CDISC Protocol Terminology

Preferred Label : CDISC Protocol Terminology;

NCIt definition : The terminology subset that includes terms relevant to the Clinical Data Interchange Standards Consortium (CDISC) protocol group.;

NCI Metathesaurus CUI : CL519719;

Details

Origin ID

C132298;

UMLS CUI

C4329538;

Semantic type(s)
- Intellectual Product [UMLS semantic type]
concept_is_in_subset
- Clinical Data Interchange Standards Consortium Terminology [NCIt concept]
subset_includes_concept
- Academic Degree [NCIt concept]
- Active Comparator [NCIt concept]
- Active Comparator Arm [NCIt concept]
- Active Ingredient [NCIt concept]
- Adaptive Randomization [NCIt concept]
- Address [NCIt concept]
- Adhesion Performance Study [NCIt concept]
- Adverse Effect Mitigation Study [NCIt concept]
- Alcohol Effect Study [NCIt concept]
- Allocation [NCIt concept]
- Alternate Protocol Identifier [NCIt concept]
- Area Under Curve [NCIt concept]
- Arm Description [NCIt concept]
- Assessment [NCIt concept]
- Basic Research [NCIt concept]
- Behavioral Intervention [NCIt concept]
- Bioavailability [NCIt concept]
- Bioavailability Study [NCIt concept]
- Biological Agent [NCIt concept]
- Biological Sample Retention Description [NCIt concept]
- Biological Sample Use Statement [NCIt concept]
- Biomarker [NCIt concept]
- Biomarker Category [NCIt concept]
- Biomarker Name [NCIt concept]
- Biosimilarity Study [NCIt concept]
- Biospecimen [NCIt concept]
- Biospecimen Collection [NCIt concept]
- Biospecimen Collection Method [NCIt concept]
- Biospecimen Collection Time [NCIt concept]
- Biospecimen Handling [NCIt concept]
- Biospecimen Handling Accountability Record [NCIt concept]
- Biospecimen Preparation [NCIt concept]
- Biospecimen Shipping [NCIt concept]
- Biospecimen Storage [NCIt concept]
- Biostatistician [NCIt concept]
- Blinded [NCIt concept]
- Blinded Medication [NCIt concept]
- Block Randomization [NCIt concept]
- Brief Protocol Title [NCIt concept]
- Brief Rationale for Protocol Change [NCIt concept]
- CDISC Protocol Amendment Attribute Terminology [NCIt concept]
- CDISC Protocol Biological Sample Attribute Terminology [NCIt concept]
- CDISC Protocol Biomarker Attribute Terminology [NCIt concept]
- CDISC Protocol Biomarker Category Value Set Terminology [NCIt concept]
- CDISC Protocol Endpoint Attribute Terminology [NCIt concept]
- CDISC Protocol Endpoint Type Value Set Terminology [NCIt concept]
- CDISC Protocol Entities Clinical Study Attribute Terminology [NCIt concept]
- CDISC Protocol Entities Clinical Trial Attribute Terminology [NCIt concept]
- CDISC Protocol Entities Physical Address Attribute Terminology [NCIt concept]
- CDISC Protocol Entities Protocol Contact Role Response Terminology [NCIt concept]
- CDISC Protocol Entities Study Contact Information Attribute Terminology [NCIt concept]
- CDISC Protocol Entities Study Design Attribute Terminology [NCIt concept]
- CDISC Protocol Entities Study Protocol Attribute Terminology [NCIt concept]
- CDISC Protocol Entities Terminology [NCIt concept]
- CDISC Protocol Expanded Access Attribute Terminology [NCIt concept]
- CDISC Protocol Expanded Access Study Type Value Set Terminology [NCIt concept]
- CDISC Protocol Informed Consent Attribute Terminology [NCIt concept]
- CDISC Protocol Ingredient Attribute Terminology [NCIt concept]
- CDISC Protocol Ingredient Type Value Set Terminology [NCIt concept]
- CDISC Protocol Intervention Attribute Terminology [NCIt concept]
- CDISC Protocol Outcome Measure Attribute Terminology [NCIt concept]
- CDISC Protocol Outcome Measure Type Value Set Terminology [NCIt concept]
- CDISC Protocol Oversight Entity Value Set Terminology [NCIt concept]
- CDISC Protocol Pharmacology Attribute Terminology [NCIt concept]
- CDISC Protocol Randomization Type Response Terminology [NCIt concept]
- CDISC Protocol Reference Attribute Terminology [NCIt concept]
- CDISC Protocol Statement Attribute Terminology [NCIt concept]
- CDISC Protocol Study Activity Attribute Terminology [NCIt concept]
- CDISC Protocol Study Arm Attribute Terminology [NCIt concept]
- CDISC Protocol Study Arm Type Value Set Terminology [NCIt concept]
- CDISC Protocol Study Blinding and Unblinding Attribute Terminology [NCIt concept]
- CDISC Protocol Study Monitoring Attribute Terminology [NCIt concept]
- CDISC Protocol Study Oversight Entity Attribute Terminology [NCIt concept]
- CDISC Protocol Study Population Attribute Terminology [NCIt concept]
- CDISC Protocol Study Product Administration Attribute Terminology [NCIt concept]
- CDISC Protocol Study Product Attribute Terminology [NCIt concept]
- CDISC Protocol Study Product Type Value Set Terminology [NCIt concept]
- CDISC Protocol Study Purpose Response Terminology [NCIt concept]
- CDISC Protocol Study Subject Discontinuation Attribute Terminology [NCIt concept]
- CDISC Protocol Subject Allocation Response Terminology [NCIt concept]
- CDISC Protocol Subject Replacement Attribute Terminology [NCIt concept]
- CDISC Protocol Substudy Attribute Terminology [NCIt concept]
- CDISC SDTM Intervention Model Terminology [NCIt concept]
- CDISC SDTM Intervention Type Terminology [NCIt concept]
- CDISC SDTM Observational Study Model Terminology [NCIt concept]
- CDISC SDTM Study Type Terminology [NCIt concept]
- CDISC SDTM Trial Blinding Schema Terminology [NCIt concept]
- CDISC SDTM Trial Indication Type Terminology [NCIt concept]
- CDISC SDTM Trial Phase Terminology [NCIt concept]
- CDISC SDTM Trial Type Terminology [NCIt concept]
- CDISC SDTM Yes No Unknown or Not Applicable Response Terminology [NCIt concept]
- Case Study [NCIt concept]
- Case-Control Study [NCIt concept]
- Citation [NCIt concept]
- City [NCIt concept]
- Clinical Coordinator [NCIt concept]
- Clinical Informaticist [NCIt concept]
- Clinical Pharmacology [NCIt concept]
- Clinical Study [NCIt concept]
- Clinical Study Sponsor [NCIt concept]
- Clinical Study by Intent [NCIt concept]
- Clinical Trial [NCIt concept]
- Clinical Trial Monitoring Plan [NCIt concept]
- Clinical Trial Protocol Synopsis [NCIt concept]
- Clinical Trial Site [NCIt concept]
- Clinical Trials Design [NCIt concept]
- Clinical Trials, Monitoring [NCIt concept]
- Cmax [NCIt concept]
- Cmin [NCIt concept]
- Cohort Study [NCIt concept]
- Comorbid Condition [NCIt concept]
- Compassionate Single Patient Indicator [NCIt concept]
- Composite Endpoint [NCIt concept]
- Condition or Disease under Study [NCIt concept]
- Conditions of Subject Withdrawal [NCIt concept]
- Conflict of Interest Statement [NCIt concept]
- Consent Form [NCIt concept]
- Continued Access Study [NCIt concept]
- Control Arm [NCIt concept]
- Control Group [NCIt concept]
- Coordinating Investigator [NCIt concept]
- Country [NCIt concept]
- Country of Recruitment [NCIt concept]
- Crossover Study [NCIt concept]
- Cure Study [NCIt concept]
- Data Integrity Statement [NCIt concept]
- Data Manager [NCIt concept]
- Data Monitoring [NCIt concept]
- Data Monitoring Committee [NCIt concept]
- Data Sharing Compliance Policy Statement [NCIt concept]
- Data and Safety Monitoring Plan [NCIt concept]
- Date of First Enrollment into Study [NCIt concept]
- Demographic Group [NCIt concept]
- Device Feasibility Study [NCIt concept]
- Device-Drug Interaction Study [NCIt concept]
- Diagnosis [NCIt concept]
- Diagnosis Study [NCIt concept]
- Diagnostic Biomarker [NCIt concept]
- Dietary Supplement [NCIt concept]
- Direct Endpoint [NCIt concept]
- Disease Screening [NCIt concept]
- Dosage Regimen [NCIt concept]
- Dose [NCIt concept]
- Dose Finding Study [NCIt concept]
- Dose Frequency [NCIt concept]
- Dose Proportionality Study [NCIt concept]
- Dose Response Study [NCIt concept]
- Double Blind Study [NCIt concept]
- Drug Binding Affinity [NCIt concept]
- Drug Clearance [NCIt concept]
- Drug Concentration [NCIt concept]
- Drug Product Component [NCIt concept]
- Drug-Drug Interaction Study [NCIt concept]
- E-mail Address [NCIt concept]
- Ecologic or Community Based Study [NCIt concept]
- Efficacy Study [NCIt concept]
- End Point [NCIt concept]
- Exclusion Criteria [NCIt concept]
- Expanded Access Study [NCIt concept]
- Expanded Access Study Type [NCIt concept]
- Experimental Group [NCIt concept]
- Exploratory Endpoint [NCIt concept]
- Exploratory Outcome Measure [NCIt concept]
- Exploratory Research [NCIt concept]
- Factorial Study [NCIt concept]
- Family Study [NCIt concept]
- Fax Number [NCIt concept]
- Female of Childbearing Potential [NCIt concept]
- Fifty Percent Inhibitory Concentration [NCIt concept]
- Food Effect Study [NCIt concept]
- GCP Adherence Statement [NCIt concept]
- Gene Therapy [NCIt concept]
- Geographic Area [NCIt concept]
- Group Sequential Design [NCIt concept]
- Half Maximal Effective Agent Concentration [NCIt concept]
- Health Services Research [NCIt concept]
- Health Status [NCIt concept]
- Healthy Subject [NCIt concept]
- Hypothesis Generation [NCIt concept]
- Immunogenicity Study [NCIt concept]
- Inclusion Criteria [NCIt concept]
- Independent Ethics Committee [NCIt concept]
- Independent Safety Monitor [NCIt concept]
- Informed Assent [NCIt concept]
- Informed Consent [NCIt concept]
- Informed Consent Process [NCIt concept]
- Ingredient [NCIt concept]
- Ingredient Type [NCIt concept]
- Institutional Review Board [NCIt concept]
- Intervention Description [NCIt concept]
- Intervention Model [NCIt concept]
- Intervention Name [NCIt concept]
- Intervention Type [NCIt concept]
- Interventional Study [NCIt concept]
- Investigational Arm [NCIt concept]
- Investigational Product [NCIt concept]
- Investigator [NCIt concept]
- Justification for Planned Dosage [NCIt concept]
- Justification for Study Endpoint [NCIt concept]
- Justification of Planned Administration [NCIt concept]
- Justification of Special Population [NCIt concept]
- Legal Representative for the Study [NCIt concept]
- Locality [NCIt concept]
- Lost To Follow-Up [NCIt concept]
- Lost to Follow-up Criteria [NCIt concept]
- Master Protocol [NCIt concept]
- Maximal Effect [NCIt concept]
- Medical Device [NCIt concept]
- Medical Monitor [NCIt concept]
- Minimization Randomization [NCIt concept]
- Monitoring Biomarker [NCIt concept]
- National Coordinating Investigator [NCIt concept]
- No Intervention Arm [NCIt concept]
- Nonrandomized Clinical Trial [NCIt concept]
- Not Applicable [NCIt concept]
- Observational Case-Crossover Study [NCIt concept]
- Observational Study [NCIt concept]
- Observational Study Model [NCIt concept]
- Observational Study Monitoring Committee [NCIt concept]
- Observer Blind Study [NCIt concept]
- Official Protocol Title [NCIt concept]
- Open Label Study [NCIt concept]
- Open Label for Treatment And Double Blind to Dose [NCIt concept]
- Organizational Affiliation Name [NCIt concept]
- Other [NCIt concept]
- Outcome [NCIt concept]
- Outcome Measure Time Frame [NCIt concept]
- Outcome Measure Title [NCIt concept]
- Outcome Measure Type [NCIt concept]
- Overall Rationale for Protocol Amendment [NCIt concept]
- Parallel Study [NCIt concept]
- Patient Registry Study [NCIt concept]
- Person Name [NCIt concept]
- Pharmaceutical Dosage Form [NCIt concept]
- Pharmaceutical Excipient [NCIt concept]
- Pharmacodynamic Biomarker [NCIt concept]
- Pharmacodynamic Study [NCIt concept]
- Pharmacodynamics [NCIt concept]
- Pharmacoeconomic Study [NCIt concept]
- Pharmacogenetic Study [NCIt concept]
- Pharmacogenomic Study [NCIt concept]
- Pharmacogenomics [NCIt concept]
- Pharmacokinetic Study [NCIt concept]
- Pharmacokinetics [NCIt concept]
- Pharmacokinetics: Absorption [NCIt concept]
- Pharmacokinetics: Distribution [NCIt concept]
- Pharmacokinetics: Excretion [NCIt concept]
- Pharmacokinetics: Metabolism [NCIt concept]
- Pharmacologic Substance [NCIt concept]
- Pharmacological Class of Investigational Therapy [NCIt concept]
- Pharmacology [NCIt concept]
- Phase 0 Trial [NCIt concept]
- Phase I Trial [NCIt concept]
- Phase I/II Trial [NCIt concept]
- Phase II Trial [NCIt concept]
- Phase II/III Trial [NCIt concept]
- Phase III Trial [NCIt concept]
- Phase IIIa Trial [NCIt concept]
- Phase IIIb Trial [NCIt concept]
- Phase IIa Trial [NCIt concept]
- Phase IIb Trial [NCIt concept]
- Phase IV Trial [NCIt concept]
- Phase V Trial [NCIt concept]
- Physical Medical Procedure [NCIt concept]
- Placebo Control [NCIt concept]
- Placebo Control Arm [NCIt concept]
- Planned Number of Arms [NCIt concept]
- Planned Number of Cohorts [NCIt concept]
- Planned Number of Subjects Per Study Arm [NCIt concept]
- Planned Subject Number [NCIt concept]
- Planned Trial Duration [NCIt concept]
- Population Rationale [NCIt concept]
- Position Effect Trial [NCIt concept]
- Postal Code [NCIt concept]
- Predictive Biomarker [NCIt concept]
- Prevention Study [NCIt concept]
- Preventive Intervention [NCIt concept]
- Primary Clinical Study Sponsor [NCIt concept]
- Primary Endpoint [NCIt concept]
- Primary Outcome Measure [NCIt concept]
- Primary Study Sponsor Name [NCIt concept]
- Principal Investigator [NCIt concept]
- Prognostic Biomarker [NCIt concept]
- Protocol Agent [NCIt concept]
- Protocol Amendment [NCIt concept]
- Protocol Approval by Sponsor Date [NCIt concept]
- Protocol Author [NCIt concept]
- Protocol Confidentiality Statement [NCIt concept]
- Protocol Regulatory Compliance Statement [NCIt concept]
- Protocol Statement [NCIt concept]
- Protocol Treatment Arm [NCIt concept]
- Province [NCIt concept]
- Public Queries Study Contact [NCIt concept]
- Publication Policy Statement [NCIt concept]
- Quality Assurance [NCIt concept]
- Quality Control [NCIt concept]
- Radiation Therapy [NCIt concept]
- Randomization [NCIt concept]
- Randomization Method [NCIt concept]
- Reactogenicity Study [NCIt concept]
- Reason for Study Discontinuation [NCIt concept]
- Reason for Subject Withdrawal from Study [NCIt concept]
- Reference Group [NCIt concept]
- Reference List [NCIt concept]
- Registry Protocol Identifier [NCIt concept]
- Research Hypothesis [NCIt concept]
- Response Biomarker [NCIt concept]
- Risk Based Monitoring [NCIt concept]
- Role [NCIt concept]
- Route of Administration [NCIt concept]
- Safety Biomarker [NCIt concept]
- Safety Data Monitoring [NCIt concept]
- Safety Monitoring [NCIt concept]
- Safety Monitoring Committee [NCIt concept]
- Safety Study [NCIt concept]
- Schedule of Activities [NCIt concept]
- Scientific Protocol Title [NCIt concept]
- Screening Study [NCIt concept]
- Secondary Clinical Study Sponsor [NCIt concept]
- Secondary Endpoint [NCIt concept]
- Secondary Outcome Measure [NCIt concept]
- Secondary Study Sponsor Name [NCIt concept]
- Sham Comparator Arm [NCIt concept]
- Sham Intervention [NCIt concept]
- Simple Randomization [NCIt concept]
- Single Blind Study [NCIt concept]
- Single Group Study [NCIt concept]
- Source of Monetary or Material Support for Study [NCIt concept]
- Sponsor Protocol Identifier [NCIt concept]
- State [NCIt concept]
- Statement of Ethical Conduct [NCIt concept]
- Statement of Progress Reporting [NCIt concept]
- Stratification [NCIt concept]
- Stratification Factors [NCIt concept]
- Stratified Randomization [NCIt concept]
- Street Address [NCIt concept]
- Study Activity [NCIt concept]
- Study Arm [NCIt concept]
- Study Arm Label [NCIt concept]
- Study Arm Type [NCIt concept]
- Study Audit [NCIt concept]
- Study Audit Statement [NCIt concept]
- Study Blinding Procedure [NCIt concept]
- Study Blinding and Unblinding [NCIt concept]
- Study Chair [NCIt concept]
- Study Consent Withdrawn [NCIt concept]
- Study Contact Information [NCIt concept]
- Study Control [NCIt concept]
- Study Day [NCIt concept]
- Study Design [NCIt concept]
- Study Design Description [NCIt concept]
- Study Design Rationale [NCIt concept]
- Study Endpoint Type [NCIt concept]
- Study Investigator Conduct Statement [NCIt concept]
- Study Monitoring [NCIt concept]
- Study Monitoring Statement [NCIt concept]
- Study Outcome Measure Description [NCIt concept]
- Study Outcome Measurement [NCIt concept]
- Study Oversight Authority [NCIt concept]
- Study Oversight Entity Approval Date [NCIt concept]
- Study Oversight Entity Approval Status [NCIt concept]
- Study Oversight Entity Type [NCIt concept]
- Study Population [NCIt concept]
- Study Primary Purpose [NCIt concept]
- Study Product [NCIt concept]
- Study Product Accountability [NCIt concept]
- Study Product Acquisition [NCIt concept]
- Study Product Administration [NCIt concept]
- Study Product Appearance [NCIt concept]
- Study Product Formulation [NCIt concept]
- Study Product Labeling [NCIt concept]
- Study Product Manufacturer [NCIt concept]
- Study Product Packaging [NCIt concept]
- Study Product Preparation [NCIt concept]
- Study Product Stability [NCIt concept]
- Study Product Storage [NCIt concept]
- Study Product Therapeutic Class [NCIt concept]
- Study Product Type [NCIt concept]
- Study Protocol [NCIt concept]
- Study Protocol Document Version Public Title [NCIt concept]
- Study Protocol Financial Disclosure Statement [NCIt concept]
- Study Protocol Version [NCIt concept]
- Study Protocol Version Acronym [NCIt concept]
- Study Protocol Version Approval by Oversight Committee Date [NCIt concept]
- Study Protocol Version Number [NCIt concept]
- Study Protocol Version Purpose Statement [NCIt concept]
- Study Schematic [NCIt concept]
- Study Secondary Purpose [NCIt concept]
- Study Sponsor Conduct Statement [NCIt concept]
- Study Subject Discontinuation [NCIt concept]
- Study Subject Discontinuation Criteria [NCIt concept]
- Study Subject Replacement Criteria [NCIt concept]
- Study Subject Replacement Statement [NCIt concept]
- Study Type [NCIt concept]
- Study Unblinding Procedure [NCIt concept]
- Study Visit [NCIt concept]
- Study Visit Window [NCIt concept]
- Subinvestigator [NCIt concept]
- Subject Data Confidentiality Statement [NCIt concept]
- Subject Discontinuation Process Description [NCIt concept]
- Subject Privacy Statement [NCIt concept]
- Substudy [NCIt concept]
- Substudy Protocol [NCIt concept]
- Suicidal Risk Monitoring [NCIt concept]
- Supportive Care [NCIt concept]
- Supportive Care Study [NCIt concept]
- Surrogate Endpoint [NCIt concept]
- Surrogate Endpoint Biomarker [NCIt concept]
- Susceptibility Biomarker [NCIt concept]
- Swallowing Function Trial [NCIt concept]
- Target Sample Size [NCIt concept]
- Target Study Population [NCIt concept]
- Technical Lead [NCIt concept]
- Telephone Number [NCIt concept]
- Therapeutic Area [NCIt concept]
- Therapeutic Equivalency Study [NCIt concept]
- Thorough QT Study [NCIt concept]
- Tmax [NCIt concept]
- Tmin [NCIt concept]
- Tolerability Study [NCIt concept]
- Treat [NCIt concept]
- Treatment Group [NCIt concept]
- Treatment Investigational New Drug Study [NCIt concept]
- Treatment Study [NCIt concept]
- Trial Blinding Schema [NCIt concept]
- Trial Indication [NCIt concept]
- Trial Phase [NCIt concept]
- Trial Primary Objective [NCIt concept]
- Trial Registration Indicator [NCIt concept]
- Trial Secondary Objective [NCIt concept]
- Trial Subject Replacement [NCIt concept]
- Trial Type [NCIt concept]
- Trough Concentration [NCIt concept]
- Unequal Randomization [NCIt concept]
- Unknown [NCIt concept]
- Usability Testing Study [NCIt concept]
- Vulnerable Subjects [NCIt concept]
- Water Effect Trial [NCIt concept]
- Withdrawal by Subject [NCIt concept]
- Withdrawn Subject Follow-Up Process Description [NCIt concept]
- Yes [NCIt concept]

Keyword's position in hierarchy(ies) :

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