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Root = eTMF_Trial - Mind Map
- Root = Trial
- Expected Document
- Site 2
- Trial Management
- Trial Committee
- Committee Member Confidentiality Disclosure Agreement
- Committee Output
- Committee Member Contract
- Committee Member CV
- Committee Member List
- Committee Process
- Committee Member Financial Disclosure Form
- Trial Team
- Trial Team Details
- Trial Team CV
- Trial Oversight
- Trial Master File Plan
- TMF Report
- Quality Plan
- List of SOPs Current During Trial
- SOP Deviations
- SOP Waivers
- Operational Procedure Manual
- Recruitment Plan
- Communication Plan
- Monitoring Plan
- Medical Monitoring Plan
- Publication Policy
- Debarment Statement
- Trial Status Report
- Investigator Newletter
- Audit Certificate
- Filenote Master List
- Risk Mangement Plan
- Vendor Management Plan
- Roles and Responsibility Matrix
- Transfer of Regulatory Obligations
- Operational Oversight
- Operational Oversight
- Meetings
- Kickoff Meeting Material
- Trial Team Evidence of Training
- Investigators Meeting Material
- Trial Team Training Material
- General
- Relevant Communications
- Other Meeting Material
- Filenote
- Tracking Information
- Central and Local Testing
- Facility Documentaiton
- Certifications of Accredations
- Lab Results Documentation
- Laboratory Validation Doc
- Normal Ranges
- Supply Import Doc
- Standardization Methods
- Manual
- Head of Facility CV
- Sample Documentation
- Specimen Label
- Shipment Records
- Sample Storage Condition log
- Sample Import or Export Doc
- Record of Retained Samples
- General
- Filenote
- Meeting Material
- Relevant Communications
- Tracking Information
- Central Trial Documents
- Protocol
- Subject Documentation
- Subject Diary
- Subject Questionnaire
- Informed Consent Form
- Subject Information Sheet
- Subject Participation Card
- Advertisements for Subject Recruitment
- Other Information Given to Subjects
- Reports
- Clinical Study Report
- Bioanalytical Report
- Product and Trial Documentation
- Investigators Brochure
- Protocol
- Financial Disclosure Summary
- Sample Case Report Form
- Report of Prior Investigations
- Marketed Product Material
- Protocol Synopsis
- Idea
- Protocol Amendment
- Insurance
- General
- Relevant Communications
- Tracking Information
- Meeting Material
- Filenote
- Data Mangement
- IP and Trial Supplies
- IRB or IEC and other Approvals
- Regulatory
- Safety Mangement
- Safety Reporting
- Statistics
- Third Parties
- Idea
- Idea
- Idea
- Site 3
- Trial Management
- Trial Committee
- Committee Member Confidentiality Disclosure Agreement
- Committee Output
- Committee Member Contract
- Committee Member CV
- Committee Member List
- Committee Process
- Committee Member Financial Disclosure Form
- Trial Team
- Trial Team Details
- Trial Team CV
- Trial Oversight
- Trial Master File Plan
- TMF Report
- Quality Plan
- List of SOPs Current During Trial
- Idea
- Idea
- Operational Procedure Manual
- Recruitment Plan
- Communication Plan
- Monitoring Plan
- Medical Monitoring Plan
- Publication Policy
- Debarment Statement
- Trial Status Report
- Investigator Newletter
- Audit Certificate
- Filenote Master List
- Risk Mangement Plan
- Vendor Management Plan
- Roles and Responsibility Matrix
- Transfer of Regulatory Obligations
- Operational Oversight
- Operational Oversight
- Meetings
- Kickoff Meeting Material
- Trial Team Evidence of Training
- Investigators Meeting Material
- Trial Team Training Material
- General
- Relevant Communications
- Other Meeting Material
- Filenote
- Tracking Information
- Central and Local Testing
- Facility Documentaiton
- Certifications of Accredations
- Lab Results Documentation
- Laboratory Validation Doc
- Normal Ranges
- Supply Import Doc
- Standardization Methods
- Manual
- Head of Facility CV
- Sample Documentation
- Specimen Label
- Shipment Records
- Sample Storage Condition log
- Sample Import or Export Doc
- Record of Retained Samples
- General
- Filenote
- Meeting Material
- Relevant Communications
- Tracking Information
- Central Trial Documents
- Protocol
- Subject Documentation
- Subject Diary
- Subject Questionnaire
- Informed Consent Form
- Subject Information Sheet
- Subject Participation Card
- Advertisements for Subject Recruitment
- Other Information Given to Subjects
- Reports
- Clinical Study Report
- Bioanalytical Report
- Product and Trial Documentation
- Investigators Brochure
- Protocol
- Financial Disclosure Summary
- Sample Case Report Form
- Report of Prior Investigations
- Marketed Product Material
- Protocol Synopsis
- Idea
- Protocol Amendment
- Insurance
- General
- Relevant Communications
- Tracking Information
- Meeting Material
- Filenote
- Data Mangement
- IP and Trial Supplies
- IRB or IEC and other Approvals
- Regulatory
- Safety Mangement
- Safety Reporting
- Statistics
- Third Parties
- Site 4
- Site 5
- Trial Management
- Trial Committee
- Committee Member Confidentiality Disclosure Agreement
- Committee Output
- Committee Member Contract
- Committee Member CV
- Committee Member List
- Committee Process
- Committee Member Financial Disclosure Form
- Trial Team
- Trial Team Details
- Trial Team CV
- Trial Oversight
- Trial Master File Plan
- TMF Report
- Quality Plan
- List of SOPs Current During Trial
- Idea
- Idea
- Operational Procedure Manual
- Recruitment Plan
- Communication Plan
- Monitoring Plan
- Medical Monitoring Plan
- Publication Policy
- Debarment Statement
- Trial Status Report
- Investigator Newletter
- Audit Certificate
- Filenote Master List
- Risk Mangement Plan
- Vendor Management Plan
- Roles and Responsibility Matrix
- Transfer of Regulatory Obligations
- Operational Oversight
- Operational Oversight
- Meetings
- Kickoff Meeting Material
- Trial Team Evidence of Training
- Investigators Meeting Material
- Trial Team Training Material
- General
- Relevant Communications
- Other Meeting Material
- Filenote
- Tracking Information
- Central and Local Testing
- Facility Documentaiton
- Certifications of Accredations
- Lab Results Documentation
- Laboratory Validation Doc
- Normal Ranges
- Supply Import Doc
- Standardization Methods
- Manual
- Head of Facility CV
- Sample Documentation
- Specimen Label
- Shipment Records
- Sample Storage Condition log
- Sample Import or Export Doc
- Record of Retained Samples
- General
- Filenote
- Meeting Material
- Relevant Communications
- Tracking Information
- Central Trial Documents
- Protocol
- Subject Documentation
- Subject Diary
- Subject Questionnaire
- Informed Consent Form
- Subject Information Sheet
- Subject Participation Card
- Advertisements for Subject Recruitment
- Other Information Given to Subjects
- Reports
- Clinical Study Report
- Bioanalytical Report
- Product and Trial Documentation
- Investigators Brochure
- Protocol
- Financial Disclosure Summary
- Sample Case Report Form
- Report of Prior Investigations
- Marketed Product Material
- Protocol Synopsis
- Idea
- Protocol Amendment
- Insurance
- General
- Relevant Communications
- Tracking Information
- Meeting Material
- Filenote
- Data Mangement
- IP and Trial Supplies
- IRB or IEC and other Approvals
- Regulatory
- Safety Mangement
- Safety Reporting
- Statistics
- Third Parties
- Site 6
- Trial Management
- Trial Committee
- Committee Member Confidentiality Disclosure Agreement
- Committee Output
- Committee Member Contract
- Committee Member CV
- Committee Member List
- Committee Process
- Committee Member Financial Disclosure Form
- Trial Team
- Trial Team Details
- Trial Team CV
- Trial Oversight
- Trial Master File Plan
- TMF Report
- Quality Plan
- List of SOPs Current During Trial
- Idea
- Idea
- Operational Procedure Manual
- Recruitment Plan
- Communication Plan
- Monitoring Plan
- Medical Monitoring Plan
- Publication Policy
- Debarment Statement
- Trial Status Report
- Investigator Newletter
- Audit Certificate
- Filenote Master List
- Risk Mangement Plan
- Vendor Management Plan
- Roles and Responsibility Matrix
- Transfer of Regulatory Obligations
- Operational Oversight
- Operational Oversight
- Meetings
- Kickoff Meeting Material
- Trial Team Evidence of Training
- Investigators Meeting Material
- Trial Team Training Material
- General
- Relevant Communications
- Other Meeting Material
- Filenote
- Tracking Information
- Central and Local Testing
- Facility Documentaiton
- Certifications of Accredations
- Lab Results Documentation
- Laboratory Validation Doc
- Normal Ranges
- Supply Import Doc
- Standardization Methods
- Manual
- Head of Facility CV
- Sample Documentation
- Specimen Label
- Shipment Records
- Sample Storage Condition log
- Sample Import or Export Doc
- Record of Retained Samples
- General
- Filenote
- Meeting Material
- Relevant Communications
- Tracking Information
- Central Trial Documents
- Protocol
- Subject Documentation
- Subject Diary
- Subject Questionnaire
- Informed Consent Form
- Subject Information Sheet
- Subject Participation Card
- Advertisements for Subject Recruitment
- Other Information Given to Subjects
- Reports
- Clinical Study Report
- Bioanalytical Report
- Product and Trial Documentation
- Investigators Brochure
- Protocol
- Financial Disclosure Summary
- Sample Case Report Form
- Report of Prior Investigations
- Marketed Product Material
- Protocol Synopsis
- Idea
- Protocol Amendment
- Insurance
- General
- Relevant Communications
- Tracking Information
- Meeting Material
- Filenote
- Data Mangement
- IP and Trial Supplies
- IRB or IEC and other Approvals
- Regulatory
- Safety Mangement
- Safety Reporting
- Statistics
- Third Parties
- Americas
- Site 7
- Trial Management
- Trial Committee
- Committee Member Confidentiality Disclosure Agreement
- Committee Output
- Committee Member Contract
- Committee Member CV
- Committee Member List
- Committee Process
- Committee Member Financial Disclosure Form
- Trial Team
- Trial Team Details
- Trial Team CV
- Trial Oversight
- Trial Master File Plan
- TMF Report
- Quality Plan
- List of SOPs Current During Trial
- Idea
- Idea
- Operational Procedure Manual
- Recruitment Plan
- Communication Plan
- Monitoring Plan
- Medical Monitoring Plan
- Publication Policy
- Debarment Statement
- Trial Status Report
- Investigator Newletter
- Audit Certificate
- Filenote Master List
- Risk Mangement Plan
- Vendor Management Plan
- Roles and Responsibility Matrix
- Transfer of Regulatory Obligations
- Operational Oversight
- Operational Oversight
- Meetings
- Kickoff Meeting Material
- Trial Team Evidence of Training
- Investigators Meeting Material
- Trial Team Training Material
- General
- Relevant Communications
- Other Meeting Material
- Filenote
- Tracking Information
- Central and Local Testing
- Facility Documentaiton
- Certifications of Accredations
- Lab Results Documentation
- Laboratory Validation Doc
- Normal Ranges
- Supply Import Doc
- Standardization Methods
- Manual
- Head of Facility CV
- Sample Documentation
- Specimen Label
- Shipment Records
- Sample Storage Condition log
- Sample Import or Export Doc
- Record of Retained Samples
- General
- Filenote
- Meeting Material
- Relevant Communications
- Tracking Information
- Central Trial Documents
- Protocol
- Subject Documentation
- Subject Diary
- Subject Questionnaire
- Informed Consent Form
- Subject Information Sheet
- Subject Participation Card
- Advertisements for Subject Recruitment
- Other Information Given to Subjects
- Reports
- Clinical Study Report
- Bioanalytical Report
- Product and Trial Documentation
- Investigators Brochure
- Protocol
- Financial Disclosure Summary
- Sample Case Report Form
- Report of Prior Investigations
- Marketed Product Material
- Protocol Synopsis
- Idea
- Protocol Amendment
- Insurance
- General
- Relevant Communications
- Tracking Information
- Meeting Material
- Filenote
- Data Mangement
- IP and Trial Supplies
- IRB or IEC and other Approvals
- Regulatory
- Safety Mangement
- Safety Reporting
- Statistics
- Third Parties
- Site 8
- Trial Management
- Trial Committee
- Committee Member Confidentiality Disclosure Agreement
- Committee Output
- Committee Member Contract
- Committee Member CV
- Committee Member List
- Committee Process
- Committee Member Financial Disclosure Form
- Trial Team
- Trial Team Details
- Trial Team CV
- Trial Oversight
- Trial Master File Plan
- TMF Report
- Quality Plan
- List of SOPs Current During Trial
- Idea
- Idea
- Operational Procedure Manual
- Recruitment Plan
- Communication Plan
- Monitoring Plan
- Medical Monitoring Plan
- Publication Policy
- Debarment Statement
- Trial Status Report
- Investigator Newletter
- Audit Certificate
- Filenote Master List
- Risk Mangement Plan
- Vendor Management Plan
- Roles and Responsibility Matrix
- Transfer of Regulatory Obligations
- Operational Oversight
- Operational Oversight
- Meetings
- Kickoff Meeting Material
- Trial Team Evidence of Training
- Investigators Meeting Material
- Trial Team Training Material
- General
- Relevant Communications
- Other Meeting Material
- Filenote
- Tracking Information
- Central and Local Testing
- Facility Documentaiton
- Certifications of Accredations
- Lab Results Documentation
- Laboratory Validation Doc
- Normal Ranges
- Supply Import Doc
- Standardization Methods
- Manual
- Head of Facility CV
- Sample Documentation
- Specimen Label
- Shipment Records
- Sample Storage Condition log
- Sample Import or Export Doc
- Record of Retained Samples
- General
- Filenote
- Meeting Material
- Relevant Communications
- Tracking Information
- Central Trial Documents
- Protocol
- Subject Documentation
- Subject Diary
- Subject Questionnaire
- Informed Consent Form
- Subject Information Sheet
- Subject Participation Card
- Advertisements for Subject Recruitment
- Other Information Given to Subjects
- Reports
- Clinical Study Report
- Bioanalytical Report
- Product and Trial Documentation
- Investigators Brochure
- Protocol
- Financial Disclosure Summary
- Sample Case Report Form
- Report of Prior Investigations
- Marketed Product Material
- Protocol Synopsis
- Idea
- Protocol Amendment
- Insurance
- General
- Relevant Communications
- Tracking Information
- Meeting Material
- Filenote
- Data Mangement
- IP and Trial Supplies
- IRB or IEC and other Approvals
- Regulatory
- Safety Mangement
- Safety Reporting
- Statistics
- Third Parties
- Continent
- Country a
- State 1
- City 1
- Site 9
- Trial Management
- Trial Committee
- Committee Member Confidentiality Disclosure Agreement
- Committee Output
- Committee Member Contract
- Committee Member CV
- Committee Member List
- Committee Process
- Committee Member Financial Disclosure Form
- Trial Team
- Trial Team Details
- Trial Team CV
- Trial Oversight
- Trial Master File Plan
- TMF Report
- Quality Plan
- List of SOPs Current During Trial
- Idea
- Idea
- Operational Procedure Manual
- Recruitment Plan
- Communication Plan
- Monitoring Plan
- Medical Monitoring Plan
- Publication Policy
- Debarment Statement
- Trial Status Report
- Investigator Newletter
- Audit Certificate
- Filenote Master List
- Risk Mangement Plan
- Vendor Management Plan
- Roles and Responsibility Matrix
- Transfer of Regulatory Obligations
- Operational Oversight
- Operational Oversight
- Meetings
- Kickoff Meeting Material
- Trial Team Evidence of Training
- Investigators Meeting Material
- Trial Team Training Material
- General
- Relevant Communications
- Other Meeting Material
- Filenote
- Tracking Information
- Central and Local Testing
- Facility Documentaiton
- Certifications of Accredations
- Lab Results Documentation
- Laboratory Validation Doc
- Normal Ranges
- Supply Import Doc
- Standardization Methods
- Manual
- Head of Facility CV
- Sample Documentation
- Specimen Label
- Shipment Records
- Sample Storage Condition log
- Sample Import or Export Doc
- Record of Retained Samples
- General
- Filenote
- Meeting Material
- Relevant Communications
- Tracking Information
- Central Trial Documents
- Protocol
- Subject Documentation
- Subject Diary
- Subject Questionnaire
- Informed Consent Form
- Subject Information Sheet
- Subject Participation Card
- Advertisements for Subject Recruitment
- Other Information Given to Subjects
- Reports
- Clinical Study Report
- Bioanalytical Report
- Product and Trial Documentation
- Investigators Brochure
- Protocol
- Financial Disclosure Summary
- Sample Case Report Form
- Report of Prior Investigations
- Marketed Product Material
- Protocol Synopsis
- Idea
- Protocol Amendment
- Insurance
- General
- Relevant Communications
- Tracking Information
- Meeting Material
- Filenote
- Data Mangement
- IP and Trial Supplies
- IRB or IEC and other Approvals
- Regulatory
- Safety Mangement
- Safety Reporting
- Statistics
- Third Parties
- Idea
- Country b
- State 2
- City 2
- Site 10
- Trial Management
- Trial Committee
- Committee Member Confidentiality Disclosure Agreement
- Committee Output
- Committee Member Contract
- Committee Member CV
- Committee Member List
- Committee Process
- Committee Member Financial Disclosure Form
- Trial Team
- Trial Team Details
- Trial Team CV
- Trial Oversight
- Trial Master File Plan
- TMF Report
- Quality Plan
- List of SOPs Current During Trial
- Idea
- Idea
- Operational Procedure Manual
- Recruitment Plan
- Communication Plan
- Monitoring Plan
- Medical Monitoring Plan
- Publication Policy
- Debarment Statement
- Trial Status Report
- Investigator Newletter
- Audit Certificate
- Filenote Master List
- Risk Mangement Plan
- Vendor Management Plan
- Roles and Responsibility Matrix
- Transfer of Regulatory Obligations
- Operational Oversight
- Operational Oversight
- Meetings
- Kickoff Meeting Material
- Trial Team Evidence of Training
- Investigators Meeting Material
- Trial Team Training Material
- General
- Relevant Communications
- Other Meeting Material
- Filenote
- Tracking Information
- Central and Local Testing
- Facility Documentaiton
- Certifications of Accredations
- Lab Results Documentation
- Laboratory Validation Doc
- Normal Ranges
- Supply Import Doc
- Standardization Methods
- Manual
- Head of Facility CV
- Sample Documentation
- Specimen Label
- Shipment Records
- Sample Storage Condition log
- Sample Import or Export Doc
- Record of Retained Samples
- General
- Filenote
- Meeting Material
- Relevant Communications
- Tracking Information
- Central Trial Documents
- Protocol
- Subject Documentation
- Subject Diary
- Subject Questionnaire
- Informed Consent Form
- Subject Information Sheet
- Subject Participation Card
- Advertisements for Subject Recruitment
- Other Information Given to Subjects
- Reports
- Clinical Study Report
- Bioanalytical Report
- Product and Trial Documentation
- Investigators Brochure
- Protocol
- Financial Disclosure Summary
- Sample Case Report Form
- Report of Prior Investigations
- Marketed Product Material
- Protocol Synopsis
- Idea
- Protocol Amendment
- Insurance
- General
- Relevant Communications
- Tracking Information
- Meeting Material
- Filenote
- Data Mangement
- IP and Trial Supplies
- IRB or IEC and other Approvals
- Regulatory
- Safety Mangement
- Safety Reporting
- Statistics
- Third Parties
- This is a dummy separator box. The below layer displays a Harmonized eTMF structure for a given Client Sponsored Trial
- Zone 1 :Central and Local Testing
- Facility Documentaiton
- Certifications of Accredations
- Lab Results Documentation
- Laboratory Validation Doc
- Normal Ranges
- Supply Import Doc
- Standardization Methods
- Manual
- Head of Facility CV
- Sample Documentation
- Specimen Label
- Shipment Records
- Sample Storage Condition log
- Sample Import or Export Doc
- Record of Retained Samples
- General
- Filenote
- Meeting Material
- Relevant Communications
- Tracking Information
- Zone 2 : Central Trial Documents
- Protocol
- Subject Documentation
- Subject Diary
- Subject Questionnaire
- Informed Consent Form
- Subject Information Sheet
- Subject Participation Card
- Advertisements for Subject Recruitment
- Other Information Given to Subjects
- Reports
- Clinical Study Report
- Bioanalytical Report
- Product and Trial Documentation
- Investigators Brochure
- Protocol
- Financial Disclosure Summary
- Sample Case Report Form
- Report of Prior Investigations
- Marketed Product Material
- Protocol Synopsis
- Idea
- Protocol Amendment
- Insurance
- General
- Relevant Communications
- Tracking Information
- Meeting Material
- Filenote
- Zone 3 : Data Management
- Zone 4: IP and Trial Supplies
- Zone 5: IRB or IEC and other Approvals
- Zone 6: Regulatory
- Zone 7: Safety Management
- Zone 8: Safety Reporting
- Zone 9 : Statistics
- Zone 10 : Third Parties
- Zone 11 - Trial Management
- Trial Committee
- Committee Member Confidentiality Disclosure Agreement
- Committee Output
- Committee Member Contract
- Committee Member CV
- Committee Member List
- Committee Process
- Committee Member Financial Disclosure Form
- Trial Team
- Trial Team Details
- Trial Team CV
- Trial Oversight
- Trial Master File Plan
- TMF Report
- Quality Plan
- List of SOPs Current During Trial
- Idea
- Idea
- Operational Procedure Manual
- Recruitment Plan
- Communication Plan
- Monitoring Plan
- Medical Monitoring Plan
- Publication Policy
- Debarment Statement
- Trial Status Report
- Investigator Newletter
- Audit Certificate
- Filenote Master List
- Risk Mangement Plan
- Vendor Management Plan
- Roles and Responsibility Matrix
- Transfer of Regulatory Obligations
- Operational Oversight
- Operational Oversight
- Meetings
- Kickoff Meeting Material
- Trial Team Evidence of Training
- Investigators Meeting Material
- Trial Team Training Material
- General
- Relevant Communications
- Other Meeting Material
- Filenote
- Tracking Information
- Idea
- Idea
- This is a dummy separator box. The below layer displays Non -Harmonized eTMF i.e Site Group Layer
- etMF Site Group A
- eTMF Tree Structure
- eTMF Site Group B
- eTMF Tree Structure
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