MIE2026

Teaching dataset used during the MIE 2026 hands-on workshop to demonstrate the TRACE (Trusted Research Access & Collaboration Environment) platform. The study simulates a multicenter, prospective observational cohort of adult patients with inflammatory bowel disease (IBD) — Crohn's disease (K50), ulcerative colitis (K51), and other non-infectious gastroenteritis/colitis (K52.3). It captures the typical lifecycle of a clinical study in REDCap: consent, demographics, diagnosis, scheduled visits, clinical assessment, medication, adverse events, laboratory results, endoscopy/imaging procedures, and study completion. All records are fully fictitious and contain no personal or identifying data. The dataset is provided so workshop participants can explore TRACE's data access application workflow, role-based permissions, and the secure remote analysis environment without any GDPR or re-identification risk.

Demonstrate the TRACE platform end-to-end — study catalogue, data access application, and secure remote analysis — using a realistic but fully synthetic IBD cohort during the MIE 2026 workshop.

Hosted on the IBE REDCap instance at LMU München and exposed to workshop participants through TRACE. Synthetic records were generated to reflect plausible distributions of demographics, diagnoses, disease behaviour, treatment patterns, adverse events, and outcomes in adult IBD cohorts; no real patient data is included. Forms follow a longitudinal structure: one-time consent and demographics intake, a diagnosis form, then repeating visit instruments (visit status, clinical assessment, medication, adverse events, lab results, endoscopy/imaging), and a final study completion form. Workshop participants apply for data access through the standard TRACE workflow and, once approved, receive read-only access to the dataset together with a Python/R analysis sandbox inside the VNC remote desktop session.

Design: Multicenter, prospective, non-interventional observational cohort study (simulated for teaching purposes).

Population: Adult patients (≥ 18 years) with a confirmed diagnosis of inflammatory bowel disease according to ICD-10 codes K50 (Crohn'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.

Setting: Outpatient gastroenterology clinics at participating centers (simulated). The dataset assumes routine clinical care; no study-specific interventions are performed.

Schedule of assessments:

• Baseline / enrolment: informed consent, demographics, family history, diagnosis (ICD code, date of diagnosis, disease duration, disease behaviour, extraintestinal manifestations).
• Follow-up visits (repeating): visit attendance, clinical assessment (visit date, symptoms, Physician's Global Assessment, current flare), current medication (corticosteroids, immunomodulators, biologics), adverse events, laboratory parameters (ESR, haemoglobin, fecal calprotectin), endoscopy and imaging procedures.
• End of study: completion status, reason for withdrawal (if applicable), clinical remission, IBD-related surgery, treatment escalation, treatment discontinuation.

Endpoints (illustrative, for teaching exercises):

• Primary: proportion of patients achieving clinical remission at study completion.
• Secondary: 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.

Data 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.

Statistical 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.

Ethics 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.

Teaching and demonstration dataset prepared by the Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie (IBE), Ludwig-Maximilians-Universität München, for the MIE 2026 workshop. No external funding was received for the synthetic data or the workshop materials; preparation was carried out as part of routine research-infrastructure work on the TRACE platform and the IBE REDCap service. TRACE is operated by IBE / LMU München.