PackagesCanonicalsLogsProblems
    Packages
    hl7.fhir.uv.ebm@1.0.0-ballot2
    http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report
description: Profile of Composition for Evidence Based Medicine IG. The M11Report Profile is used for the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Clinical Electronic Structured Harmonised Protocol (CeSHarP) M11 Technical Specification.
package_name: hl7.fhir.uv.ebm
derivation: constraint
name: M11Report
type: Composition
elements:
  type:
    elements:
      coding:
        pattern:
          type: Coding
          value: {code: 35528-9, system: 'http://loinc.org', display: Clinical trial protocol Clinical trial protocol}
        index: 0
      text:
        pattern: {type: String, value: CeSHarP Report}
        index: 1
    required: [coding]
  section:
    array: true
    min: 15
    index: 2
    slicing:
      rules: open
      discriminator:
      - {path: code.text, type: value}
      min: 15
      slices:
        intervention:
          match:
            code: {text: section6-trial-intervention}
          schema:
            mustSupport: true
            _required: true
            index: 206
            elements:
              title:
                pattern: {type: String, value: Trial Intervention and Concomitant Therapy}
                index: 207
              code:
                elements:
                  text:
                    pattern: {type: String, value: section6-trial-intervention}
                    index: 208
                required: [text]
              text: {index: 209}
              section:
                array: true
                min: 9
                index: 210
                slicing:
                  rules: open
                  discriminator:
                  - {path: code.text, type: value}
                  min: 9
                  slices:
                    description:
                      match:
                        code: {text: section6.1-description-of-trial-intervention}
                      schema:
                        type: BackboneElement
                        mustSupport: true
                        _required: true
                        index: 211
                        elements:
                          title:
                            pattern: {type: String, value: Description of Investigational Trial Intervention}
                            index: 212
                          code:
                            elements:
                              text:
                                pattern: {type: String, value: section6.1-description-of-trial-intervention}
                                index: 213
                            required: [text]
                          text: {index: 214}
                          entry:
                            type: Reference
                            refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/conceptual-exposure-definition']
                            index: 215
                        required: [text]
                    treatmentOfOverdose:
                      match:
                        code: {text: section6.5-management-of-overdose}
                      schema:
                        type: BackboneElement
                        mustSupport: true
                        _required: true
                        index: 231
                        elements:
                          title:
                            pattern: {type: String, value: Management of Investigational Trial Intervention Overdose}
                            index: 232
                          code:
                            elements:
                              text:
                                pattern: {type: String, value: section6.5-management-of-overdose}
                                index: 233
                            required: [text]
                          text: {index: 234}
                          entry:
                            type: Reference
                            refers: ['http://hl7.org/fhir/StructureDefinition/ActivityDefinition', 'http://hl7.org/fhir/StructureDefinition/PlanDefinition']
                            index: 235
                        required: [text]
                    assignmentAndBlinding:
                      match:
                        code: {text: section6.7-assignment-randomisation-blinding}
                      schema:
                        type: BackboneElement
                        mustSupport: true
                        _required: true
                        index: 252
                        elements:
                          title:
                            pattern: {type: String, value: 'Investigational Trial Intervention Assignment, Randomisation and Blinding'}
                            index: 253
                          code:
                            elements:
                              text:
                                pattern: {type: String, value: section6.7-assignment-randomisation-blinding}
                                index: 254
                            required: [text]
                          section:
                            array: true
                            min: 4
                            index: 255
                            slicing:
                              rules: open
                              discriminator:
                              - {path: code.text, type: value}
                              min: 4
                              slices:
                                assignment:
                                  match:
                                    code: {text: section6.7.1-assignment}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    _required: true
                                    index: 256
                                    elements:
                                      title:
                                        pattern: {type: String, value: Participant Assignment to Investigational Trial Intervention}
                                        index: 257
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section6.7.1-assignment}
                                            index: 258
                                        required: [text]
                                      text: {index: 259}
                                    required: [text]
                                randomisation:
                                  match:
                                    code: {text: section6.7.2-randomisation}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    _required: true
                                    index: 260
                                    elements:
                                      title:
                                        pattern: {type: String, value: Randomisation}
                                        index: 261
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section6.7.2-randomisation}
                                            index: 262
                                        required: [text]
                                      text: {index: 263}
                                    required: [text]
                                blinding:
                                  match:
                                    code: {text: section6.7.3-blinding}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    _required: true
                                    index: 264
                                    elements:
                                      title:
                                        pattern: {type: String, value: Measures to Maintain Blinding}
                                        index: 265
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section6.7.3-blinding}
                                            index: 266
                                        required: [text]
                                      text: {index: 267}
                                    required: [text]
                                unblinding:
                                  match:
                                    code: {text: section6.7.4-unblinding}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    _required: true
                                    index: 268
                                    elements:
                                      title:
                                        pattern: {type: String, value: Emergency Unblinding at the Site}
                                        index: 269
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section6.7.4-unblinding}
                                            index: 270
                                        required: [text]
                                      text: {index: 271}
                                    required: [text]
                    dosingAdministration:
                      match:
                        code: {text: section6.3-dosing-and-administration}
                      schema:
                        type: BackboneElement
                        mustSupport: true
                        _required: true
                        index: 221
                        elements:
                          title:
                            pattern: {type: String, value: Investigational Trial Intervention Administration}
                            index: 222
                          code:
                            elements:
                              text:
                                pattern: {type: String, value: section6.3-dosing-and-administration}
                                index: 223
                            required: [text]
                          text: {index: 224}
                          entry:
                            type: Reference
                            refers: ['http://hl7.org/fhir/StructureDefinition/ActivityDefinition']
                            index: 225
                        required: [text]
                    preparation:
                      match:
                        code: {text: section6.6-preparation-storage-handling}
                      schema:
                        type: BackboneElement
                        mustSupport: true
                        _required: true
                        index: 236
                        elements:
                          title:
                            pattern: {type: String, value: 'Preparation, Storage, Handling and Accountability of Investigational Trial Intervention'}
                            index: 237
                          code:
                            elements:
                              text:
                                pattern: {type: String, value: section6.6-preparation-storage-handling}
                                index: 238
                            required: [text]
                          section:
                            array: true
                            min: 3
                            index: 239
                            slicing:
                              rules: open
                              discriminator:
                              - {path: code.text, type: value}
                              min: 3
                              slices:
                                preparationIntervention:
                                  match:
                                    code: {text: section6.6.1-preparation}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    _required: true
                                    index: 240
                                    elements:
                                      title:
                                        pattern: {type: String, value: Preparation of Investigational Trial Intervention}
                                        index: 241
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section6.6.1-preparation}
                                            index: 242
                                        required: [text]
                                      text: {index: 243}
                                    required: [text]
                                storageHandling:
                                  match:
                                    code: {text: section6.6.2-storage-handling}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    _required: true
                                    index: 244
                                    elements:
                                      title:
                                        pattern: {type: String, value: Storage and Handling of Investigational Trial Intervention}
                                        index: 245
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section6.6.2-storage-handling}
                                            index: 246
                                        required: [text]
                                      text: {index: 247}
                                    required: [text]
                                accountability:
                                  match:
                                    code: {text: section6.6.3-accountability}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    _required: true
                                    index: 248
                                    elements:
                                      title:
                                        pattern: {type: String, value: Accountability of Investigational Trial Intervention}
                                        index: 249
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section6.6.3-accountability}
                                            index: 250
                                        required: [text]
                                      text: {index: 251}
                                    required: [text]
                    adherence:
                      match:
                        code: {text: section6.8-intervention-adherence}
                      schema:
                        type: BackboneElement
                        mustSupport: true
                        _required: true
                        index: 272
                        elements:
                          title:
                            pattern: {type: String, value: Investigational Trial Intervention Adherence}
                            index: 273
                          code:
                            elements:
                              text:
                                pattern: {type: String, value: section6.8-intervention-adherence}
                                index: 274
                            required: [text]
                          text: {index: 275}
                        required: [text]
                    rationale:
                      match:
                        code: {text: section6.2-rationale-for-trial-intervention-regimen}
                      schema:
                        type: BackboneElement
                        mustSupport: true
                        _required: true
                        index: 216
                        elements:
                          title:
                            pattern: {type: String, value: Rationale for Investigational Trial Intervention Dose and Regimen}
                            index: 217
                          code:
                            elements:
                              text:
                                pattern: {type: String, value: section6.2-rationale-for-trial-intervention-regimen}
                                index: 218
                            required: [text]
                          text: {index: 219}
                          entry:
                            type: Reference
                            refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/conceptual-exposure-definition']
                            index: 220
                        required: [text]
                    noninvestigationalTherapy:
                      match:
                        code: {text: section6.9-noninvestigational-interventions}
                      schema:
                        type: BackboneElement
                        mustSupport: true
                        index: 276
                        elements:
                          title:
                            pattern: {type: String, value: Non-Investigational Trial Intervention}
                            index: 277
                          code:
                            elements:
                              text:
                                pattern: {type: String, value: section6.9-noninvestigational-interventions}
                                index: 278
                            required: [text]
                          text: {index: 279}
                          section:
                            index: 280
                            slicing:
                              rules: open
                              discriminator:
                              - {path: code.text, type: value}
                              min: null
                              slices:
                                background:
                                  match:
                                    code: {text: section6.9.1-background-intervention}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    index: 281
                                    elements:
                                      title:
                                        pattern: {type: String, value: Background Trial Intervention}
                                        index: 282
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section6.9.1-background-intervention}
                                            index: 283
                                        required: [text]
                                      text: {index: 284}
                                    required: [text]
                                rescue:
                                  match:
                                    code: {text: section6.9.2-rescue-therapy}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    index: 285
                                    elements:
                                      title:
                                        pattern: {type: String, value: Rescue Therapy}
                                        index: 286
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section6.9.2-rescue-therapy}
                                            index: 287
                                        required: [text]
                                      text: {index: 288}
                                    required: [text]
                                other:
                                  match:
                                    code: {text: section6.9.3-other-therapy}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    index: 289
                                    elements:
                                      title:
                                        pattern: {type: String, value: Other Noninvestigational Trial Intervention}
                                        index: 290
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section6.9.3-other-therapy}
                                            index: 291
                                        required: [text]
                                      text: {index: 292}
                                    required: [text]
                        required: [text]
                    doseModification:
                      match:
                        code: {text: section6.4-dose-modification}
                      schema:
                        type: BackboneElement
                        mustSupport: true
                        index: 226
                        elements:
                          title:
                            pattern: {type: String, value: Investigational Trial Intervention Dose Modification}
                            index: 227
                          code:
                            elements:
                              text:
                                pattern: {type: String, value: section6.4-dose-modification}
                                index: 228
                            required: [text]
                          text: {index: 229}
                          entry:
                            type: Reference
                            refers: ['http://hl7.org/fhir/StructureDefinition/ActivityDefinition']
                            index: 230
                        required: [text]
                    concomitantTherapy:
                      match:
                        code: {text: section6.10-concomitant-therapy}
                      schema:
                        type: BackboneElement
                        mustSupport: true
                        _required: true
                        index: 293
                        elements:
                          title:
                            pattern: {type: String, value: Concomitant Therapy}
                            index: 294
                          code:
                            elements:
                              text:
                                pattern: {type: String, value: section6.10-concomitant-therapy}
                                index: 295
                            required: [text]
                          text: {index: 296}
                          section:
                            index: 297
                            slicing:
                              rules: open
                              discriminator:
                              - {path: code.text, type: value}
                              min: null
                              slices:
                                prohibited:
                                  match:
                                    code: {text: section6.10.1-prohibited-concomitant-therapy}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    index: 298
                                    elements:
                                      title:
                                        pattern: {type: String, value: Prohibited Concomitant Therapy}
                                        index: 299
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section6.10.1-prohibited-concomitant-therapy}
                                            index: 300
                                        required: [text]
                                      text: {index: 301}
                                    required: [text]
                                permitted:
                                  match:
                                    code: {text: section6.10.2-permitted-concomitant-therapy}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    index: 302
                                    elements:
                                      title:
                                        pattern: {type: String, value: Permitted Concomitant Therapy}
                                        index: 303
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section6.10.2-permitted-concomitant-therapy}
                                            index: 304
                                        required: [text]
                                      text: {index: 305}
                                    required: [text]
                        required: [text]
        assessments:
          match:
            code: {text: section8-assessments}
          schema:
            mustSupport: true
            _required: true
            index: 334
            elements:
              title:
                pattern: {type: String, value: Trial Assessments and Procedures}
                index: 335
              code:
                elements:
                  text:
                    pattern: {type: String, value: section8-assessments}
                    index: 336
                required: [text]
              section:
                array: true
                min: 8
                index: 337
                slicing:
                  rules: open
                  discriminator:
                  - {path: code.text, type: value}
                  min: 8
                  slices:
                    considerations:
                      match:
                        code: {text: section8.1-assessments-procedures}
                      schema:
                        type: BackboneElement
                        mustSupport: true
                        index: 338
                        elements:
                          title:
                            pattern: {type: String, value: Trial Assessments and Procedures Considerations}
                            index: 339
                          code:
                            elements:
                              text:
                                pattern: {type: String, value: section8.1-assessments-procedures}
                                index: 340
                            required: [text]
                          text: {index: 341}
                        required: [text]
                    screeningBaseline:
                      match:
                        code: {text: section8.2-screening-baseline-assessments}
                      schema:
                        type: BackboneElement
                        mustSupport: true
                        _required: true
                        index: 342
                        elements:
                          title:
                            pattern: {type: String, value: Screening/Baseline Assessments and Procedures}
                            index: 343
                          code:
                            elements:
                              text:
                                pattern: {type: String, value: section8.2-screening-baseline-assessments}
                                index: 344
                            required: [text]
                          text: {index: 345}
                        required: [text]
                    efficacy:
                      match:
                        code: {text: section8.3-efficacy-assessments}
                      schema:
                        type: BackboneElement
                        mustSupport: true
                        _required: true
                        index: 346
                        elements:
                          title:
                            pattern: {type: String, value: Efficacy Assessments and Procedures}
                            index: 347
                          code:
                            elements:
                              text:
                                pattern: {type: String, value: section8.3-efficacy-assessments}
                                index: 348
                            required: [text]
                          text: {index: 349}
                        required: [text]
                    safety:
                      match:
                        code: {text: section8.4-safety-assessments}
                      schema:
                        type: BackboneElement
                        mustSupport: true
                        _required: true
                        index: 350
                        elements:
                          title:
                            pattern: {type: String, value: Safety Assessments and Procedures}
                            index: 351
                          code:
                            elements:
                              text:
                                pattern: {type: String, value: section8.4-safety-assessments}
                                index: 352
                            required: [text]
                          text: {index: 353}
                          section:
                            index: 354
                            slicing:
                              rules: open
                              discriminator:
                              - {path: code.text, type: value}
                              min: null
                              slices:
                                physical:
                                  match:
                                    code: {text: section8.4.1-physical-examination}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    index: 355
                                    elements:
                                      title:
                                        pattern: {type: String, value: Physical Examination}
                                        index: 356
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section8.4.1-physical-examination}
                                            index: 357
                                        required: [text]
                                      text: {index: 358}
                                    required: [text]
                                vitals:
                                  match:
                                    code: {text: section8.4.2-vital-signs}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    index: 359
                                    elements:
                                      title:
                                        pattern: {type: String, value: Vital Signs}
                                        index: 360
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section8.4.2-vital-signs}
                                            index: 361
                                        required: [text]
                                      text: {index: 362}
                                    required: [text]
                                ecg:
                                  match:
                                    code: {text: section8.4.3-electrocardiograms}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    index: 363
                                    elements:
                                      title:
                                        pattern: {type: String, value: Electrocardiograms}
                                        index: 364
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section8.4.3-electrocardiograms}
                                            index: 365
                                        required: [text]
                                      text: {index: 366}
                                    required: [text]
                                laboratory:
                                  match:
                                    code: {text: section8.4.4-clinical-laboratory-assessments}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    index: 367
                                    elements:
                                      title:
                                        pattern: {type: String, value: Clinical Laboratory Assessments}
                                        index: 368
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section8.4.4-clinical-laboratory-assessments}
                                            index: 369
                                        required: [text]
                                      text: {index: 370}
                                    required: [text]
                                pregnancy:
                                  match:
                                    code: {text: section8.4.5-pregnancy-testing}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    index: 371
                                    elements:
                                      title:
                                        pattern: {type: String, value: Pregnancy Testing}
                                        index: 372
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section8.4.5-pregnancy-testing}
                                            index: 373
                                        required: [text]
                                      text: {index: 374}
                                    required: [text]
                                suicidal:
                                  match:
                                    code: {text: section8.4.6-suicidal-ideation}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    index: 375
                                    elements:
                                      title:
                                        pattern: {type: String, value: Suicidal Ideation and Behaviour Risk Monitoring}
                                        index: 376
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section8.4.6-suicidal-ideation}
                                            index: 377
                                        required: [text]
                                      text: {index: 378}
                                    required: [text]
                    pharmacokinetics:
                      match:
                        code: {text: section8.5-pharmacokinetics}
                      schema:
                        type: BackboneElement
                        mustSupport: true
                        _required: true
                        index: 379
                        elements:
                          title:
                            pattern: {type: String, value: Pharmacokinetics}
                            index: 380
                          code:
                            elements:
                              text:
                                pattern: {type: String, value: section8.5-pharmacokinetics}
                                index: 381
                            required: [text]
                          text: {index: 382}
                        required: [text]
                    biomarkers:
                      match:
                        code: {text: section8.6-biomarkers}
                      schema:
                        type: BackboneElement
                        mustSupport: true
                        _required: true
                        index: 383
                        elements:
                          title:
                            pattern: {type: String, value: Biomarkers}
                            index: 384
                          code:
                            elements:
                              text:
                                pattern: {type: String, value: section8.6-biomarkers}
                                index: 385
                            required: [text]
                          text: {index: 386}
                          section:
                            array: true
                            min: 2
                            index: 387
                            slicing:
                              rules: open
                              discriminator:
                              - {path: code.text, type: value}
                              min: 2
                              slices:
                                genetics:
                                  match:
                                    code: {text: section8.6.1-genetics-pharmacogenomics}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    _required: true
                                    index: 388
                                    elements:
                                      title:
                                        pattern: {type: String, value: Genetics and Pharmacogenomics}
                                        index: 389
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section8.6.1-genetics-pharmacogenomics}
                                            index: 390
                                        required: [text]
                                      text: {index: 391}
                                    required: [text]
                                pharmacodynamics:
                                  match:
                                    code: {text: section8.6.2-pharmacodynamics}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    _required: true
                                    index: 392
                                    elements:
                                      title:
                                        pattern: {type: String, value: Pharmacodynamic Biomarkers}
                                        index: 393
                                      code:
                                        elements:
                                          text:
                                            pattern: {type: String, value: section8.6.2-pharmacodynamics}
                                            index: 394
                                        required: [text]
                                      text: {index: 395}
                                    required: [text]
                                other:
                                  match:
                                    code: {text: section8.6.3-other-biomarkers}
                                  schema:
                                    type: BackboneElement
                                    mustSupport: true
                                    index: 396
                                    elements:
                                      title:
                                        pattern: {type: String, value: Other Biomarkers}
                                        index: 397
                                      code:
                                        elements:
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package_version: 1.0.0-ballot2
class: profile
kind: resource
url: http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-report
base: http://hl7.org/fhir/uv/ebm/StructureDefinition/evidence-report
version: 1.0.0-ballot2