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-- IWRS tabulky pro databázi studie
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-- Spustit jednou: mysql -h 192.168.1.76 -u root -p studie < create_iwrs_tables.sql
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USE studie;
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-- ── Import log ───────────────────────────────────────────────────────────────
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CREATE TABLE IF NOT EXISTS iwrs_import (
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import_id INT AUTO_INCREMENT PRIMARY KEY,
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study VARCHAR(20) NOT NULL,
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imported_at DATETIME NOT NULL DEFAULT CURRENT_TIMESTAMP,
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source_file VARCHAR(500) NOT NULL,
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INDEX idx_study (study)
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);
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-- ── UCO3001 subject summary ───────────────────────────────────────────────────
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CREATE TABLE IF NOT EXISTS iwrs_uco3001_subject_summary (
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id INT AUTO_INCREMENT PRIMARY KEY,
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import_id INT NOT NULL,
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subject VARCHAR(20) NOT NULL,
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prior_subject_identifier VARCHAR(20),
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site VARCHAR(50),
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investigator VARCHAR(100),
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location VARCHAR(50),
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cohort_per_irt VARCHAR(100),
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informed_consent_date DATE,
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adolescent_assent_date DATE,
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age SMALLINT,
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weight DECIMAL(5,1),
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rescreened_subject VARCHAR(10),
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adt_ir VARCHAR(10),
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three_or_more_advanced_therapies VARCHAR(10),
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only_oral_5asa_compounds VARCHAR(10),
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ustekinumab VARCHAR(10),
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isolated_proctitis VARCHAR(10),
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clinical_responder_status_i12_m0 VARCHAR(100),
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irt_subject_status VARCHAR(50),
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i0_rand_date_local DATE,
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last_irt_transaction VARCHAR(100),
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last_irt_transaction_date_local DATE,
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last_irt_transaction_date_utc DATE,
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next_irt_transaction VARCHAR(100),
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next_irt_transaction_date_local DATE,
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most_recent_med_assignment_date DATE,
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days_since_last_med_assignment SMALLINT,
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patient_forecast_status VARCHAR(50),
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patient_forecast_status_changed_date DATE,
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FOREIGN KEY (import_id) REFERENCES iwrs_import(import_id),
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INDEX idx_import (import_id),
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INDEX idx_subject (subject)
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);
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-- ── MDD3003 subject summary ───────────────────────────────────────────────────
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CREATE TABLE IF NOT EXISTS iwrs_mdd3003_subject_summary (
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id INT AUTO_INCREMENT PRIMARY KEY,
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import_id INT NOT NULL,
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subject VARCHAR(20) NOT NULL,
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prior_subject_identifier VARCHAR(20),
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site VARCHAR(50),
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investigator VARCHAR(100),
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location VARCHAR(50),
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cohort_per_irt VARCHAR(50),
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madrs_criteria_integrated VARCHAR(50),
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informed_consent_date DATE,
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age SMALLINT,
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madrs_criteria_v15 VARCHAR(10),
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madrs_criteria_v16 VARCHAR(10),
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madrs_criteria_v17 VARCHAR(10),
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stratification_country VARCHAR(10),
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age_group VARCHAR(20),
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stable_remitters VARCHAR(50),
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irt_subject_status VARCHAR(100),
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last_irt_transaction VARCHAR(100),
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last_irt_transaction_date_local DATE,
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last_irt_transaction_date_utc DATE,
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next_irt_transaction VARCHAR(100),
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next_irt_transaction_date_local DATE,
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date_screened DATE,
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date_screen_failed DATE,
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date_randomized_part1 DATE,
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date_early_withdraw_randomized_part1 DATE,
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date_open_label_induction DATE,
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date_early_withdraw_open_label_induction DATE,
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date_randomized_part2 DATE,
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date_early_withdraw_randomized_part2 DATE,
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date_completed DATE,
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date_unblinded DATE,
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FOREIGN KEY (import_id) REFERENCES iwrs_import(import_id),
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INDEX idx_import (import_id),
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INDEX idx_subject (subject)
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);
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-- ── Subject visits / transactions (obě studie) ───────────────────────────────
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CREATE TABLE IF NOT EXISTS iwrs_subject_visits (
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id INT AUTO_INCREMENT PRIMARY KEY,
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import_id INT NOT NULL,
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study VARCHAR(20) NOT NULL,
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subject VARCHAR(20) NOT NULL,
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visit_type ENUM('Past','Upcoming') NOT NULL,
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scheduled_date DATE,
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window_days VARCHAR(20),
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actual_date DATE,
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irt_transaction_no SMALLINT,
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irt_transaction_description VARCHAR(200),
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medication_assignment VARCHAR(200),
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quantity_assigned SMALLINT,
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medication_id VARCHAR(20),
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FOREIGN KEY (import_id) REFERENCES iwrs_import(import_id),
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INDEX idx_import (import_id),
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INDEX idx_study_subject (study, subject)
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);
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