What is it? Why is it important?

Access Right (AR) is the permission granted a user enagling him/her to read, enter, or change data in a given application.

The SP-INV is responsible to: 

  • Decide on allotted study database and CRF ARs
  • Maintain a list of all staff members having current access to the database
  • Maintain current and ongoing oversight of ARs at different sites in a multicentre study

Upon successful testing, database validation and the request by the SP-INV to release the database, the data manager:

  • Switches the setting of the study database from testing/validation phase to productive mode, allowing for real-life data entry
  • The productive database is an export into the productive phase without the inclusion of dummy variables (test data) entered during the testing phase.
  • Based on delegated tasks, allocates personalised access rights to study staff

More

Study database access rights should be adapted and:

  • Limited based on individual user rights (e.g. view only, data entry and change, data monitor and quality control, data manager responsibilities)
  • Based on the degree of data confidentiality and on any risks associated with data leaks
  • Granted according to applicable study site in a multicentre study. This requires that each participating study site only has access to its own data. Thus, access to data from other participating sites is not possible. An exception is the SP-INV who has access to data from all sites (participant identifiers excluded)

What do I need to do?

  • Grant access to the study database only to staff members actively involved in the study, and who require access based on performance of delegated tasks
  • Update access rights on a regular basis. Ensure only current staff or other current collaborating members have access to the database
  • Deactivate user access as soon as a staff member leaves the study
  • Maintain a list of ongoing access rights including names, date of access and date of access closure (keep the list in a secure and safe place)

More

In some studies, participants might be asked to enter data about themselves into the study database (e.g. daily diary, the timing of medication intake, adverse events).

In these cases participants are given access only to those parts of the CRF reserved for participant data entry. Participants can directly enter their own data into the CRF, but have no access or possibilities to view other data, including entries made by other participants.

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 guidelines

  • 5.5. Trial Management, data handling, and record-keeping
Abbreviations
  • AR – Access Rights
  • CRF – Case Report Form
  • CTU – Clinical Trials Unit
  • SP-INV – Sponsor-Investigator
Set-Up ↦ Data Handling ↦ Database ↦ Access Rights
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 Products
    3. In Vitro Diagnostic Medical Device
    4. Standardized Transplant Products
    5. Gene Therapy, GMO, Pathogenic
    6. Transplantation
    7. Other Clinical Studies
    8. Ionising Radiation
  5. 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
  6. Medical Device Ordinance
    1. Aim
    2. In Clinical Studies
    3. Notified Bodies
  7. Organisation Ordinance
    1. Aim
  8. Portals
    1. Human Research Portal
    2. Ethics Portal BASEC
    3. Swissmedic Portal
  9. 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-Clinial 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. General Data Protection 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
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. Study Categorisation
    1. Procedures
    2. Risk Categories
  2. Regulatory Advice
    1. Scientific Advice
    2. Pre-Submission
  3. Regulatory Advice Meeting
    1. Ethics Clarification
  4. Research Aim
    1. Advancing Science
    2. Marketing Products
  5. Research Integrity
    1. Principles
    2. Conflict of Interest
    3. Participant Protection
  6. Study Planning
    1. Ethics Requirements
    2. Laws and Guidelines
    3. Institution Requirements
  7. Study Feasibility
    1. Ethics and Laws
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
    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 Feasibility
Concept Drug or Device
Concept Biobanking
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. Quality Mgmt. System
    1. Implementation
    2. Interim Analysis
  3. Study Management
    1. Oversight
    2. Tracking
    3. Infratructure and Maintenance
    4. Multi-centre Studies
    5. Insurance
    6. Outsourced Services
    7. Contract
    8. Budget
  4. 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
  5. Study Approval
    1. Ethics Committee
    2. Swissmedic
    3. Fed. Off. Public Health
  6. Biobanking
    1. Management
    2. Emergency Plan
Development Ethics and Laws
  1. Ethics Application
    1. Submission
    2. Application Dossier
    3. Approva
  2. Swissmedic Application
    1. Application Dossier
    2. Early Clarification Meeting
    3. Late Clarification Meeting
    4. Approval Medicinal Products
    5. 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. Study Database Set-Up
    1. Variables
    2. Variable Specification
    3. Case Report Form
    4. Automated Data Processing
    5. Data Confidentiality
    6. Data Coding and Anonymisation
  2. Data Quality
    1. Requirement
    2. Quality Management
    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. Quality Documents
    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 Monitoring
    5. Monitoring Plan
Development Drug or Device
Development Biobanking
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
  3. Document Management
    1. Requirements
  4. Investigational Product
    1. In Studies
  5. Laboratory
    1. Aim
  6. Study Ready for Conduct
    1. Requirements
  7. Study Monitoring
    1. 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
    1. Development
    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
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 of Recruitment
  2. Amendment
    1. Protocol
    2. Patient Information Sheet
  3. Safety
    1. Reporting
    2. Annual Safety Reporting
    3. Interim Analysis
  4. Responsibility and Oversight
    1. Site-Investigator
    2. Routine Monitoring
    3. Risk Review
    4. Drug Accountability
    5. Compliance
    6. Newsletter
    7. Essential Documents
    8. Budget
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. Training
  3. Data Handling
    1. Data Import
    2. Interim Lock
    3. Intermediate Data Eport
    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
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. Regulatory Requirements
  3. Publishing
    1. Study Registries
    2. Scientific Publications
  4. Archiving
    1. Storage
Completion Ethics and Laws
  1. End of Study Notification
    1. ReportingTimelines
    2. Liability Coverage
    3. Registry Update
  2. Clinical Study Report
    1. Procedures
  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 and Tranfer
    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
Current Path (click to copy): Set-Up ↦ Data Handling ↦ Database ↦ Access Rights

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