<custodian> <reference value="Organization/118079"/> <type value="Organization"/> <display value="Computable Publishing LLC"/> </custodian> <relatesTo> <type value="derived-from"/> <targetReference> <reference value="ResearchStudy/568025"/> <type value="ResearchStudy"/> <display value="M11ResearchStudy Template"/> </targetReference> </relatesTo> <relatesTo> <type value="cite-as"/> <targetMarkdown value="M11 Report Section 8 (Trial Assessments) for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568050. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568050. Computable resource at: https://fevir.net/resources/Composition/568050#json."/> </relatesTo> <section> <title value="Trial Assessments and Procedures"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218590"/> <display value="ICH M11 Protocol Section 8 TRIAL ASSESSMENTS AND PROCEDURES"/> </coding> <text value="section8-assessments"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[No text is intended here (heading only).]</div> </text> <section> <title value="Trial Assessments and Procedures Considerations"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218591"/> <display value="ICH M11 Protocol Section 8.1 Trial Assessments and Procedures Considerations"/> </coding> <text value="section8.1-assessments-procedures"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Describe general considerations applicable across trial assessments and procedures.]</div> </text> </section> <section> <title value="Screening/Baseline Assessments and Procedures"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218592"/> <display value="ICH M11 Protocol Section 8.2 Screening/Baseline Assessments and Procedures"/> </coding> <text value="section8.2-screening-baseline-assessments"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Describe any assessments and procedures that are unique to screening/baseline (e.g., collection of data on participant characteristics, assessments/procedures performed for the purpose of determining eligibility or for stratification) in this section. Describe screening and baseline assessments and procedures separately when screening and baseline are different or performed at different visits.]</div> </text> </section> <section> <title value="Efficacy Assessments and Procedures"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218593"/> <display value="ICH M11 Protocol Section 8.3 Efficacy Assessments and Procedures"/> </coding> <text value="section8.3-efficacy-assessments"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Describe efficacy assessments and procedures in this section. Cross reference Section 8.7 Immunogenicity Assessments if immunogenicity assessments are used in efficacy determination.]</div> </text> </section> <section> <title value="Safety Assessments and Procedures"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218594"/> <display value="ICH M11 Protocol Section 8.4 Safety Assessments and Procedures"/> </coding> <text value="section8.4-safety-assessments"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Describe safety assessments and procedures utilizing the following subsections as applicable. Add level 3 headings as needed. • Identify any noninvestigator party responsible for evaluation of laboratory or other safety assessments (e.g., Sponsor or external Independent Data Monitoring Committee; cross refer to Section 11.4 Committees for details as applicable). • Include guidelines for the medical management of relevant laboratory or other safety assessment abnormalities.]</div> </text> <section> <title value="Physical Examination"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218595"/> <display value="ICH M11 Protocol Section 8.4.1 Physical Examination"/> </coding> <text value="section8.4.1-physical-examination"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Include any specific instructions for the collection and interpretation of physical examinations.]</div> </text> </section> <section> <title value="Vital Signs"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218596"/> <display value="ICH M11 Protocol Section 8.4.2 Vital Signs"/> </coding> <text value="section8.4.2-vital-signs"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Include any specific instructions for the collection and interpretation of vital signs.]</div> </text> </section> <section> <title value="Electrocardiograms"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218597"/> <display value="ICH M11 Protocol Section 8.4.3 Electrocardiograms"/> </coding> <text value="section8.4.3-electrocardiograms"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Include any specific instructions for the collection, interpretation, and archiving of ECGs.]</div> </text> </section> <section> <title value="Clinical Laboratory Assessments"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218598"/> <display value="ICH M11 Protocol Section 8.4.4 Clinical Laboratory Assessments"/> </coding> <text value="section8.4.4-clinical-laboratory-assessments"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Describe any specific instructions for the collection and interpretation of clinical laboratory assessments, including: • type of laboratory (central/local/hybrid) • acceptability of additional tests deemed necessary by the investigator or local regulations • instructions for situations in which central laboratory results are not available in time for trial intervention and/or response evaluation, or in the event of a severe disruption (e.g., a pandemic or natural disaster) • treatment algorithms for results out of normal range • cross reference Section 12.1 Clinical Laboratory Tests for laboratory assessment panels]</div> </text> </section> <section> <title value="Pregnancy Testing"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218599"/> <display value="ICH M11 Protocol Section 8.4.5 Pregnancy Testing"/> </coding> <text value="section8.4.5-pregnancy-testing"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Include any specific instructions for the collection and interpretation of pregnancy testing.]</div> </text> </section> <section> <title value="Suicidal Ideation and Behaviour Risk Monitoring"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218600"/> <display value="ICH M11 Protocol Section 8.4.6 Suicidal Ideation and Behaviour Risk Monitoring"/> </coding> <text value="section8.4.6-suicidal-ideation"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[If the trial meets any of the criteria requiring suicidal ideation and behaviour risk monitoring by the guidance/guideline in each region, include justification for the need for suicidal ideation and behaviour risk monitoring in the study and add any specific instructions for the collection and interpretation of the assessment. In case this is an AESI in the study, justification should also be provided in Section 9.2.4 Adverse Events of Special Interest.]</div> </text> </section> </section> <section> <title value="Pharmacokinetics"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218601"/> <display value="ICH M11 Protocol Section 8.5 Pharmacokinetics"/> </coding> <text value="section8.5-pharmacokinetics"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Include any specific instructions for the collection and assay of samples and interpretation of PK assessments. • Describe the biological samples collected, the handling of samples, and the assay method. o Specific sample collection and processing instructions can be described in an appendix or a separate document and cross referenced. • Describe the retention time for the samples (ensuring alignment with the ICF). • Indicate the types of analyses for each sample. • Define the PK parameters to be calculated and the calculation methods.]</div> </text> </section> <section> <title value="Biomarkers"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218602"/> <display value="ICH M11 Protocol Section 8.6 Biomarkers"/> </coding> <text value="section8.6-biomarkers"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[No text is intended here (heading only). Include any specific instructions for the collection of samples and assessment of biomarkers, including pharmacodynamics. If biomarker or pharmacodynamic testing is not included in the study, state “Not Applicable.” • Describe the biological samples that will be collected (for example, tissue, serum, plasma, etc.). o Specific sample collection and processing instructions can be described in an appendix or a separate document and cross-referenced. • Describe the retention time for the samples (ensuring alignment with the ICF). • Indicate the types of biomarkers that will be studied for each sample. • Specify whether each sample is optional or required. Required samples must be based on a protocol objective.]</div> </text> <section> <title value="Genetics, Genomics, Pharmacogenetics, and Pharmacogenomics"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218603"/> <display value="ICH M11 Protocol Section 8.6.1 Genetics, Genomics, Pharmacogenetics and Pharmacogenomics"/> </coding> <text value="section8.6.1-genetics-pharmacogenomics"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Include any specific instructions for the collection and assay of samples for genetic, genomic, pharmacogenetic and/or pharmacogenomic analysis. • Describe the biological samples that will be collected (for example, tissue, serum, plasma, etc.), handling of samples, and the assay method. o Specific sample collection and processing instructions can be described in an appendix or a separate document and cross-referenced. • Describe the retention time for the samples (ensuring alignment with the ICF). • Indicate the types of analyses that may be studied for each sample.]</div> </text> </section> <section> <title value="Pharmacodynamic Biomarkers"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218604"/> <display value="ICH M11 Protocol Section 8.6.2 Pharmacodynamic Biomarkers"/> </coding> <text value="section8.6.2-pharmacodynamics"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Include any specific instructions for the collection of samples and assessment of pharmacodynamic biomarkers. • Describe the biological samples that will be collected (for example, tissue, serum, plasma, etc.). o Specific sample collection and processing instructions can be described in an appendix or a separate document and cross-referenced. • Describe the retention time for the samples (ensuring alignment with the ICF). • Indicate the types of biomarkers that will be studied for each sample. • Specify whether each sample is optional or required. Required samples must be based on a protocol objective.]</div> </text> </section> <section> <title value="Other Biomarkers"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218605"/> <display value="ICH M11 Protocol Section 8.6.3 Other Biomarkers"/> </coding> <text value="section8.6.3-other"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Include any specific instructions for the collection of samples and assessment of other biomarkers. • Describe the biological samples that will be collected (for example, tissue, serum, plasma, etc.). o Specific sample collection and processing instructions can be described in an appendix or a separate document and cross-referenced. • Describe the retention time for the samples (ensuring alignment with the ICF). • Indicate the types of biomarkers that will be studied for each sample. • Specify whether each sample is optional or required. Required samples must be based on a protocol objective.]</div> </text> </section> </section> <section> <title value="Immunogenicity Assessments"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218606"/> <display value="ICH M11 Protocol Section 8.7 Immunogenicity Assessments"/> </coding> <text value="section8.7-immunogenicity-assessments"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Include any specific instructions for the collection of samples and interpretation of immunogenicity. If immunogenicity assessments are included within Efficacy Assessments or Safety Assessments, cross-reference to that section. • Describe the biological samples that will be collected (e.g., tissue, serum, plasma). o Specific sample collection and processing instructions can be described in an appendix or a separate document and cross referenced. • Describe the retention time for the samples (ensuring alignment with the ICF). • Indicate the types of biomarkers that will be studied for each sample. • Specify whether each sample is optional or required. Required samples must be based on a protocol objective.]</div> </text> </section> <section> <title value="Medical Resource Utilisation and Health Economics"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218607"/> <display value="ICH M11 Protocol Section 8.8 Medical Resource Utilisation and Health Economics"/> </coding> <text value="section8.8-economics"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[This section does not apply to COAs. Include this section only for any value evidence and outcomes assessments not included in either the efficacy or safety sections. Describe the health outcome measures, collection method (e.g., diary, physician interview), and participant burden.]</div> </text> </section> </section> </Composition>

Generated Narrative: Composition 568050

version: 1; Last updated: 2026-05-30 15:21:18+0000

Profile: M11ReportSection08

ArtifactPublicationStatus: Active

url: https://fevir.net/resources/Composition/568050

identifier: FEvIR Object Identifier/568050

status: Final

type: CeSHarP Report

category: section8-assessments

date: 2026-05-30 15:21:18+0000

author: Brian S. Alper, MD, MSPH

title: M11 Report Section 8 (Trial Assessments) for M11ResearchStudy Template

custodian: Computable Publishing LLC

relatesTo
type: Derived From
target: M11ResearchStudy Template

relatesTo
type: Cite As
target:
M11 Report Section 8 (Trial Assessments) for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568050. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568050. Computable resource at: https://fevir.net/resources/Composition/568050#json.