CareLex eTMF Terminology

Preferred Label : CareLex eTMF Terminology;

NCIt synonyms : CareLex electronic Trial Master File Terminology;

NCIt definition : A controlled vocabulary developed to support content interoperability between electronic Trial Master File systems for clinical trials.;

Alternative definition : CareLex: CareLex eTMF is a controlled vocabulary developed to support content interoperability between electronic Trial Master File systems for clinical trials.;

Details

Origin ID

C114548;

UMLS CUI

C3899705;

Semantic type(s)
- Intellectual Product [UMLS semantic type]
subset_includes_concept
- Abbreviation [NCIt concept]
- Analysis Documentation [NCIt concept]
- Analysis Quality Control Document [NCIt concept]
- Annotation Property [NCIt concept]
- Approval for Database Activation Document [NCIt concept]
- Audit Certificate [NCIt concept]
- Bioanalytical Report [NCIt concept]
- Bioanalytical Validation Method [NCIt concept]
- Biological Sample Export Document [NCIt concept]
- Biological Sample Storage Condition Log [NCIt concept]
- Case Report Form [NCIt concept]
- Case Report Form Annotation Guideline [NCIt concept]
- Case Report Form Guideline [NCIt concept]
- Category Code [NCIt concept]
- Category Type [NCIt concept]
- Central Clinical Trial Filenote [NCIt concept]
- Central Clinical Trial Study Documentation [NCIt concept]
- Central Trial Communication Material [NCIt concept]
- Central Trial Documentation [NCIt concept]
- Central Trial Meeting Material [NCIt concept]
- Central Trial Tracking Document [NCIt concept]
- Centralized Testing Communication Document [NCIt concept]
- Centralized Testing Documentation [NCIt concept]
- Centralized Testing Filenote [NCIt concept]
- Centralized Testing Meeting Material [NCIt concept]
- Centralized Testing Tracking Document [NCIt concept]
- Clinical Data Capture Document [NCIt concept]
- Clinical Study Committee Financial Disclosure Form [NCIt concept]
- Clinical Study Protocol [NCIt concept]
- Clinical Study Report Synopsis [NCIt concept]
- Clinical Study Reports and Related Information [NCIt concept]
- Clinical Study Sponsor [NCIt concept]
- Clinical Study Sponsor Financial Disclosure Form [NCIt concept]
- Clinical Trial Adjudication Committee Document [NCIt concept]
- Clinical Trial Agreement [NCIt concept]
- Clinical Trial Central Laboratory Certification Document [NCIt concept]
- Clinical Trial Centralized Testing Documentation [NCIt concept]
- Clinical Trial Committe Member Contract [NCIt concept]
- Clinical Trial Committee Member Confidentiality Disclosure Agreement [NCIt concept]
- Clinical Trial Coordinating Investigator Documentation [NCIt concept]
- Clinical Trial Core Documentation [NCIt concept]
- Clinical Trial Data Privacy Agreement [NCIt concept]
- Clinical Trial Device Review Committee [NCIt concept]
- Clinical Trial Dose Escalation Document [NCIt concept]
- Clinical Trial Expedited Safety Report [NCIt concept]
- Clinical Trial Filenotes Master List [NCIt concept]
- Clinical Trial Final Report [NCIt concept]
- Clinical Trial Financial Agreement [NCIt concept]
- Clinical Trial Financial Document [NCIt concept]
- Clinical Trial Import-Export License Application [NCIt concept]
- Clinical Trial Indemnity Document [NCIt concept]
- Clinical Trial Independent Data Monitoring Committee Charter [NCIt concept]
- Clinical Trial Independent Data Monitoring Committee Correspondence [NCIt concept]
- Clinical Trial Independent Data Monitoring Committee Member List [NCIt concept]
- Clinical Trial Initiation Monitoring Report [NCIt concept]
- Clinical Trial Insurance Documentation [NCIt concept]
- Clinical Trial Interactive Response Technology Documentation [NCIt concept]
- Clinical Trial Interfacility Standardization Method Document [NCIt concept]
- Clinical Trial Investigator Brochure [NCIt concept]
- Clinical Trial Investigator Confidentiality Agreement [NCIt concept]
- Clinical Trial Investigator Meeting Material [NCIt concept]
- Clinical Trial Investigator Newsletter [NCIt concept]
- Clinical Trial Investigator Regulatory Agreement [NCIt concept]
- Clinical Trial Investigator Site Documentation [NCIt concept]
- Clinical Trial Kick-off Meeting Material [NCIt concept]
- Clinical Trial Laboratory Sample Detail Documentation [NCIt concept]
- Clinical Trial Management [NCIt concept]
- Clinical Trial Management Communication Documentation [NCIt concept]
- Clinical Trial Management Communication and Tracking Document [NCIt concept]
- Clinical Trial Management Filenote [NCIt concept]
- Clinical Trial Management Meeting Material [NCIt concept]
- Clinical Trial Management Plan [NCIt concept]
- Clinical Trial Management Tracking Documentation [NCIt concept]
- Clinical Trial Medical Device Investigators Agreement [NCIt concept]
- Clinical Trial Medical Monitoring Plan [NCIt concept]
- Clinical Trial Member Detail Documentation [NCIt concept]
- Clinical Trial Monitoring Plan [NCIt concept]
- Clinical Trial Monitoring Visit Follow-up Letter [NCIt concept]
- Clinical Trial Monitoring Visit Log [NCIt concept]
- Clinical Trial Monitoring Visit Report [NCIt concept]
- Clinical Trial Non-Investigational Product Documentation [NCIt concept]
- Clinical Trial Non-Investigational Product Supplies Documentation of Return [NCIt concept]
- Clinical Trial Non-Investigational Product Supplies Plan [NCIt concept]
- Clinical Trial Non-Investigational Product Supplies Shipment Documentation [NCIt concept]
- Clinical Trial Notification of Safety Information [NCIt concept]
- Clinical Trial Notification of Termination Document [NCIt concept]
- Clinical Trial Notification to Investigators of Safety Information Document [NCIt concept]
- Clinical Trial Ongoing Third Party Oversight Document [NCIt concept]
- Clinical Trial Operation Documentation [NCIt concept]
- Clinical Trial Operational Oversight [NCIt concept]
- Clinical Trial Oversight Committee Information [NCIt concept]
- Clinical Trial Patient Database Change Control [NCIt concept]
- Clinical Trial Pregnancy Report [NCIt concept]
- Clinical Trial Principal Investigator Curriculum Vitae [NCIt concept]
- Clinical Trial Principal Investigator License [NCIt concept]
- Clinical Trial Protocol Amendment Summary [NCIt concept]
- Clinical Trial Protocol Deviation Document [NCIt concept]
- Clinical Trial Protocol Synopsis [NCIt concept]
- Clinical Trial Publication Policy [NCIt concept]
- Clinical Trial Recruitment Plan [NCIt concept]
- Clinical Trial Regulatory Approval Documentation [NCIt concept]
- Clinical Trial Regulatory Filenote [NCIt concept]
- Clinical Trial Regulatory Status Report [NCIt concept]
- Clinical Trial Regulatory Tracking Document [NCIt concept]
- Clinical Trial Roles and Responsibilities Matrix [NCIt concept]
- Clinical Trial Safety Documentation [NCIt concept]
- Clinical Trial Safety Management Plan [NCIt concept]
- Clinical Trial Safety Reporting Documentation [NCIt concept]
- Clinical Trial Safety Status Report Documentation [NCIt concept]
- Clinical Trial Site Communications and Tracking Management Documentation [NCIt concept]
- Clinical Trial Site Feasibility Document [NCIt concept]
- Clinical Trial Site Initiation Documentation [NCIt concept]
- Clinical Trial Site Management Communication Material [NCIt concept]
- Clinical Trial Site Management Documentation [NCIt concept]
- Clinical Trial Site Management Filenote [NCIt concept]
- Clinical Trial Site Management Meeting Material [NCIt concept]
- Clinical Trial Site Management Tracking Document [NCIt concept]
- Clinical Trial Site Personnel Contact Document [NCIt concept]
- Clinical Trial Site Personnel Supporting Information [NCIt concept]
- Clinical Trial Site Selection Documentation [NCIt concept]
- Clinical Trial Site Task Assignment Document [NCIt concept]
- Clinical Trial Site Training Completion Document [NCIt concept]
- Clinical Trial Site Training Material [NCIt concept]
- Clinical Trial Source Data [NCIt concept]
- Clinical Trial Stakeholder Communication Plan [NCIt concept]
- Clinical Trial Startup Material [NCIt concept]
- Clinical Trial Status Report Documentation [NCIt concept]
- Clinical Trial Sub-Investigator Curriculum Vitae [NCIt concept]
- Clinical Trial Subject Document Form [NCIt concept]
- Clinical Trial Subject Eligibility Verification Form and Worksheet [NCIt concept]
- Clinical Trial Subject Enrollment Log [NCIt concept]
- Clinical Trial Subject Identification Log [NCIt concept]
- Clinical Trial Subject Information Form [NCIt concept]
- Clinical Trial Subject Miscellaneous Form [NCIt concept]
- Clinical Trial Subject Participation Form [NCIt concept]
- Clinical Trial Subject Questionnaire [NCIt concept]
- Clinical Trial Subject Recruitment Advertisement [NCIt concept]
- Clinical Trial Subject Screen Log [NCIt concept]
- Clinical Trial Supply Storage Condition Document [NCIt concept]
- Clinical Trial Supply Storage Documentation [NCIt concept]
- Clinical Trial Supply Storage Excursion Document [NCIt concept]
- Clinical Trial Team Curriculum Vitae [NCIt concept]
- Clinical Trial Team Documentation [NCIt concept]
- Clinical Trial Team Member Curriculum Vitae [NCIt concept]
- Clinical Trial Team Training Document [NCIt concept]
- Clinical Trial Team Training Material [NCIt concept]
- Clinical Trial Unblinding Documentation [NCIt concept]
- Clinical Trials Operational Procedure Manual [NCIt concept]
- Clinical Trials Third Party Curriculum Vitae [NCIt concept]
- Completed Case Report Form [NCIt concept]
- Computed Tomography Study File [NCIt concept]
- Consent Form [NCIt concept]
- Content Classification System Term Indicator [NCIt concept]
- Content Creation Date [NCIt concept]
- Content Identifier [NCIt concept]
- Content Item [NCIt concept]
- Content Item Creator [NCIt concept]
- Content Model [NCIt concept]
- Content Model Content Type [NCIt concept]
- Content Type Requirement [NCIt concept]
- Contractual Agreement [NCIt concept]
- Country Code [NCIt concept]
- Created By [NCIt concept]
- Credential [NCIt concept]
- Cross-Reference [NCIt concept]
- Data Change Date [NCIt concept]
- Data Clarification Form [NCIt concept]
- Data Definitions for Analysis Dataset Document [NCIt concept]
- Data Entry Guideline [NCIt concept]
- Data Management Communication Document [NCIt concept]
- Data Management Document [NCIt concept]
- Data Management Documentation [NCIt concept]
- Data Management Filenote [NCIt concept]
- Data Management Meeting Material [NCIt concept]
- Data Management Oversight Documentation [NCIt concept]
- Data Management Plan [NCIt concept]
- Data Management Tracking Document [NCIt concept]
- Data Property [NCIt concept]
- Data Type [NCIt concept]
- Data Validation Certification Document [NCIt concept]
- Data Validation Test Document [NCIt concept]
- Database Account Team Management Document [NCIt concept]
- Database Lock and Unlock Approval [NCIt concept]
- Database Management Documentation [NCIt concept]
- Database Quality Plan [NCIt concept]
- Database Specification [NCIt concept]
- Database Validation Plan [NCIt concept]
- Date [NCIt concept]
- Debarment Statement [NCIt concept]
- Definition [NCIt concept]
- Description [NCIt concept]
- Digital Archive [NCIt concept]
- Digital Content Category [NCIt concept]
- Digital Data Repository [NCIt concept]
- Digital Photography Study File [NCIt concept]
- Digital Signature [NCIt concept]
- Digital Signature Status [NCIt concept]
- Display Name [NCIt concept]
- Edit Check Program [NCIt concept]
- Electronic Case Report Form Technical Design Document [NCIt concept]
- Electronic Data Capture Final Output [NCIt concept]
- Electronic Data Capture Management Team Documentation [NCIt concept]
- Electronic Trial Master File [NCIt concept]
- Evidence of Contractor Compliance Document [NCIt concept]
- External Data Transfer Specification [NCIt concept]
- Final Analysis Dataset [NCIt concept]
- Final Analysis Output [NCIt concept]
- Final Analysis Program [NCIt concept]
- Final Clinical Trial Close Out Monitoring Report [NCIt concept]
- Final Statistical Report [NCIt concept]
- Financial Disclosure Summary [NCIt concept]
- Form FDA 1572 [NCIt concept]
- Format [NCIt concept]
- Import-Export License [NCIt concept]
- Independent Review Committee Member Curriculum Vitae [NCIt concept]
- Institutional Review Board - Independent Ethics Committee Communication Material [NCIt concept]
- Institutional Review Board - Independent Ethics Committee Filenote [NCIt concept]
- Institutional Review Board - Independent Ethics Committee Meeting Material [NCIt concept]
- Institutional Review Board - Independent Ethics Committee Shared Documentation [NCIt concept]
- Institutional Review Board - Independent Ethics Committee Sponsor Communication [NCIt concept]
- Institutional Review Board - Independent Ethics Committee Tracking Document [NCIt concept]
- Institutional Review Board Approval [NCIt concept]
- Institutional Review Board Independent Ethics Committee Additional Subject Information Document [NCIt concept]
- Institutional Review Board Independent Ethics Committee Advertisement for Subject Recruitment [NCIt concept]
- Institutional Review Board Independent Ethics Committee Clinical Trial Status Report [NCIt concept]
- Institutional Review Board Independent Ethics Committee Composition Document [NCIt concept]
- Institutional Review Board Independent Ethics Committee Documentation of Non-Voting Status Document [NCIt concept]
- Institutional Review Board Independent Ethics Committee Good Clinical Practices Compliance Statement [NCIt concept]
- Institutional Review Board Independent Ethics Committee Human Subject in Research Approval Documentation [NCIt concept]
- Institutional Review Board Independent Ethics Committee Informed Consent Document [NCIt concept]
- Institutional Review Board Independent Ethics Committee Notification of Safety Information Document [NCIt concept]
- Institutional Review Board Independent Ethics Committee Notification of Trial Termination Document [NCIt concept]
- Institutional Review Board Independent Ethics Committee Progress Report [NCIt concept]
- Institutional Review Board Independent Ethics Committee Report [NCIt concept]
- Institutional Review Board Independent Ethics Committee Subject Diary [NCIt concept]
- Institutional Review Board Independent Ethics Committee Subject Information Document [NCIt concept]
- Institutional Review Board Independent Ethics Committee Subject Participation Document [NCIt concept]
- Institutional Review Board Independent Ethics Committee Subject Questionnaire [NCIt concept]
- Institutional Review Board Independent Ethics Committee Submission [NCIt concept]
- Interactive Response Technology User Acceptance Testing Certificate [NCIt concept]
- Interactive Response Technology User Manual [NCIt concept]
- Interactive Response Technology User Notification [NCIt concept]
- Interactive Response Technology User Specification [NCIt concept]
- Interactive Response Technology Validation Certificate [NCIt concept]
- Interim Analysis Dataset [NCIt concept]
- Interim Analysis Output [NCIt concept]
- Interim Analysis Program [NCIt concept]
- Interim Statistical Report [NCIt concept]
- Investigational Medicinal Product Documentation [NCIt concept]
- Investigational Product Accountability Record [NCIt concept]
- Investigational Product Certificate of Analysis [NCIt concept]
- Investigational Product Certificate of Destruction [NCIt concept]
- Investigational Product Communications and Tracking Documentation [NCIt concept]
- Investigational Product Device Maintenance Log [NCIt concept]
- Investigational Product Handling Instruction [NCIt concept]
- Investigational Product Quality Complaint Form [NCIt concept]
- Investigational Product Randomization Documentation [NCIt concept]
- Investigational Product Randomization Plan [NCIt concept]
- Investigational Product Recall Plan [NCIt concept]
- Investigational Product Regulatory Release Document [NCIt concept]
- Investigational Product Relabeling Plan [NCIt concept]
- Investigational Product Release Process Documentation [NCIt concept]
- Investigational Product Retest and Expiry Document [NCIt concept]
- Investigational Product Return Record [NCIt concept]
- Investigational Product Sample Label [NCIt concept]
- Investigational Product Shipment Record [NCIt concept]
- Investigational Product Site Release Document [NCIt concept]
- Investigational Product Supply Plan [NCIt concept]
- Investigational Product Transfer Record [NCIt concept]
- Investigational Product and Clinical Trial Supplies Communication Record [NCIt concept]
- Investigational Product and Clinical Trial Supplies Filenote [NCIt concept]
- Investigational Product and Clinical Trial Supplies Meeting Material [NCIt concept]
- Investigational Product and Clinical Trial Supplies Tracking Document [NCIt concept]
- Investigational Product and Trial Supplies Shipping Handling and Labeling Documentation [NCIt concept]
- Investigational Product and Trial Supplies Tracking Documentation [NCIt concept]
- Investigator Brochure Acceptance Document [NCIt concept]
- Joint Vendor Quality Assurance Plan [NCIt concept]
- Label [NCIt concept]
- Laboratory Certification Document [NCIt concept]
- Laboratory Director Curriculum Vitae [NCIt concept]
- Laboratory Normal Ranges [NCIt concept]
- Laboratory Sample Manual [NCIt concept]
- Laboratory Shipment Record [NCIt concept]
- Letter of Authorization [NCIt concept]
- Local Laboratory Certification or Accreditation Document [NCIt concept]
- Location [NCIt concept]
- Login Name [NCIt concept]
- Magnetic Resonance Imaging Study File [NCIt concept]
- Master Randomization List [NCIt concept]
- Medical Coding Process Document [NCIt concept]
- Medical Device Report of Prior Investigations [NCIt concept]
- Medical Imaging File Not Otherwise Specified [NCIt concept]
- Medical Imaging and Imaging Technique Documentation [NCIt concept]
- Metadata [NCIt concept]
- Metadata Content Type [NCIt concept]
- Metadata Use Type [NCIt concept]
- Modified By [NCIt concept]
- Non-Institutional Review Board Independent Ethics Committee Approved Submission Document [NCIt concept]
- Notification of Regulatory Identification Number Document [NCIt concept]
- Nuclear Medicine Study File [NCIt concept]
- Organization Name [NCIt concept]
- Organization Role [NCIt concept]
- Other Clinical Trial Submission Document [NCIt concept]
- Person Name [NCIt concept]
- Person Role Title [NCIt concept]
- Pharmacovigilance Data List [NCIt concept]
- Pre-Clinical Trial Site Evaluation Report [NCIt concept]
- Preferred_Name [NCIt concept]
- Process [NCIt concept]
- Protocol Amendment Signature Page [NCIt concept]
- Protocol Signature Page [NCIt concept]
- Qualified Person Investigational Product Certification Document [NCIt concept]
- Radiography Study File [NCIt concept]
- Randomization Documentation [NCIt concept]
- Randomization Plan [NCIt concept]
- Randomization Programming Code [NCIt concept]
- Randomization Protocol Document [NCIt concept]
- Randomization Validation [NCIt concept]
- Raw Dataset for Final Analysis [NCIt concept]
- Raw Dataset for Interim Analysis [NCIt concept]
- Record of Retained Body Fluids or Tissue Sample [NCIt concept]
- Reference Range [NCIt concept]
- Regulation [NCIt concept]
- Regulatory Affair Documentation [NCIt concept]
- Regulatory Communication Material [NCIt concept]
- Regulatory Documentation Not Other Wise Specified [NCIt concept]
- Regulatory Meeting Material [NCIt concept]
- Regulatory Report [NCIt concept]
- Regulatory Submission [NCIt concept]
- Safety Communication Document [NCIt concept]
- Safety Filenote [NCIt concept]
- Safety Meeting Material [NCIt concept]
- Safety Reporting Documentation [NCIt concept]
- Safety Tracking Document [NCIt concept]
- Safety and Clinical Database Reconciliation Document [NCIt concept]
- Sample Size Calculation [NCIt concept]
- Serious Adverse Event Report [NCIt concept]
- Source [NCIt concept]
- Source Data Verification Document [NCIt concept]
- Special Event of Interest Document [NCIt concept]
- Specimen Label [NCIt concept]
- Standard Operating Procedure List [NCIt concept]
- Statistic Meeting Material [NCIt concept]
- Statistic Tracking Document [NCIt concept]
- Statistical Analysis Documentation [NCIt concept]
- Statistical Analysis Plan [NCIt concept]
- Statistical Report Record [NCIt concept]
- Statistics Communication Document [NCIt concept]
- Statistics Communication and Tracking Documentation [NCIt concept]
- Statistics Filenote [NCIt concept]
- Statistics Oversight Documentation [NCIt concept]
- Study Identifier [NCIt concept]
- Study Registry Document [NCIt concept]
- Study Reports: Pharmacokinetics [NCIt concept]
- Study Site Identifier [NCIt concept]
- Study Subject Computed Tomography Image [NCIt concept]
- Study Subject Computed Tomography Report [NCIt concept]
- Study Subject Digital Photograph [NCIt concept]
- Study Subject MRI Report [NCIt concept]
- Study Subject Magnetic Resonance Imaging [NCIt concept]
- Study Subject Medical Imaging [NCIt concept]
- Study Subject Medical Imaging Report [NCIt concept]
- Study Subject Nuclear Medicine Image [NCIt concept]
- Study Subject Nuclear Medicine Report [NCIt concept]
- Study Subject Radiograph [NCIt concept]
- Study Subject Radiography Report [NCIt concept]
- Study Subject Ultrasound Image [NCIt concept]
- Study Subject Ultrasound Report [NCIt concept]
- Subcategory [NCIt concept]
- Subject Diary [NCIt concept]
- Subject Digital Photograph Report [NCIt concept]
- Subject Evaluability Criteria and Classification Document [NCIt concept]
- Subject Unblinding Event Record [NCIt concept]
- Subject Unblinding Plan [NCIt concept]
- Subject Unique Identifier [NCIt concept]
- Submission Response Document [NCIt concept]
- Supplementary Monitoring Activity Document [NCIt concept]
- Supplies and Non-Drug Investigational Product Import Document [NCIt concept]
- Synonym [NCIt concept]
- Task [NCIt concept]
- Taxonomy Category Name [NCIt concept]
- Term Source [NCIt concept]
- Term Uniform Resource Locator [NCIt concept]
- Terminology Value Set [NCIt concept]
- Title [NCIt concept]
- Transmissible Spongiform Encephalopathy Statement [NCIt concept]
- Trial Master File [NCIt concept]
- Trial Master File Plan [NCIt concept]
- Type [NCIt concept]
- Ultrasound Study File [NCIt concept]
- Uniform Resource Identifier [NCIt concept]
- Unselected Clinical Trial Site Document [NCIt concept]
- Unspecified non-Independent Data Monitoring Committee Document [NCIt concept]
- Vendor Communication Documentation [NCIt concept]
- Vendor Confidentiality Agreement [NCIt concept]
- Vendor Documentation [NCIt concept]
- Vendor Filenote [NCIt concept]
- Vendor Information Documentation [NCIt concept]
- Vendor Management Plan [NCIt concept]
- Vendor Meeting Material [NCIt concept]
- Vendor Oversight Document [NCIt concept]
- Vendor Record Documentation [NCIt concept]
- Vendor Role and Responsibility Document [NCIt concept]
- Vendor Selection Process Document [NCIt concept]
- Vendor Tracking Document [NCIt concept]
- Visit Number [NCIt concept]
- eTMF Content Model Code [NCIt concept]

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