{"@context": "https://schema.org", "@type": "Dataset", "name": "MIE2026", "description": "Metadata record for the clinical research dataset of the study \u201cMIE2026\u201d, curated in the TRACE research data platform. It describes the data structure of a longitudinal study with 5 events, comprising 37 variables.", "identifier": ["13", {"@type": "PropertyValue", "propertyID": "REDCap project ID", "value": "202"}], "url": "https://trace.ibe.med.uni-muenchen.de/harvest/project/13/", "dateCreated": "2026-05-09T14:42:26.123239+00:00", "dateModified": "2026-06-08T13:55:04.836558+00:00", "keywords": ["Design: Multicenter, prospective, non-interventional observational cohort study (simulated for teaching purposes).\r\n\r\nPopulation: Adult patients (&ge; 18 years) with a confirmed diagnosis of inflammatory bowel disease according to ICD-10 codes K50 (Crohn&#39;s disease), K51 (ulcerative colitis), or K52.3 (other non-infectious gastroenteritis and colitis). Inclusion requires written informed consent and the absence of pre-defined exclusion criteria captured on the consent form.\r\n\r\nSetting: Outpatient gastroenterology clinics at participating centers (simulated). The dataset assumes routine clinical care; no study-specific interventions are performed.\r\n\r\nSchedule of assessments:\r\n\r\n\r\n\tBaseline / enrolment: informed consent, demographics, family history, diagnosis (ICD code, date of diagnosis, disease duration, disease behaviour, extraintestinal manifestations).\r\n\tFollow-up visits (repeating): visit attendance, clinical assessment (visit date, symptoms, Physician&#39;s Global Assessment, current flare), current medication (corticosteroids, immunomodulators, biologics), adverse events, laboratory parameters (ESR, haemoglobin, fecal calprotectin), endoscopy and imaging procedures.\r\n\tEnd of study: completion status, reason for withdrawal (if applicable), clinical remission, IBD-related surgery, treatment escalation, treatment discontinuation.\r\n\r\n\r\nEndpoints (illustrative, for teaching exercises):\r\n\r\n\r\n\tPrimary: proportion of patients achieving clinical remission at study completion.\r\n\tSecondary: incidence of IBD-related surgery, treatment escalation, treatment discontinuation, and adverse events; association of baseline characteristics (diagnosis, disease behaviour, smoking, BMI, family history) with outcomes.\r\n\r\n\r\nData management: Captured in REDCap with field-level validation (date ranges, controlled vocabularies). Branching logic is used for adverse-event detail and withdrawal reason. Repeating instruments handle the longitudinal visit structure.\r\n\r\nStatistical considerations: No formal sample-size calculation; the synthetic cohort size is chosen to support the workshop exercises. Participants are encouraged to perform descriptive statistics, simple group comparisons, and time-to-event analyses on the dataset as part of the hands-on session.\r\n\r\nEthics and data protection: As a fully synthetic dataset, no ethics approval or data protection agreement is required. The workflow shown in TRACE mirrors what would be required for real data: data access application, approval, and analysis exclusively inside the secure remote environment.", "Demonstrate the TRACE platform end-to-end &mdash; study catalogue, data access application, and secure remote analysis &mdash; using a realistic but fully synthetic IBD cohort during the MIE 2026 workshop."], "variableMeasured": [{"@type": "PropertyValue", "name": "record_id", "description": "Record ID"}, {"@type": "PropertyValue", "name": "screen_date", "description": "What is the date of enrollment?"}, {"@type": "PropertyValue", "name": "ic_obtained", "description": "Was informed consent obtained?", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Yes"}, {"@type": "DefinedTerm", "termCode": "0", "name": "No"}]}, {"@type": "PropertyValue", "name": "consent_date", "description": "Date Informed Consent Obtained"}, {"@type": "PropertyValue", "name": "ie_all", "description": "Did the subject meet all inclusion and no exclusion criteria?", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Yes"}, {"@type": "DefinedTerm", "termCode": "0", "name": "No"}]}, {"@type": "PropertyValue", "name": "clinical_report_code", "description": "Code"}, {"@type": "PropertyValue", "name": "email_versandt", "description": "Email versandt"}, {"@type": "PropertyValue", "name": "brthdtc", "description": "Date of birth"}, {"@type": "PropertyValue", "name": "sex", "description": "Sex", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Female"}, {"@type": "DefinedTerm", "termCode": "2", "name": "Male"}]}, {"@type": "PropertyValue", "name": "ethnic", "description": "Ethnicity", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Caucasian"}, {"@type": "DefinedTerm", "termCode": "2", "name": "Asian"}, {"@type": "DefinedTerm", "termCode": "3", "name": "African"}, {"@type": "DefinedTerm", "termCode": "4", "name": "Other"}]}, {"@type": "PropertyValue", "name": "smoking", "description": "Smoking Status", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Never Smoker"}, {"@type": "DefinedTerm", "termCode": "2", "name": "Ex-Smoker"}, {"@type": "DefinedTerm", "termCode": "3", "name": "Current Smoker"}]}, {"@type": "PropertyValue", "name": "bmi", "description": "BMI", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "< 18.5"}, {"@type": "DefinedTerm", "termCode": "2", "name": "18.5 - 24.9"}, {"@type": "DefinedTerm", "termCode": "3", "name": "25 - 29.9"}, {"@type": "DefinedTerm", "termCode": "4", "name": ">30"}]}, {"@type": "PropertyValue", "name": "mhcat", "description": "Family history of IBD", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Yes"}, {"@type": "DefinedTerm", "termCode": "0", "name": "No"}]}, {"@type": "PropertyValue", "name": "icd", "description": "Diagnosis", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "K51"}, {"@type": "DefinedTerm", "termCode": "2", "name": "K50"}, {"@type": "DefinedTerm", "termCode": "3", "name": "K52.3"}]}, {"@type": "PropertyValue", "name": "mhstdtc", "description": "Date of Diagnosis"}, {"@type": "PropertyValue", "name": "disease_duration", "description": "Disease Duration in years"}, {"@type": "PropertyValue", "name": "disease_behaviour", "description": "Disease Behaviour", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "non-stricturing non-penetrating"}, {"@type": "DefinedTerm", "termCode": "2", "name": "stricturing"}, {"@type": "DefinedTerm", "termCode": "3", "name": "penetrating"}]}, {"@type": "PropertyValue", "name": "eim_present", "description": "Extraintestinal manifestations?", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Yes"}, {"@type": "DefinedTerm", "termCode": "0", "name": "No"}]}, {"@type": "PropertyValue", "name": "visit_attended", "description": "Has the patient attended the visit?", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Yes"}, {"@type": "DefinedTerm", "termCode": "0", "name": "No"}]}, {"@type": "PropertyValue", "name": "visit_date", "description": "Date of visit?"}, {"@type": "PropertyValue", "name": "symptoms", "description": "Symptoms", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Abdominal pain"}, {"@type": "DefinedTerm", "termCode": "2", "name": "Bleeding"}, {"@type": "DefinedTerm", "termCode": "3", "name": "Stool frequency > 3/d"}, {"@type": "DefinedTerm", "termCode": "4", "name": "Other"}]}, {"@type": "PropertyValue", "name": "pga", "description": "Physician's Global Assessment of Disease Activity", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Remission"}, {"@type": "DefinedTerm", "termCode": "2", "name": "Mild disease"}, {"@type": "DefinedTerm", "termCode": "3", "name": "Moderate disease"}, {"@type": "DefinedTerm", "termCode": "4", "name": "Severe disease"}]}, {"@type": "PropertyValue", "name": "current_flare", "description": "Current flare?", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Yes"}, {"@type": "DefinedTerm", "termCode": "0", "name": "No"}]}, {"@type": "PropertyValue", "name": "cmtrt", "description": "Current treatment", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Corticosteroids"}, {"@type": "DefinedTerm", "termCode": "2", "name": "Immunomodulators"}, {"@type": "DefinedTerm", "termCode": "3", "name": "Biologics"}]}, {"@type": "PropertyValue", "name": "aeyn", "description": "Has the subject experienced any adverse events since the last visit?", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Yes"}, {"@type": "DefinedTerm", "termCode": "0", "name": "No"}]}, {"@type": "PropertyValue", "name": "aeterm", "description": "Adverse effects", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Gastrointestinal tract infections"}, {"@type": "DefinedTerm", "termCode": "2", "name": "Respiratory tract infections"}, {"@type": "DefinedTerm", "termCode": "3", "name": "Malignancies"}, {"@type": "DefinedTerm", "termCode": "4", "name": "Renal impairment"}, {"@type": "DefinedTerm", "termCode": "5", "name": "Infusion reactions"}, {"@type": "DefinedTerm", "termCode": "6", "name": "Treatment emergent adverse effect"}, {"@type": "DefinedTerm", "termCode": "7", "name": "Death"}]}, {"@type": "PropertyValue", "name": "esr_mm_h", "description": "ESR mm/h", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "< 30 mm/h"}, {"@type": "DefinedTerm", "termCode": "2", "name": "\u2265 30 mm/h"}]}, {"@type": "PropertyValue", "name": "hb_mg_dl", "description": "Haemoglobin g/dl", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "< 10.5"}, {"@type": "DefinedTerm", "termCode": "2", "name": "\u2265 10.5"}]}, {"@type": "PropertyValue", "name": "fec_cal", "description": "Fecal calprotectin", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": ">50 \u03bcg/mg"}, {"@type": "DefinedTerm", "termCode": "2", "name": "< 50 \u03bcg/mg"}]}, {"@type": "PropertyValue", "name": "proc_type", "description": "Procedure type", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Colonoscopy"}, {"@type": "DefinedTerm", "termCode": "2", "name": "Flexible sigmoidoscopy"}, {"@type": "DefinedTerm", "termCode": "3", "name": "Upper endoscopy"}, {"@type": "DefinedTerm", "termCode": "4", "name": "MRI enterography"}, {"@type": "DefinedTerm", "termCode": "5", "name": "CT enterography"}, {"@type": "DefinedTerm", "termCode": "6", "name": "Intestinal ultrasound"}, {"@type": "DefinedTerm", "termCode": "7", "name": "Other"}]}, {"@type": "PropertyValue", "name": "proc_date", "description": "Procedure date"}, {"@type": "PropertyValue", "name": "dscompl", "description": "Did the subject complete the study?", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Completed"}, {"@type": "DefinedTerm", "termCode": "2", "name": "Withdrawn"}]}, {"@type": "PropertyValue", "name": "dsreas", "description": "Main reason for withdrawal", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Withdrew consent"}, {"@type": "DefinedTerm", "termCode": "2", "name": "Lost to follow-up"}, {"@type": "DefinedTerm", "termCode": "3", "name": "Adverse event"}, {"@type": "DefinedTerm", "termCode": "4", "name": "Protocol deviation"}, {"@type": "DefinedTerm", "termCode": "5", "name": "Investigator decision"}, {"@type": "DefinedTerm", "termCode": "6", "name": "Death"}, {"@type": "DefinedTerm", "termCode": "7", "name": "Other"}]}, {"@type": "PropertyValue", "name": "clinical_remission", "description": "Clinical remission achieved?", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Yes"}, {"@type": "DefinedTerm", "termCode": "0", "name": "No"}]}, {"@type": "PropertyValue", "name": "ibd_surgery", "description": "IBD-related surgery?", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Yes"}, {"@type": "DefinedTerm", "termCode": "0", "name": "No"}]}, {"@type": "PropertyValue", "name": "trt_escalation", "description": "Treatment escalation?", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Yes"}, {"@type": "DefinedTerm", "termCode": "0", "name": "No"}]}, {"@type": "PropertyValue", "name": "trt_discontinuation", "description": "Treatment discontinued?", "valueReference": [{"@type": "DefinedTerm", "termCode": "1", "name": "Yes"}, {"@type": "DefinedTerm", "termCode": "0", "name": "No"}]}]}