Pharmaceutical Research Protocol (Vulcan UDP)
1.0.0-ballot - STU 1 - Ballot International flag

This page is part of the Pharmaceutical Clinical Trial Protocols (v1.0.0-ballot: STU 1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v6.0.0. No current official version has been published yet. For a full list of available versions, see the Directory of published versions

ValueSet: M11 Section Codes Value Set

Official URL: http://hl7.org/fhir/uv/pharmaceutical-research-protocol/ValueSet/m11-section-codes-vs Version: 1.0.0-ballot
Standards status: Trial-use Maturity Level: 2 Computable Name: M11SectionCodesVS

Codes representing sections of M11.

References

Logical Definition (CLD)

  • Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    CodeDisplay
    C2185141 PROTOCOL SUMMARY
    C2185151.1 Protocol Synopsis
    C2185161.1.1 Primary and Secondary Objectives and Estimands
    C2185171.1.2 Overall Design
    C2185181.2 Trial Schema
    C2185191.3 Schedule of Activities
    C2185202 INTRODUCTION
    C2185212.1 Purpose of Trial
    C2185222.2 Assessment of Risks and Benefits
    C2185232.2.1 Risk Summary and Mitigation Strategy
    C2185242.2.2 Benefit Summary
    C2185252.2.3 Overall Risk-Benefit Assessment
    C2185263 TRIAL OBJECTIVES AND ASSOCIATED ESTIMANDS
    C2185273.1 Primary Objective(s) and Associated Estimand(s)
    C2185283.1.1 Primary Objective
    C2185293.2 Secondary Objective(s) and Associated Estimand(s)
    C2185303.2.1 Secondary Objective
    C2185313.3 Exploratory Objective(s)
    C2185323.3.1 Exploratory Objective
    C2185334 TRIAL DESIGN
    C2185344.1 Description of Trial Design
    C2185354.1.1 Stakeholder Input into Design
    C2185364.2 Rationale for Trial Design
    C2185374.2.1 Rationale for Estimand(s)
    C2185384.2.2 Rationale for Intervention Model
    C2185394.2.3 Rationale for Control Type
    C2185404.2.4 Rationale for Trial Duration
    C2185414.2.5 Rationale for Adaptive or Novel Trial Design
    C2185424.2.6 Rationale for Interim Analysis
    C2185434.2.7 Rationale for Other Trial Design Aspects
    C2185444.3 Trial Stopping Rules
    C2185454.4 Start of Trial and End of Trial
    C2185464.5 Access to Trial Intervention After End of Trial
    C2185475 TRIAL POPULATION
    C2185485.1 Description of Trial Population and Rationale
    C2185495.2 Inclusion Criteria
    C2185505.3 Exclusion Criteria
    C2185515.4 Contraception
    C2185525.4.1 Definitions Related to Childbearing Potential
    C2185535.4.2 Contraception Requirements
    C2185545.5 Lifestyle Restrictions
    C2185555.5.1 Meals and Dietary Restrictions
    C2185565.5.2 Caffeine, Alcohol, Tobacco, and Other Restrictions
    C2185575.5.3 Physical Activity Restrictions
    C2185585.5.4 Other Activity Restrictions
    C2185595.6 Screen Failure and Rescreening
    C2185606 TRIAL INTERVENTION AND CONCOMITANT THERAPY
    C2185616.1 Description of Investigational Trial Intervention
    C2185626.2 Rationale for Investigational Trial Intervention Dose and Regimen
    C2185636.3 Investigational Trial Intervention Administration
    C2185646.4 Investigational Trial Intervention Dose Modification
    C2185656.5 Management of Investigational Trial Intervention Overdose
    C2185666.6 Preparation, Storage, Handling and Accountability of Investigational Trial Intervention
    C2185676.6.1 Preparation of Investigational Trial Intervention
    C2185686.6.2 Storage and Handling of Investigational Trial Intervention
    C2185696.6.3 Accountability of Investigational Trial Intervention
    C2185706.7 Investigational Trial Intervention Assignment, Randomisation and Blinding
    C2185716.7.1 Participant Assignment to Investigational Trial Intervention
    C2185726.7.2 Randomisation
    C2185736.7.3 Measures to Maintain Blinding
    C2185746.7.4 Emergency Unblinding at the Site
    C2185756.8 Investigational Trial Intervention Adherence
    C2185766.9 Description of Noninvestigational Trial Intervention
    C2185776.9.1 Background Trial Intervention
    C2185786.9.2 Rescue Therapy
    C2185796.9.3 Other Noninvestigational Trial Intervention
    C2185806.10 Concomitant Therapy
    C2185816.10.1 Prohibited Concomitant Therapy
    C2185826.10.2 Permitted Concomitant Therapy
    C2185837 PARTICIPANT DISCONTINUATION OF TRIAL INTERVENTION AND DISCONTINUATION OR WITHDRAWAL FROM TRIAL
    C2185847.1 Discontinuation of Trial Intervention for Individual Participants
    C2185857.1.1 Permanent Discontinuation of Trial Intervention
    C2185867.1.2 Temporary Discontinuation of Trial Intervention
    C2185877.1.3 Rechallenge
    C2185887.2 Participant Discontinuation or Withdrawal from the Trial
    C2185897.3 Management of Loss to Follow-Up
    C2185908 TRIAL ASSESSMENTS AND PROCEDURES
    C2185918.1 Trial Assessments and Procedures Considerations
    C2185928.2 Screening/Baseline Assessments and Procedures
    C2185938.3 Efficacy Assessments and Procedures
    C2185948.4 Safety Assessments and Procedures
    C2185958.4.1 Physical Examination
    C2185968.4.2 Vital Signs
    C2185978.4.3 Electrocardiograms
    C2185988.4.4 Clinical Laboratory Assessments
    C2185998.4.5 Pregnancy Testing
    C2186008.4.6 Suicidal Ideation and Behaviour Risk Monitoring
    C2186018.5 Pharmacokinetics
    C2186028.6 Biomarkers
    C2186038.6.1 Genetics and Pharmacogenomics
    C2186048.6.2 Pharmacodynamic Biomarkers
    C2186058.6.3 Other Biomarkers
    C2186068.7 Immunogenicity Assessments
    C2186078.8 Medical Resource Utilisation and Health Economics
    C2186089 ADVERSE EVENTS, SERIOUS ADVERSE EVENTS, PRODUCT COMPLAINTS, PREGNANCY AND POSTPARTUM INFORMATION, AND SPECIAL SAFETY SITUATIONS
    C2186099.1 Definitions
    C2186109.1.1 Definitions of Adverse Events
    C2186119.1.2 Definitions of Serious Adverse Events
    C2186129.1.3 Definitions of Product Complaints
    C2186139.1.3.1 Definition of Medical Device Product Complaints
    C2186149.2 Timing and Procedures for Collection and Reporting
    C2186159.2.1 Timing
    C2186169.2.2 Collection Procedures
    C2186179.2.3 Reporting
    C2186189.2.3.1 Regulatory Reporting Requirements
    C2186199.2.4 Adverse Events of Special Interest
    C2186209.2.5 Disease-related Events or Outcomes Not Qualifying as AEs or SAEs
    C2186219.3 Pregnancy and Postpartum Information
    C2186229.3.1 Participants Who Become Pregnant During the Trial
    C2186239.3.2 Participants Whose Partners Become Pregnant During the Trial
    C2186249.4 Special Safety Situations
    C21862510 STATISTICAL CONSIDERATIONS
    C21862610.1 General Considerations
    C21862710.2 Analysis Sets
    C21862810.3 Analyses of Demographics and Other Baseline Variables
    C21862910.4 Analyses Associated with the Primary Objective(s)
    C21863010.4.1 Primary Objective
    C21863110.4.1.1 Statistical Analysis Method
    C21863210.4.1.2 Handling of Data in Relation to Primary Estimand(s)
    C21863310.4.1.3 Handling of Missing Data in Relation to Primary Estimand(s)
    C21863410.4.1.4 Sensitivity Analysis
    C21863510.4.1.5 Supplementary Analysis
    C21863610.5 Analyses Associated with the Secondary Objective(s)
    C21863710.5.1 Secondary Objective
    C21863810.5.1.1 Statistical Analysis Method
    C21863910.5.1.2 Handling of Data in Relation to Secondary Estimand(s)
    C21864010.5.1.3 Handling of Missing Data in Relation to Secondary Estimand(s)
    C21864110.5.1.4 Sensitivity Analysis
    C21864210.5.1.5 Supplementary Analysis
    C21864310.6 Analyses Associated with the Exploratory Objective(s)
    C21864410.7 Safety Analyses
    C21864510.8 Other Analyses
    C21864610.9 Interim Analyses
    C21864710.10 Multiplicity Adjustments
    C21864810.11 Sample Size Determination
    C21864911 TRIAL OVERSIGHT AND OTHER GENERAL CONSIDERATIONS
    C21865011.1 Regulatory and Ethical Considerations
    C21865111.2 Trial Oversight
    C21865211.2.1 Investigator Responsibilities
    C21865311.2.2 Sponsor Responsibilities
    C21865411.3 Informed Consent Process
    C21865511.3.1 Informed Consent for Rescreening
    C21865611.3.2 Informed Consent for Use of Remaining Samples in Exploratory Research
    C21865711.4 Committees
    C21865811.5 Insurance and Indemnity
    C21865911.6 Risk-Based Quality Management
    C21866011.7 Data Governance
    C21866111.8 Data Protection
    C21866211.9 Source Data
    C21866311.10 Protocol Deviations
    C21866411.11 Early Site Closure
    C21866511.12 Data Dissemination
    C21866612 APPENDIX: SUPPORTING DETAILS
    C21866712.1 Clinical Laboratory Tests
    C21866812.2 Country/Region-Specific Differences
    C21866912.3 Prior Protocol Amendment(s)
    C21867013 APPENDIX: GLOSSARY OF TERMS AND ABBREVIATIONS
    C21867114 APPENDIX: REFERENCES

 

Expansion

This value set contains 0 concepts

CodeSystemDisplay (en-US)

Explanation of the columns that may appear on this page:

Level A few code lists that FHIR defines are hierarchical - each code is assigned a level. In this scheme, some codes are under other codes, and imply that the code they are under also applies
System The source of the definition of the code (when the value set draws in codes defined elsewhere)
Code The code (used as the code in the resource instance)
Display The display (used in the display element of a Coding). If there is no display, implementers should not simply display the code, but map the concept into their application
Definition An explanation of the meaning of the concept
Comments Additional notes about how to use the code