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The document further specifies participating countries, the clinical investigation plan and CIP elements, study scientific opinion, design methodology, development stage, objectives and endpoints, synopsis, subject population characteristics, and enrollment criteria. It also details investigational device information, comparator selection, and additional research-related information such as non-experimental products and procedures.","\u0003Contents\n\u0013 TOC \\o \"1-3\" \\h \\z \\u \u0014\u0013 HYPERLINK \\l \"_Toc72316146\" \u00141\tClinical investigation identification\t\u0013 PAGEREF _Toc72316146 \\h \u00142\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316147\" \u00141.1\tSponsor identification\t\u0013 PAGEREF _Toc72316147 \\h \u00143\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316148\" \u00141.2\tLegal representative identification contact\t\u0013 PAGEREF _Toc72316148 \\h \u00144\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316149\" \u00141.3\tClinical investigation type\t\u0013 PAGEREF _Toc72316149 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316150\" \u00141.4\tSubmission type\t\u0013 PAGEREF _Toc72316150 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316151\" \u00141.5\tParticipating countries within the EU/EEA/UK (Northern Ireland), Turkey and Switzerland\t\u0013 PAGEREF _Toc72316151 \\h \u00145\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316152\" \u00141.6\tParticipating countries outside EU/EEA/UK\t\u0013 PAGEREF _Toc72316152 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316153\" \u00141.7\tClinical investigation plan CIP\t\u0013 PAGEREF _Toc72316153 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316154\" \u00141.8\tClinical investigation identification\t\u0013 PAGEREF _Toc72316154 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316155\" \u00142\tClinical investigation description\t\u0013 PAGEREF _Toc72316155 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316156\" \u00142.1\tScientific opinion\t\u0013 PAGEREF _Toc72316156 \\h \u00146\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316157\" \u00142.2\tDesign of the clinical investigation\t\u0013 PAGEREF _Toc72316157 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316158\" \u00142.3\tDesign methodology\t\u0013 PAGEREF _Toc72316158 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316159\" \u00142.4\tDevelopment stage\t\u0013 PAGEREF _Toc72316159 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316160\" \u00142.5\tObjectives and endpoints\t\u0013 PAGEREF _Toc72316160 \\h \u00147\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316161\" \u00142.6\tSynopsis of the clinical investigation\t\u0013 PAGEREF _Toc72316161 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316162\" \u00142.7\tPlanned number of subjects\t\u0013 PAGEREF _Toc72316162 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316163\" \u00142.8\tDuration of the clinical investigation\t\u0013 PAGEREF _Toc72316163 \\h \u00148\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316164\" \u00142.9\tPopulation\t\u0013 PAGEREF _Toc72316164 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316165\" \u00142.9.1\tMedical condition\t\u0013 PAGEREF _Toc72316165 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316166\" \u00142.9.2\tTherapeutic area\t\u0013 PAGEREF _Toc72316166 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316167\" \u00142.9.3\tGender of subjects\t\u0013 PAGEREF _Toc72316167 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316168\" \u00142.9.4\tInclusion criteria\t\u0013 PAGEREF _Toc72316168 \\h \u00149\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316169\" \u00142.9.5\tExclusion criteria\t\u0013 PAGEREF _Toc72316169 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316170\" \u00142.9.6\tType of subjects that the clinical investigation plans to recruit\t\u0013 PAGEREF _Toc72316170 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316171\" \u00142.9.7\tAge range of the participants that the clinical investigation plans to include\t\u0013 PAGEREF _Toc72316171 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316172\" \u00142.10\tIs there an independent Data Safety Monitoring Board in the investigation?\t\u0013 PAGEREF _Toc72316172 \\h \u001410\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316173\" \u00142.11\tScope of the investigational device\t\u0013 PAGEREF _Toc72316173 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316174\" \u00142.11.1\tCombined investigation Medical Device/In Vitro Diagnostic?\t\u0013 PAGEREF _Toc72316174 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316175\" \u00142.11.2\tIs the application submitted in parallel with an application for a clinical trial on medicinal products?\t\u0013 PAGEREF _Toc72316175 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316176\" \u00142.11.3\tCoordinating investigator\t\u0013 PAGEREF _Toc72316176 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316177\" \u00142.12\tIs there a laboratory or technical platform used in the investigation?\t\u0013 PAGEREF _Toc72316177 \\h \u001411\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316178\" \u00143\tInvestigation device(s)\t\u0013 PAGEREF _Toc72316178 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316179\" \u00143.1\tInvestigational medical device\t\u0013 PAGEREF _Toc72316179 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316180\" \u00143.1.1\tDevice purposes\t\u0013 PAGEREF _Toc72316180 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316181\" \u00143.1.2\tDevice type\t\u0013 PAGEREF _Toc72316181 \\h \u001412\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316182\" \u00143.1.3\tInvasiness\t\u0013 PAGEREF _Toc72316182 \\h \u001413\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316183\" \u00143.1.4\tDevice Identifiers\t\u0013 PAGEREF _Toc72316183 \\h \u001413\u0015\u0015\n\u0013 HYPERLINK \\l \"_Toc72316184\" \u00143.2\tPrevious clinical investigation\t\u0013 PAGER","cbCaihtKdvxoSpiO","https://ap.wps.com/l/cbCaihtKdvxoSpiO","docx",186380,23,"English","en",105,"# Clinical investigation identification\n## Sponsor identification\n## Legal representative identification contact\n## Clinical investigation type\n## Submission type\n## Participating countries within the EU/EEA/UK, Turkey and Switzerland\n## Participating countries outside EU/EEA/UK\n## Clinical investigation plan CIP\n## Clinical investigation identification\n# Clinical investigation description\n## Scientific opinion\n## Design of the clinical investigation\n## Design methodology\n## Development stage\n## Objectives and endpoints\n## Synopsis of the clinical investigation\n## Planned number of subjects\n## Duration of the clinical investigation\n## Population\n## Medical condition\n## Therapeutic area\n## Gender of subjects\n## Inclusion criteria\n## Exclusion criteria\n## Type of subjects that the clinical investigation plans to recruit\n## Age range of the participants\n## Independent Data Safety Monitoring Board\n## Scope of the investigational device\n## Combined investigation Medical Device/In Vitro Diagnostic\n## Parallel submission with medicinal products clinical trial\n## Coordinating investigator\n## Laboratory or technical platform used","[{\"question\":\"What information is required under clinical investigation identification?\",\"answer\":\"The document requires sponsor identification, legal representative contact, investigation type, submission type, participating countries, and elements related to the clinical investigation plan (CIP).\"},{\"question\":\"How does the document define the clinical investigation description?\",\"answer\":\"It specifies the scientific opinion, design of the investigation and methodology, development stage, objectives and endpoints, synopsis, subject numbers, duration, and detailed population attributes including inclusion and exclusion criteria.\"},{\"question\":\"What investigational device details must be provided?\",\"answer\":\"It requires information on the investigational medical device such as device purposes and type, invasiness, device identifiers, prior clinical investigations, scientific opinion/view, and manufacturer and authorized representative details, plus comparator information and additional research-related data.\"}]","Clinical Investigation Description - Sponsor and Device Identification | 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