<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 11 (Trial Oversight) for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568053. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568053. Computable resource at: https://fevir.net/resources/Composition/568053#json."/> </relatesTo> <section> <title value="Trial Oversight and Other General Considerations"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218649"/> <display value="ICH M11 Protocol Section 11 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS"/> </coding> <text value="section11-oversight"/> </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="Regulatory and Ethical Considerations"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218650"/> <display value="ICH M11 Protocol Section 11.1 Regulatory and Ethical Considerations"/> </coding> <text value="section11.1-regulatory-considerations"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Provide a high-level statement on the prevailing ethical, legal, and regulatory guidelines that will be applied throughout the trial. For example, This trial will be conducted in accordance with the protocol and with the following: • Ethical principles that have their origin in the Declaration of Helsinki for medical research involving human subjects • Consensus ethical principles derived from international guidelines including the Declaration of Helsinki and the Council for International Organisations of Medical Sciences (CIOMS) International Ethical Guidelines • ICH Good Clinical Practice (GCP) Guidelines • Applicable laws and regulations]</div> </text> </section> <section> <title value="Trial Oversight"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218651"/> <display value="ICH M11 Protocol Section 11.2 Trial Oversight"/> </coding> <text value="section11.2-trial-oversight"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Concisely summarize the trial oversight listing the investigator and sponsor responsibilities not covered in other sections of the protocol which are essential for the operations of the trial, specifying the ones related to quality assurance.]</div> </text> <section> <title value="Investigator Responsibilities"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218652"/> <display value="ICH M11 Protocol Section 11.2.1 Investigator Responsibilities"/> </coding> <text value="section11.2.1-investigator-responsibilities"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Describe the investigator duties, including the oversight of duties delegated to a third party that may impact the trial conduct at sites, if applicable and if not addressed elsewhere.]</div> </text> </section> <section> <title value="Sponsor Responsibilities"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218653"/> <display value="ICH M11 Protocol Section 11.2.2 Sponsor Responsibilities"/> </coding> <text value="section11.2.2-sponsor-responsibilities"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Describe the sponsor duties, including those to be transferred to a third party that may impact the investigators sites, if applicable.]</div> </text> </section> </section> <section> <title value="Informed Consent Process"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218654"/> <display value="ICH M11 Protocol Section 11.3 Informed Consent Process"/> </coding> <text value="section11.3-informed-consent-process"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Specify the key elements of the informed consent process, including any special needs and how these are addressed (for example, assent, capacity, legally acceptable representative, adolescents who may reach age of majority during the trial, pregnant participants and pregnant partners of participants).]</div> </text> <section> <title value="Assent Process"/> <code> <text value="section11.3.0-assent-process"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Enter Description of Assent Process.]</div> </text> </section> <section> <title value="Emergency Consent Process"/> <code> <text value="section11.3.0-emergency-consent-process"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[If enrollment in the trial may occur during an emergency in which the participant or their legally acceptable representative is not able or available to give consent, describe the consent process.]</div> </text> </section> <section> <title value="Informed Consent for Rescreening"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218655"/> <display value="ICH M11 Protocol Section 11.3.1 Informed Consent for Rescreening"/> </coding> <text value="section11.3.1-rescreening-consent-process"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[If participants can be rescreened as described in Section 5.6, state whether the participant needs to complete a new consent. Screen failure and rescreening should be clearly defined in the protocol, with cross reference to those definitions.]</div> </text> </section> <section> <title value="Informed Consent for Use of Remaining Samples in Exploratory Research"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218656"/> <display value="ICH M11 Protocol Section 11.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research"/> </coding> <text value="section11.3.2-remaining-samples"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[If participants will be asked to consent to optional exploratory research using the remainder of mandatory samples, describe the use of remaining samples for optional exploratory research. If any exploratory research is planned and additional written consent regarding the use of remaining samples for exploratory research will be obtained, describe the consent process.]</div> </text> </section> </section> <section> <title value="Committees"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218657"/> <display value="ICH M11 Protocol Section 11.4 Committees"/> </coding> <text value="section11.4-committees"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Briefly describe the administrative structure of committees that will be reviewing data while the trial is ongoing, and the type of committee (e.g., Dose Escalation Committee, Data Monitoring Committee or Data Safety Monitoring Board). Note that specific details may be required depending on local law or regulation. If applicable, Committee Charters may be cross referenced. If no committees are involved, state “Not applicable.”]</div> </text> </section> <section> <title value="Insurance and Indemnity"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218658"/> <display value="ICH M11 Protocol Section 11.5 Insurance and Indemnity"/> </coding> <text value="section11.5-insurance-and-indemnity"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Concisely summarize the arrangements for participants insurance and indemnity if not addressed in a separate agreement, if required by the applicable regulatory requirements.]</div> </text> </section> <section> <title value="Risk-Based Quality Management"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218659"/> <display value="ICH M11 Protocol Section 11.6 Risk-Based Quality Management"/> </coding> <text value="section11.6-risk-management"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Describe the identified critical to quality factors, associated risks and risk mitigation strategies in the trial or refer to a separate document where this is described.]</div> </text> </section> <section> <title value="Data Governance"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218660"/> <display value="ICH M11 Protocol Section 11.7 Data Governance"/> </coding> <text value="section11.7-data-governance"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Describe the key systems and processes for critical trial integrity, traceability and security including a summary of the monitoring approaches enabling accurate collection, reporting, monitoring, transfer, retention, and access if not addressed in separate agreement(s).]</div> </text> </section> <section> <title value="Data Protection"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218661"/> <display value="ICH M11 Protocol Section 11.8 Data Protection"/> </coding> <text value="section11.8-data-protection"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Describe the measures to protect the privacy and confidentiality of personal information of trial participants in accordance with applicable regulatory requirements on personal data protection and any measures that should be taken in case of a data security breach.]</div> </text> </section> <section> <title value="Source Records"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218662"/> <display value="ICH M11 Protocol Section 11.9 Source Records"/> </coding> <text value="section11.9-source-data"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[State the importance of source records and expectation for traceability. Delineate expectations for investigators (e.g., maintain and ensure availability of essential records) and trial monitors (e.g., ensure participant protections, ensure that the trial is conducted according to GCP). Identify what constitutes source records and its origin or provide a reference to the location of this information, if contained in a separate document. Describe the provision for direct access to source records enabling clinical trial-related monitoring, audits and regulatory inspections, if not included in separate agreement(s).]</div> </text> </section> <section> <title value="Protocol Deviations"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218663"/> <display value="ICH M11 Protocol Section 11.10 Protocol Deviations"/> </coding> <text value="section11.10-protocol-deviations"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Describe plans for detecting, reviewing, and reporting any deviations from the protocol or include reference to a separate document.]</div> </text> </section> <section> <title value="Early Site Closure"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218664"/> <display value="ICH M11 Protocol Section 11.11 Early Site Closure"/> </coding> <text value="section11.11-early-site-closure"/> </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="Decision Rights for Site Closure"/> <code> <text value="section11.11-early-site-closure#decisionRights"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[List the sponsor’s rights to close a site early. Likewise, list the investigator’s rights to initiate early site closure.]</div> </text> </section> <section> <title value="Crteria for Early Closure"/> <code> <text value="section11.11-early-site-closure#criteria"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[List the criteria for early closure of a site by the sponsor or investigator.]</div> </text> </section> <section> <title value="Responsibilities Following Early Site Closure"/> <code> <text value="section11.11-early-site-closure#responsibilities"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[List the responsibilities of the sponsor and investigator following early site closure, such as informing the ethics committee(s), and prompt notification of the participant and their transition to appropriate therapy and/or follow-up.]</div> </text> </section> </section> <section> <title value="Data Dissemination"/> <code> <coding> <system value="http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl"/> <code value="C218665"/> <display value="ICH M11 Protocol Section 11.12 Data Dissemination"/> </coding> <text value="section11.12-data-dissemination"/> </code> <text> <status value="empty"/><div xmlns="http://www.w3.org/1999/xhtml">[Describe whether the clinical trial will be registered in public databases, including reporting of results, if applicable.]</div> </text> </section> </section> </Composition>

Generated Narrative: Composition 568053

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

Profile: M11ReportSection11

ArtifactPublicationStatus: Active

url: https://fevir.net/resources/Composition/568053

identifier: FEvIR Object Identifier/568053

status: Final

type: CeSHarP Report

category: section11-oversight

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

author: Brian S. Alper, MD, MSPH

title: M11 Report Section 11 (Trial Oversight) for M11ResearchStudy Template

custodian: Computable Publishing LLC

relatesTo
type: Derived From
target: M11ResearchStudy Template

relatesTo
type: Cite As
target:
M11 Report Section 11 (Trial Oversight) for M11ResearchStudy Template [Database Entry: FHIR Composition Resource]. Contributors: Brian S. Alper, MD, MSPH [Authors/Creators]. In: Fast Evidence Interoperability Resources (FEvIR) Platform, FOI 568053. Revised 2026-05-30. Available at: https://fevir.net/resources/Composition/568053. Computable resource at: https://fevir.net/resources/Composition/568053#json.