What is it? Why is it important?

The Data Safety Monitoring Board (DSMB) consists of an independent group of experts who primarily review the safety, and if applicable the efficacy of a study. The composition of a DSMB depends on the type and complexity of the study. A DSMB charter defines membership responsibilities and describes the data to be reviewed.

 

The aim of the DSMB is to:

  • Review study data while the study is ongoing
  • Ensure that the safety of study participants is guaranteed at all times
  • Monitor the progress of a study (e.g. participant recruitment, ongoing safety concerns, achievement of study endpoint)
  • Provide recommendations on whether to prematurely terminate a study based on:
    • Participant safety concerns
    • The research question has been answered before study completion

Although safety assessment is an essential and integral part of any study, not all studies require a DSMB.

More

Although safety assessment is an essential and integral part of any study, not all studies require a DSMB. The establishment of a DSMB may be critical for studies that intend to:

  •  
  • Save lives
  • Has death as a primary endpoint
  • Involve high-risk intervention(s) to study participants with a potential high probability of early study termination due to safety or efficacy concerns
  • Embark on long-term studies, even if the focus are non-life-threatening diseases
  • Include data analysis during study conduct in order to protect participant from harm (e.g. statistical interim analysis)
  • Have multi-centre settings (e.g. more than one centre)
  • Have a blinded design (e.g. treatment and placebo group allocation in study participants is unknown)
  • Involve vulnerable persons (e.g. participants without capacity, children, pregnant women)

What do I need to do?

As a SP-INV and based on the complexity of your study:

  • Decide whether a DSMB might be warranted for your study
  • Decide on DSMB composition, ensuring the right type of experts are recruited (e.g. physician, statistician, patient advocates)
  • Ensure members are independent of the study staff, organisation or institution conducting the study
  • Write a DSMB charter signed by all parties. The charter documents the composition of the DSMB, members responsibilities, the management of the board and processes for decision making
  • As applicable, evaluate DSMB recommendations and act accordingly

Where can I get help?

Your local CTU↧ can support you with experienced staff regarding this topic

References

ICH GCP E6(R2) – see in particular guideline

  • 1.25 Definition of the DSMB

 

ISO 14155:2020 Medical device (access liable to cost) – see in particular sections

  • 3.17 Definition data monitoring committee
  • 6.11 Data monitoring committee
Abbreviations
  • CTU – Clinical Trials Unit
  • DSMB – Data Safety Monitoring Board
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • ISO – International Organization for Standardization
  • SP-INV – Sponsor-Investigator
Set-Up ↦ Safety ↦ Data Safety Monitoring Board ↦ Aim
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Management
  1. Study Management
    1. Definition
Basic Ethics and Laws
  1. Principles of Ethics Research
    1. Declaration of Helsinki
    2. Declaration of Taipei
  2. Authorities
    1. Ethics Committee
    2. Swissmedic
    3. Federal Office of Public Health
    4. International
  3. Swiss Law
    1. Human Research Act
    2. Transplantation Act
    3. Stem Cell Research Act
    4. Data Protection Act
  4. Clinical Trials Ordinance
    1. Aim
    2. Medicinal Product Studies
    3. Other Clinical Studies
    4. Transplantation
    5. Standardized Transplant Products
    6. Gene Therapy, GMO, Pathogenic
    7. Ionising Radiation
  5. Clinical Trials with Medical Device Ordinance
    1. Aim
    2. Medical Device Studies
    3. In Vitro Diagnostic Medical Device Studies
    4. Ionising Radiation
  6. Medical Device Ordinance
    1. Aim
    2. Notified Bodies
  7. Human Research Ordinance
    1. Aim
    2. Projects with Data and Biological Material
    3. Further-use of Data and Biological Material
    4. Further-use and Informed Consent
    5. Deceased Persons Embryos and Foetuses
  8. Organisation Ordinance
    1. Aim
  9. Human Research Coordination Portal
    1. Federal Office of Public Health
  10. Submission Portal
    1. Ethics Portal BASEC
    2. Swissmedic Portal
  11. Guidelines
    1. Good Clinical Practice
    2. ISO 14155
    3. ISO 20916
Basic Documents
  1. Document Management
    1. Purpose
    2. In Studies
    3. Document Identification
    4. Document Filing
  2. Standard Operating Procedures
    1. Purpose
  3. Working Instructions
    1. Purpose
  4. Logs
    1. Purpose
  5. Essential Documents
    1. Requirement
  6. Certified Copies
    1. Procedures
  7. Staff Documents
    1. Qualifications
    2. Training
Basic Safety
  1. Safety Laws
    1. Aim
  2. Safety Terminology
    1. Overview
  3. Safety Data
    1. Product Development
    2. Pre-Clinical Studies
    3. In Clinical Studies
  4. Safety Information
    1. Investigator Brochure
  5. Safety Vigilance
    1. Pharmacovigilance
    2. Materiovigilance
Basic Data Handling
  1. Data Management in Studies
    1. Aim
  2. Study Database
    1. Clinical Data Management System
    2. Study Data
    3. Raw Data
    4. Metadata
  3. Regulatory Requirements
    1. Swiss Law
    2. EU Regulation
Basic Statistics
Basic Quality and Risk
  1. Risk Management Definitions
    1. Risk-Based Approach
    2. Risk Identification
    3. Risk Evaluation and Prioritisation
    4. Risk Evaluation Matrix
    5. Risk Control Measures
  2. Quality Management System (QMS)
    1. Risk Based
  3. Risk-Based QMS Responsibilities
    1. Sponsor-Investigator
    2. Site-Investigator
    3. Study Staff
Basic Monitoring
Basic Drug or Device
Basic Biobanking
  1. Definition
    1. Biobank
    2. Biological Material
    3. Specimen / Sample
    4. Pre-Analytical Phase
    5. Data Coding / Anonymisation
    6. Incidental Findings
  2. Donor
    1. In Research
  3. The Swiss Law
    1. Human Research Ordinance
    2. Research with Biological Material
    3. Further Use of Biological Material
    4. Further Use and Informed Consent
  4. Ethics Principles
    1. Declaration of Taipei
  5. Biobanking Standards
    1. ISO Biobanking
  6. Swiss Biobanking Platform
    1. Aim
    2. Services
    3. Quality Labels
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Management
  1. Study Idea
    1. Implementation
    2. Design
  2. Resources
    1. Study Staff
    2. Infrastructure
    3. Storage
    4. Partners
    5. Budget
Concept Ethics and Laws
  1. Research Aim
    1. Advancing Science
    2. Marketing Products
  2. Research Integrity
    1. Principles
    2. Conflict of Interest
    3. Participant Protection
  3. Ethics and Regulatory Requirements
    1. Ethics Requirements
    2. Laws and Guidelines
    3. Institution Requirements
    4. Study Compliance
  4. Study Categorisation
    1. Procedures
    2. Risk Categories
  5. Ethics and Regulatory Advice
    1. Ethics Clarification
    2. Swissmedic Scientific Advice
    3. Swissmedic Pre-Submission
Concept Documents
  1. Required Documents
    1. Protocol and Synopsis
    2. Feasibility
    3. Investigator's Brochure
Concept Safety
  1. Safety in Studies
    1. Risk-Benefit Ratio
    2. Participant Risk-Benefit
Concept Data Handling
  1. Stakeholders
    1. Sponsor-Investigator
    2. Data Manager
    3. Statistician
    4. Site-Investigator
    5. Monitor
  2. Clinical Data Mgmt. System
    1. Selection
  3. Server Management
    1. Data Storage
    2. Back-Up and Recovery
Concept Statistics
Concept Quality and Risk
  1. Study Feasibility
    1. Aim
    2. Feasibility Questionnaire
    3. Risk Assessment Form
    4. Study Team
Concept Monitoring
  1. Monitoring
    1. Aim
    2. Study Requirement
    3. Site Qualification
Concept Drug or Device
Concept Biobanking
  1. Biobanking in Studies
    1. Requirement
    2. Quality of Biological Material
  2. Management of a Biobank
    1. Biobank Goverance
    2. Biobank Regulation
    3. Material Transfer Agreement
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Management
  1. Responsibilities
    1. Sponsor-Investigator
    2. Site-Investigator
    3. Staff Qualification and Training
    4. Good Clinical Practice Training
  2. Study Quality
    1. Implementation
  3. Study Safety
    1. Requirement
    2. Interim Analysis
  4. Study Management
    1. Oversight
    2. Tracking
    3. Infratructure and Maintenance
    4. Multicentre Studies
    5. Insurance
    6. Outsourced Services
    7. Contract
    8. Budget
  5. Study Documents
    1. Protocol
    2. Participant Information Sheet
    3. Informed Consent Form
    4. Exemption from written Consent
    5. Informed Consent Process
    6. General Consent
    7. Essential Documents
    8. Source Data
  6. Study Approval
    1. Ethics Committee
    2. Swissmedic
    3. Fed. Off. Public Health
  7. Biobanking
    1. Management
    2. Emergency Plan
Development Ethics and Laws
  1. Ethics Application
    1. Submission
    2. Application Dossier
    3. Approval
  2. Swissmedic Application
    1. Submission
    2. Application Dossier
    3. Early Clarification Meeting
    4. Late Clarification Meeting
    5. Approval Medicinal Products
    6. Approval Medical Device
  3. Federal Office of Public Health
    1. Submission
    2. Approval
  4. Liability
    1. Insurance
    2. Good Clinical Practice
Development Documents
  1. Required Documents
    1. Study Protocol
    2. Participant Information
    3. Insurance and Contract
    4. Study Documents
    5. Document Submission
Development Safety
  1. Safety Documentation
    1. The Protocol
    2. Study Documents
    3. Data Protection
Development Data Handling
  1. Database Development
    1. Variables
    2. Variable Specification
    3. Case Report Form
    4. Automated Data Processing
    5. Data Coding and Anonymisation
    6. Data Confidentiality
  2. Data Quality
    1. Requirement
    2. Quality Assurance
    3. Data Mgmt. Plan
  3. Database Lock
    1. Procedures
Development Statistics
Development Quality and Risk
  1. Study Risk Management
    1. Risk Identification
    2. Risk Evaluation and Prioritisation
    3. Risk Control Measures
    4. Process Verification and Training
  2. Quality Assurance
    1. Aim
    2. Verification
    3. Audit
  3. Quality Control
    1. Aim
    2. Monitoring
    3. Non-Compliance
  4. Risk Communication
    1. Strategy
Development Monitoring
  1. Montoring Strategy
    1. Aim
    2. Risk-Based Monitoring
    3. On-Site Monitoring
    4. Central Data Monitoring
    5. Off-Site Monitoring
    6. Monitoring Plan
Development Drug or Device
Development Biobanking
  1. Biobank Set-Up
    1. Biobank Database
    2. Facilities and Materials
    3. Collection / Storage Containers
    4. Storage Equipment
    5. Equipment Maintenance
    6. Freezer Emergency Plan
  2. Donor Consent
    1. In Clinical Studies
    2. In Research Projects
    3. For Further Use
    4. Communication
  3. Handling of Biological Material
    1. Sample Workflow
    2. Sample Collection
    3. Sample Transport
    4. Sample Reception
    5. Sample Processing
    6. Sample Storage
    7. Sample Distribution
    8. Sample Analysis
  4. Documentation
    1. Forms and Logs
    2. Non-Conformities
  5. Safety
    1. Risk-Based Approach
    2. Donors
    3. Biobanking Staff
  6. Quality Control
    1. Quality Control Indicators
    2. Data Monitoring
    3. Method Validation
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Management
  1. Registration
    1. Research Transparency
  2. Study Training
    1. Staff Delegation
  3. Document Management
    1. Requirements
  4. Investigational Product
    1. Definition and Handling
  5. Laboratory
    1. Purpose and Requirement
  6. Study Ready for Conduct
    1. Requirements
    2. Site Initiation Visit
Set-Up Ethics and Laws
  1. Study Set-Up
    1. Requirements
Set-Up Documents
  1. Required Documents
    1. Study Initiation
    2. Master and Site File
Set-Up Safety
  1. Safety Management
    1. Safety Management Plan
    2. Emergency Unblinding
  2. Data Safety Monitoring Board
    1. Aim
Set-Up Data Handling
  1. Database Set-Up
    1. Requirement
    2. Access Rights
    3. Training
Set-Up Statistics
Set-Up Quality and Risk
Set-Up Monitoring
  1. Site Initation Visit
    1. Aim
    2. Prerequisite
    3. Preparation
    4. Conduct
    5. Report
Set-Up Drug or Device
Set-Up Biobanking
  1. Regulatory Affairs
    1. Requirement
  2. Staff Management
    1. Requirement
  3. Sample Management
    1. Sample Traceability
    2. Packaging and Shipment
  4. Biobanking in Studies
    1. Procedures
  5. Data Integrity
    1. Data Accuracy
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Management
  1. Participant Recruitment
    1. Pre-Screening
    2. Screening and Consent
    3. Documentation
  2. Amendment
    1. Protocol
    2. Patient Information Sheet
  3. Responsibility and Oversight
    1. Sponsor and Site-Investigator
    2. Drug and Device Accountability
    3. Compliance
    4. Newsletter
Conduct Ethics and Laws
  1. Study Conduct
    1. Ongoing Tasks
    2. Data Protection
  2. Participant Protection
    1. Requirements
    2. Consent of Vulnerable Participants
  3. Amendment
    1. Type
    2. Submission
    3. Approval
  4. Safety
    1. Requirements
  5. Inspections and Audits
    1. Inspection Conduct
    2. Audit Conduct
    3. Audit Certificate
  6. Premature Study Termination
    1. Rationale
    2. ReportingTimelines
Conduct Documents
  1. Required Documents
    1. Study Documentation
    2. Patient File
    3. Source Data
    4. Amendment
Conduct Safety
  1. Safety Risk Review
    1. Aim
  2. Safety Assessment
    1. Medicinal Product
    2. Medical Device
    3. Other Clinical Trials
    4. Research Projects
  3. Safety Reporting
    1. Procedures
    2. Responsibilities
  4. Medicinal Product Safety Reporting
    1. Adverse Event
    2. Serious Adverse Event
    3. (Serious) Adverse Drug Reaction
    4. Suspected Unexpected Serious Adverse Reaction
    5. Advanced Therapies
  5. Medical Device Safety Reporting
    1. Adverse Event / Adverse Device Effect
    2. Serious Adverse Event and Device Effect
    3. Device Deficiency
  6. Research Project Safety Reporting
    1. Serious Events
  7. Safety and Protective Measures
    1. Procedures
  8. Annual Safety Report
    1. Procedures
Conduct Data Handling
  1. Data Entry
    1. Requirement
    2. Collection
  2. Data Quality
    1. Responsibility
    2. Adding Stakeholders
  3. Data Handling
    1. Data Import
    2. Interim Lock
    3. Intermediate Data Export
    4. Amendment
Conduct Statistics
Conduct Quality and Risk
  1. Risk Review
    1. Re-Evaluation
    2. Risk Documentation
  2. Deviation Documentation
    1. Note to File
  3. Regulatory Inspections
    1. Conduct
    2. Findings
    3. Corrective and Preventive Actions
Conduct Monitoring
  1. Routine Monitoring Visit
    1. Preparation
    2. Conduct
    3. Findings
    4. Report
    5. Follow-Up Letter
Conduct Drug or Device
Conduct Biobanking
  1. Biobanking Operation
    1. Processes
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Management
  1. Study Closure
    1. Close-Out Visit
    2. Database Lock
    3. Notification of Closure
    4. Lessons Learned
  2. Clinical Study Report
    1. Requirement
  3. Publishing
    1. Study Registries
    2. Scientific Publications
  4. Archiving
    1. Storage
Completion Ethics and Laws
  1. End of Study Notification
    1. Reporting and Liability
    2. Registry Update
  2. Clinical Study Report
    1. Requirement
  3. Publications
    1. Responsibilities
  4. Inspections and Audits
    1. Procedures
  5. Archiving
    1. Requirements
    2. Duration
Completion Documents
  1. Required Documents
    1. Study Closure
    2. Doument Archiving
    3. Document Destruction
Completion Safety
  1. Clinical Study Report
    1. Procedures
Completion Data Handling
  1. Final Database Lock
    1. Procedures
  2. Data Export
    1. Data Formatting
    2. Data Transfer Agreement
  3. Clinical Study Report
    1. Requirement
  4. Archiving
    1. Requirement
Completion Statistics
Completion Quality and Risk
  1. Clinical Study Report
    1. Risk Reporting
    2. Lessons Learned
  2. Archiving
    1. Study Records
Completion Monitoring
  1. Close-Out Visit
    1. Preparation
    2. Conduct
    3. Report
    4. Follow-Up Letter
    5. Archiving
Completion Drug or Device
Completion Biobanking
  1. Leftover Biological Material
    1. For Further-Use
    2. Destruction
  2. Publication
    1. Analytical Results
Current Path (click to copy): Set-Up ↦ Safety ↦ Data Safety Monitoring Board ↦ Aim

Please note: the Easy-GCS tool is currently under construction.