"02/Jan/2010\",\"BASO\",\"Whole blood\",1000,\"/uL\",0,1000,\n", "\"STU001\",\"1004\",\"SCR\",\"02/Jan/2010\",\"EOS\",\"Whole blood\",2100,\"/uL\",500,3000,\n", "\"STU001\",\"1004\",\"SCR\",\"02/Jan/2010\",\"FIBRINO\",\"Plasma\",260,\"mg/dL\",150,350,\n", "\"STU001\",\"1004\",\"SCR\",\"02/Jan/2010\",\"HCT\",\"Whole blood\",50,\"%\",38,54,\n", "\"STU001\",\"1004\",\"SCR\",\"02/Jan/2010\",\"HGB\",\"Whole blood\",19,\"g/dL\",14,18,\n", "\"STU001\",\"1004\",\"SCR\",\"02/Jan/2010\",\"LYM\",\"Whole blood\",36000,\"/uL\",10000,40000,\n", "\"STU001\",\"1004\",\"SCR\",\"02/Jan/2010\",\"MCH\",\"Whole blood\",30,\"pg/cell\",27,32,\n", "\"STU001\",\"1004\",\"SCR\",\"02/Jan/2010\",\"MCHC\",\"Whole blood\",39,\"g/dL\",33,36,\n", "\"STU001\",\"1004\",\"SCR\",\"02/Jan/2010\",\"MCV\",\"Whole blood\",103,\"um^3\",80,94,\n", "\"STU001\",\"1004\",\"SCR\",\"02/Jan/2010\",\"MONO\",\"Whole blood\",3000,\"/uL\",2000,8000,\n", "\"STU001\",\"1004\",\"SCR\",\"02/Jan/2010\",\"NEUT\",\"Whole blood\",7900,\"/uL\",1800,7500,\n", "\"STU001\",\"1004\",\"SCR\",\"02/Jan/2010\",\"NEUTSG\",\"Whole blood\",53000,\"/uL\",25000,60000,\n", "\"STU001\",\"1004\",\"SCR\",\"02/Jan/2010\",\"PT\",\"Plasma\",17,\"s\",10,20,\n", "\"STU001\",\"1004\",\"SCR\",\"02/Jan/2010\",\"RBC\",\"Whole blood\",0.57,\"10^6 /uL\",0.45,0.6,\n", "\"STU001\",\"1004\",\"SCR\",\"02/Jan/2010\",\"RETI\",\"Whole blood\",60,\"10^3 /uL\",23,90,\n", "\"STU001\",\"1004\",\"SCR\",\"02/Jan/2010\",\"WBC\",\"Whole blood\",50000,\"/uL\",50000,100000,\n", "\"STU001\",\"1004\",\"WEEK 1\",\"05/Jan/2010\",\"BASO\",\"Whole blood\",0,\"/uL\",0,1000,\n", "\"STU001\",\"1004\",\"WEEK 1\",\"05/Jan/2010\",\"EOS\",\"Whole blood\",2500,\"/uL\",500,3000,\n", "\"STU001\",\"1004\",\"WEEK 1\",\"05/Jan/2010\",\"FIBRINO\",\"Plasma\",140,\"mg/dL\",150,350,\n", "\"STU001\",\"1004\",\"WEEK 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"\"STU001\",\"1006\",\"SCR\",\"27/Feb/2010\",\"MCH\",\"Whole blood\",24,\"pg/cell\",27,32,\n", "\"STU001\",\"1006\",\"SCR\",\"27/Feb/2010\",\"MCHC\",\"Whole blood\",37,\"g/dL\",33,36,\n", "\"STU001\",\"1006\",\"SCR\",\"27/Feb/2010\",\"MCV\",\"Whole blood\",91,\"um^3\",80,94,\n", "\"STU001\",\"1006\",\"SCR\",\"27/Feb/2010\",\"MONO\",\"Whole blood\",5000,\"/uL\",2000,8000,\n", "\"STU001\",\"1006\",\"SCR\",\"27/Feb/2010\",\"NEUT\",\"Whole blood\",3500,\"/uL\",1800,7500,\n", "\"STU001\",\"1006\",\"SCR\",\"27/Feb/2010\",\"NEUTSG\",\"Whole blood\",25000,\"/uL\",25000,60000,\n", "\"STU001\",\"1006\",\"SCR\",\"27/Feb/2010\",\"PT\",\"Plasma\",12,\"s\",10,20,\n", "\"STU001\",\"1006\",\"SCR\",\"27/Feb/2010\",\"RBC\",\"Whole blood\",0.6,\"10^6 /uL\",0.45,0.6,\n", "\"STU001\",\"1006\",\"SCR\",\"27/Feb/2010\",\"RETI\",\"Whole blood\",46,\"10^3 /uL\",23,90,\n", "\"STU001\",\"1006\",\"SCR\",\"27/Feb/2010\",\"WBC\",\"Whole blood\",71000,\"/uL\",50000,100000,\n", "\"STU001\",\"1006\",\"WEEK 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"\"STU001\",\"1008\",\"WEEK 3\",\"11/Jul/2010\",\"\",\"CREAT\",\"Serum\",1.34,\"mg/dL\",1,2,\n", "\"STU001\",\"1008\",\"WEEK 3\",\"11/Jul/2010\",\"\",\"GGT\",\"Serum\",14.07,\"U/L\",8,78,\n", "\"STU001\",\"1008\",\"WEEK 3\",\"11/Jul/2010\",\"\",\"HDL\",\"Serum\",36.68,\"mg/dL\",40.15,0,\n", "\"STU001\",\"1008\",\"WEEK 3\",\"11/Jul/2010\",\"\",\"K\",\"Serum\",3.5,\"mEq/L\",3.5,5.5,\n", "\"STU001\",\"1008\",\"WEEK 3\",\"11/Jul/2010\",\"\",\"LDH\",\"Serum\",77.84,\"U/L\",59.88,100,\n", "\"STU001\",\"1008\",\"WEEK 3\",\"11/Jul/2010\",\"\",\"LDL\",\"Serum\",64.09,\"mg/dL\",0,129.73,\n", "\"STU001\",\"1008\",\"WEEK 3\",\"11/Jul/2010\",\"\",\"MG\",\"Serum\",2.21,\"mg/dL\",1.8,3.6,\n", "\"STU001\",\"1008\",\"WEEK 3\",\"11/Jul/2010\",\"\",\"PHOS\",\"Serum\",4.45,\"mg/dL\",3,4.49,\n", "\"STU001\",\"1008\",\"WEEK 3\",\"11/Jul/2010\",\"\",\"PROT\",\"Serum\",8,\"g/dL\",6,8,\n", "\"STU001\",\"1008\",\"WEEK 3\",\"11/Jul/2010\",\"\",\"SODIUM\",\"Serum\",124,\"mEq/L\",135,147,\n", "\"STU001\",\"1008\",\"WEEK 3\",\"11/Jul/2010\",\"\",\"TRIG\",\"Serum\",69.74,\"mg/dL\",40,200,\n", "\"STU001\",\"1008\",\"WEEK 3\",\"11/Jul/2010\",\"\",\"UREAN\",\"Serum\",15.7,\"mg/dL\",8.1,19.9,\n", ")\n", "\n", "eligcrit<-tribble(\n", "~study,~pt,~folder,~elignum,~eligsp,\n", "\"STU001\",\"1001\",\"SCR\",\"INCL103\",\"\",\n", "\"STU001\",\"1001\",\"SCR\",\"EXCL103\",\"\",\n", "\"STU001\",\"1004\",\"SCR\",\"EXCL105\",\"\",\n", ")\n", "\n", "conmeds<-tribble(\n", "~study,~pt,~cmcat,~cmvt,~cmpt,~cmindc,~cmdose_raw,~cmdosu_raw,~cmdosfrq,~route,~cmstdt_raw,~cmendt_raw,\n", "\"STU001\",\"1004\",\"General\",\"OMEPRAZOLE\",\"Omeprazole\",\"GASTRITIS\",\"20\",\"Milligram\",\"Daily\",\"Oral\",\"UN/UNK/2007\",\"\",\n", "\"STU001\",\"1006\",\"\",\"PARACETAMOL\",\"Paracetamol\",\"AE MID LOWER BACK PAIN\",\"750\",\"Milligram\",\"As needed\",\"Oral\",\"6/MAR/2010\",\"25/MAR/2010\",\n", "\"STU001\",\"1007\",\"General\",\"LOPERAMIDE\",\"Loperamide\",\"DIARRHEA\",\"2\",\"Milligram\",\"Daily\",\"Oral\",\"10/MAY/2010\",\"12/MAY/2010\",\n", ")\n", "\n", "adverse<-tribble(\n", "~study,~pt,~aecat,~aevt,~prefdose,~aestdt_raw,~aeendt_raw,~aesev,~aerel,~aeacn,~aeacnoth,~aeser,~sdeath,~slife,~shosp,~sdisab,~scong,\n", " ~smie,~aeout,~hadmtdt_raw,~hadmttm_raw,~hdsdt_raw,~hdstm_raw,~aellt,~aedecod,~aehlt,~aehlgt,~aebodsys,\n", "\"STU001\",\"1001\",\"General Adverse Event\",\"nausea\",\"Y\",\"01/JAN/2010\",\"01/JAN/2010\",\"Mild\",\"No\",\"No action taken\",\"\",\"No\",\"\",\"\",\"\",\"\",\"\",\n", " \"\",\"Recovered/Resolved\",\"\",\"\",\"\",\"\",\"\",\"\",\"\",\"\",\"\",\n", "\"STU001\",\"1003\",\"General Adverse Event\",\"CARDIAC ARREST\",\"Y\",\"05/JAN/2010\",\"05/JAN/2010\",\"Severe\",\"No\",\"No action taken\",\"\",\"Yes\",\"Yes\",\n", " \"\",\"\",\"\",\"\",\"\",\"FATAL\",\"5/JAN/2010\",\"\",\"5/JAN/2010\",\"\",\"Cardiac arrest\",\"Cardiac arrest\",\"\",\"\",\"Cardiac disorders\",\n", "\"STU001\",\"1004\",\"General Adverse Event\",\"nausea\",\"Y\",\"01/JAN/2010\",\"01/JAN/2010\",\"Mild\",\"No\",\"No action taken\",\"\",\"No\",\"\",\"\",\"\",\"\",\"\",\"\",\n", " \"Recovered/Resolved\",\"\",\"\",\"\",\"\",\"Nausea\",\"Nausea\",\"\",\"\",\"Gastrointestinal disorders\",\n", "\"STU001\",\"1004\",\"General Adverse Event\",\"PAIN ABDOMINAL\",\"Y\",\"03/JAN/2010\",\"07/JAN/2010\",\"Mild\",\"No\",\"No action taken\",\"\",\"No\",\"\",\"\",\"\",\"\"\n", " ,\"\",\"\",\"Recovered/Resolved\",\"\",\"\",\"\",\"\",\"Pain abdominal\",\"Abdominal pain\",\"\",\"\",\"Gastrointestinal disorders\",\n", "\"STU001\",\"1004\",\"General Adverse Event\",\"PAIN ABDOMINAL\",\"N\",\"08/JAN/2010\",\"09/JAN/2010\",\"Moderate\",\"Yes\",\"No action taken\",\"\",\"No\",\"\",\"\"\n", " ,\"\",\"\",\"\",\"\",\"Recovered/Resolved\",\"\",\"\",\"\",\"\",\"Pain abdominal\",\"Abdominal pain\",\"\",\"\",\"Gastrointestinal disorders\",\n", "\"STU001\",\"1004\",\"General Adverse Event\",\"Neuropathy\",\"N\",\"10/JAN/2010\",\"\",\"Severe\",\"No\",\"No action taken\",\"\",\"\",\"\",\"\",\"\",\"\",\"\",\"\",\n", " \"Not Recovered/Not Resolved\",\"\",\"\",\"\",\"\",\"Neuropathy\",\"Neuropaty peripheral\",\"\",\"\",\"Nervous system disorders\",\n", "\"STU001\",\"1005\",\"General Adverse Event\",\"GALLSTONES\",\"N\",\"18/FEB/2010\",\"21/FEB/2010\",\"Mild\",\"No\",\"No action taken\",\"Surgical Intervention\",\n", " \"Yes\",\"\",\"\",\"Yes\",\"\",\"\",\"\",\"Recovered/Resolved\",\"20/FEB/2020\",\"\",\"20/FEB/2020\",\"\",\"Gallstones\",\"Cholelithiasis\",\"\",\"\",\n", " \"Hepatobiliary disorders\",\n", "\"STU001\",\"1006\",\"General Adverse Event\",\"MID LOWER BACK PAIN\",\"N\",\"UN/MAR/2010\",\"25/MAR/2010\",\"Mild\",\"No\",\"No action taken\",\"\",\"\",\"\",\n", " \"\",\"\",\"\",\"\",\"\",\"Recovered/Resolved\",\"\",\"\",\"\",\"\",\"Lower Back Pain\",\"Back pain\",\"\",\"\",\"Musculoskeletal and connective tissue disorders\",\n", "\"STU001\",\"1007\",\"General Adverse Event\",\"DIARRHEA\",\"N\",\"9/MAY/2010\",\"12/MAY/2010\",\"Moderate\",\"No\",\"No action taken\",\"\",\"\",\"\",\"\",\"\",\"\",\"\",\n", "\"\",\"Recovered/Resolved\",\"\",\"\",\"\",\"\",\"Diarrhea\",\"Diarrhea\",\"\",\"\",\"Gastrointestinal disorders\",\n", ")\n", "\n", "eq5d3l<-tribble(\n", "~study,~pt,~folder,~dt_raw,~stat,~reasnd,~eq5d01,~eq5d02,~eq5d03,~eq5d04,~eq5d05,~eq5d06,\n", "\"STU001\",\"1004\",\"SCR\",\"03/JAN/2010\",\"\",\"\",\"I have no problems in walking about\",\"I have no problems with self-care\",\n", "\"I have no problems with performing my usual activities\",\"I have no pain or discomfort\",\"I am not anxious or depressed\",\"95\",\n", "\"STU001\",\"1004\",\"WEEK 2\",\"12/JAN/2010\",\"\",\"\",\"I have no problems in walking about\",\"I have no problems with self-care\",\n", "\"I have no problems with performing my usual activities\",\"I have no pain or discomfort\",\"I am moderately anxious or depressed\",\"87\",\n", ")\n", "\n", "hosp<-tribble(\n", "~study,~pt,~stdt_raw,~sttm_raw,~endt_raw,~entm_raw,~rsn,~unit,\n", ")\n", "\n", "surg<-tribble(\n", "~study,~pt,~surgdt_raw,~surgery,~surgreas,~sreassp,~surgindic,\n", "\"STU001\",\"1005\",\"20/FEB/2010\",\"Cholecystectomy\",\"Curative\",\"\",\"Gallstones\",\n", ")\n" ] }, { "cell_type": "markdown", "id": "ca2792f7-28d3-4c1b-be9e-414d55a82713", "metadata": { "id": "ca2792f7-28d3-4c1b-be9e-414d55a82713" }, "source": [ " " ] }, { "cell_type": "markdown", "id": "ff2a653a-7b65-4d4c-a82c-83e8980d16ab", "metadata": { "id": "ff2a653a-7b65-4d4c-a82c-83e8980d16ab" }, "source": [ "**Save the dummy raw data in the raw data folder**" ] }, { "cell_type": "code", "execution_count": null, "id": "b48def82-9e77-428a-a96c-b9dd5c7f5dc0", "metadata": { "id": "b48def82-9e77-428a-a96c-b9dd5c7f5dc0" }, "outputs": [], "source": [ "save(demog, ipadmin, eos, eoip, enrlment, rand, box, ecg, physmeas, vitals, lab_hema, lab_chem, eligcrit, conmeds, adverse, eq5d3l,\n", " hosp, surg, file=\"dm_rawdata.RData\")" ] }, { "cell_type": "markdown", "id": "f4c8c61d-ccbd-4567-82c8-118adcf76eb5", "metadata": { "id": "f4c8c61d-ccbd-4567-82c8-118adcf76eb5" }, "source": [ "## πŸ“¬ Contacts\n", "\n", "Your comments and questions are valued and encouraged. Please feel free to contact the author:\n", "\n", "**Alpha Traore** \n", "Sr Data Scientist \n", "Biostat Consultants Inc. \n", "312 Ridgewood Pl \n", "Fort Thomas, KY 41075 \n", "πŸ“§ alpha@alphatraore.com \n", "πŸ”— [LinkedIn Profile] (https://www.linkedin.com/in/alphatraore)" ] }, { "cell_type": "code", "execution_count": null, "id": "c54c6ad8-f675-4a5c-8946-69da2a838b24", "metadata": { "id": "c54c6ad8-f675-4a5c-8946-69da2a838b24" }, "outputs": [], "source": [] } ], "metadata": { "kernelspec": { "display_name": "R", "language": "R", "name": "ir" }, "language_info": { "codemirror_mode": "r", "file_extension": ".r", "mimetype": "text/x-r-source", "name": "R", "pygments_lexer": "r", "version": "4.2.1" }, "toc-autonumbering": true, "toc-showtags": true, "colab": { "provenance": [], "include_colab_link": true } }, "nbformat": 4, "nbformat_minor": 5 }