CDISC TMF Terminology

Preferred Label : CDISC TMF Terminology;

NCIt related terms : TMF;

NCIt definition : The terminology subset that includes terms pertaining to the CDISC Trial Master Files (TMF) standards.;

Alternative definition : CDISC: The terminology subset that includes terms pertaining to the Clinical Data Interchange Standards Consortium (CDISC) Trial Master File (TMF) standards.;

Details

Origin ID

C207069;

concept_is_in_subset
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]
subset_includes_concept
- Audit Certificate Documentation [NCIt concept]
- CDISC TMF-RM Central Trial Documents Zone Terminology [NCIt concept]
- CDISC TMF-RM Central and Local Testing Zone Terminology [NCIt concept]
- CDISC TMF-RM Data Management Zone Terminology [NCIt concept]
- CDISC TMF-RM IP and Trial Supplies Zone Terminology [NCIt concept]
- CDISC TMF-RM IRB or IEC and Other Approvals Zone Terminology [NCIt concept]
- CDISC TMF-RM Regulatory Zone Terminology [NCIt concept]
- CDISC TMF-RM Safety Reporting Zone Terminology [NCIt concept]
- CDISC TMF-RM Sections Terminology [NCIt concept]
- CDISC TMF-RM Site Management Zone Terminology [NCIt concept]
- CDISC TMF-RM Statistics Zone Terminology [NCIt concept]
- CDISC TMF-RM Trial Management Zone Terminology [NCIt concept]
- CDISC TMF-RM Vendor Zone Terminology [NCIt concept]
- CDISC TMF-RM Zones Terminology [NCIt concept]
- Case Report Form [NCIt concept]
- Case Report Form Annotation Guideline Documentation [NCIt concept]
- Case Report Form Guideline Documentation [NCIt concept]
- Clincial Trial Contractual Agreement Documentation [NCIt concept]
- Clincial Trial Master File Plan Documentation [NCIt concept]
- Clincial Trial Standard Operating Procedure List Documentation [NCIt concept]
- Clinical Study Protocol [NCIt concept]
- Clinical Study Protocol Amendment Documentation [NCIt concept]
- Clinical Study Protocol Amendment Signature Page Documentation [NCIt concept]
- Clinical Study Protocol Deviation Documentation [NCIt concept]
- Clinical Study Protocol Signature Page Documentation [NCIt concept]
- Clinical Study Protocol Synopsis Documentation [NCIt concept]
- Clinical Trial Agreement Documentation [NCIt concept]
- Clinical Trial Approval for Database Activation Documentation [NCIt concept]
- Clinical Trial Bioanalytical Report Documentation [NCIt concept]
- Clinical Trial Biological Sample Import or Export Documentation [NCIt concept]
- Clinical Trial Biological Sample Storage Condition Log Documentation [NCIt concept]
- Clinical Trial Committee Member Confidentiality Disclosure Agreement Documentation [NCIt concept]
- Clinical Trial Committee Member Contract Documentation [NCIt concept]
- Clinical Trial Committee Member Curriculum Vitae Documentation [NCIt concept]
- Clinical Trial Committee Member Financial Disclosure Form Documentation [NCIt concept]
- Clinical Trial Committee Member List Documentation [NCIt concept]
- Clinical Trial Committee Output Documentation [NCIt concept]
- Clinical Trial Committee Process Documentation [NCIt concept]
- Clinical Trial Coordinating Investigator Documentation [NCIt concept]
- Clinical Trial Corrections to Entered Data Documentation [NCIt concept]
- Clinical Trial Data Definitions for Tabulation and Analysis Dataset Documentation [NCIt concept]
- Clinical Trial Data Entry Guidelines From Paper Forms Documentation [NCIt concept]
- Clinical Trial Data Management Plan Documentation [NCIt concept]
- Clinical Trial Data Privacy Agreement Documentation [NCIt concept]
- Clinical Trial Data Review Documentation [NCIt concept]
- Clinical Trial Data Validation Testing Documentation [NCIt concept]
- Clinical Trial Database Change Control Documentation [NCIt concept]
- Clinical Trial Database Lock and Unlock Approval Documentation [NCIt concept]
- Clinical Trial Database Requirements Documentation [NCIt concept]
- Clinical Trial Database Validation Plan Documentation [NCIt concept]
- Clinical Trial Edit Check Programming Documentation [NCIt concept]
- Clinical Trial Electronic Data Capture System Technical Design Documentation [NCIt concept]
- Clinical Trial Electronic Data Capture System Validation Documentation [NCIt concept]
- Clinical Trial End of Trial or Interim Unblinding Documentation [NCIt concept]
- Clinical Trial Expedited Safety Report Documentation [NCIt concept]
- Clinical Trial External Data Transfer Specification Documentation [NCIt concept]
- Clinical Trial Filenote Documentation [NCIt concept]
- Clinical Trial Filenotes Master List Documentation [NCIt concept]
- Clinical Trial Final Analysis Datasets Documentation [NCIt concept]
- Clinical Trial Final Analysis Output Documentation [NCIt concept]
- Clinical Trial Final Analysis Programs Documentation [NCIt concept]
- Clinical Trial Final Statistical Report Documentation [NCIt concept]
- Clinical Trial Final Subject Data Documentation [NCIt concept]
- Clinical Trial Financial Agreement Documentation [NCIt concept]
- Clinical Trial Financial Documentation [NCIt concept]
- Clinical Trial Head of Facility Curriculum Vitae Documentation [NCIt concept]
- Clinical Trial Import or Export Documentation [NCIt concept]
- Clinical Trial Import-Export License Application Documentation [NCIt concept]
- Clinical Trial Indemnity Documentation [NCIt concept]
- Clinical Trial Insurance Documentation [NCIt concept]
- Clinical Trial Interfacility Standardization Methods Documentation [NCIt concept]
- Clinical Trial Interim Analysis Datasets Documentation [NCIt concept]
- Clinical Trial Interim Analysis Output Documentation [NCIt concept]
- Clinical Trial Interim Analysis Programs Documentation [NCIt concept]
- Clinical Trial Interim Statistical Report Documentation [NCIt concept]
- Clinical Trial Investigational Product Accountability Documentation [NCIt concept]
- Clinical Trial Investigational Product Certificate of Analysis Documentation [NCIt concept]
- Clinical Trial Investigational Product Certificate of Destruction Documentation [NCIt concept]
- Clinical Trial Investigational Product Handling Instruction Documentation [NCIt concept]
- Clinical Trial Investigational Product Quality Complaint Documentation [NCIt concept]
- Clinical Trial Investigational Product Recall Documentation [NCIt concept]
- Clinical Trial Investigational Product Regulatory Release Documentation [NCIt concept]
- Clinical Trial Investigational Product Relabeling Documentation [NCIt concept]
- Clinical Trial Investigational Product Retest and Expiry Documentation [NCIt concept]
- Clinical Trial Investigational Product Return Documentation [NCIt concept]
- Clinical Trial Investigational Product Sample Label [NCIt concept]
- Clinical Trial Investigational Product Shipment Documentation [NCIt concept]
- Clinical Trial Investigational Product Storage Condition Documentation [NCIt concept]
- Clinical Trial Investigational Product Storage Condition Excursion Documentation [NCIt concept]
- Clinical Trial Investigational Product Supply Plan Documentation [NCIt concept]
- Clinical Trial Investigational Product Transfer Documentation [NCIt concept]
- Clinical Trial Investigational Product Treatment Allocation Documentation [NCIt concept]
- Clinical Trial Investigational Product Treatment Decoding Documentation [NCIt concept]
- Clinical Trial Investigational Product Unblinding Plan Documentation [NCIt concept]
- Clinical Trial Investigational Product Verification Statements Documentation [NCIt concept]
- Clinical Trial Investigator Brochure Documentation [NCIt concept]
- Clinical Trial Investigator Meeting Material Documentation [NCIt concept]
- Clinical Trial Investigator Newsletter Documentation [NCIt concept]
- Clinical Trial Investigator Regulatory Agreement Documentation [NCIt concept]
- Clinical Trial Investigators Financial Disclosure Form [NCIt concept]
- Clinical Trial Investigators Financial Disclosure Form Summary Documentation [NCIt concept]
- Clinical Trial Kick-off Meeting Material Documentation [NCIt concept]
- Clinical Trial Laboratory Results Documentation [NCIt concept]
- Clinical Trial Laboratory Validation Documentation [NCIt concept]
- Clinical Trial Maintenance Logs Documentation [NCIt concept]
- Clinical Trial Management Plan Documentation [NCIt concept]
- Clinical Trial Master Randomization List [NCIt concept]
- Clinical Trial Medical Device Investigators Agreement Documentation [NCIt concept]
- Clinical Trial Medical Dictionary Coding Documentation [NCIt concept]
- Clinical Trial Medical Monitoring Plan Documentation [NCIt concept]
- Clinical Trial Meeting Material Documentation [NCIt concept]
- Clinical Trial Monitoring Plan Documentation [NCIt concept]
- Clinical Trial Non-Investigational Product Supplies Documentation of Return [NCIt concept]
- Clinical Trial Non-Investigational Product Supplies Plan Documentation [NCIt concept]
- Clinical Trial Non-Investigational Product Supplies Shipment Documentation [NCIt concept]
- Clinical Trial Non-Investigational Product Supplies Storage Documentation [NCIt concept]
- Clinical Trial Notification of Regulatory Identification Number Documentation [NCIt concept]
- Clinical Trial Notification of Safety or Other Trial Information Documentation [NCIt concept]
- Clinical Trial Notification to Investigators of Safety Information Documentation [NCIt concept]
- Clinical Trial Ongoing Vendor Oversight Documentation [NCIt concept]
- Clinical Trial Operational Oversight Documentation [NCIt concept]
- Clinical Trial Other Committees Decisions Documentation [NCIt concept]
- Clinical Trial Pharmacovigilance Data Line List Documentation [NCIt concept]
- Clinical Trial Pregnancy Report Documentation [NCIt concept]
- Clinical Trial Principal Investigator Curriculum Vitae Documentation [NCIt concept]
- Clinical Trial Public Registration Documentation [NCIt concept]
- Clinical Trial Publication Policy Documentation [NCIt concept]
- Clinical Trial Qualified Person Investigational Product Certification Documentation [NCIt concept]
- Clinical Trial Quality Assurance Plan Documentation [NCIt concept]
- Clinical Trial Randomization Plan Documentation [NCIt concept]
- Clinical Trial Randomization Procedure Documentation [NCIt concept]
- Clinical Trial Randomization Programming Documentation [NCIt concept]
- Clinical Trial Randomization Validation Documentation [NCIt concept]
- Clinical Trial Raw Dataset for Final Tabulation and Analysis Documentation [NCIt concept]
- Clinical Trial Raw Dataset for Interim Tabulation and Analysis Documentation [NCIt concept]
- Clinical Trial Record of Retained Biological Samples Documentation [NCIt concept]
- Clinical Trial Recruitment Plan Documentation [NCIt concept]
- Clinical Trial Regulatory Authority Decision Documentation [NCIt concept]
- Clinical Trial Regulatory Notification of Termination or Closure Documentation [NCIt concept]
- Clinical Trial Regulatory Progress Report Documentation [NCIt concept]
- Clinical Trial Relevant Communications Documentation [NCIt concept]
- Clinical Trial Reports and Related Information Documentation [NCIt concept]
- Clinical Trial Risk Management Plans Documentation [NCIt concept]
- Clinical Trial Roles and Responsibilities Matrix Documentation [NCIt concept]
- Clinical Trial Safety Management Plan Documentation [NCIt concept]
- Clinical Trial Safety and Clinical Database Reconciliation Documentation [NCIt concept]
- Clinical Trial Sample Size Calculation Documentation [NCIt concept]
- Clinical Trial Serious Adverse Event Report Documentation [NCIt concept]
- Clinical Trial Site Additional Monitoring Activity Documentation [NCIt concept]
- Clinical Trial Site Feasibility Documentation [NCIt concept]
- Clinical Trial Site Initiation Monitoring Report Documentation [NCIt concept]
- Clinical Trial Site Investigator Confidentiality Agreement Documentation [NCIt concept]
- Clinical Trial Site Monitoring Visit Follow-up Documentation [NCIt concept]
- Clinical Trial Site Monitoring Visit Report Documentation [NCIt concept]
- Clinical Trial Site Other Personnel Curriculum Vitae Documentation [NCIt concept]
- Clinical Trial Site Personnel Contact Detail Documentation [NCIt concept]
- Clinical Trial Site Staff Qualification Supporting Information Documentation [NCIt concept]
- Clinical Trial Site Task Assignment Documentation [NCIt concept]
- Clinical Trial Site Training Completion Documentation [NCIt concept]
- Clinical Trial Site Training Material Documentation [NCIt concept]
- Clinical Trial Site Visit Log Documentation [NCIt concept]
- Clinical Trial Source Data Documentation [NCIt concept]
- Clinical Trial Source Data Verification Documentation [NCIt concept]
- Clinical Trial Special Events of Interest Documentation [NCIt concept]
- Clinical Trial Specimen Label Documentation [NCIt concept]
- Clinical Trial Specimen Shipment Records Documentation [NCIt concept]
- Clinical Trial Sponsor Team Member Curriculum Vitae Documentation [NCIt concept]
- Clinical Trial Stakeholder Communication Plan Documentation [NCIt concept]
- Clinical Trial Statistical Analysis Plan Documentation [NCIt concept]
- Clinical Trial Status Report Documentation [NCIt concept]
- Clinical Trial Sub-Investigator Curriculum Vitae Documentation [NCIt concept]
- Clinical Trial Subject Eligibility Verification Form and Worksheet Documentation [NCIt concept]
- Clinical Trial Subject Evaluability Criteria and Subject Classification Documentation [NCIt concept]
- Clinical Trial Subject Identification Log Documentation [NCIt concept]
- Clinical Trial Subject Information Form Documentation [NCIt concept]
- Clinical Trial Subject Log Documentation [NCIt concept]
- Clinical Trial Subject Miscellaneous Form Documentation [NCIt concept]
- Clinical Trial Subject Participation Form Documentation [NCIt concept]
- Clinical Trial Subject Questionnaire Documentation [NCIt concept]
- Clinical Trial Subject Recruitment Advertisement Documentation [NCIt concept]
- Clinical Trial Submission to Other Committees Documentation [NCIt concept]
- Clinical Trial Supply Import Documentation [NCIt concept]
- Clinical Trial System Account Management Documentation [NCIt concept]
- Clinical Trial Tabulation and Analysis Quality Control Documentation [NCIt concept]
- Clinical Trial Team Details Documentation [NCIt concept]
- Clinical Trial Team Evidence of Training Documentation [NCIt concept]
- Clinical Trial Team Training Material Documentation [NCIt concept]
- Clinical Trial Testing Facility Manual Documentation [NCIt concept]
- Clinical Trial Tracking Information Documentation [NCIt concept]
- Clinical Trial Transfer of Regulatory Obligations Documentation [NCIt concept]
- Clinical Trial Vendor Confidentiality Agreement Documentation [NCIt concept]
- Clinical Trial Vendor Management Plan Documentation [NCIt concept]
- Clinical Trial Vendor Qualification and Compliance Documentation [NCIt concept]
- Clinical Trial Vendor Selection Documentation [NCIt concept]
- Clinical Trials Operational Procedure Manual Documentation [NCIt concept]
- Clinical Trials Vendor Curriculum Vitae Documentation [NCIt concept]
- Debarment Statement Documentation [NCIt concept]
- Final Clinical Trial Site Close Out Monitoring Report Documentation [NCIt concept]
- Form FDA 1572 [NCIt concept]
- Institutional Review Board Independent Ethics Committee Compliance Documentation [NCIt concept]
- Institutional Review Board Independent Ethics Committee Composition Documentation [NCIt concept]
- Institutional Review Board Independent Ethics Committee Decision Documentation [NCIt concept]
- Institutional Review Board Independent Ethics Committee Documentation of Non-Voting Status [NCIt concept]
- Institutional Review Board Independent Ethics Committee Notification of Safety Information Documentation [NCIt concept]
- Institutional Review Board Independent Ethics Committee Notification of Trial Termination or Closure Documentation [NCIt concept]
- Institutional Review Board Independent Ethics Committee Progress Report Documentation [NCIt concept]
- Institutional Review Board Independent Ethics Committee Submission Documentation [NCIt concept]
- Interactive Response Technology User Acceptance Testing Certification Documentation [NCIt concept]
- Interactive Response Technology User Account Management Documentation [NCIt concept]
- Interactive Response Technology User Manual Documentation [NCIt concept]
- Interactive Response Technology User Specification Documentation [NCIt concept]
- Interactive Response Technology Validation Certification Documentation [NCIt concept]
- Investigational Product Clinical Trial Site Release Documentation [NCIt concept]
- Investigator Brochure Acceptance Documentation [NCIt concept]
- Marketed Clinical Trial Investigational Product Material Legal Documentation [NCIt concept]
- Medical Device Report of Prior Investigations Documentation [NCIt concept]
- Pre-Clinical Trial Site Evaluation Report Documentation [NCIt concept]
- Reference Range [NCIt concept]
- Regulatory Submission [NCIt concept]
- Subject Diary Documentation [NCIt concept]
- TMF-RM Central Trial Documents Zone [NCIt concept]
- TMF-RM Central Trial Reports Section [NCIt concept]
- TMF-RM Central and Local Testing Zone [NCIt concept]
- TMF-RM Data Capture Section [NCIt concept]
- TMF-RM Data Management Oversight Section [NCIt concept]
- TMF-RM Data Management Zone [NCIt concept]
- TMF-RM Database Section [NCIt concept]
- TMF-RM EDC Management Section [NCIt concept]
- TMF-RM Facility Documentation Section [NCIt concept]
- TMF-RM General Section [NCIt concept]
- TMF-RM IP Allocation Documentation Section [NCIt concept]
- TMF-RM IP Documentation Section [NCIt concept]
- TMF-RM IP Release Process Documentation Section [NCIt concept]
- TMF-RM IP Storage Section [NCIt concept]
- TMF-RM IRB or IEC Trial Approval Section [NCIt concept]
- TMF-RM Institutional Review Board or Independent Ethics Committee and Other Approvals Zone [NCIt concept]
- TMF-RM Interactive Response Technology Section [NCIt concept]
- TMF-RM Investigational Medicinal Product Section [NCIt concept]
- TMF-RM Investigational Products and Trial Supplies Zone [NCIt concept]
- TMF-RM Non-IP Documentation Section [NCIt concept]
- TMF-RM Other Committees Section [NCIt concept]
- TMF-RM Product and Trial Documentation Section [NCIt concept]
- TMF-RM Randomization Section [NCIt concept]
- TMF-RM Regulatory Zone [NCIt concept]
- TMF-RM Safety Documentation Section [NCIt concept]
- TMF-RM Safety Reporting Zone [NCIt concept]
- TMF-RM Sample Documentation Section [NCIt concept]
- TMF-RM Site Initiation Section [NCIt concept]
- TMF-RM Site Management Section [NCIt concept]
- TMF-RM Site Management Zone [NCIt concept]
- TMF-RM Site Selection Section [NCIt concept]
- TMF-RM Site Set-up Section [NCIt concept]
- TMF-RM Statistics Analysis Section [NCIt concept]
- TMF-RM Statistics Oversight Section [NCIt concept]
- TMF-RM Statistics Reports Section [NCIt concept]
- TMF-RM Statistics Zone [NCIt concept]
- TMF-RM Subject Documentation Section [NCIt concept]
- TMF-RM Trial Committee Section [NCIt concept]
- TMF-RM Trial Management Meetings Section [NCIt concept]
- TMF-RM Trial Management Zone [NCIt concept]
- TMF-RM Trial Oversight Section [NCIt concept]
- TMF-RM Trial Regulatory Approval Section [NCIt concept]
- TMF-RM Trial Status Reporting Section [NCIt concept]
- TMF-RM Trial Team Section [NCIt concept]
- TMF-RM Vendor Oversight Section [NCIt concept]
- TMF-RM Vendor Set-up Section [NCIt concept]
- TMF-RM Vendors Zone [NCIt concept]
- Template Informed Consent Form Documentation [NCIt concept]
- Testing Facility Certification or Accreditation Documentation [NCIt concept]
- Unselected Clinical Trial Site Documentation [NCIt concept]

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