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: text: pattern: {type: String, value: section8.6.3-other-biomarkers} index: 398 required: [text] text: {index: 399} required: [text] immunogenicity: match: code: {text: section8.7-immunogenicity-assessments} schema: type: BackboneElement mustSupport: true _required: true index: 400 elements: title: pattern: {type: String, value: Immunogenicity Assessments} index: 401 code: elements: text: pattern: {type: String, value: section8.7-immunogenicity-assessments} index: 402 required: [text] text: {index: 403} required: [text] economics: match: code: {text: section8.8-economics} schema: type: BackboneElement mustSupport: true index: 404 elements: title: pattern: {type: String, value: Medical Resource Utilisation and Health Economics} index: 405 code: elements: text: pattern: {type: String, value: section8.8-economics} index: 406 required: [text] text: {index: 407} required: [text] definitions: match: code: {text: section12-supporting-details} schema: mustSupport: true _required: true index: 691 elements: title: pattern: {type: String, value: 'Appendix: Supporting Details'} index: 692 code: elements: text: pattern: {type: String, value: section12-supporting-details} index: 693 required: [text] section: array: true min: 3 index: 694 slicing: rules: open discriminator: - {path: code.text, type: value} min: 3 slices: clinicalLaboratoryTests: match: code: {text: section12.1-clinical-laboratory-tests} schema: type: BackboneElement mustSupport: true _required: true index: 695 elements: title: pattern: {type: String, value: Clinical Laboratory Tests} index: 696 code: elements: text: pattern: {type: String, value: section12.1-clinical-laboratory-tests} index: 697 required: [text] text: {index: 698} required: [text] regional: match: code: {text: section12.2-country-specific-differences} schema: type: BackboneElement mustSupport: true _required: true index: 699 elements: title: pattern: {type: String, value: Country/Region-Specific Differences} index: 700 code: elements: text: pattern: {type: String, value: section12.2-country-specific-differences} index: 701 required: [text] text: {index: 702} required: [text] priorAmendments: match: code: {text: section12.3-prior-protocol-amendments} schema: type: BackboneElement mustSupport: true _required: true index: 703 elements: title: pattern: {type: String, value: Prior Protocol Amendment(s)} index: 704 code: elements: text: pattern: {type: String, value: section12.3-prior-protocol-amendments} index: 705 required: [text] text: {index: 706} required: [text] dropout: match: code: {text: section7-participant-discontinuation} schema: mustSupport: true _required: true index: 306 elements: title: pattern: {type: String, value: Participant Discontinuation of Trial Intervention and Discontinuation or Withdrawal from Trial} index: 307 code: elements: text: pattern: {type: String, value: section7-participant-discontinuation} index: 308 required: [text] section: array: true min: 3 index: 309 slicing: rules: open discriminator: - {path: code.text, type: value} min: 3 slices: discontinuation: match: code: {text: section7.1-discontinuation-of-trial-intervention} schema: type: BackboneElement mustSupport: true _required: true index: 310 elements: title: pattern: {type: String, value: Discontinuation of Trial Intervention for Individual Participants} index: 311 code: elements: text: pattern: {type: String, value: section7.1-discontinuation-of-trial-intervention} index: 312 required: [text] section: array: true min: 3 index: 313 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: 314 elements: title: pattern: {type: String, value: Permanent Discontinuation of Trial Intervention} index: 315 code: elements: text: pattern: {type: String, value: section7.1.1-permanent-discontinuation-of-trial-intervention} index: 316 required: [text] text: {index: 317} required: [text] temporary: match: code: {text: section7.1.2-temporary-discontinuation-of-trial-intervention} schema: type: BackboneElement mustSupport: true _required: true index: 318 elements: title: pattern: {type: String, value: Temporary Discontinuation of Trial Intervention} index: 319 code: elements: text: pattern: {type: String, value: section7.1.2-temporary-discontinuation-of-trial-intervention} index: 320 required: [text] text: {index: 321} required: [text] rechallenge: match: code: {text: section7.1.3-rechallenge} schema: type: BackboneElement mustSupport: true _required: true index: 322 elements: title: pattern: {type: String, value: Rechallenge} index: 323 code: elements: text: pattern: {type: String, value: section7.1.3-rechallenge} index: 324 required: [text] text: {index: 325} required: [text] withdrawal: match: code: {text: section7.2-participant-withdrawal} schema: type: BackboneElement mustSupport: true _required: true index: 326 elements: title: pattern: {type: String, value: Discontinuation or Withdrawal from the Trial} index: 327 code: elements: text: pattern: {type: String, value: section7.2-participant-withdrawal} index: 328 required: [text] text: {index: 329} required: [text] lostToFollowUp: match: code: {text: section7.3-lost-to-follow-up} schema: type: BackboneElement mustSupport: true _required: true index: 330 elements: title: pattern: {type: String, value: Management of Loss to Follow-Up} index: 331 code: elements: text: pattern: {type: String, value: section7.3-lost-to-follow-up} index: 332 required: [text] text: {index: 333} required: [text] references: match: code: {text: section14-references} schema: mustSupport: true _required: true index: 712 elements: title: pattern: {type: String, value: 'Appendix: References'} index: 713 code: elements: text: pattern: {type: String, value: section14-references} index: 714 required: [text] text: {index: 715} entry: type: Reference refers: ['http://hl7.org/fhir/StructureDefinition/Citation'] index: 716 required: [text] statistics: match: code: {text: section10-statistics} schema: mustSupport: true _required: true index: 495 elements: title: pattern: {type: String, value: Statistical Considerations} index: 496 code: elements: text: pattern: {type: String, value: section10-statistics} index: 497 required: [text] text: {index: 498} section: array: true min: 6 index: 499 slicing: rules: open discriminator: - {path: code.text, type: value} min: 6 slices: multiplicity: match: code: {text: section10.10-multiplicity-adjustments} schema: type: BackboneElement mustSupport: true _required: true index: 588 elements: title: pattern: {type: String, value: Multiplicity Adjustments} index: 589 code: elements: text: pattern: {type: String, value: section10.10-multiplicity-adjustments} index: 590 required: [text] text: {index: 591} required: [text] considerations: match: code: {text: section10.1-general-considerations} schema: type: BackboneElement mustSupport: true _required: true index: 500 elements: title: pattern: {type: String, value: General Considerations} index: 501 code: elements: text: pattern: {type: String, value: section10.1-general-considerations} index: 502 required: [text] text: {index: 503} required: [text] analysisBaseline: match: code: {text: section10.3-analyses-demographics} schema: type: BackboneElement mustSupport: true _required: true index: 508 elements: title: pattern: {type: String, value: Analyses of Demographics and Other Baseline Variables} index: 509 code: elements: text: pattern: {type: String, value: section10.3-analyses-demographics} index: 510 required: [text] text: {index: 511} required: [text] analysisSets: match: code: {text: section10.2-analysis-sets} schema: type: BackboneElement mustSupport: true _required: true index: 504 elements: title: pattern: {type: String, value: Analysis Sets} index: 505 code: elements: text: pattern: {type: String, value: section10.2-analysis-sets} index: 506 required: [text] text: {index: 507} required: [text] sampleSize: match: code: {text: section10.11-sample-size-determination} schema: type: BackboneElement mustSupport: true _required: true index: 596 elements: title: pattern: {type: String, value: Sample Size Determination} index: 597 code: elements: text: pattern: {type: String, value: section10.11-sample-size-determination} index: 598 required: [text] text: {index: 599} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan'] index: 600 required: [text] interimAnalyses: match: code: {text: section10.9-interim-analyses} schema: type: BackboneElement mustSupport: true index: 592 elements: title: pattern: {type: String, value: Interim Analyses} index: 593 code: elements: text: pattern: {type: String, value: section10.9-interim-analyses} index: 594 required: [text] text: {index: 595} required: [text] exploratoryAnalysis: match: code: {text: section10.6-analysis-exploratory-objective} schema: type: BackboneElement mustSupport: true index: 576 elements: title: pattern: {type: String, value: Analyses Associated with the Exploratory Objective(s)} index: 577 code: elements: text: pattern: {type: String, value: section10.6-analysis-exploratory-objective} index: 578 required: [text] text: {index: 579} required: [text] secondaryAnalysis: match: code: {text: section10.5-analysis-secondary-objective} schema: type: BackboneElement mustSupport: true array: true index: 544 elements: title: pattern: {type: String, value: Analyses Associated with the Secondary Objective(s)} index: 545 code: elements: text: pattern: {type: String, value: section10.5-analysis-secondary-objective} index: 546 required: [text] text: {index: 547} section: index: 548 slicing: rules: open discriminator: - {path: code.text, type: value} min: 1 slices: analysisSecondaryInstance: match: code: {text: section10.5.1-analysis-secondary-objective-instance} schema: type: BackboneElement mustSupport: true array: true min: 1 _required: true index: 549 elements: code: elements: text: pattern: {type: String, value: section10.5.1-analysis-secondary-objective-instance} index: 550 required: [text] focus: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition'] index: 551 text: {index: 552} section: index: 553 slicing: rules: open discriminator: - {path: code.text, type: value} min: null slices: statisticalModel: match: code: {text: section10.5.1.1-statistical-method} schema: type: BackboneElement mustSupport: true index: 554 elements: title: pattern: {type: String, value: Statistical Analysis Method} index: 555 code: elements: text: pattern: {type: String, value: section10.5.1.1-statistical-method} index: 556 required: [text] text: {index: 557} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan'] index: 558 required: [text] intercurrentEventHandling: match: code: {text: section10.5.1.2-data-handling} schema: type: BackboneElement mustSupport: true index: 559 elements: title: pattern: {type: String, value: Handling of Data in Relation to Secondary Estimand(s)} index: 560 code: elements: text: pattern: {type: String, value: section10.5.1.2-data-handling} index: 561 required: [text] text: {index: 562} required: [text] missingData: match: code: {text: section10.5.1.3-missing-data-handling} schema: type: BackboneElement mustSupport: true index: 563 elements: title: pattern: {type: String, value: Handling of Missing Data in Relation to Secondary Estimand(s)} index: 564 code: elements: text: pattern: {type: String, value: section10.5.1.3-missing-data-handling} index: 565 required: [text] text: {index: 566} required: [text] sensitvityAnalysis: match: code: {text: section10.5.1.4-sensitivity-analysis} schema: type: BackboneElement mustSupport: true index: 567 elements: title: pattern: {type: String, value: Sensitivity Analysis} index: 568 code: elements: text: pattern: {type: String, value: section10.5.1.4-sensitivity-analysis} index: 569 required: [text] text: {index: 570} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan'] index: 571 required: [text] supplementaryAnalysis: match: code: {text: section10.5.1.5-supplementary-analysis} schema: type: BackboneElement mustSupport: true index: 572 elements: title: pattern: {type: String, value: Supplementary Analysis} index: 573 code: elements: text: pattern: {type: String, value: section10.5.1.5-supplementary-analysis} index: 574 required: [text] text: {index: 575} required: [text] required: [section] safetyAnalyses: match: code: {text: section10.7-safety-analyses} schema: type: BackboneElement mustSupport: true index: 580 elements: title: pattern: {type: String, value: Safety Analyses} index: 581 code: elements: text: pattern: {type: String, value: section10.7-safety-analyses} index: 582 required: [text] text: {index: 583} required: [text] analysisPrimaryObjective: match: code: {text: section10.4-analysis-primary-objective} schema: type: BackboneElement mustSupport: true array: true min: 1 _required: true index: 512 elements: title: pattern: {type: String, value: Analyses Associated with the Primary Objective(s)} index: 513 code: elements: text: pattern: {type: String, value: section10.4-analysis-primary-objective} index: 514 required: [text] text: {index: 515} section: index: 516 slicing: rules: open discriminator: - {path: code.text, type: value} min: 1 slices: analysisPrimaryInstance: match: code: {text: section10.4.1-analysis-primary-objective-instance} schema: type: BackboneElement mustSupport: true array: true min: 1 _required: true index: 517 elements: code: elements: text: pattern: {type: String, value: section10.4.1-analysis-primary-objective-instance} index: 518 required: [text] focus: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/variable-definition'] index: 519 text: {index: 520} section: array: true min: 3 index: 521 slicing: rules: open discriminator: - {path: code.text, type: value} min: 3 slices: statisticalModel: match: code: {text: section10.4.1.1-statistical-method} schema: type: BackboneElement mustSupport: true _required: true index: 522 elements: title: pattern: {type: String, value: Statistical Analysis Method} index: 523 code: elements: text: pattern: {type: String, value: section10.4.1.1-statistical-method} index: 524 required: [text] text: {index: 525} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan'] index: 526 required: [text] intercurrentEventHandling: match: code: {text: section10.4.1.2-data-handling} schema: type: BackboneElement mustSupport: true index: 527 elements: title: pattern: {type: String, value: Handling of Data in Relation to Primary Estimand(s)} index: 528 code: elements: text: pattern: {type: String, value: section10.4.1.2-data-handling} index: 529 required: [text] text: {index: 530} required: [text] missingData: match: code: {text: section10.4.1.3-missing-data-handling} schema: type: BackboneElement mustSupport: true _required: true index: 531 elements: title: pattern: {type: String, value: Handling of Missing Data in Relation to Primary Estimand(s)} index: 532 code: elements: text: pattern: {type: String, value: section10.4.1.3-missing-data-handling} index: 533 required: [text] text: {index: 534} required: [text] sensitvityAnalysis: match: code: {text: section10.4.1.4-sensitivity-analysis} schema: type: BackboneElement mustSupport: true _required: true index: 535 elements: title: pattern: {type: String, value: Sensitivity Analysis} index: 536 code: elements: text: pattern: {type: String, value: section10.4.1.4-sensitivity-analysis} index: 537 required: [text] text: {index: 538} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/endpoint-analysis-plan'] index: 539 required: [text] supplementaryAnalysis: match: code: {text: section10.4.1.5-supplementary-analysis} schema: type: BackboneElement mustSupport: true index: 540 elements: title: pattern: {type: String, value: Supplementary Analysis} index: 541 code: elements: text: pattern: {type: String, value: section10.4.1.5-supplementary-analysis} index: 542 required: [text] text: {index: 543} required: [text] required: [section] otherAnalyses: match: code: {text: section10.8-other-analyses} schema: type: BackboneElement mustSupport: true index: 584 elements: title: pattern: {type: String, value: Other Analyses} index: 585 code: elements: text: pattern: {type: String, value: section10.8-other-analyses} index: 586 required: [text] text: {index: 587} required: [text] summary: match: code: {text: section1-protocol-summary} schema: mustSupport: true _required: true index: 7 elements: title: pattern: {type: String, value: Protocol Summary} index: 8 code: elements: text: pattern: {type: String, value: section1-protocol-summary} index: 9 required: [text] section: array: true min: 3 index: 10 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: 11 elements: title: pattern: {type: String, value: Protocol Synopsis} index: 12 code: elements: text: pattern: {type: String, value: section1.1-protocol-synopsis} index: 13 required: [text] section: array: true min: 6 index: 14 slicing: rules: open discriminator: - {path: code.text, type: value} min: 6 slices: objectivesEndpoints: match: code: {text: section1.1.1-objectives-estimands} schema: type: BackboneElement mustSupport: true _required: true index: 15 elements: title: pattern: {type: String, value: Primary and Secondary Objectives and Estimands} index: 16 code: elements: text: pattern: {type: String, value: section1.1.1-objectives-estimands} index: 17 required: [text] text: {index: 18} entry: type: Reference refers: ['http://hl7.org/fhir/StructureDefinition/Composition'] index: 19 required: [text] overallDesign: match: code: {text: section1.1.2-overall-design} schema: type: BackboneElement _required: true index: 20 elements: title: pattern: {type: String, value: Overall Design} index: 21 code: elements: text: pattern: {type: String, value: section1.1.2-overall-design} index: 22 required: [text] text: {index: 23} entry: type: Reference refers: ['http://hl7.org/fhir/StructureDefinition/Composition', 'http://hl7.org/fhir/StructureDefinition/ResearchStudy'] index: 24 required: [text] numberOfArms: match: code: {text: Number of Arms} schema: type: BackboneElement _required: true index: 25 elements: code: elements: text: pattern: {type: String, value: Number of Arms} index: 26 required: [text] text: {index: 27} required: [text] blinding: match: code: {text: Blinding} schema: type: BackboneElement _required: true index: 28 elements: code: elements: text: pattern: {type: String, value: Blinding} index: 29 required: [text] text: {index: 30} required: [text] numberOfParticipants: match: code: {text: Number of Participants} schema: type: BackboneElement _required: true index: 31 elements: code: elements: text: pattern: {type: String, value: Number of Participants} index: 32 required: [text] text: {index: 33} required: [text] duration: match: code: {text: Duration} schema: type: BackboneElement index: 34 elements: code: elements: text: pattern: {type: String, value: Duration} index: 35 required: [text] text: {index: 36} required: [text] committees: match: code: {text: Committees} schema: type: BackboneElement _required: true index: 37 elements: code: elements: text: pattern: {type: String, value: Committees} index: 38 required: [text] text: {index: 39} required: [text] trialSchema: match: code: {text: section1.2-trial-schema} schema: type: BackboneElement mustSupport: true _required: true index: 40 elements: title: pattern: {type: String, value: Trial Schema} index: 41 code: elements: text: pattern: {type: String, value: section1.2-trial-schema} index: 42 required: [text] text: {index: 43} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/soa-plandefinition'] index: 44 required: [text] scheduleOfActivities: match: code: {text: section1.3-schedule-of-activities} schema: type: BackboneElement mustSupport: true _required: true index: 45 elements: title: pattern: {type: String, value: Schedule of Activities} index: 46 code: elements: text: pattern: {type: String, value: section1.3-schedule-of-activities} index: 47 required: [text] text: {index: 48} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/soa-plandefinition'] index: 49 required: [text] titlepage: match: code: {text: section0-title-page} schema: mustSupport: true _required: true index: 3 elements: title: pattern: {type: String, value: Title Page} index: 4 code: elements: text: pattern: {type: String, value: section0-title-page} index: 5 required: [text] entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-research-study'] index: 6 estimands: match: code: {text: section3-estimands} schema: mustSupport: true _required: true index: 88 elements: title: pattern: {type: String, value: Trial Objectives and Associated Estimands} index: 89 code: elements: text: pattern: {type: String, value: section3-estimands} index: 90 required: [text] entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/m11-research-study'] index: 91 adverseEvents: match: code: {text: section9-adverse-events} schema: mustSupport: true _required: true index: 408 elements: title: pattern: {type: String, value: 'Adverse Events, Serious Adverse Events, Product Complaints, Pregnancy and Postpartum Information, and Special Safety Situations'} index: 409 code: elements: text: pattern: {type: String, value: section9-adverse-events} index: 410 required: [text] section: array: true min: 4 index: 411 slicing: rules: open discriminator: - {path: code.text, type: value} min: 4 slices: definitions: match: code: {text: section9.1-definitions} schema: type: BackboneElement mustSupport: true _required: true index: 412 elements: title: pattern: {type: String, value: Definitions} index: 413 code: elements: text: pattern: {type: String, value: section9.1-definitions} index: 414 required: [text] section: array: true min: 2 index: 415 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: 416 elements: title: pattern: {type: String, value: Definitions of Adverse Events} index: 417 code: elements: text: pattern: {type: String, value: section9.1.1-definitions-adverse-events} index: 418 required: [text] text: {index: 419} required: [text] seriousAdverseEventsDefinitions: match: code: {text: section9.1.2-definitions-serious-adverse-events} schema: type: BackboneElement mustSupport: true _required: true index: 420 elements: title: pattern: {type: String, value: Definitions of Serious Adverse Events} index: 421 code: elements: text: pattern: {type: String, value: section9.1.2-definitions-serious-adverse-events} index: 422 required: [text] text: {index: 423} required: [text] productComplaintsDefinitions: match: code: {text: section9.1.3-definitions-product-complaints} schema: type: BackboneElement mustSupport: true index: 424 elements: title: pattern: {type: String, value: Definitions of Product Complaints} index: 425 code: elements: text: pattern: {type: String, value: section9.1.3-definitions-product-complaints} index: 426 required: [text] text: {index: 427} required: [text] collectionMethods: match: code: {text: section9.2-collection-methods} schema: type: BackboneElement mustSupport: true _required: true index: 428 elements: title: pattern: {type: String, value: Timing and Procedures for Collection and Reporting} index: 429 code: elements: text: pattern: {type: String, value: section9.2-collection-methods} index: 430 required: [text] text: {index: 431} section: array: true min: 5 index: 432 slicing: rules: open discriminator: - {path: code.text, type: value} min: 5 slices: timing: match: code: {text: section9.2.1-timing} schema: type: BackboneElement _required: true index: 433 elements: title: pattern: {type: String, value: Timing} index: 434 code: elements: text: pattern: {type: String, value: section9.2.1-timing} index: 435 required: [text] text: {index: 436} required: [text] procedures: match: code: {text: section9.2.2-collection-procedures} schema: type: BackboneElement _required: true index: 437 elements: title: pattern: {type: String, value: Collection Procedures} index: 438 code: elements: text: pattern: {type: String, value: section9.2.2-collection-procedures} index: 439 required: [text] text: {index: 440} section: array: true min: 5 index: 441 slicing: rules: open discriminator: - {path: code.text, type: value} min: 5 slices: identifying: match: code: {text: section9.2.2.1-identification} schema: type: BackboneElement _required: true index: 442 elements: title: pattern: {type: String, value: Identification} index: 443 code: elements: text: pattern: {type: String, value: section9.2.2.1-identification} index: 444 required: [text] text: {index: 445} required: [text] intensity: match: code: {text: section9.2.2.2-severity} schema: type: BackboneElement _required: true index: 446 elements: title: pattern: {type: String, value: Severity} index: 447 code: elements: text: pattern: {type: String, value: section9.2.2.2-severity} index: 448 required: [text] text: {index: 449} required: [text] causality: match: code: {text: section9.2.2.3-causality} schema: type: BackboneElement _required: true index: 450 elements: title: pattern: {type: String, value: Causality} index: 451 code: elements: text: pattern: {type: String, value: section9.2.2.3-causality} index: 452 required: [text] text: {index: 453} required: [text] recording: match: code: {text: section9.2.2.4-recording} schema: type: BackboneElement _required: true index: 454 elements: title: pattern: {type: String, value: Recording} index: 455 code: elements: text: pattern: {type: String, value: section9.2.2.4-recording} index: 456 required: [text] text: {index: 457} required: [text] followup: match: code: {text: section9.2.2.5-followup} schema: type: BackboneElement _required: true index: 458 elements: title: pattern: {type: String, value: Follow-up} index: 459 code: elements: text: pattern: {type: String, value: section9.2.2.5-followup} index: 460 required: [text] text: {index: 461} required: [text] required: [text] reporting: match: code: {text: section9.2.3-reporting-events} schema: type: BackboneElement _required: true index: 462 elements: title: pattern: {type: String, value: Reporting} index: 463 code: elements: text: pattern: {type: String, value: section9.2.3-reporting-events} index: 464 required: [text] text: {index: 465} section: index: 466 slicing: rules: open discriminator: - {path: code.text, type: value} min: 1 slices: regulatoryRequirements: match: code: {text: section9.2.3.1-regulatory-requirements} schema: type: BackboneElement _required: true index: 467 elements: title: pattern: {type: String, value: Regulatory Reporting Requirements} index: 468 code: elements: text: pattern: {type: String, value: section9.2.3.1-regulatory-requirements} index: 469 required: [text] text: {index: 470} required: [text] required: [section, text] specialInterest: match: code: {text: section9.2.4-special-interest} schema: type: BackboneElement _required: true index: 471 elements: title: pattern: {type: String, value: Adverse Events of Special Interest} index: 472 code: elements: text: pattern: {type: String, value: section9.2.4-special-interest} index: 473 required: [text] text: {index: 474} required: [text] diseaseRelatedEvents: match: code: {text: section9.2.5-disease-related-events} schema: type: BackboneElement _required: true index: 475 elements: title: pattern: {type: String, value: Disease-related Events or Outcomes Not Qualifying as AEs or SAEs} index: 476 code: elements: text: pattern: {type: String, value: section9.2.5-disease-related-events} index: 477 required: [text] text: {index: 478} required: [text] required: [text] pregnancy: match: code: {text: section9.3-pregnancy-postpartum} schema: type: BackboneElement mustSupport: true _required: true index: 479 elements: title: pattern: {type: String, value: Pregnancy and Postpartum Information} index: 480 code: elements: text: pattern: {type: String, value: section9.3-pregnancy-postpartum} index: 481 required: [text] section: index: 482 slicing: rules: open discriminator: - {path: code.text, type: value} min: null slices: pregnant: match: code: {text: section9.3.1-pregnant} schema: type: BackboneElement mustSupport: true index: 483 elements: title: pattern: {type: String, value: Participants Who Become Pregnant During the Trial} index: 484 code: elements: text: pattern: {type: String, value: section9.3.1-pregnant} index: 485 required: [text] text: {index: 486} required: [text] pregnantPartner: match: code: {text: section9.3.2-pregnant-partner} schema: type: BackboneElement mustSupport: true index: 487 elements: title: pattern: {type: String, value: Participants Whose Partners Become Pregnant} index: 488 code: elements: text: pattern: {type: String, value: section9.3.2-pregnant-partner} index: 489 required: [text] text: {index: 490} required: [text] special: match: code: {text: section9.4-special-safety-situations} schema: type: BackboneElement mustSupport: true _required: true index: 491 elements: title: pattern: {type: String, value: Special Safety Situations} index: 492 code: elements: text: pattern: {type: String, value: section9.4-special-safety-situations} index: 493 required: [text] text: {index: 494} required: [text] population: match: code: {text: section5-trial-population} schema: mustSupport: true _required: true index: 150 elements: title: pattern: {type: String, value: Trial Population} index: 151 code: elements: text: pattern: {type: String, value: section5-trial-population} index: 152 required: [text] section: array: true min: 6 index: 153 slicing: rules: open discriminator: - {path: code.text, type: value} min: 6 slices: description: match: code: {text: section5.1-population-description} schema: type: BackboneElement mustSupport: true _required: true index: 154 elements: title: pattern: {type: String, value: Description of Trial Population and Rationale} index: 155 code: elements: text: pattern: {type: String, value: section5.1-population-description} index: 156 required: [text] text: {index: 157} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/cohort-definition'] index: 158 required: [text] inclusionCriteria: match: code: {text: section5.2-inclusion-criteria} schema: type: BackboneElement mustSupport: true _required: true index: 159 elements: title: pattern: {type: String, value: Inclusion Criteria} index: 160 code: elements: text: pattern: {type: String, value: section5.2-inclusion-criteria} index: 161 required: [text] text: {index: 162} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/cohort-definition'] index: 163 required: [text] exclusionCriteria: match: code: {text: section5.3-exclusion-criteria} schema: type: BackboneElement mustSupport: true _required: true index: 164 elements: title: pattern: {type: String, value: Exclusion Criteria} index: 165 code: elements: text: pattern: {type: String, value: section5.3-exclusion-criteria} index: 166 required: [text] text: {index: 167} entry: type: Reference refers: ['http://hl7.org/fhir/uv/ebm/StructureDefinition/cohort-definition'] index: 168 required: [text] contraception: match: code: {text: section5.4-contraception} schema: type: BackboneElement mustSupport: true _required: true index: 169 elements: title: pattern: {type: String, value: Contraception} index: 170 code: elements: text: pattern: {type: String, value: section5.4-contraception} index: 171 required: [text] section: array: true min: 2 index: 172 slicing: rules: open discriminator: - {path: code.text, type: value} min: 2 slices: contraceptionDefinitions: match: code: {text: section5.4.1-contraception-definitions} schema: type: BackboneElement mustSupport: true _required: true index: 173 elements: title: pattern: {type: String, value: Definitions Related to Childbearing Potential} index: 174 code: elements: text: pattern: {type: String, value: section5.4.1-contraception-definitions} index: 175 required: [text] text: {index: 176} required: [text] contraceptionDetails: match: code: {text: section5.4.2-contraception-details} schema: type: BackboneElement mustSupport: true _required: true index: 177 elements: title: pattern: {type: String, value: Contraception Requirements} index: 178 code: elements: text: pattern: {type: String, value: section5.4.2-contraception-details} index: 179 required: [text] text: {index: 180} required: [text] lifestyle: match: code: {text: section5.5-lifestyle-restrictions} schema: type: BackboneElement mustSupport: true index: 181 elements: title: pattern: {type: String, value: Lifestyle Restrictions} index: 182 code: elements: text: pattern: {type: String, value: section5.5-lifestyle-restrictions} index: 183 required: [text] text: {index: 184} section: index: 185 slicing: rules: open discriminator: - {path: code.text, type: value} min: null slices: dietary: match: code: {text: section5.5.1-dietary-restrictions} schema: type: BackboneElement mustSupport: true index: 186 elements: title: pattern: {type: String, value: Meals and Dietary Restrictions} index: 187 code: elements: text: pattern: {type: String, value: section5.5.1-dietary-restrictions} index: 188 required: [text] text: {index: 189} required: [text] substances: match: code: {text: section5.5.2-substances-restrictions} schema: type: BackboneElement mustSupport: true index: 190 elements: title: pattern: {type: String, value: 'Caffeine, Alcohol, Tobacco, and Other Restrictions'} index: 191 code: elements: text: pattern: {type: String, value: section5.5.2-substances-restrictions} index: 192 required: [text] text: {index: 193} required: [text] activity: match: code: {text: section5.5.3-activity-restrictions} schema: type: BackboneElement mustSupport: true index: 194 elements: title: pattern: {type: String, value: Physical Activity Restrictions} index: 195 code: elements: text: pattern: {type: String, value: section5.5.3-activity-restrictions} index: 196 required: [text] text: {index: 197} required: [text] other: match: code: {text: section5.5.4-other-restrictions} schema: type: BackboneElement mustSupport: true index: 198 elements: title: pattern: {type: String, value: Other Activity Restrictions} index: 199 code: elements: text: pattern: {type: String, value: section5.5.4-other-restrictions} index: 200 required: [text] text: {index: 201} required: [text] required: [text] screenFailures: match: code: {text: section5.6-screen-failure} schema: type: BackboneElement mustSupport: true index: 202 elements: title: pattern: {type: String, value: Screen Failure and Rescreening} index: 203 code: elements: text: pattern: {type: String, value: section5.6-screen-failure} index: 204 required: [text] text: {index: 205} required: [text] oversight: match: code: {text: section11-oversight} schema: mustSupport: true _required: true index: 601 elements: title: pattern: {type: String, value: Trial Oversight and Other General Considerations} index: 602 code: elements: text: pattern: {type: String, value: section11-oversight} index: 603 required: [text] section: array: true min: 12 index: 604 slicing: rules: open discriminator: - {path: code.text, type: value} min: 12 slices: riskManagement: match: code: {text: section11.6-risk-management} schema: type: BackboneElement mustSupport: true _required: true index: 651 elements: title: pattern: {type: String, value: Risk-Based Quality Management} index: 652 code: elements: text: pattern: {type: String, value: section11.6-risk-management} index: 653 required: [text] text: {index: 654} required: [text] trialOversight: match: code: {text: section11.2-trial-oversight} schema: type: BackboneElement mustSupport: true _required: true index: 609 elements: title: pattern: {type: String, value: Trial Oversight} index: 610 code: elements: text: pattern: {type: String, value: section11.2-trial-oversight} index: 611 required: [text] text: {index: 612} section: array: true min: 2 index: 613 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: 614 elements: title: pattern: {type: String, value: Investigator Responsibilities} index: 615 code: elements: text: pattern: {type: String, value: section11.2.1-investigator-responsibilities} index: 616 required: [text] text: {index: 617} required: [text] sponsorResponsibilities: match: code: {text: section11.2.2-sponsor-responsibilities} schema: type: BackboneElement mustSupport: true _required: true index: 618 elements: title: pattern: {type: String, value: Sponsor Responsibilities} index: 619 code: elements: text: pattern: {type: String, value: section11.2.2-sponsor-responsibilities} index: 620 required: [text] text: {index: 621} required: [text] dataDissemination: match: code: {text: section11.12-data-dissemination} schema: type: BackboneElement mustSupport: true _required: true index: 687 elements: title: pattern: {type: String, value: Data Dissemination} index: 688 code: elements: text: pattern: {type: String, value: section11.12-data-dissemination} index: 689 required: [text] text: {index: 690} required: [text] regulatory: match: code: {text: section11.1-regulatory-considerations} schema: type: BackboneElement mustSupport: true _required: true index: 605 elements: title: pattern: {type: String, value: Regulatory and Ethical Considerations} index: 606 code: elements: text: pattern: {type: String, value: section11.1-regulatory-considerations} index: 607 required: [text] text: {index: 608} required: [text] insurance: match: code: {text: section11.5-insurance-and-indemnity} schema: type: BackboneElement mustSupport: true _required: true index: 647 elements: title: pattern: {type: String, value: Insurance and Indemnity} index: 648 code: elements: text: pattern: {type: String, value: section11.5-insurance-and-indemnity} index: 649 required: [text] text: {index: 650} required: [text] protcolDeviations: match: code: {text: section11.10-protocol-deviations} schema: type: BackboneElement mustSupport: true _required: true index: 667 elements: title: pattern: {type: String, value: Protocol Deviations} index: 668 code: elements: text: pattern: {type: String, value: section11.10-protocol-deviations} index: 669 required: [text] text: {index: 670} required: [text] committees: match: code: {text: section11.4-committees} schema: type: BackboneElement mustSupport: true _required: true index: 622 elements: title: pattern: {type: String, value: Committees} index: 623 code: elements: text: pattern: {type: String, value: section11.4-committees} index: 624 required: [text] text: {index: 625} required: [text] sourceData: match: code: {text: section11.9-source-data} schema: type: BackboneElement mustSupport: true _required: true index: 663 elements: title: pattern: {type: String, value: Source Data} index: 664 code: elements: text: pattern: {type: String, value: section11.9-source-data} index: 665 required: [text] text: {index: 666} required: [text] earlySiteClosure: match: code: {text: section11.11-early-site-closure} schema: type: BackboneElement mustSupport: true _required: true index: 671 elements: title: pattern: {type: String, value: Early Site Closure} index: 672 code: elements: text: pattern: {type: String, value: section11.11-early-site-closure} index: 673 required: [text] section: array: true min: 3 index: 674 slicing: rules: open discriminator: - {path: code.text, type: value} min: 3 slices: decisionRights: match: code: {text: section11.11-early-site-closure#decisionRights} schema: type: BackboneElement mustSupport: true _required: true index: 675 elements: title: pattern: {type: String, value: Decision Rights for Site Closure} index: 676 code: elements: text: pattern: {type: String, value: section11.11-early-site-closure#decisionRights} index: 677 required: [text] text: {index: 678} required: [text] criteria: match: code: {text: section11.11-early-site-closure#criteria} schema: type: BackboneElement mustSupport: true _required: true index: 679 elements: title: pattern: {type: String, value: Crteria for Early Closure} index: 680 code: elements: text: pattern: {type: String, value: section11.11-early-site-closure#criteria} index: 681 required: [text] text: {index: 682} required: [text] responsibilities: match: code: {text: section11.11-early-site-closure#responsibilities} schema: type: BackboneElement mustSupport: true _required: true index: 683 elements: title: pattern: {type: String, value: Responsibilities Following Early Site Closure} index: 684 code: elements: text: pattern: {type: String, value: section11.11-early-site-closure#responsibilities} index: 685 required: [text] text: {index: 686} required: [text] informedConsent: match: code: {text: section11.3-informed-consent-process} schema: type: BackboneElement mustSupport: true _required: true index: 626 elements: title: pattern: {type: String, value: Informed Consent Process} index: 627 code: elements: text: pattern: {type: String, value: section11.3-informed-consent-process} index: 628 required: [text] text: {index: 629} section: index: 630 slicing: rules: open discriminator: - {path: code.text, type: value} min: null slices: assentProcess: match: code: {text: section11.3.0-assent-process} schema: type: BackboneElement mustSupport: true index: 631 elements: title: pattern: {type: String, value: Assent Process} index: 632 code: elements: text: pattern: {type: String, value: section11.3.0-assent-process} index: 633 required: [text] text: {index: 634} required: [text] emergency: match: code: {text: section11.3.0-emergency-consent-process} schema: type: BackboneElement mustSupport: true index: 635 elements: title: pattern: {type: String, value: Emergency Consent Process} index: 636 code: elements: text: pattern: {type: String, value: section11.3.0-emergency-consent-process} index: 637 required: [text] text: {index: 638} required: [text] rescreening: match: code: {text: section11.3.1-rescreening-consent-process} schema: type: BackboneElement mustSupport: true index: 639 elements: title: pattern: {type: String, value: Informed Consent for Rescreening} index: 640 code: elements: text: pattern: {type: String, value: section11.3.1-rescreening-consent-process} index: 641 required: [text] text: {index: 642} required: [text] remainingSamples: match: code: {text: section11.3.2-remaining-samples} schema: type: BackboneElement mustSupport: true index: 643 elements: title: pattern: {type: String, value: Informed Consent for Remaining Samples in Exploratory Research} index: 644 code: elements: text: pattern: {type: String, value: section11.3.2-remaining-samples} index: 645 required: [text] text: {index: 646} required: [text] required: [text] dataProtection: match: code: {text: section11.8-data-protection} schema: type: BackboneElement mustSupport: true _required: true index: 659 elements: title: pattern: {type: String, value: Data Protection} index: 660 code: elements: text: pattern: {type: String, value: section11.8-data-protection} index: 661 required: [text] text: {index: 662} required: [text] dataGovernance: match: code: {text: section11.7-data-governance} schema: type: BackboneElement mustSupport: true _required: true index: 655 elements: title: pattern: {type: String, value: Data Governance} index: 656 code: elements: text: pattern: {type: String, value: section11.7-data-governance} index: 657 required: [text] text: {index: 658} required: [text] design: match: code: {text: section4-trial-design} schema: mustSupport: true _required: true index: 92 elements: title: pattern: {type: String, value: Trial Design} index: 93 code: elements: text: pattern: {type: String, value: section4-trial-design} index: 94 required: [text] section: array: true min: 4 index: 95 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: 96 elements: title: pattern: {type: String, value: Description of Trial Design} index: 97 code: elements: text: pattern: {type: String, value: section4.1-description-of-trial-design} index: 98 required: [text] text: {index: 99} section: index: 100 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: 101 elements: title: pattern: {type: String, value: Stakeholder Input into Design} index: 102 code: elements: text: pattern: {type: String, value: section4.1.1-stakeholder-input-into-design} index: 103 required: [text] text: {index: 104} required: [text] required: [text] rationale: match: code: {text: section4.2-rationale-for-trial-design} schema: type: BackboneElement mustSupport: true _required: true index: 105 elements: title: pattern: {type: String, value: Rationale for Trial Design} index: 106 code: elements: text: pattern: {type: String, value: section4.2-rationale-for-trial-design} index: 107 required: [text] text: {index: 108} section: index: 109 slicing: rules: open discriminator: - {path: code.text, type: value} min: null slices: endpoints: match: code: {text: section4.2.1-rationale-estimands} schema: type: BackboneElement mustSupport: true index: 110 elements: title: pattern: {type: String, value: Rationale for Estimand(s)} index: 111 code: elements: text: pattern: {type: String, value: section4.2.1-rationale-estimands} index: 112 required: [text] text: {index: 113} required: [text] model: match: code: {text: section4.2.2-rationale-intervention-model} schema: type: BackboneElement mustSupport: true index: 114 elements: title: pattern: {type: String, value: Rationale for Intervention Model} index: 115 code: elements: text: pattern: {type: String, value: section4.2.2-rationale-intervention-model} index: 116 required: [text] text: {index: 117} required: [text] comparator: match: code: {text: section4.2.3-rationale-comparator} schema: type: BackboneElement mustSupport: true index: 118 elements: title: pattern: {type: String, value: Rationale for Control Type} index: 119 code: elements: text: pattern: {type: String, value: section4.2.3-rationale-comparator} index: 120 required: [text] text: {index: 121} required: [text] duration: match: code: {text: section4.2.4-rationale-duration} schema: type: BackboneElement mustSupport: true index: 122 elements: title: pattern: {type: String, value: Rationale for Duration} index: 123 code: elements: text: pattern: {type: String, value: section4.2.4-rationale-duration} index: 124 required: [text] text: {index: 125} required: [text] adaptive: match: code: {text: section4.2.5-rationale-adaptive} schema: type: BackboneElement mustSupport: true index: 126 elements: title: pattern: {type: String, value: Rationale for Adaptive or Novel Trial Design} index: 127 code: elements: text: pattern: {type: String, value: section4.2.5-rationale-adaptive} index: 128 required: [text] text: {index: 129} required: [text] interim: match: code: {text: section4.2.6-rationale-interim-analysis} schema: type: BackboneElement mustSupport: true index: 130 elements: title: pattern: {type: String, value: Rationale for Interim Analysis} index: 131 code: elements: text: pattern: {type: String, value: section4.2.6-rationale-interim-analysis} index: 132 required: [text] text: {index: 133} required: [text] otherAspects: match: code: {text: section4.2.7-rationale-other-aspects} schema: type: BackboneElement mustSupport: true index: 134 elements: title: pattern: {type: String, value: Rationale for Other Trial Design Aspects} index: 135 code: elements: text: pattern: {type: String, value: section4.2.7-rationale-other-aspects} index: 136 required: [text] text: {index: 137} required: [text] trialStoppingRules: match: code: {text: section4.3-trial-stopping-rules} schema: type: BackboneElement mustSupport: true _required: true index: 138 elements: title: pattern: {type: String, value: Trial Stopping Rules} index: 139 code: elements: text: pattern: {type: String, value: section4.3-trial-stopping-rules} index: 140 required: [text] text: {index: 141} required: [text] startEnd: match: code: {text: section4.4-start-and-end} schema: type: BackboneElement mustSupport: true _required: true index: 142 elements: title: pattern: {type: String, value: Start of Trial and End of Trial} index: 143 code: elements: text: pattern: {type: String, value: section4.4-start-and-end} index: 144 required: [text] text: {index: 145} required: [text] access: match: code: {text: section4.5-access-after-trial} schema: type: BackboneElement mustSupport: true index: 146 elements: title: pattern: {type: String, value: Access to Trial Intervention After End of Trial} index: 147 code: elements: text: pattern: {type: String, value: section4.5-access-after-trial} index: 148 required: [text] text: {index: 149} required: [text] introduction: match: code: {text: section2-introduction} schema: mustSupport: true _required: true index: 50 elements: title: pattern: {type: String, value: Introduction} index: 51 code: elements: text: pattern: {type: String, value: section2-introduction} index: 52 required: [text] section: array: true min: 2 index: 53 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: 54 elements: title: pattern: {type: String, value: Purpose of Trial} index: 55 code: elements: text: pattern: {type: String, value: section2.1-trial-purpose} index: 56 required: [text] text: {index: 57} required: [text] benefitsAndRisks: match: code: {text: section2.2-benefits-risks} schema: type: BackboneElement mustSupport: true _required: true index: 58 elements: title: pattern: {type: String, value: Assessment of Risks and Benefits} index: 59 code: elements: text: pattern: {type: String, value: section2.2-benefits-risks} index: 60 required: [text] text: {index: 61} section: array: true min: 3 index: 62 slicing: rules: open discriminator: - {path: code.text, type: value} min: 3 slices: riskSummary: match: code: {text: section2.2.1-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: section2.2.1-risk-summary} index: 65 required: [text] text: {index: 66} section: index: 67 slicing: rules: open discriminator: - {path: code.text, type: value} min: null slices: trialIntervention: match: code: {text: section2.2.1.1-trial-intervention-risk-summary} schema: type: BackboneElement mustSupport: true index: 68 elements: title: pattern: {type: String, value: Trial-specific Intervention Risks and Mitigations} index: 69 code: elements: text: pattern: {type: String, value: section2.2.1.1-trial-intervention-risk-summary} index: 70 required: [text] text: {index: 71} required: [text] trialProcedures: match: code: {text: section2.2.1.2-trial-procedures-risk-summary} schema: type: BackboneElement index: 72 elements: title: pattern: {type: String, value: Trial-specific Procedure Risks and Mitigations} index: 73 code: elements: text: pattern: {type: String, value: section2.2.1.2-trial-procedures-risk-summary} index: 74 required: [text] text: {index: 75} required: [text] otherRisk: match: code: {text: section2.2.1.3-trial-other-risk-summary} schema: type: BackboneElement index: 76 elements: title: pattern: {type: String, value: Trial-specific Other Risks and Mitigations} index: 77 code: elements: text: pattern: {type: String, value: section2.2.1.3-trial-other-risk-summary} index: 78 required: [text] text: {index: 79} required: [text] benefitSummary: match: code: {text: section2.2.2-benefit-summary} schema: type: BackboneElement mustSupport: true _required: true index: 80 elements: title: pattern: {type: String, value: Benefit Summary} index: 81 code: elements: text: pattern: {type: String, value: section2.2.2-benefit-summary} index: 82 required: [text] text: {index: 83} required: [text] overallBenefitRisk: match: code: {text: section2.2.3-overall-benefit-risk-conclusion} schema: type: BackboneElement _required: true index: 84 elements: title: pattern: {type: String, value: Overall Risk-Benefit Assessment} index: 85 code: elements: text: pattern: {type: String, value: section2.2.3-overall-benefit-risk-conclusion} index: 86 required: [text] text: {index: 87} required: [text] required: [text] glossary: match: code: {text: section13-glossary} schema: mustSupport: true _required: true index: 707 elements: title: pattern: {type: String, value: 'Appendix: Glossary of Terms and Abbreviations'} index: 708 code: elements: text: pattern: {type: String, value: section13-glossary} index: 709 required: [text] text: {index: 710} entry: type: Reference refers: ['http://hl7.org/fhir/StructureDefinition/CodeSystem', 'http://hl7.org/fhir/StructureDefinition/ValueSet'] index: 711 required: [text] 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