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: category: index: 0 slicing: rules: open discriminator: - {path: text, type: value} min: 1 slices: m11report: match: {text: CeSHarP Report} schema: mustSupport: true _required: true index: 1 elements: text: pattern: {type: String, value: CeSHarP Report} index: 2 required: [text] section: array: true min: 15 index: 3 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: 214 elements: title: pattern: {type: String, value: Trial Intervention} index: 215 code: elements: text: pattern: {type: String, value: section6-trial-intervention} index: 216 required: [text] section: array: true min: 8 index: 217 slicing: rules: open discriminator: - {path: code.text, type: value} min: 8 slices: description: match: code: {text: section6.1-description-of-trial-intervention} schema: type: BackboneElement mustSupport: true _required: true index: 218 elements: title: pattern: {type: String, value: Description of Investigational Trial Intervention} index: 219 code: elements: text: pattern: {type: String, value: section6.1-description-of-trial-intervention} index: 220 required: [text] text: {index: 221} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/exposure-definition'] index: 222 required: [text] treatmentOfOverdose: match: code: {text: section6.4-management-of-overdose} schema: type: BackboneElement mustSupport: true _required: true index: 239 elements: title: pattern: {type: String, value: Management of Investigational Trial Intervention Overdose} index: 240 code: elements: text: pattern: {type: String, value: section6.4-management-of-overdose} index: 241 required: [text] text: {index: 242} entry: type: Reference refers: ['http://hl7.org/fhir/StructureDefinition/ActivityDefinition', 'http://hl7.org/fhir/StructureDefinition/PlanDefinition'] index: 243 required: [text] assignmentAndBlinding: match: code: {text: section6.6-assignment-randomisation-blinding} schema: type: BackboneElement mustSupport: true _required: true index: 260 elements: title: pattern: {type: String, value: 'Investigational Trial Intervention Assignment, Randomisation and Blinding'} index: 261 code: elements: text: pattern: {type: String, value: section6.6-assignment-randomisation-blinding} index: 262 required: [text] section: array: true min: 4 index: 263 slicing: rules: open discriminator: - {path: code.text, type: value} min: 4 slices: assignment: match: code: {text: section6.6.1-assignment} schema: type: BackboneElement mustSupport: true _required: true index: 264 elements: title: pattern: {type: String, value: Participant Assignment to Investigational Trial Intervention} index: 265 code: elements: text: pattern: {type: String, value: section6.6.1-assignment} index: 266 required: [text] text: {index: 267} required: [text] randomisation: match: code: {text: section6.6.2-randomisation} schema: type: BackboneElement mustSupport: true _required: true index: 268 elements: title: pattern: {type: String, value: Randomisation} index: 269 code: elements: text: pattern: {type: String, value: section6.6.2-randomisation} index: 270 required: [text] text: {index: 271} required: [text] blinding: match: code: {text: section6.6.3-blinding} schema: type: BackboneElement mustSupport: true _required: true index: 272 elements: title: pattern: {type: String, value: Blinding} index: 273 code: elements: text: pattern: {type: String, value: section6.6.3-blinding} index: 274 required: [text] text: {index: 275} required: [text] unblinding: match: code: {text: section6.6.4-unblinding} schema: type: BackboneElement mustSupport: true _required: true index: 276 elements: title: pattern: {type: String, value: Emergency Unblinding at the Site} index: 277 code: elements: text: pattern: {type: String, value: section6.6.4-unblinding} index: 278 required: [text] text: {index: 279} required: [text] dosingAdministration: match: code: {text: section6.3-dosing-and-administration} schema: type: BackboneElement mustSupport: true _required: true index: 228 elements: title: pattern: {type: String, value: Investigational Trial Intervention Administration} index: 229 code: elements: text: pattern: {type: String, value: section6.3-dosing-and-administration} index: 230 required: [text] text: {index: 231} entry: type: Reference refers: ['http://hl7.org/fhir/StructureDefinition/ActivityDefinition'] index: 232 section: index: 233 slicing: rules: open discriminator: - {path: code.text, type: value} min: null slices: doseModification: match: code: {text: section6.3.1-dose-modification} schema: type: BackboneElement mustSupport: true index: 234 elements: title: pattern: {type: String, value: Investigational Trial Intervention Dose Modification} index: 235 code: elements: text: pattern: {type: String, value: section6.3.1-dose-modification} index: 236 required: [text] text: {index: 237} entry: type: Reference refers: ['http://hl7.org/fhir/StructureDefinition/ActivityDefinition'] index: 238 required: [text] required: [text] preparation: match: code: {text: section6.5-preparation-storage-handling} schema: type: BackboneElement mustSupport: true _required: true index: 244 elements: title: pattern: {type: String, value: 'Preparation, Storage, Handling and Accountability of Investigational Trial Intervention(s)'} index: 245 code: elements: text: pattern: {type: String, value: section6.5-preparation-storage-handling} index: 246 required: [text] section: array: true min: 3 index: 247 slicing: rules: open discriminator: - {path: code.text, type: value} min: 3 slices: preparationIntervention: match: code: {text: section6.5.1-preparation} schema: type: BackboneElement mustSupport: true _required: true index: 248 elements: title: pattern: {type: String, value: Preparation of Investigational Trial Intervention(s)} index: 249 code: elements: text: pattern: {type: String, value: section6.5.1-preparation} index: 250 required: [text] text: {index: 251} required: [text] storageHandling: match: code: {text: section6.5.2-storage-handling} schema: type: BackboneElement mustSupport: true _required: true index: 252 elements: title: pattern: {type: String, value: Storage and Handling of Investigational Trial Intervention} index: 253 code: elements: text: pattern: {type: String, value: section6.5.2-storage-handling} index: 254 required: [text] text: {index: 255} required: [text] accountability: match: code: {text: section6.5.3-accountability} schema: type: BackboneElement mustSupport: true _required: true index: 256 elements: title: pattern: {type: String, value: Accountability of Investigational Trial Intervention} index: 257 code: elements: text: pattern: {type: String, value: section6.5.3-accountability} index: 258 required: [text] text: {index: 259} required: [text] rationale: match: code: {text: section6.2-rationale-for-trial-intervention-regimen} schema: type: BackboneElement mustSupport: true _required: true index: 223 elements: title: pattern: {type: String, value: Rationale for Investigational Trial Intervention Dose and Regimen} index: 224 code: elements: text: pattern: {type: String, value: section6.2-rationale-for-trial-intervention-regimen} index: 225 required: [text] text: {index: 226} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/exposure-definition'] index: 227 required: [text] noninvestigationalTherapy: match: code: {text: section6.8-noninvestigational-interventions} schema: type: BackboneElement mustSupport: true index: 284 elements: title: pattern: {type: String, value: Non-Investigational Trial Intervention(s)} index: 285 code: elements: text: pattern: {type: String, value: section6.8-noninvestigational-interventions} index: 286 required: [text] section: index: 287 slicing: rules: open discriminator: - {path: code.text, type: value} min: null slices: background: match: code: {text: section6.8.1-background-intervention} schema: type: BackboneElement mustSupport: true index: 288 elements: title: pattern: {type: String, value: Background Intervention} index: 289 code: elements: text: pattern: {type: String, value: section6.8.1-background-intervention} index: 290 required: [text] text: {index: 291} required: [text] rescue: match: code: {text: section6.8.2-rescue-therapy} schema: type: BackboneElement mustSupport: true index: 292 elements: title: pattern: {type: String, value: Rescue Therapy} index: 293 code: elements: text: pattern: {type: String, value: section6.8.2-rescue-therapy} index: 294 required: [text] text: {index: 295} required: [text] other: match: code: {text: section6.8.3-other-therapy} schema: type: BackboneElement mustSupport: true index: 296 elements: title: pattern: {type: String, value: Other Therapy} index: 297 code: elements: text: pattern: {type: String, value: section6.8.3-other-therapy} index: 298 required: [text] text: {index: 299} required: [text] concomitantTherapy: match: code: {text: section6.9-concomitant-therapy} schema: type: BackboneElement mustSupport: true _required: true index: 300 elements: title: pattern: {type: String, value: Concomitant Therapy} index: 301 code: elements: text: pattern: {type: String, value: section6.9-concomitant-therapy} index: 302 required: [text] text: {index: 303} section: index: 304 slicing: rules: open discriminator: - {path: code.text, type: value} min: null slices: prohibited: match: code: {text: section6.9.1-prohibited-concomitant-therapy} schema: type: BackboneElement mustSupport: true index: 305 elements: title: pattern: {type: String, value: Prohibited Concomitant Therapy} index: 306 code: elements: text: pattern: {type: String, value: section6.9.1-prohibited-concomitant-therapy} index: 307 required: [text] text: {index: 308} required: [text] permitted: match: code: {text: section6.9.2-permitted-concomitant-therapy} schema: type: BackboneElement mustSupport: true index: 309 elements: title: pattern: {type: String, value: Permitted Concomitant Therapy} index: 310 code: elements: text: pattern: {type: String, value: section6.9.2-permitted-concomitant-therapy} index: 311 required: [text] text: {index: 312} required: [text] required: [text] compliance: match: code: {text: section6.7-intervention-compliance} schema: type: BackboneElement mustSupport: true _required: true index: 280 elements: title: pattern: {type: String, value: Investigational Trial Intervention Compliance} index: 281 code: elements: text: pattern: {type: String, value: section6.7-intervention-compliance} index: 282 required: [text] text: {index: 283} required: [text] assessments: match: code: {text: section8-assessments} schema: mustSupport: true _required: true index: 345 elements: title: pattern: {type: String, value: Trial Assessments and Procedures} index: 346 code: elements: text: pattern: {type: String, value: section8-assessments} index: 347 required: [text] text: {index: 348} section: array: true min: 8 index: 349 slicing: rules: open discriminator: - {path: code.text, type: value} min: 8 slices: screeningBaseline: match: code: {text: section8.1-screening-baseline-assessments} schema: type: BackboneElement mustSupport: true _required: true index: 350 elements: title: pattern: {type: String, value: Screening/Baseline Assessments and Procedures} index: 351 code: elements: text: pattern: {type: String, value: section8.1-screening-baseline-assessments} index: 352 required: [text] text: {index: 353} required: [text] efficacy: match: code: {text: section8.2-efficacy-assessments} schema: type: BackboneElement mustSupport: true _required: true index: 354 elements: title: pattern: {type: String, value: Efficacy Assessments and Procedures} index: 355 code: elements: text: pattern: {type: String, value: section8.2-efficacy-assessments} index: 356 required: [text] text: {index: 357} required: [text] safety: match: code: {text: section8.3-safety-assessments} schema: type: BackboneElement mustSupport: true _required: true index: 358 elements: title: pattern: {type: String, value: Safety Assessments and Procedures} index: 359 code: elements: text: pattern: {type: String, value: section8.3-safety-assessments} index: 360 required: [text] section: index: 361 slicing: rules: open discriminator: - {path: code.text, type: value} min: null slices: physical: match: code: {text: section8.3.1-physical-examination} schema: type: BackboneElement mustSupport: true index: 362 elements: title: pattern: {type: String, value: Physical Examination} index: 363 code: elements: text: pattern: {type: String, value: section8.3.1-physical-examination} index: 364 required: [text] text: {index: 365} required: [text] vitals: match: code: {text: section8.3.2-vital-signs} schema: type: BackboneElement mustSupport: true index: 366 elements: title: pattern: {type: String, value: Vital Signs} index: 367 code: elements: text: pattern: {type: String, value: section8.3.2-vital-signs} index: 368 required: [text] text: {index: 369} required: [text] ecg: match: code: {text: section8.3.3-electrocardiograms} schema: type: BackboneElement mustSupport: true index: 370 elements: title: pattern: {type: String, value: Electrocardiograms} index: 371 code: elements: text: pattern: {type: String, value: section8.3.3-electrocardiograms} index: 372 required: [text] text: {index: 373} required: [text] laboratory: match: code: {text: section8.3.4-clinical-laboratory-assessments} schema: type: BackboneElement mustSupport: true index: 374 elements: title: pattern: {type: String, value: Clinical Laboratory Assessments} index: 375 code: elements: text: pattern: {type: String, value: section8.3.4-clinical-laboratory-assessments} index: 376 required: [text] text: {index: 377} required: [text] pregnancy: match: code: {text: section8.3.5-pregnancy-testing} schema: type: BackboneElement mustSupport: true index: 378 elements: title: pattern: {type: String, value: Pregnancy Testing} index: 379 code: elements: text: pattern: {type: String, value: section8.3.5-pregnancy-testing} index: 380 required: [text] text: {index: 381} required: [text] suicidal: match: code: {text: section8.3.6-suicidal-ideation} schema: type: BackboneElement mustSupport: true index: 382 elements: title: pattern: {type: String, value: Suicidal Ideation and Behaviour Risk Monitoring} index: 383 code: elements: text: pattern: {type: String, value: section8.3.6-suicidal-ideation} index: 384 required: [text] text: {index: 385} required: [text] pharmacokinetics: match: code: {text: section8.4-pharmacokinetics} schema: type: BackboneElement mustSupport: true _required: true index: 386 elements: title: pattern: {type: String, value: Pharmacokinetics} index: 387 code: elements: text: pattern: {type: String, value: section8.4-pharmacokinetics} index: 388 required: [text] text: {index: 389} required: [text] genetics: match: code: {text: section8.5-genetic-testing} schema: type: BackboneElement mustSupport: true _required: true index: 390 elements: title: pattern: {type: String, value: Genetic Testing} index: 391 code: elements: text: pattern: {type: String, value: section8.5-genetic-testing} index: 392 required: [text] text: {index: 393} required: [text] biomarkers: match: code: {text: section8.6-biomarkers} schema: type: BackboneElement mustSupport: true _required: true index: 394 elements: title: pattern: {type: String, value: Biomarkers} index: 395 code: elements: text: pattern: {type: String, value: section8.6-biomarkers} index: 396 required: [text] text: {index: 397} required: [text] immunogenicity: match: code: {text: section8.7-immunogenicity-assessments} schema: type: BackboneElement mustSupport: true _required: true index: 398 elements: title: pattern: {type: String, value: Immunogenicity Assessments} index: 399 code: elements: text: pattern: {type: String, value: section8.7-immunogenicity-assessments} index: 400 required: [text] text: {index: 401} required: [text] economics: match: code: {text: section8.8-economics} schema: type: BackboneElement mustSupport: true index: 402 elements: title: pattern: {type: String, value: Medical Resource Utilisation and Health Economics} index: 403 code: elements: text: pattern: {type: String, value: section8.8-economics} index: 404 required: [text] text: {index: 405} required: [text] definitions: match: code: {text: section13-definitions} schema: mustSupport: true _required: true index: 682 elements: title: pattern: {type: String, value: 'Appendix: Definitions and Supporting Operational Details'} index: 683 code: elements: text: pattern: {type: String, value: section13-definitions} index: 684 required: [text] section: array: true min: 4 index: 685 slicing: rules: open discriminator: - {path: code.text, type: value} min: 4 slices: contraception: match: code: {text: section13.1-contraception} schema: type: BackboneElement mustSupport: true _required: true index: 686 elements: title: pattern: {type: String, value: Contraception} index: 687 code: elements: text: pattern: {type: String, value: section13.1-contraception} index: 688 required: [text] section: array: true min: 2 index: 689 slicing: rules: open discriminator: - {path: code.text, type: value} min: 2 slices: contraceptionDefinitions: match: code: {text: section13.1.1-contraception-definitions} schema: type: BackboneElement mustSupport: true _required: true index: 690 elements: title: pattern: {type: String, value: Definitions Related to Childbearing Potential} index: 691 code: elements: text: pattern: {type: String, value: section13.1.1-contraception-definitions} index: 692 required: [text] text: {index: 693} required: [text] contraceptionDetails: match: code: {text: section13.1.2-contraception-details} schema: type: BackboneElement mustSupport: true _required: true index: 694 elements: title: pattern: {type: String, value: Contraception} index: 695 code: elements: text: pattern: {type: String, value: section13.1.2-contraception-details} index: 696 required: [text] text: {index: 697} required: [text] clinicalLaboratoryTests: match: code: {text: section13.2-clinical-laboratory-tests} schema: type: BackboneElement mustSupport: true _required: true index: 698 elements: title: pattern: {type: String, value: Clinical Laboratory Tests} index: 699 code: elements: text: pattern: {type: String, value: section13.2-clinical-laboratory-tests} index: 700 required: [text] text: {index: 701} required: [text] regional: match: code: {text: section13.3-country-specific-differences} schema: type: BackboneElement mustSupport: true _required: true index: 702 elements: title: pattern: {type: String, value: Country/Region-Specific Differences} index: 703 code: elements: text: pattern: {type: String, value: section13.3-country-specific-differences} index: 704 required: [text] text: {index: 705} required: [text] priorAmendments: match: code: {text: section13.4-prior-protocol-amendments} schema: type: BackboneElement mustSupport: true _required: true index: 706 elements: title: pattern: {type: String, value: Prior Protocol Amendment(s)} index: 707 code: elements: text: pattern: {type: String, value: section13.4-prior-protocol-amendments} index: 708 required: [text] text: {index: 709} required: [text] dropout: match: code: {text: section7-participant-discontinuation} schema: mustSupport: true _required: true index: 313 elements: title: pattern: {type: String, value: Participant Discontinuation of Trial Intervention and Withdrawal from Trial} index: 314 code: elements: text: pattern: {type: String, value: section7-participant-discontinuation} index: 315 required: [text] section: array: true min: 4 index: 316 slicing: rules: open discriminator: - {path: code.text, type: value} min: 4 slices: discontinuation: match: code: {text: section7.1-discontinuation-of-trial-intervention} schema: type: BackboneElement mustSupport: true _required: true index: 317 elements: title: pattern: {type: String, value: Discontinuation of Trial Intervention for Individual Participants} index: 318 code: elements: text: pattern: {type: String, value: section7.1-discontinuation-of-trial-intervention} index: 319 required: [text] section: array: true min: 3 index: 320 slicing: rules: open discriminator: - {path: code.text, type: value} min: 3 slices: permanent: match: code: {text: section7.1.1-permanent-discontinuation-of-trial-intervention} schema: type: BackboneElement mustSupport: true _required: true index: 321 elements: title: pattern: {type: String, value: Permanent Discontinuation of Trial Intervention} index: 322 code: elements: text: pattern: {type: String, value: section7.1.1-permanent-discontinuation-of-trial-intervention} index: 323 required: [text] text: {index: 324} required: [text] temporary: match: code: {text: section7.1.2-temporary-discontinuation-of-trial-intervention} schema: type: BackboneElement mustSupport: true _required: true index: 325 elements: title: pattern: {type: String, value: Temporary Discontinuation of Trial Intervention} index: 326 code: elements: text: pattern: {type: String, value: section7.1.2-temporary-discontinuation-of-trial-intervention} index: 327 required: [text] text: {index: 328} required: [text] rechallenge: match: code: {text: section7.1.3-rechallenge} schema: type: BackboneElement mustSupport: true _required: true index: 329 elements: title: pattern: {type: String, value: Rechallenge} index: 330 code: elements: text: pattern: {type: String, value: section7.1.3-rechallenge} index: 331 required: [text] text: {index: 332} required: [text] withdrawal: match: code: {text: section7.2-participant-withdrawal} schema: type: BackboneElement mustSupport: true _required: true index: 333 elements: title: pattern: {type: String, value: Withdrawal from the Trial} index: 334 code: elements: text: pattern: {type: String, value: section7.2-participant-withdrawal} index: 335 required: [text] text: {index: 336} required: [text] lostToFollowUp: match: code: {text: section7.3-lost-to-follow-up} schema: type: BackboneElement mustSupport: true _required: true index: 337 elements: title: pattern: {type: String, value: Lost to Follow-Up} index: 338 code: elements: text: pattern: {type: String, value: section7.3-lost-to-follow-up} index: 339 required: [text] text: {index: 340} required: [text] trialStoppingRules: match: code: {text: section7.4-participant-stopping-rules} schema: type: BackboneElement mustSupport: true _required: true index: 341 elements: title: pattern: {type: String, value: Participant Stopping Rules} index: 342 code: elements: text: pattern: {type: String, value: section7.4-participant-stopping-rules} index: 343 required: [text] text: {index: 344} required: [text] references: match: code: {text: section15-references} schema: mustSupport: true _required: true index: 715 elements: title: pattern: {type: String, value: 'Appendix: References'} index: 716 code: elements: text: pattern: {type: String, value: section15-references} index: 717 required: [text] text: {index: 718} entry: type: Reference refers: ['http://hl7.org/fhir/StructureDefinition/Citation'] index: 719 required: [text] riskManagementAndData: match: code: {text: section12-risk-management-and-data-governance} schema: mustSupport: true _required: true index: 666 elements: title: pattern: {type: String, value: 'General Considerations: Risk Management and Data Governance'} index: 667 code: elements: text: pattern: {type: String, value: section12-risk-management-and-data-governance} index: 668 required: [text] section: array: true min: 3 index: 669 slicing: rules: open discriminator: - {path: code.text, type: value} min: 3 slices: riskManagement: match: code: {text: section12.1-risk-management} schema: type: BackboneElement mustSupport: true _required: true index: 670 elements: title: pattern: {type: String, value: Risk Management} index: 671 code: elements: text: pattern: {type: String, value: section12.1-risk-management} index: 672 required: [text] text: {index: 673} required: [text] dataGovernance: match: code: {text: section12.2-data-governance} schema: type: BackboneElement mustSupport: true _required: true index: 674 elements: title: pattern: {type: String, value: Data Governance} index: 675 code: elements: text: pattern: {type: String, value: section12.2-data-governance} index: 676 required: [text] text: {index: 677} required: [text] sourceData: match: code: {text: section12.3-source-data} schema: type: BackboneElement mustSupport: true _required: true index: 678 elements: title: pattern: {type: String, value: Source Data} index: 679 code: elements: text: pattern: {type: String, value: section12.3-source-data} index: 680 required: [text] text: {index: 681} required: [text] statistics: match: code: {text: section10-statistics} schema: mustSupport: true _required: true index: 486 elements: title: pattern: {type: String, value: Statistical Considerations} index: 487 code: elements: text: pattern: {type: String, value: section10-statistics} index: 488 required: [text] text: {index: 489} section: array: true min: 4 index: 490 slicing: rules: open discriminator: - {path: code.text, type: value} min: 4 slices: analysisSets: match: code: {text: section10.1-analysis-sets} schema: type: BackboneElement mustSupport: true _required: true index: 491 elements: title: pattern: {type: String, value: Analysis Sets} index: 492 code: elements: text: pattern: {type: String, value: section10.1-analysis-sets} index: 493 required: [text] text: {index: 494} required: [text] sampleSize: match: code: {text: section10.8-sample-size-determination} schema: type: BackboneElement mustSupport: true _required: true index: 591 elements: title: pattern: {type: String, value: Sample Size Determination} index: 592 code: elements: text: pattern: {type: String, value: section10.8-sample-size-determination} index: 593 required: [text] text: {index: 594} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan'] index: 595 required: [text] interimAnalyses: match: code: {text: section10.7-interim-analyses} schema: type: BackboneElement mustSupport: true index: 587 elements: title: pattern: {type: String, value: Interim Analyses} index: 588 code: elements: text: pattern: {type: String, value: section10.7-interim-analyses} index: 589 required: [text] text: {index: 590} required: [text] exploratoryAnalysis: match: code: {text: section10.4-analysis-exploratory-objective} schema: type: BackboneElement mustSupport: true array: true index: 551 elements: title: pattern: {type: String, value: Analysis of Exploratory Objective} index: 552 code: elements: text: pattern: {type: String, value: section10.4-analysis-exploratory-objective} index: 553 required: [text] focus: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition'] index: 554 text: {index: 555} section: index: 556 slicing: rules: open discriminator: - {path: code.text, type: value} min: null slices: statisticalModel: match: code: {text: section10.4.1-statistical-model} schema: type: BackboneElement mustSupport: true index: 557 elements: title: pattern: {type: String, value: 'Statistical Model, Hypothesis, and Method of Analysis'} index: 558 code: elements: text: pattern: {type: String, value: section10.4.1-statistical-model} index: 559 required: [text] text: {index: 560} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan'] index: 561 required: [text] intercurrentEventHandling: match: code: {text: section10.4.2-intercurrent-events-handling} schema: type: BackboneElement mustSupport: true index: 562 elements: title: pattern: {type: String, value: Handling of Intercurrent Events of Exploratory Estimand} index: 563 code: elements: text: pattern: {type: String, value: section10.4.2-intercurrent-events-handling} index: 564 required: [text] text: {index: 565} required: [text] missingData: match: code: {text: section10.4.3-missing-data-handling} schema: type: BackboneElement mustSupport: true index: 566 elements: title: pattern: {type: String, value: Handling of Missing Data} index: 567 code: elements: text: pattern: {type: String, value: section10.4.3-missing-data-handling} index: 568 required: [text] text: {index: 569} required: [text] sensitvityAnalysis: match: code: {text: section10.4.4-sensitivity-analysis} schema: type: BackboneElement mustSupport: true index: 570 elements: title: pattern: {type: String, value: Sensitivity Analysis} index: 571 code: elements: text: pattern: {type: String, value: section10.4.4-sensitivity-analysis} index: 572 required: [text] text: {index: 573} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan'] index: 574 required: [text] supplementaryAnalysis: match: code: {text: section10.4.5-supplementary-analysis} schema: type: BackboneElement mustSupport: true index: 575 elements: title: pattern: {type: String, value: Supplementary Analysis} index: 576 code: elements: text: pattern: {type: String, value: section10.4.5-supplementary-analysis} index: 577 required: [text] text: {index: 578} required: [text] required: [text] secondaryAnalysis: match: code: {text: section10.3-analysis-secondary-objective} schema: type: BackboneElement mustSupport: true array: true index: 523 elements: title: pattern: {type: String, value: Analysis Supporting Secondary Objective} index: 524 code: elements: text: pattern: {type: String, value: section10.3-analysis-secondary-objective} index: 525 required: [text] focus: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition'] index: 526 text: {index: 527} section: index: 528 slicing: rules: open discriminator: - {path: code.text, type: value} min: null slices: statisticalModel: match: code: {text: section10.3.1-statistical-model} schema: type: BackboneElement mustSupport: true index: 529 elements: title: pattern: {type: String, value: 'Statistical Model, Hypothesis, and Method of Analysis'} index: 530 code: elements: text: pattern: {type: String, value: section10.3.1-statistical-model} index: 531 required: [text] text: {index: 532} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan'] index: 533 required: [text] intercurrentEventHandling: match: code: {text: section10.3.2-intercurrent-events-handling} schema: type: BackboneElement mustSupport: true index: 534 elements: title: pattern: {type: String, value: Handling of Intercurrent Events of Secondary Estimand} index: 535 code: elements: text: pattern: {type: String, value: section10.3.2-intercurrent-events-handling} index: 536 required: [text] text: {index: 537} required: [text] missingData: match: code: {text: section10.3.3-missing-data-handling} schema: type: BackboneElement mustSupport: true index: 538 elements: title: pattern: {type: String, value: Handling of Missing Data} index: 539 code: elements: text: pattern: {type: String, value: section10.3.3-missing-data-handling} index: 540 required: [text] text: {index: 541} required: [text] sensitvityAnalysis: match: code: {text: section10.3.4-sensitivity-analysis} schema: type: BackboneElement mustSupport: true index: 542 elements: title: pattern: {type: String, value: Sensitivity Analysis} index: 543 code: elements: text: pattern: {type: String, value: section10.3.4-sensitivity-analysis} index: 544 required: [text] text: {index: 545} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan'] index: 546 required: [text] supplementaryAnalysis: match: code: {text: section10.3.5-supplementary-analysis} schema: type: BackboneElement mustSupport: true index: 547 elements: title: pattern: {type: String, value: Supplementary Analysis} index: 548 code: elements: text: pattern: {type: String, value: section10.3.5-supplementary-analysis} index: 549 required: [text] text: {index: 550} required: [text] required: [text] safetyAnalyses: match: code: {text: section10.5-safety-analyses} schema: type: BackboneElement mustSupport: true index: 579 elements: title: pattern: {type: String, value: Safety Analyses} index: 580 code: elements: text: pattern: {type: String, value: section10.5-safety-analyses} index: 581 required: [text] text: {index: 582} required: [text] protocolDeviations: match: code: {text: section10.9-protocol-deviations} schema: type: BackboneElement mustSupport: true _required: true index: 596 elements: title: pattern: {type: String, value: Protocol Deviations} index: 597 code: elements: text: pattern: {type: String, value: section10.9-protocol-deviations} index: 598 required: [text] text: {index: 599} required: [text] analysisPrimaryObjective: match: code: {text: section10.2-analysis-primary-objective} schema: type: BackboneElement mustSupport: true array: true min: 1 _required: true index: 495 elements: title: pattern: {type: String, value: Analysis Supporting Primary Objective} index: 496 code: elements: text: pattern: {type: String, value: section10.2-analysis-primary-objective} index: 497 required: [text] focus: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition'] index: 498 text: {index: 499} section: array: true min: 3 index: 500 slicing: rules: open discriminator: - {path: code.text, type: value} min: 3 slices: statisticalModel: match: code: {text: section10.2.1-statistical-model} schema: type: BackboneElement mustSupport: true _required: true index: 501 elements: title: pattern: {type: String, value: 'Statistical Model, Hypothesis, and Method of Analysis'} index: 502 code: elements: text: pattern: {type: String, value: section10.2.1-statistical-model} index: 503 required: [text] text: {index: 504} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan'] index: 505 required: [text] intercurrentEventHandling: match: code: {text: section10.2.2-intercurrent-events-handling} schema: type: BackboneElement mustSupport: true index: 506 elements: title: pattern: {type: String, value: Handling of Intercurrent Events of Primary Estimand} index: 507 code: elements: text: pattern: {type: String, value: section10.2.2-intercurrent-events-handling} index: 508 required: [text] text: {index: 509} required: [text] missingData: match: code: {text: section10.2.3-missing-data-handling} schema: type: BackboneElement mustSupport: true _required: true index: 510 elements: title: pattern: {type: String, value: Handling of Missing Data} index: 511 code: elements: text: pattern: {type: String, value: section10.2.3-missing-data-handling} index: 512 required: [text] text: {index: 513} required: [text] sensitvityAnalysis: match: code: {text: section10.2.4-sensitivity-analysis} schema: type: BackboneElement mustSupport: true _required: true index: 514 elements: title: pattern: {type: String, value: Sensitivity Analysis} index: 515 code: elements: text: pattern: {type: String, value: section10.2.4-sensitivity-analysis} index: 516 required: [text] text: {index: 517} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan'] index: 518 required: [text] supplementaryAnalysis: match: code: {text: section10.2.5-supplementary-analysis} schema: type: BackboneElement mustSupport: true index: 519 elements: title: pattern: {type: String, value: Supplementary Analysis} index: 520 code: elements: text: pattern: {type: String, value: section10.2.5-supplementary-analysis} index: 521 required: [text] text: {index: 522} required: [text] required: [text] otherAnalyses: match: code: {text: section10.6-other-analyses} schema: type: BackboneElement mustSupport: true index: 583 elements: title: pattern: {type: String, value: Other Analyses} index: 584 code: elements: text: pattern: {type: String, value: section10.6-other-analyses} index: 585 required: [text] text: {index: 586} required: [text] required: [text] summary: match: code: {text: section1-protocol-summary} schema: mustSupport: true _required: true index: 4 elements: title: pattern: {type: String, value: Protocol Summary} index: 5 code: elements: text: pattern: {type: String, value: section1-protocol-summary} index: 6 required: [text] section: array: true min: 3 index: 7 slicing: rules: open discriminator: - {path: code.text, type: value} min: 3 slices: protocolSynopsis: match: code: {text: section1.1-protocol-synopsis} schema: type: BackboneElement mustSupport: true _required: true index: 8 elements: title: pattern: {type: String, value: Protocol Synopsis} index: 9 code: elements: text: pattern: {type: String, value: section1.1-protocol-synopsis} index: 10 required: [text] section: array: true min: 6 index: 11 slicing: rules: open discriminator: - {path: code.text, type: value} min: 6 slices: objectivesEndpoints: match: code: {text: section1.1.1-objectives-endpoints} schema: type: BackboneElement mustSupport: true _required: true index: 12 elements: title: pattern: {type: String, value: Primary and Secondary Objectives and Endpoints} index: 13 code: elements: text: pattern: {type: String, value: section1.1.1-objectives-endpoints} index: 14 required: [text] text: {index: 15} entry: type: Reference refers: ['http://hl7.org/fhir/StructureDefinition/Composition'] index: 16 required: [text] overallDesign: match: code: {text: section1.1.2-overall-design} schema: type: BackboneElement _required: true index: 17 elements: title: pattern: {type: String, value: Overall Design} index: 18 code: elements: text: pattern: {type: String, value: section1.1.2-overall-design} index: 19 required: [text] text: {index: 20} entry: type: Reference refers: ['http://hl7.org/fhir/StructureDefinition/Composition', 'http://hl7.org/fhir/StructureDefinition/ResearchStudy'] index: 21 required: [text] numberOfArms: match: code: {text: Number of Arms} schema: type: BackboneElement _required: true index: 22 elements: code: elements: text: pattern: {type: String, value: Number of Arms} index: 23 required: [text] text: {index: 24} required: [text] blinding: match: code: {text: Blinding} schema: type: BackboneElement _required: true index: 25 elements: code: elements: text: pattern: {type: String, value: Blinding} index: 26 required: [text] text: {index: 27} required: [text] numberOfParticipants: match: code: {text: Number of Participants} schema: type: BackboneElement _required: true index: 28 elements: code: elements: text: pattern: {type: String, value: Number of Participants} index: 29 required: [text] text: {index: 30} required: [text] duration: match: code: {text: Arms and Duration} schema: type: BackboneElement index: 31 elements: code: elements: text: pattern: {type: String, value: Arms and Duration} index: 32 required: [text] text: {index: 33} required: [text] committees: match: code: {text: Committees} schema: type: BackboneElement _required: true index: 34 elements: code: elements: text: pattern: {type: String, value: Committees} index: 35 required: [text] text: {index: 36} required: [text] trialSchema: match: code: {text: section1.2-trial-schema} schema: type: BackboneElement mustSupport: true _required: true index: 37 elements: title: pattern: {type: String, value: Trial Schema} index: 38 code: elements: text: pattern: {type: String, value: section1.2-trial-schema} index: 39 required: [text] text: {index: 40} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/soa-plandefinition'] index: 41 required: [text] scheduleOfActivities: match: code: {text: section1.3-schedule-of-activities} schema: type: BackboneElement mustSupport: true _required: true index: 42 elements: title: pattern: {type: String, value: Schedule of Activities} index: 43 code: elements: text: pattern: {type: String, value: section1.3-schedule-of-activities} index: 44 required: [text] text: {index: 45} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/soa-plandefinition'] index: 46 required: [text] endpoints: match: code: {text: section3-endpoints} schema: mustSupport: true array: true min: 1 _required: true index: 83 elements: title: pattern: {type: String, value: 'Trial Objectives, Endpoints and Estimands'} index: 84 code: elements: text: pattern: {type: String, value: section3-endpoints} index: 85 required: [text] section: index: 86 slicing: rules: open discriminator: - {path: code.text, type: value} min: 1 slices: objectiveEndpoint: match: code: {text: section3.1-objective-endpoint-estimand} schema: type: BackboneElement mustSupport: true array: true min: 1 _required: true index: 87 elements: title: pattern: {type: String, value: Objective + Associated Endpoint (and Estimand)} index: 88 code: elements: text: pattern: {type: String, value: section3.1-objective-endpoint-estimand} index: 89 required: [text] focus: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition'] index: 90 section: array: true min: 4 index: 91 slicing: rules: open discriminator: - {path: code.text, type: value} min: 4 slices: primarySecondaryExploratory: match: code: {text: Primary/Secondary/Exploratory} schema: type: BackboneElement mustSupport: true _required: true index: 92 elements: title: pattern: {type: String, value: Primary/Secondary/Exploratory Classification} index: 93 code: elements: text: pattern: {type: String, value: Primary/Secondary/Exploratory} index: 94 required: [text] text: {index: 95} required: [text] objective: match: code: {text: Objective} schema: type: BackboneElement mustSupport: true _required: true index: 96 elements: title: pattern: {type: String, value: Objective} index: 97 code: elements: text: pattern: {type: String, value: Objective} index: 98 required: [text] text: {index: 99} required: [text] endpoint: match: code: {text: Endpoint} schema: type: BackboneElement mustSupport: true _required: true index: 100 elements: title: pattern: {type: String, value: Endpoint} index: 101 code: elements: text: pattern: {type: String, value: Endpoint} index: 102 required: [text] text: {index: 103} required: [text] estimand: match: code: {text: Estimand} schema: type: BackboneElement mustSupport: true _required: true index: 104 elements: title: pattern: {type: String, value: Estimand} index: 105 code: elements: text: pattern: {type: String, value: Estimand} index: 106 required: [text] text: {index: 107} required: [text] required: [focus] required: [section] adverseEvents: match: code: {text: section9-adverse-events} schema: mustSupport: true _required: true index: 406 elements: title: pattern: {type: String, value: 'Adverse Events, Serious Adverse Events, and Product Complaints'} index: 407 code: elements: text: pattern: {type: String, value: section9-adverse-events} index: 408 required: [text] section: array: true min: 5 index: 409 slicing: rules: open discriminator: - {path: code.text, type: value} min: 5 slices: definitions: match: code: {text: section9.1-definitions} schema: type: BackboneElement mustSupport: true _required: true index: 410 elements: title: pattern: {type: String, value: Definitions} index: 411 code: elements: text: pattern: {type: String, value: section9.1-definitions} index: 412 required: [text] section: array: true min: 2 index: 413 slicing: rules: open discriminator: - {path: code.text, type: value} min: 2 slices: adverseEventsDefinitions: match: code: {text: section9.1.1-definitions-adverse-events} schema: type: BackboneElement mustSupport: true _required: true index: 414 elements: title: pattern: {type: String, value: Definitions of Adverse Events} index: 415 code: elements: text: pattern: {type: String, value: section9.1.1-definitions-adverse-events} index: 416 required: [text] text: {index: 417} required: [text] seriousAdverseEventsDefinitions: match: code: {text: section9.1.2-definitions-serious-adverse-events} schema: type: BackboneElement mustSupport: true _required: true index: 418 elements: title: pattern: {type: String, value: Definitions of Serious Adverse Events} index: 419 code: elements: text: pattern: {type: String, value: section9.1.2-definitions-serious-adverse-events} index: 420 required: [text] text: {index: 421} required: [text] productComplaintsDefinitions: match: code: {text: section9.1.3-definitions-product-complaints} schema: type: BackboneElement mustSupport: true index: 422 elements: title: pattern: {type: String, value: Definitions of Medical Device Product Complaints} index: 423 code: elements: text: pattern: {type: String, value: section9.1.3-definitions-product-complaints} index: 424 required: [text] text: {index: 425} required: [text] collectionMethods: match: code: {text: section9.2-collection-methods} schema: type: BackboneElement mustSupport: true _required: true index: 426 elements: title: pattern: {type: String, value: 'Timing and Mechanism for Collection and Reporting of AEs, SAEs, Pregnancy, and Product Complaints'} index: 427 code: elements: text: pattern: {type: String, value: section9.2-collection-methods} index: 428 required: [text] text: {index: 429} required: [text] recording: match: code: {text: section9.3-recording-and-follow-up} schema: type: BackboneElement mustSupport: true _required: true index: 430 elements: title: pattern: {type: String, value: 'Recording and Follow-Up of AEs, SAEs, Pregnancy, and Product Complaints'} index: 431 code: elements: text: pattern: {type: String, value: section9.3-recording-and-follow-up} index: 432 required: [text] section: array: true min: 5 index: 433 slicing: rules: open discriminator: - {path: code.text, type: value} min: 5 slices: identifying: match: code: {text: section9.3.1-identifying-events} schema: type: BackboneElement mustSupport: true _required: true index: 434 elements: title: pattern: {type: String, value: 'Identifying AEs, SAEs and Product Complaints'} index: 435 code: elements: text: pattern: {type: String, value: section9.3.1-identifying-events} index: 436 required: [text] text: {index: 437} required: [text] intensity: match: code: {text: section9.3.2-intensity} schema: type: BackboneElement mustSupport: true _required: true index: 438 elements: title: pattern: {type: String, value: Intensity} index: 439 code: elements: text: pattern: {type: String, value: section9.3.2-intensity} index: 440 required: [text] text: {index: 441} required: [text] causality: match: code: {text: section9.3.3-causality} schema: type: BackboneElement mustSupport: true _required: true index: 442 elements: title: pattern: {type: String, value: Causality} index: 443 code: elements: text: pattern: {type: String, value: section9.3.3-causality} index: 444 required: [text] text: {index: 445} required: [text] recordingEvents: match: code: {text: section9.3.4-recording-events} schema: type: BackboneElement mustSupport: true _required: true index: 446 elements: title: pattern: {type: String, value: 'Recording of AEs, SAEs, Pregnancy and Product Complaints'} index: 447 code: elements: text: pattern: {type: String, value: section9.3.4-recording-events} index: 448 required: [text] text: {index: 449} required: [text] followup: match: code: {text: section9.3.5-followup} schema: type: BackboneElement mustSupport: true _required: true index: 450 elements: title: pattern: {type: String, value: Follow-up} index: 451 code: elements: text: pattern: {type: String, value: section9.3.5-followup} index: 452 required: [text] text: {index: 453} required: [text] reporting: match: code: {text: section9.4-reporting-events} schema: type: BackboneElement mustSupport: true _required: true index: 454 elements: title: pattern: {type: String, value: 'Reporting of AEs, SAEs, Pregnancy, and Product Complaints'} index: 455 code: elements: text: pattern: {type: String, value: section9.4-reporting-events} index: 456 required: [text] section: array: true min: 4 index: 457 slicing: rules: open discriminator: - {path: code.text, type: value} min: 4 slices: reportingSAEs: match: code: {text: section9.4.1-reporting-serious-events} schema: type: BackboneElement mustSupport: true _required: true index: 458 elements: title: pattern: {type: String, value: Reporting of SAEs} index: 459 code: elements: text: pattern: {type: String, value: section9.4.1-reporting-serious-events} index: 460 required: [text] text: {index: 461} required: [text] regulatoryRequirements: match: code: {text: section9.4.2-regulatory-requirements} schema: type: BackboneElement mustSupport: true _required: true index: 462 elements: title: pattern: {type: String, value: Regulatory Reporting Requirements for SAEs and Product Complaints} index: 463 code: elements: text: pattern: {type: String, value: section9.4.2-regulatory-requirements} index: 464 required: [text] text: {index: 465} required: [text] specialInterest: match: code: {text: section9.4.3-special-interest} schema: type: BackboneElement mustSupport: true _required: true index: 466 elements: title: pattern: {type: String, value: Adverse Events of Special Interest} index: 467 code: elements: text: pattern: {type: String, value: section9.4.3-special-interest} index: 468 required: [text] text: {index: 469} required: [text] diseaseRelatedEvents: match: code: {text: section9.4.4-disease-related-events} schema: type: BackboneElement mustSupport: true _required: true index: 470 elements: title: pattern: {type: String, value: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs} index: 471 code: elements: text: pattern: {type: String, value: section9.4.4-disease-related-events} index: 472 required: [text] text: {index: 473} required: [text] pregnancy: match: code: {text: section9.5-collection-methods} schema: type: BackboneElement mustSupport: true _required: true index: 474 elements: title: pattern: {type: String, value: 'Timing and Mechanism for Collection and Reporting of AEs, SAEs, Pregnancy, and Product Complaints'} index: 475 code: elements: text: pattern: {type: String, value: section9.5-collection-methods} index: 476 required: [text] section: index: 477 slicing: rules: open discriminator: - {path: code.text, type: value} min: null slices: pregnant: match: code: {text: section9.5.1-pregnant} schema: type: BackboneElement mustSupport: true index: 478 elements: title: pattern: {type: String, value: Participants Who Become Pregnant During the Trial} index: 479 code: elements: text: pattern: {type: String, value: section9.5.1-pregnant} index: 480 required: [text] text: {index: 481} required: [text] pregnantPartner: match: code: {text: section9.5.2-pregnant-partner} schema: type: BackboneElement mustSupport: true index: 482 elements: title: pattern: {type: String, value: Participants Whose Partners Become Pregnant} index: 483 code: elements: text: pattern: {type: String, value: section9.5.2-pregnant-partner} index: 484 required: [text] text: {index: 485} required: [text] population: match: code: {text: section5-trial-population} schema: mustSupport: true _required: true index: 170 elements: title: pattern: {type: String, value: Trial Population} index: 171 code: elements: text: pattern: {type: String, value: section5-trial-population} index: 172 required: [text] section: array: true min: 5 index: 173 slicing: rules: open discriminator: - {path: code.text, type: value} min: 5 slices: description: match: code: {text: section5.1-population-description} schema: type: BackboneElement mustSupport: true _required: true index: 174 elements: title: pattern: {type: String, value: Description of Trial Population and Rationale} index: 175 code: elements: text: pattern: {type: String, value: section5.1-population-description} index: 176 required: [text] text: {index: 177} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/cohort-definition'] index: 178 required: [text] inclusionCriteria: match: code: {text: section5.2-inclusion-criteria} schema: type: BackboneElement mustSupport: true _required: true index: 179 elements: title: pattern: {type: String, value: Inclusion Criteria} index: 180 code: elements: text: pattern: {type: String, value: section5.2-inclusion-criteria} index: 181 required: [text] text: {index: 182} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/cohort-definition'] index: 183 required: [text] exclusionCriteria: match: code: {text: section5.3-exclusion-criteria} schema: type: BackboneElement mustSupport: true _required: true index: 184 elements: title: pattern: {type: String, value: Exclusion Criteria} index: 185 code: elements: text: pattern: {type: String, value: section5.3-exclusion-criteria} index: 186 required: [text] text: {index: 187} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/cohort-definition'] index: 188 required: [text] lifestyle: match: code: {text: section5.4-lifestyle-restrictions} schema: type: BackboneElement mustSupport: true index: 189 elements: title: pattern: {type: String, value: Lifestyle Restrictions} index: 190 code: elements: text: pattern: {type: String, value: section5.4-lifestyle-restrictions} index: 191 required: [text] text: {index: 192} section: index: 193 slicing: rules: open discriminator: - {path: code.text, type: value} min: null slices: dietary: match: code: {text: section5.4.1-dietary-restrictions} schema: type: BackboneElement mustSupport: true index: 194 elements: title: pattern: {type: String, value: Meals and Dietary Restrictions} index: 195 code: elements: text: pattern: {type: String, value: section5.4.1-dietary-restrictions} index: 196 required: [text] text: {index: 197} required: [text] substances: match: code: {text: section5.4.2-substances-restrictions} schema: type: BackboneElement mustSupport: true index: 198 elements: title: pattern: {type: String, value: 'Caffeine, Alcohol, Tobacco, and Other Restrictions'} index: 199 code: elements: text: pattern: {type: String, value: section5.4.2-substances-restrictions} index: 200 required: [text] text: {index: 201} required: [text] activity: match: code: {text: section5.4.3-activity-restrictions} schema: type: BackboneElement mustSupport: true index: 202 elements: title: pattern: {type: String, value: Physical Activity Restrictions} index: 203 code: elements: text: pattern: {type: String, value: section5.4.3-activity-restrictions} index: 204 required: [text] text: {index: 205} required: [text] other: match: code: {text: section5.4.4-other-restrictions} schema: type: BackboneElement mustSupport: true index: 206 elements: title: pattern: {type: String, value: Other Activity Restrictions} index: 207 code: elements: text: pattern: {type: String, value: section5.4.4-other-restrictions} index: 208 required: [text] text: {index: 209} required: [text] required: [text] screenFailures: match: code: {text: section5.5-screen-failure} schema: type: BackboneElement mustSupport: true index: 210 elements: title: pattern: {type: String, value: Screen Failure and Rescreening} index: 211 code: elements: text: pattern: {type: String, value: section5.5-screen-failure} index: 212 required: [text] text: {index: 213} required: [text] oversight: match: code: {text: section11-oversight} schema: mustSupport: true _required: true index: 600 elements: title: pattern: {type: String, value: 'General Considerations: Regulatory, Ethical, and Trial Oversight'} index: 601 code: elements: text: pattern: {type: String, value: section11-oversight} index: 602 required: [text] section: array: true min: 6 index: 603 slicing: rules: open discriminator: - {path: code.text, type: value} min: 6 slices: regulatory: match: code: {text: section11.1-regulatory-considerations} schema: type: BackboneElement mustSupport: true _required: true index: 604 elements: title: pattern: {type: String, value: Regulatory and Ethical Considerations} index: 605 code: elements: text: pattern: {type: String, value: section11.1-regulatory-considerations} index: 606 required: [text] text: {index: 607} required: [text] trialOversight: match: code: {text: section11.2-trial-oversight} schema: type: BackboneElement mustSupport: true _required: true index: 608 elements: title: pattern: {type: String, value: Trial Oversight} index: 609 code: elements: text: pattern: {type: String, value: section11.2-trial-oversight} index: 610 required: [text] text: {index: 611} section: array: true min: 2 index: 612 slicing: rules: open discriminator: - {path: code.text, type: value} min: 2 slices: investigatorResponsibilities: match: code: {text: section11.2.1-investigator-responsibilities} schema: type: BackboneElement mustSupport: true _required: true index: 613 elements: title: pattern: {type: String, value: Investigator Responsibilities} index: 614 code: elements: text: pattern: {type: String, value: section11.2.1-investigator-responsibilities} index: 615 required: [text] text: {index: 616} required: [text] sponsorResponsibilities: match: code: {text: section11.2.2-sponsor-responsibilities} schema: type: BackboneElement mustSupport: true _required: true index: 617 elements: title: pattern: {type: String, value: Sponsor Responsibilities} index: 618 code: elements: text: pattern: {type: String, value: section11.2.2-sponsor-responsibilities} index: 619 required: [text] text: {index: 620} required: [text] committees: match: code: {text: section11.3-committees} schema: type: BackboneElement mustSupport: true _required: true index: 621 elements: title: pattern: {type: String, value: Committees} index: 622 code: elements: text: pattern: {type: String, value: section11.3-committees} index: 623 required: [text] text: {index: 624} required: [text] informedConsent: match: code: {text: section11.4-informed-consent-process} schema: type: BackboneElement mustSupport: true _required: true index: 625 elements: title: pattern: {type: String, value: Informed Consent Process} index: 626 code: elements: text: pattern: {type: String, value: section11.4-informed-consent-process} index: 627 required: [text] text: {index: 628} section: index: 629 slicing: rules: open discriminator: - {path: code.text, type: value} min: null slices: assentProcess: match: code: {text: section11.4.0-assent-process} schema: type: BackboneElement mustSupport: true index: 630 elements: title: pattern: {type: String, value: Assent Process} index: 631 code: elements: text: pattern: {type: String, value: section11.4.0-assent-process} index: 632 required: [text] text: {index: 633} required: [text] emergency: match: code: {text: section11.4.0-emergency-consent-process} schema: type: BackboneElement mustSupport: true index: 634 elements: title: pattern: {type: String, value: Emergency Consent Process} index: 635 code: elements: text: pattern: {type: String, value: section11.4.0-emergency-consent-process} index: 636 required: [text] text: {index: 637} required: [text] rescreening: match: code: {text: section11.4.1-rescreening-consent-process} schema: type: BackboneElement mustSupport: true index: 638 elements: title: pattern: {type: String, value: Informed Consent for Rescreening} index: 639 code: elements: text: pattern: {type: String, value: section11.4.1-rescreening-consent-process} index: 640 required: [text] text: {index: 641} required: [text] remainingSamples: match: code: {text: section11.4.2-remaining-samples} schema: type: BackboneElement mustSupport: true index: 642 elements: title: pattern: {type: String, value: Informed Consent for Remaining Samples in Exploratory Research} index: 643 code: elements: text: pattern: {type: String, value: section11.4.2-remaining-samples} index: 644 required: [text] text: {index: 645} required: [text] required: [text] insurance: match: code: {text: section11.5-insurance-and-indemnity} schema: type: BackboneElement mustSupport: true _required: true index: 646 elements: title: pattern: {type: String, value: Insurance and Indemnity} index: 647 code: elements: text: pattern: {type: String, value: section11.5-insurance-and-indemnity} index: 648 required: [text] text: {index: 649} required: [text] earlySiteClosure: match: code: {text: section11.6-early-site-closure} schema: type: BackboneElement mustSupport: true _required: true index: 650 elements: title: pattern: {type: String, value: Early Site Closure} index: 651 code: elements: text: pattern: {type: String, value: section11.6-early-site-closure} index: 652 required: [text] section: array: true min: 3 index: 653 slicing: rules: open discriminator: - {path: code.text, type: value} min: 3 slices: decisionRights: match: code: {text: section11.6-early-site-closure#decisionRights} schema: type: BackboneElement mustSupport: true _required: true index: 654 elements: title: pattern: {type: String, value: Decision Rights for Site Closure} index: 655 code: elements: text: pattern: {type: String, value: section11.6-early-site-closure#decisionRights} index: 656 required: [text] text: {index: 657} required: [text] criteria: match: code: {text: section11.6-early-site-closure#criteria} schema: type: BackboneElement mustSupport: true _required: true index: 658 elements: title: pattern: {type: String, value: Crteria for Early Closure} index: 659 code: elements: text: pattern: {type: String, value: section11.6-early-site-closure#criteria} index: 660 required: [text] text: {index: 661} required: [text] responsibilities: match: code: {text: section11.6-early-site-closure#responsibilities} schema: type: BackboneElement mustSupport: true _required: true index: 662 elements: title: pattern: {type: String, value: Responsibilities Following Early Site Closure} index: 663 code: elements: text: pattern: {type: String, value: section11.6-early-site-closure#responsibilities} index: 664 required: [text] text: {index: 665} required: [text] design: match: code: {text: section4-trial-design} schema: mustSupport: true _required: true index: 108 elements: title: pattern: {type: String, value: Trial Design} index: 109 code: elements: text: pattern: {type: String, value: section4-trial-design} index: 110 required: [text] section: array: true min: 4 index: 111 slicing: rules: open discriminator: - {path: code.text, type: value} min: 4 slices: description: match: code: {text: section4.1-description-of-trial-design} schema: type: BackboneElement mustSupport: true _required: true index: 112 elements: title: pattern: {type: String, value: Description of Trial Design} index: 113 code: elements: text: pattern: {type: String, value: section4.1-description-of-trial-design} index: 114 required: [text] text: {index: 115} section: index: 116 slicing: rules: open discriminator: - {path: code.text, type: value} min: null slices: stakeholderInput: match: code: {text: section4.1.1-stakeholder-input-into-design} schema: type: BackboneElement mustSupport: true index: 117 elements: title: pattern: {type: String, value: Stakeholder Input into Design} index: 118 code: elements: text: pattern: {type: String, value: section4.1.1-stakeholder-input-into-design} index: 119 required: [text] text: {index: 120} required: [text] required: [text] rationale: match: code: {text: section4.2-rationale-for-trial-design} schema: type: BackboneElement mustSupport: true _required: true index: 121 elements: title: pattern: {type: String, value: Rationale for Trial Design} index: 122 code: elements: text: pattern: {type: String, value: section4.2-rationale-for-trial-design} index: 123 required: [text] section: index: 124 slicing: rules: open discriminator: - {path: code.text, type: value} min: null slices: model: match: code: {text: section4.2.1-rationale-intervention-model} schema: type: BackboneElement mustSupport: true index: 125 elements: title: pattern: {type: String, value: Rationale for Intervention Model} index: 126 code: elements: text: pattern: {type: String, value: section4.2.1-rationale-intervention-model} index: 127 required: [text] text: {index: 128} required: [text] duration: match: code: {text: section4.2.2-rationale-duration} schema: type: BackboneElement mustSupport: true index: 129 elements: title: pattern: {type: String, value: Rationale for Duration} index: 130 code: elements: text: pattern: {type: String, value: section4.2.2-rationale-duration} index: 131 required: [text] text: {index: 132} required: [text] endpoints: match: code: {text: section4.2.3-rationale-endpoints} schema: type: BackboneElement mustSupport: true index: 133 elements: title: pattern: {type: String, value: Rationale for Endpoints} index: 134 code: elements: text: pattern: {type: String, value: section4.2.3-rationale-endpoints} index: 135 required: [text] text: {index: 136} required: [text] interim: match: code: {text: section4.2.4-rationale-interim-analysis} schema: type: BackboneElement mustSupport: true index: 137 elements: title: pattern: {type: String, value: Rationale for Interim Analysis} index: 138 code: elements: text: pattern: {type: String, value: section4.2.4-rationale-interim-analysis} index: 139 required: [text] text: {index: 140} required: [text] comparator: match: code: {text: section4.2.5-rationale-comparator} schema: type: BackboneElement mustSupport: true index: 141 elements: title: pattern: {type: String, value: Rationale for Comparator} index: 142 code: elements: text: pattern: {type: String, value: section4.2.5-rationale-comparator} index: 143 required: [text] text: {index: 144} required: [text] adaptive: match: code: {text: section4.2.6-rationale-adaptive} schema: type: BackboneElement mustSupport: true index: 145 elements: title: pattern: {type: String, value: Rationale for Adaptive or Novel Trial Design} index: 146 code: elements: text: pattern: {type: String, value: section4.2.6-rationale-adaptive} index: 147 required: [text] text: {index: 148} required: [text] otherAspects: match: code: {text: section4.2.7-rationale-other-aspects} schema: type: BackboneElement mustSupport: true index: 149 elements: title: pattern: {type: String, value: Rationale for Other Trial Design Aspects} index: 150 code: elements: text: pattern: {type: String, value: section4.2.7-rationale-other-aspects} index: 151 required: [text] text: {index: 152} required: [text] trialStoppingRules: match: code: {text: section4.3-trial-stopping-rules} schema: type: BackboneElement mustSupport: true _required: true index: 153 elements: title: pattern: {type: String, value: Trial Stopping Rules} index: 154 code: elements: text: pattern: {type: String, value: section4.3-trial-stopping-rules} index: 155 required: [text] text: {index: 156} section: index: 157 slicing: rules: open discriminator: - {path: code.text, type: value} min: null slices: temporaryHalt: match: code: {text: section4.3.1-temporary-trial-halt} schema: type: BackboneElement mustSupport: true index: 158 elements: title: pattern: {type: String, value: Temporary Trial Halt} index: 159 code: elements: text: pattern: {type: String, value: section4.3.1-temporary-trial-halt} index: 160 required: [text] text: {index: 161} required: [text] required: [text] startEnd: match: code: {text: section4.4-start-and-end} schema: type: BackboneElement mustSupport: true _required: true index: 162 elements: title: pattern: {type: String, value: Start of Trial and End of Trial} index: 163 code: elements: text: pattern: {type: String, value: section4.4-start-and-end} index: 164 required: [text] text: {index: 165} required: [text] access: match: code: {text: section4.5-access-after-trial} schema: type: BackboneElement mustSupport: true index: 166 elements: title: pattern: {type: String, value: Access to Trial Intervention After End of Trial} index: 167 code: elements: text: pattern: {type: String, value: section4.5-access-after-trial} index: 168 required: [text] text: {index: 169} required: [text] introduction: match: code: {text: section2-introduction} schema: mustSupport: true _required: true index: 47 elements: title: pattern: {type: String, value: Introduction} index: 48 code: elements: text: pattern: {type: String, value: section2-introduction} index: 49 required: [text] section: array: true min: 2 index: 50 slicing: rules: open discriminator: - {path: code.text, type: value} min: 2 slices: purposeOfTrial: match: code: {text: section2.1-trial-purpose} schema: type: BackboneElement mustSupport: true _required: true index: 51 elements: title: pattern: {type: String, value: Purpose of Trial} index: 52 code: elements: text: pattern: {type: String, value: section2.1-trial-purpose} index: 53 required: [text] text: {index: 54} required: [text] benefitsAndRisks: match: code: {text: section2.2-benefits-risks} schema: type: BackboneElement mustSupport: true _required: true index: 55 elements: title: pattern: {type: String, value: Summary of Benefits and Risks} index: 56 code: elements: text: pattern: {type: String, value: section2.2-benefits-risks} index: 57 required: [text] section: array: true min: 3 index: 58 slicing: rules: open discriminator: - {path: code.text, type: value} min: 3 slices: benefitSummary: match: code: {text: section2.2.1-benefit-summary} schema: type: BackboneElement mustSupport: true _required: true index: 59 elements: title: pattern: {type: String, value: Benefit Summary} index: 60 code: elements: text: pattern: {type: String, value: section2.2.1-benefit-summary} index: 61 required: [text] text: {index: 62} required: [text] riskSummary: match: code: {text: section2.2.2-risk-summary} schema: type: BackboneElement _required: true index: 63 elements: title: pattern: {type: String, value: Risk Summary and Mitigation Strategy} index: 64 code: elements: text: pattern: {type: String, value: section2.2.2-risk-summary} index: 65 required: [text] section: array: true min: 3 index: 66 slicing: rules: open discriminator: - {path: code.text, type: value} min: 3 slices: trialIntervention: match: code: {text: section2.2.2.1-trial-intervention-risk-summary} schema: type: BackboneElement mustSupport: true _required: true index: 67 elements: title: pattern: {type: String, value: Trial-specific Intervention Risks and Mitigations} index: 68 code: elements: text: pattern: {type: String, value: section2.2.2.1-trial-intervention-risk-summary} index: 69 required: [text] text: {index: 70} required: [text] trialProcedures: match: code: {text: section2.2.2.2-trial-procedures-risk-summary} schema: type: BackboneElement _required: true index: 71 elements: title: pattern: {type: String, value: Trial-specific Procedure Risks and Mitigations} index: 72 code: elements: text: pattern: {type: String, value: section2.2.2.2-trial-procedures-risk-summary} index: 73 required: [text] text: {index: 74} required: [text] otherRisk: match: code: {text: section2.2.2.3-trial-other-risk-summary} schema: type: BackboneElement _required: true index: 75 elements: title: pattern: {type: String, value: Trial-specific Other Risks and Mitigations} index: 76 code: elements: text: pattern: {type: String, value: section2.2.2.3-trial-other-risk-summary} index: 77 required: [text] text: {index: 78} required: [text] overallBenefitRisk: match: code: {text: section2.2.3-overall-benefit-risk-conclusion} schema: type: BackboneElement _required: true index: 79 elements: title: pattern: {type: String, value: 'Overall Benefit:Risk Conclusion'} index: 80 code: elements: text: pattern: {type: String, value: section2.2.3-overall-benefit-risk-conclusion} index: 81 required: [text] text: {index: 82} required: [text] glossary: match: code: {text: section14-glossary} schema: mustSupport: true _required: true index: 710 elements: title: pattern: {type: String, value: 'Appendix: Glossary of Terms and Abbreviations'} index: 711 code: elements: text: pattern: {type: String, value: section14-glossary} index: 712 required: [text] text: {index: 713} entry: type: Reference refers: ['http://hl7.org/fhir/StructureDefinition/CodeSystem', 'http://hl7.org/fhir/StructureDefinition/ValueSet'] index: 714 required: [text] package_version: 1.0.0-ballot 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-ballot required: [category]