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Create Study Configuration for Standard Datasets

Source: R/study_builder.R
create_standard_study_config.Rd

Convenience function to create a study configuration with standard clinical datasets.

Usage

create_standard_study_config(
  study_id = "STUDY001",
  participant_count = 100,
  site_count = 10,
  analytics_package = NULL,
  analytics_workflows = NULL,
  study = TRUE,
  subjects = TRUE,
  sites_data = TRUE,
  adverse_events = TRUE,
  protocol_deviations = TRUE,
  lab_data = TRUE,
  subject_visits = TRUE,
  visit_schedule = TRUE,
  enrollment = TRUE,
  data_changes = TRUE,
  data_entry = TRUE,
  queries = TRUE,
  pharmacokinetics = TRUE,
  study_drug_completion = TRUE,
  study_completion = TRUE,
  inclusion_exclusion = TRUE,
  country = TRUE,
  death = TRUE,
  randomization = TRUE,
  overall_response = TRUE,
  outlier_intensity = 1
)

Arguments

study_id

Study identifier

participant_count

Number of participants

site_count

Number of sites

analytics_package

Analytics package to use

analytics_workflows

Specific workflows to run

study

Include study metadata (Raw_STUDY)

subjects

Include subject demographics (Raw_SUBJ)

sites_data

Include site information (Raw_SITE)

adverse_events

Include adverse event data

protocol_deviations

Include protocol deviation data

lab_data

Include laboratory data

subject_visits

Include subject visit data (Raw_VISIT)

visit_schedule

Include visit schedule data (Raw_VISIT)

enrollment

Include enrollment data

data_changes

Include data change tracking (Raw_DATACHG)

data_entry

Include data entry tracking (Raw_DATAENT)

queries

Include query data (Raw_QUERY)

pharmacokinetics

Include pharmacokinetics data

study_drug_completion

Include study drug completion (Raw_SDRGCOMP)

study_completion

Include overall study completion (Raw_STUDCOMP)

inclusion_exclusion

Include inclusion/exclusion criteria (Raw_IE)

country

Include country mapping

death

Include death events (Raw_Death)

randomization

Include randomization data (Raw_Randomization)

overall_response

Include overall response data (Raw_OverallResponse)

outlier_intensity

Global multiplier for outlier-like values in domain generators.

Value

Study configuration with standard datasets

Examples

# All default datasets
config <- create_standard_study_config("TRIAL001", participant_count = 100, site_count = 10)
names(config$dataset_configs)
#>  [1] "Raw_STUDY"           "Raw_SITE"            "Raw_SUBJ"           
#>  [4] "Raw_ENROLL"          "Raw_AE"              "Raw_PD"             
#>  [7] "Raw_LB"              "Raw_VISIT"           "Raw_DATACHG"        
#> [10] "Raw_DATAENT"         "Raw_QUERY"           "Raw_PK"             
#> [13] "Raw_SDRGCOMP"        "Raw_STUDCOMP"        "Raw_IE"             
#> [16] "Raw_COUNTRY"         "Raw_Death"           "Raw_Randomization"  
#> [19] "Raw_OverallResponse"

# Select a subset of domains
config <- create_standard_study_config(
  "TRIAL002",
  participant_count = 50,
  adverse_events = TRUE, lab_data = TRUE,
  pharmacokinetics = FALSE, overall_response = FALSE
)