dsmb_ccru {BiostatsUHNplus}

Outputs the three DSMB-CCRU AE summary tables in Excel format per UHN template

Description

Outputs the three DSMB-CCRU AE summary tables in Excel format per UHN template

Usage

dsmb_ccru(
  protocol,
  setwd,
  title,
  comp = NULL,
  pi,
  presDate,
  cutDate,
  boundDate = NULL,
  subjID,
  subjID_ineligText = NULL,
  baseline_datasets,
  ae_dataset,
  ineligVar = NULL,
  ineligVarText = NULL,
  genderVar,
  enrolDtVar,
  ae_detailVar,
  ae_categoryVar,
  ae_severityVar,
  ae_onsetDtVar,
  ae_detailOtherText = NULL,
  ae_detailOtherVar = NULL,
  ae_verbatimVar = NULL,
  numSubj = NULL,
  fileNameUnderscore = TRUE
)

Arguments

protocol

study protocol name (uppercase, no spaces permitted)

setwd

directory to write Excel summary files to

title

full character vector with name of study

comp

baseline comparison group, for example, cohort (if provided)

pi

character vector name of study principal investigator

presDate

presentation date (i.e. 17NOV2023) for DSMB

cutDate

recent cutoff date for AEs (i.e. 31AUG2023)

boundDate

lower bound cutoff date for AEs (if provided)

subjID

key identifier field for participant ID in data sets

subjID_ineligText

character text that denotes participant IDs to exclude, for example, c("New Subject") (if provided)

baseline_datasets

list of data frames that contain baseline participant characteristics, for example, list(enrollment_DF,demography_DF,ineligibility_DF)

ae_dataset

data frame that contains subject AEs

ineligVar

field that denotes participant ineligibility (if provided)

ineligVarText

character text that denotes participant ineligibility, for example, c("Yes", "Y") (if provided)

genderVar

field that denotes participant gender

enrolDtVar

field that denotes participant enrollment date (i.e. 10MAY2021)

ae_detailVar

field that denotes participant AE detail (lowest level term)

ae_categoryVar

field that denotes participant AE category (system organ class)

ae_severityVar

field that denotes participant AE severity grade (numeric)

ae_onsetDtVar

field that denotes participant AE onset date

ae_detailOtherText

character text that denotes referencing verbatim AE field, for example, c("Other, specify", "OTHER") (if provided)

ae_detailOtherVar

field that denotes participant AE detail other (if provided)

ae_verbatimVar

field that denotes participant AE detail verbatim (if provided)

numSubj

vector to override value for number of participants in summary (if provided)

fileNameUnderscore

boolean that denotes if spaces should be underscore in filename

Value

three Excel files containing DSMB-CCRU AE summary tables

Examples

data("enrollment", "demography", "ineligibility", "ae");
dsmb_ccru(protocol="EXAMPLE_STUDY",setwd="./man/tables/",
  title="Phase X Study to Evaluate Treatments A-D",
  comp="COHORT",pi="Dr. Principal Investigator",
  presDate="30OCT2020",cutDate="31AUG2020",
  boundDate=NULL,subjID="Subject",subjID_ineligText=c("New Subject","Test"),
  baseline_datasets=list(enrollment,demography,ineligibility),
  ae_dataset=ae,ineligVar="INELIGIBILITY_STATUS",ineligVarText=c("Yes","Y"),
  genderVar="GENDER_CODE",enrolDtVar="ENROL_DATE_INT",ae_detailVar="ae_detail",
  ae_categoryVar="ae_category",ae_severityVar="AE_SEV_GD",
  ae_onsetDtVar="AE_ONSET_DT_INT",ae_detailOtherText="Other, specify",
  ae_detailOtherVar="CTCAE5_LLT_NM",ae_verbatimVar="AE_VERBATIM_TRM_TXT",
  numSubj=c(2,4,5,6))