Logical model for the PROTECT-CHILD bio_sample table.

Logical model for the PROTECT-CHILD clinical_event table. Each visit record captures either the start or end of a clinical event.

Logical model for the PROTECT-CHILD clinical_event_type table.

Logical model for the PROTECT-CHILD clinical_variable table. Includes weight, height, diuresis, and concomitant disease.

Logical model for the PROTECT-CHILD concomitant_medication table.

Logical model for the PROTECT-CHILD donor table.

Logical model for the PROTECT-CHILD imm_pat table. Phase field (Induction / Maintenance) maps to MedicationStatement.category.

Logical model for the PROTECT-CHILD immunological_data table. Covers blood group, Rh, HLA allele typing, DSA, Banff category, C4d, and ANCA.

Logical model for the PROTECT-CHILD immunosuppressant catalogue table.

Logical model for the PROTECT-CHILD instrumental_investigation table.

Logical model for the PROTECT-CHILD lab_result table.

Logical model for the PROTECT-CHILD lab_test catalogue table.

Logical model for the PROTECT-CHILD microbiology table. Covers viral serology, DNA quantification, culture results, and BKVAN evidence.

Logical model for the PROTECT-CHILD patient table.

Logical model for the PROTECT-CHILD pre_medication table.

Logical model for the PROTECT-CHILD transplant table.

Logical model for the PROTECT-CHILD visit table.

Logical model for the PROTECT-CHILD vital_sign table. Contains standard vitals and ABPM measurements.

Biological sample linked to a transplant visit, aligned with the DMv1.2 bio_sample table. Patient navigable via Specimen.subject. Visit linked via extension[visit_id]. Analysis intent (genomic_sample / epigenomic_sample) is represented as BioSampleAnalysisRequest (ServiceRequest) resources with specimen = Reference(BioSample). send_ingemm_date maps to the native Specimen.receivedTime.

A work order representing the intent to perform omics analysis (genomic or epigenomic) on a BioSample. One instance per analysis type per sample. Analysis intent (genomic_sample / epigenomic_sample) is carried here as ServiceRequest.code; Specimen.type remains free for specimen material type. specimen = Reference(BioSample).

A clinical event for a transplant patient, aligned with the DMv1.2 clinical_event table. Event phase (START/END) is represented via native Condition lifecycle. Boolean DM fields are in Condition.evidence.code (presence = true). Free-text fields are in Condition.note. Dialysis episodes, retransplantation, and transplant-list entry are linked ClinicalEventProcedure resources via Procedure.reasonReference.

Boolean flag associated with a clinical event (DMv1.2 clinical_event table). Each instance represents one true flag. Absence of an instance for a given code means the flag is false. Linked to the parent ClinicalEvent via Observation.focus. The transplant type extension enables organ-specific invariants pc-flag-1 through pc-flag-3.

A procedure sub-event associated with a clinical event (DMv1.2 dialysis episodes, retransplantation, transplant-list entry). Linked to the parent ClinicalEvent Condition via Procedure.reasonReference.

Clinical variables recorded for a transplant patient at a visit, aligned with the DMv1.2 clinical_variable table. Captures weight, height, diuresis, and concomitant disease(s). Vital signs (BP, HR, O2, temperature) moved to the VitalSign profile in DMv1.2.

Concomitant medication record for a transplant patient at a visit, aligned with the DMv1.2 concomitant_medication table.

Type of liver graft (complete vs partial) captured as an Observation (LOINC 74836-8). Only applicable for liver or combined transplants — invariant pc-donor-1 enforces this when tx_type extension is present.

Dialysis method prior to kidney transplantation (LOINC 70958-4). Only applicable for kidney or combined transplants — invariant pc-donor-2 enforces this when tx_type extension is present.

Immunological data panel for a transplant patient at a given visit, aligned with the DMv1.2 immunological_data table. Covers ABO/Rh blood typing, HLA allele typing (IMGT/HLA notation), DSA, Banff category, C4d, ANCA, and related fields.

Conformance: Systems producing this resource SHALL populate identifier, status, category, code, subject, encounter, and at least one component. Systems consuming this resource SHALL be able to process all defined components.

Immunosuppressive drug catalogue entry. imm_id is carried as an identifier; the drug name maps to Medication.code.

Pharmacokinetic monitoring result (pre-dose trough level, 2 h post-dose level / C2, or AUC) for an immunosuppressant therapy record. Linked to the parent ImmPat MedicationStatement via Observation.partOf. Use Observation.subject to carry the patient directly for FHIR searchability.

Immunosuppressive treatment record for a transplant patient (induction or maintenance), aligned with the DMv1.2 imm_pat table. Covers both induction and maintenance phases via MedicationStatement.category. Patient is navigable via context (Visit) → Visit.subject. Pharmacokinetic monitoring values (pre_dose_level, csa_2h_post_dose_level, auc) are represented as linked ImmPatPKObservation resources via Observation.partOf.

Catalogue entry for an instrumental investigation test type, aligned with the instrumental_investigation table.

Individual laboratory result for a transplant recipient, aligned with the lab_result table.

Definition of a laboratory test (catalogue entry), aligned with the lab_test table. Systems SHALL use LOINC codes from LabTestNameVS as the primary code. Local codes from LabTestLocalCS SHALL only be used for calculated values without a single unambiguous LOINC code.

Laboratory report grouping one or more lab result observations for a transplant recipient.

Microbiology panel for transplant recipients and/or donors. Component slices cover virology (EBV, CMV, Parvovirus B19, HSV, Adenovirus, VZV, BKV) plus organ-specific findings. The transplant type (extension[tx-type]) is required when organ-specific components are populated; invariants pc-micro-1 through pc-micro-4 enforce applicability.

Panel Observation for patient or donor age at transplant (age_years, age_months). Category is #survey to distinguish from laboratory results. One instance per patient or donor. Subject accepts PatientTransplant or Donor.

Instrumental investigation performed on a transplant patient, aligned with the pat_inst_inv table. All DM fields map to native Observation elements — no extensions.

Primary liver disease diagnosis that led to transplantation, aligned with DMv1.2 diag_primary_disease and date_diag_primary_disease. date_diag_primary_disease maps to Condition.onsetDateTime.

Panel Observation for pre-transplant immunological scalar facts: maximum PRA, most recent PRA, and histological diagnosis date. Category is #laboratory. One instance per transplant recipient. ABO/Rh and HLA typing are in ImmunologicalData.

Primary renal disease diagnosis that led to transplantation, aligned with DMv1.2 diag_primary_disease and date_diag_primary_disease. date_diag_primary_disease maps to Condition.onsetDateTime.

Pre-transplant medication record aligned with the pre_medication table.

A subsidiary pre-transplant medication record (rituximab desensitisation or antiviral prophylaxis) linked to its parent PreMedication via MedicationStatement.partOf. status #completed = given; status #not-taken = explicitly not given.

A PROTECT-CHILD participating transplant centre. center_no (1–4) is carried as identifier.value in the study-centre namespace. All PatientTransplant resources reference their centre via Patient.managingOrganization.

Procedure profile representing a transplant, aligned with DMv1.2 transplant table. The donor is linked via extension[donor_id]. The associated Visit is linked natively via Procedure.encounter. Intraoperative details are represented as a single TransplantDetails panel Observation linked via Observation.partOf.

Intraoperative and peri-operative details panel for a transplant, aligned with the DMv1.2 transplant table. All detail fields are components of a single Observation linked to the Transplant Procedure via Observation.partOf. One instance per transplant. The mandatory txType component carries the transplant type (liver / kidney / combined) so organ-specific invariants (pc-td-1 through pc-td-5) can be evaluated without cross-resource resolution.

Transplant donor profile based on the FHIR Patient resource, aligned with the donor table.

Transplant recipient profile based on the FHIR Patient resource, aligned with the DMv1.2 patient table. Blood group, Rh, and HLA data are in ImmunologicalData. Age at transplant is in PatientDemographicsObservation; PRA and histological date are in PatientImmunologyObservation. Patient.birthDate SHOULD also be populated when known. Primary disease diagnoses are PatientLiverDiseaseDiagnosis / PatientRenalDiseaseDiagnosis (Condition).

Encounter profile representing a visit in the transplant follow-up schedule. All clinical resources back-reference this Visit via their native encounter/context element or a slim extension on the resource itself. No extensions are needed on Visit.

Vital signs panel for a transplant patient at a visit, aligned with the DMv1.2 vital_sign table. Captures standard vitals plus ABPM (24-hour ambulatory blood pressure) metrics.

Reference to the donor associated with this transplant.

Records the transplant type (liver / kidney / combined) on resources that carry organ-specific data fields, enabling organ-specific FHIRPath invariants within a single resource.

visit_id – reference to the Visit during which this sample was collected.

ABO blood groups for transplant recipients and donors.

Allowed analysis type codes for BioSampleAnalysisRequest.code.

Codes for ClinicalEventFlagObservation.code — one per boolean DM flag on the clinical_event table. Presence of an Observation with this code means the flag is true.

Allowed procedure types for ClinicalEventProcedure.

Allowed clinical event types in the PROTECT-CHILD study (DMv1.2).

Allowed concomitant disease codes in clinical_variable (DMv1.2).

Dialysis method values using LOINC answer codes.

Allowed UCUM dose units for immunosuppressant therapy records (DMv1.2 imm_pat.unit field).

ValueSet of immunosuppressive drug types.

Allowed PK observation types for ImmPatPKObservation.

Allowed phase values for MedicationStatement.category on ImmPat records.

ValueSet of instrumental investigation tests conducted.

Allowed intraoperative complications during transplantation.

Allowed UCUM units of measurement for lab result values (DMv1.2 unit field).

Allowed laboratory test names for the PROTECT-CHILD data model. LOINC codes are used as the primary standard; local codes from LabTestLocalCS are used only for calculated or composite measures without a single unambiguous LOINC equivalent.

Allowed results for the instrumental investigation test (Normal, Abnormal).

Allowed antihypertensive drugs for antihypertensive_treatment.

Allowed codes for transplant detail Observation components.

Allowed transplant types.

Allowed types of biliary anastomosis in liver transplant.

Allowed ureteral graft anastomosis types.

Allowed types of visits in the transplant follow-up schedule (DMv1.2).

ABO blood groups for transplant recipients and donors.

Banff working classification of kidney/liver allograft pathology categories (Solez et al.). See https://www.banfffoundation.org/ for the full classification.

Intended omics analysis type for a biological sample. Used as the ServiceRequest.code on BioSampleAnalysisRequest resources.

Coded findings used in Condition.evidence.code to represent boolean DM fields. Presence of a code means the flag is true; absence means false.

Types of procedures linked to a ClinicalEvent via ClinicalEventProcedure.reasonReference. Used for dialysis episodes, retransplantation, and transplant-list entry (DMv1.2).

Types of clinical events in the PROTECT-CHILD study (DMv1.2), replacing outcome_type and post_event_type.

Local codes for ClinicalVariable Observation component slices that are not covered by LOINC. Currently used for the concomitant_disease repeating component.

Concomitant disease codes used in the DMv1.2 clinical_variable table. Coded values are carried as ClinicalVariable Observation components (component[concomitant_disease]).

Post-transplant donor-specific antibody HLA class.

Type of liver donation (complete vs partial).

Local component codes for immunological data panel slices. HLA allele positions use per-position codes (hla-a-1, hla-a-2, …) so that pattern-discriminator slicing can distinguish allele 1 from allele 2. Non-HLA codes cover DSA, Banff, C4d, ANCA, and related fields.

Local code for the PROTECT-CHILD composite immunological data panel, which covers ABO/Rh typing, HLA allele typing, DSA, Banff category, C4d, and ANCA.

Types of immunosuppressive drugs used in the transplant setting.

Types of pharmacokinetic monitoring observations for immunosuppressant therapy (DMv1.2 pre_dose_level, csa_2h_post_dose_level, auc).

Whether the immunosuppressant record is for induction or maintenance phase (DMv1.2). Used as MedicationStatement.category codes.

Types of instrumental investigation tests conducted (expanded for DMv1.2).

Intraoperative complications during transplantation (liver or kidney).

Local codes for laboratory tests that do not have a single unambiguous LOINC code in the PROTECT-CHILD context (e.g., calculated values or composite measures).

Mean fluorescence intensity category for DSA.

Local codes for microbiology panel Observation components.

Distinguishes maximum (historical) vs most recent PRA measurements. Used as component codes in PatientImmunologyObservation.

Result of the instrumental investigation test conducted (Normal / Abnormal).

Local codes for PROTECT-CHILD patient observation panels.

Antihypertensive drugs used as pre-transplant medication.

Rh factor for transplant recipients and donors.

Codes for transplant-level details captured as Observation components.

Type of solid-organ transplant (liver, kidney, combined liver-kidney).

Types of biliary anastomosis used in liver transplantation.

Types of ureteral graft anastomosis used in transplantation (DMv1.2).

Types of vascular complications in transplant (DMv1.2).

Type of visit in the transplant follow-up schedule.

Local codes for ABPM-derived metrics that have no published LOINC code: systolic/diastolic blood pressure load and nocturnal dip percentages.

Namespace for PROTECT-CHILD study centre identifiers (center_no = 1–4).

Example biological sample aligned with DMv1.2. genomic_sample=true, epigenomic_sample=false.

Hemodialysis episode linked to a clinical event via reasonReference.

Retransplantation event linked to the graft-failure clinical event. retransplantation=true is implicit from the existence of this resource.

Date patient was listed for retransplantation, linked to the triggering clinical event.

Example clinical event recording the start of a kidney rejection episode at a 3-month visit.

Example clinical variables for a transplant patient at a 1-month follow-up visit (DMv1.2).

Example ongoing concomitant antihypertensive medication (DMv1.2).

Tacrolimus trough level (C0) linked to the maintenance ImmPat record via partOf.

Example immunological data panel for a liver transplant recipient at 1-month visit.

Methylprednisolone as an immunosuppressant catalogue entry.

Example induction immunosuppressant record (methylprednisolone) at time of transplant.

Example maintenance immunosuppressant record (tacrolimus) at 1-month visit. PK monitoring values are separate ImmPatPKObservation resources linked via Observation.partOf.

Example instrumental investigation catalogue entry — Liver doppler ultrasound.

Example creatinine result for a transplant recipient.

Example lab test catalogue entry — Albumin, reported in g/dL.

Example lab report grouping a single creatinine result.

Example microbiology panel for a liver transplant recipient.

Example liver doppler ultrasound result for a transplant recipient.

Example record of pre-transplant medications for a liver transplant recipient.

Example transplant details panel for a liver transplant (DMv1.2).

Example vital signs panel for a transplant recipient at 1-month visit.

Age at donation for the transplant donor (PatientDemographicsObservation; subject = Reference(Donor)).

Complete liver graft from a deceased donor.

Hemodialysis prior to kidney transplant.

ServiceRequest representing genomic_sample = true for BioSampleExample1.

Age at transplant for the recipient (PatientDemographicsObservation).

Primary liver disease diagnosis leading to transplantation.

PRA and histological diagnosis date for the recipient (PatientImmunologyObservation).

Primary renal disease diagnosis leading to transplantation.

Example transplant instance mapped from the DMv1.2 transplant table.

Example Patient instance conforming to Donor.

Example Patient instance conforming to DMv1.2 PatientTransplant.

Example visit. Clinical resources (ClinicalVariable, Microbiology, PreMedication, etc.) carry the back-reference to this Visit via their own .encounter / .context element or extension.

La Paz University Hospital, Madrid, Spain (center_no = 1).

University of Padova, Italy (center_no = 2).

Son Espases University Hospital, Palma, Spain (center_no = 3).

University Medical Centre Hamburg-Eppendorf, Germany (center_no = 4).