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1 SDTMIG 3.4 (Public Review) TS 1 STUDYID Study Identifier Char   Identifier Unique identifier for a study. Req Trial Design STUDYID
2 SDTMIG 3.4 (Public Review) TS 2 DOMAIN Domain Abbreviation Char TS Identifier Two-character abbreviation for the domain. Req Trial Design DOMAIN
3 SDTMIG 3.4 (Public Review) TS 3 TSSEQ Sequence Number Num   Identifier Sequence number given to ensure uniqueness within a dataset. Allows inclusion of multiple records for the same TSPARMCD. Req Trial Design SEQ
4 SDTMIG 3.4 (Public Review) TS 4 TSGRPID Group ID Char   Identifier Used to tie together a group of related records. Perm Trial Design GRPID
5 SDTMIG 3.4 (Public Review) TS 5 TSPARMCD Trial Summary Parameter Short Name Char (TSPARMCD) Topic TSPARMCD (the companion to TSPARM) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that TSPARMCD will need to serve as variable names. Examples: "AGEMIN", "AGEMAX". Req Trial Design PARMCD
6 SDTMIG 3.4 (Public Review) TS 6 TSPARM Trial Summary Parameter Char (TSPARM) Synonym Qualifier Term for the Trial Summary Parameter. The value in TSPARM cannot be longer than 40 characters. Examples: "Planned Minimum Age of Subjects", "Planned Maximum Age of Subjects". Req Trial Design PARM
7 SDTMIG 3.4 (Public Review) TS 7 TSVAL Parameter Value Char   Result Qualifier Value of TSPARM. Example: "ASTHMA" when TSPARM value is "Trial Indication". TSVAL can only be null when TSVALNF is populated. Text over 200 characters can be added to additional columns TSVAL1-TSVALn. See Assumption 8. Exp Trial Design VAL
8 SDTMIG 3.4 (Public Review) TS 8 TSVALNF Parameter Null Flavor Char ISO 21090 NullFlavor Enumeration Result Qualifier Null flavor for the value of TSPARM, to be populated if and only if TSVAL is null. Perm Trial Design VALNF
9 SDTMIG 3.4 (Public Review) TS 9 TSVALCD Parameter Value Code Char   Result Qualifier This is the code of the term in TSVAL. For example, "6CW7F3G59X" is the code for Gabapentin; "C49488" is the code for Y. The length of this variable can be longer than 8 to accommodate the length of the external terminology. Exp Trial Design VALCD
10 SDTMIG 3.4 (Public Review) TS 10 TSVCDREF Name of the Reference Terminology Char (DICTNAM) Result Qualifier The name of the Reference Terminology from which TSVALCD is taken. For example; CDISC CT, SNOMED, ISO 8601". Exp Trial Design VCDREF
11 SDTMIG 3.4 (Public Review) TS 11 TSVCDVER Version of the Reference Terminology Char   Result Qualifier The version number of the Reference Terminology, if applicable. Exp Trial Design VCDVER

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2 2020-03-27 DICTNAM CDISC CT     .   C66788 Dictionary Name Yes CDISC Dictionary Name Terminology A standard terminology developed and maintained by Clinical Data Interchange Standards Consortium (CDISC) and the National Cancer Institute Enterprise Vocabulary Services (NCI-EVS) to support CDISC models, domains and specifications for data representation in regulated research. CDISC Controlled Terminology; Clinical Data Interchange Standards Consortium Controlled Terminology C163415 Clinical Data Interchange Standards Consortium Controlled Terminology
3 2020-03-27 DICTNAM COSTART     .   C66788 Dictionary Name Yes CDISC Dictionary Name Terminology A terminology developed and used by the Food and Drug Administration (FDA) for the coding, filing and retrieving of post marketing adverse reaction reports. (NCI) Coding Symbols for a Thesaurus of Adverse Reaction Terms C49471 Thesaurus of Adverse Reaction Term Coding Symbols
4 2020-03-27 DICTNAM CTCAE     .   C66788 Dictionary Name Yes CDISC Dictionary Name Terminology A standard terminology developed and maintained by the National Cancer Institute to report adverse events occurring in clinical trials. The CTCAE contains a grading scale for each adverse event term representing the severity of the event. Common Terminology Criteria for Adverse Events C49704 Common Terminology Criteria for Adverse Events
5 2020-03-27 DICTNAM D-U-N-S NUMBER     .   C66788 Dictionary Name Yes CDISC Dictionary Name Terminology A proprietary system developed and regulated by Dun & Bradstreet that assigns a unique nine digit numeric identifier to a single business entity location. DUNS Numbers; Data Universal Number System C134003 Data Universal Numbering System
6 2020-03-27 DICTNAM ICD     .   C66788 Dictionary Name Yes CDISC Dictionary Name Terminology A system of categories to which morbid entries are assigned according to established criteria. Included is the entire range of conditions in a manageable number of categories, grouped to facilitate mortality reporting. It is produced by the World Health Organization (from ICD-10, p1). The Clinical Modifications, produced by the United States Dept. of Health and Human Services, are larger extensions used for morbidity and general epidemiological purposes, primarily in the U.S. (MSH2005_2004_10_12) International Classification of Diseases C49474 International Classification of Diseases
7 2020-03-27 DICTNAM LOINC     .   C66788 Dictionary Name Yes CDISC Dictionary Name Terminology Published by The Regenstrief Institute, the Logical Observation Identifiers Names and Codes covers clinical and clinical laboratory terminology. (NCI) Logical Observation Identifiers Names and Codes C49476 Logical Observation Identifiers Names and Codes
8 2020-03-27 DICTNAM MED-RT     .   C66788 Dictionary Name Yes CDISC Dictionary Name Terminology A standard terminology developed and maintained by the Veterans Health Administration (VHA) that includes terminology to support the mechanism of action, physiologic effect, and asserted pharmacologic classification relationships of medications. MED-RT incorporates terminology from RxNORM, MeSH, and SNOMED CT. Medication Reference Terminology; NDF-RT C163416 Medication Reference Terminology
9 2020-03-27 DICTNAM MedDRA     .   C66788 Dictionary Name Yes CDISC Dictionary Name Terminology MedDRA is an international medical terminology designed to support the classification, retrieval, presentation, and communication of medical information throughout the medical product regulatory cycle. MedDRA was developed under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The MedDRA Maintenance and Support Services Organization (MSSO) holds a contract with the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) to maintain and support the implementation of the terminology. (NCI) Medical Dictionary for Regulatory Activities C43820 MedDRA
10 2020-03-27 DICTNAM SNOMED     .   C66788 Dictionary Name Yes CDISC Dictionary Name Terminology A multiaxial, hierarchical classification system for diseases in man developed by the College of American Pathologists. (NCI) Systematized Nomenclature of Medicine C53489 Systematized Nomenclature of Medicine
11 2020-03-27 DICTNAM UNII     .   C66788 Dictionary Name Yes CDISC Dictionary Name Terminology A standard terminology developed and maintained by the Department of Veterans Affairs/Veterans Health Administration designated federal collaborative Structured Product Labeling Interagency Expert Panel (SPLIEP). It contains terminology to support the mechanism of action, physiologic effect, and asserted pharmacologic classification relationships of drug ingredients and food allergens. SRS-UNII; Substance Registration System-Unique Ingredient Identifier C163417 Substance Registration System-Unique Ingredient Identifier
12 2020-03-27 DICTNAM WHO ATC CLASSIFICATION SYSTEM     .   C66788 Dictionary Name Yes CDISC Dictionary Name Terminology A World Health Organization (WHO) classification system, developed and maintained by the WHO Collaborating Centre for Drug Statistics Methodology, for medicinal substances where active substances are divided into different groups according to the organ or system on which they act and their therapeutic, pharmacological, and chemical properties. Anatomical Therapeutic Chemical Classification System C154331 Anatomical Therapeutic Chemical Classification System
13 2020-03-27 DICTNAM WHOART     .   C66788 Dictionary Name Yes CDISC Dictionary Name Terminology A terminology implemented by the World Health Organization to describe adverse reactions to a prescribed medication or treatment regimen. (NCI) World Health Organization Adverse Reaction Terms C49468 World Health Organization Adverse Reaction Terminology
14 2020-03-27 DICTNAM WHODD     .   C66788 Dictionary Name Yes CDISC Dictionary Name Terminology A reference source of drugs and drug associated information maintained by the World Health Organization. (NCI) WHODrug Global; World Health Organization Drug Dictionary C49475 World Health Organization Drug Dictionary
15 2020-03-27 TSPARM Actual Number of Subjects     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology Actual number of subjects enrolled; may include subjects who were not randomized. Actual Number of Subjects C98703 Actual Subject Number
16 2020-03-27 TSPARM Adaptive Design     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology Indicate if the study includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study. Adaptive Design C146995 Adaptive Study Design Indicator
17 2020-03-27 TSPARM Added on to Existing Treatments     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The addition of a therapeutic product to the existing regimen in a clinical trial, where both entities remain as discrete products. Added on to Existing Treatments C49703 Test Product Added to Existing Treatment
18 2020-03-27 TSPARM Additional Outcome Measure     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology Additional key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. These are the outcome measures not used to assess primary or secondary objectives. Additional Outcome Measure C156601 Additional Outcome Measure
19 2020-03-27 TSPARM Biospecimen Retention Contains DNA     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology A textual description as to whether a biospecimen is retained and/or contains DNA. Biospecimen Retention Contains DNA C126058 Biospecimen Retained and/or Contains DNA Indicator
20 2020-03-27 TSPARM CDISC Therapeutic Area User Guide     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The name and version of the CDISC therapeutic area user guide that is being used in the study submission. CDISC Therapeutic Area User Guide C156602 CDISC Therapeutic Area User Guide Name and Version
21 2020-03-27 TSPARM Citation Used in Study     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology A bibliographical reference related to a particular study. Citation Used in Study C127788 Clinical Study Citation
22 2020-03-27 TSPARM Clinical Study Report Archive Date     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The date when the clinical study report was archived. Clinical Study Report Archive Date C139273 Clinical Study Report Archive Date
23 2020-03-27 TSPARM Clinical Study Sponsor     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An entity that is responsible for the initiation, management, and/or financing of a clinical study. Clinical Study Sponsor; Sponsor; Study Sponsor C70793 Clinical Study Sponsor
24 2020-03-27 TSPARM Commercial Sponsor Status     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The state or condition of the sponsor as pertains to whether the sponsor is considered a commercial entity. Commercial Sponsor Status C127789 Sponsor Commercial Status
25 2020-03-27 TSPARM Comparative Treatment Name     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology A therapeutically active agent that is intended to provide reference measurements for the experimental protocol of a clinical trial. Comparative Treatment Name C68612 Active Comparator Drug
26 2020-03-27 TSPARM Confirmed Response Minimum Duration     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The protocol specified minimum amount of time needed to meet the definition of a confirmed response to treatment. Confirmed Response Minimum Duration C98715 Confirmed Response Minimum Duration
27 2020-03-27 TSPARM Control Type     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology Comparator against which the study treatment is evaluated. Control Type C49647 Control Type
28 2020-03-27 TSPARM Country of Manufacture     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The name of the country within which the final product under study is produced. Country of Manufacture C124455 Country of Manufacture
29 2020-03-27 TSPARM Current Therapy or Treatment     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The literal identifier of the therapy or medication that is currently being given per protocol. Current Therapy or Treatment C85582 Current Therapy
30 2020-03-27 TSPARM Data Cutoff Date     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology A date which indicates any data collected by this date will be used for analysis. Data Cutoff Date C98717 Data Cutoff Date
31 2020-03-27 TSPARM Data Cutoff Description     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology Text that describes the cutoff date. Data Cutoff Description C98718 Data Cutoff Date Description
32 2020-03-27 TSPARM Data Monitoring Committee Indicator     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An indication as to whether the clinical trial has an appointed data monitoring committee. Data Monitoring Committee Indicator C127790 Data Monitoring Committee Indicator
33 2020-03-27 TSPARM Delayed Graft Function Dx Criteria     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology A standard by which the determination of delayed graft function (DGF) is established. Delayed Graft Function Diagnostic Criteria; Delayed Graft Function Dx Criteria C135514 Delayed Graft Function Diagnostic Criteria Name
34 2020-03-27 TSPARM Diagnosis Group     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology A grouping of individuals on the basis of a shared procedure or disease, or lack thereof. Diagnosis Group C49650 Diagnosis Group
35 2020-03-27 TSPARM Diagnostic Criteria     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology A standard from which a judgment concerning a medical diagnosis can be established. Diagnostic Criteria C117960 Diagnostic Criteria
36 2020-03-27 TSPARM Dose Form     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The pharmaceutical dosage form of the drug administered. Dose Form C42636 Pharmaceutical Dosage Form
37 2020-03-27 TSPARM Dose Regimen     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The planned schedule for the administration of an agent (such as a drug, substance or radiation). Dose Regimen C71137 Dose Regimen
38 2020-03-27 TSPARM Dose Units     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The unit of measure for the dosage form. Dose Units C73558 Dosage Form Unit
39 2020-03-27 TSPARM Dose per Administration     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The amount of drug administered to a patient or test subject at one time or the total quantity administered. [AMA Manual of Style] (CDISC Glossary) Dose Level; Dose per Administration C25488 Dose
40 2020-03-27 TSPARM Dosing Frequency     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The number of doses administered per a specific interval. Dosing Frequency C89081 Dose Frequency
41 2020-03-27 TSPARM ECG Continuous Monitoring     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology Indicates whether the 10-second ECGs for this study were extracted from a continuous recording. ECG Continuous Monitoring C119561 ECG Continuous Monitoring Indicator
42 2020-03-27 TSPARM ECG Planned Primary Lead     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The ECG lead which was planned to be used for ECG interval measurements for this study. ECG Planned Primary Lead C119562 ECG Planned Primary Lead for Study
43 2020-03-27 TSPARM ECG Read Method     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The degree of automation involved in assessing the ECGs for this study. ECG Read Method C119564 ECG Read Method Degree of Automation
44 2020-03-27 TSPARM ECG Reading Blinded     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology Indicates whether assessors of ECGs for this study were blinded to subject identity, timing and treatment. ECG Reading Blinded C119560 ECG Evaluator Blinding Parameters
45 2020-03-27 TSPARM ECG Replicates On-Treatment     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology Indicates whether this study includes replicate ECGs for time points during the on-treatment portion of the study. ECG Replicates On-Treatment C119566 ECG Replicates On-Treatment Indicator
46 2020-03-27 TSPARM ECG Replicates at Baseline     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology Indicates whether this study includes replicate ECGs for time points during the baseline portion of the study. ECG Replicates at Baseline C119565 ECG Replicates at Baseline Indicator
47 2020-03-27 TSPARM ECG Twave Algorithm     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The algorithm used to identify the end of the T wave for ECGs for this study. ECG Twave Algorithm C119582 ECG T Wave Algorithm
48 2020-03-27 TSPARM ECG Used Same Lead     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology Indicates whether all ECG interval measurements for the study were based on the same lead. ECG Used Same Lead C119563 ECG Used Same Lead Indicator
49 2020-03-27 TSPARM EMA Decision Number for PIP     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An alphanumeric code assigned by the European Medicines Agency (EMA) to an EMA regulatory decision for a pediatric investigation plan (PIP). EMA Decision Number for PIP C126059 EMA Decision Number for Pediatric Investigation Plan
50 2020-03-27 TSPARM Email Address for XML File     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The Email address to which copies of the XML format of the EudraCT application should be sent. Email Address for XML File C127791 E-mail Address for XML File Feedback
51 2020-03-27 TSPARM EudraCT Resubmission Indicator     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An indication as to whether the trial being submitted to the EudraCT is a trial that has been previously submitted to the EudraCT system. EudraCT Resubmission Indicator C126060 EudraCT Resubmission Indicator
52 2020-03-27 TSPARM EudraVigilance Sender ID     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology A unique identifier assigned to the organization that is transmitting an adverse drug reaction report to the EudraVigilance system. EudraVigilance Sender ID C126061 EudraVigilance Sender Identifier
53 2020-03-27 TSPARM EudraVigilance Sender Organization     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The name of the group or institution that is transmitting an adverse drug reaction report to the EudraVigilance system. EudraVigilance Sender Organization C126090 EudraVigilance Sender Organization
54 2020-03-27 TSPARM Expanded Access Record NCT Number     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The unique alphanumeric identifier for the study with associated expanded access record, as assigned by the clinicaltrials.gov protocol registration and results system (PRS). Expanded Access Record NCT Number C127792 Clinicaltrials.gov NCT Number for the Expanded Access Record
55 2020-03-27 TSPARM Expanded Access Status     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology Status indicating availability of an experimental drug or device outside any clinical trial protocol. (clinicaltrials.gov) Expanded Access Status C127793 Trial Expanded Access Status
56 2020-03-27 TSPARM Exploratory Outcome Measure     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The outcome measure(s) that is part of a pre-specified analysis plan used to evaluate the exploratory endpoint(s) associated with exploratory study objective(s) and/or any other measures, excluding post-hoc measures, that are a focus of the study. (After clinicaltrials.gov) Exploratory Outcome Measure C98724 Exploratory Outcome Measure
57 2020-03-27 TSPARM Extension Trial Indicator     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An indication as to whether the clinical trial is an extension trial. Extension Trial Indicator C139274 Extension Trial Indicator
58 2020-03-27 TSPARM FDA Technical Specification     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The name and version of the FDA technical specification that is being used in the study submission. FDA Technical Specification C156603 FDA Technical Specification Name and Version
59 2020-03-27 TSPARM FDA-Regulated Device Study Indicator     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An indication as to whether the study involves an FDA-regulated device. FDA-Regulated Device Study Indicator C123629 FDA-Regulated Device Study Indicator
60 2020-03-27 TSPARM FDA-Regulated Drug Study Indicator     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An indication as to whether the study involves an FDA-regulated drug. FDA-Regulated Drug Study Indicator C123630 FDA-Regulated Drug Study Indicator
61 2020-03-27 TSPARM Healthy Subject Indicator     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology Indicate if persons who have not had the condition(s) being studied or otherwise related conditions or symptoms, as specified in the eligibility requirements, may participate in the study. Healthy Subject Indicator C98737 Healthy Subject Indicator
62 2020-03-27 TSPARM Intervention Model     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The general design of the strategy for assigning interventions to participants in a clinical study. (clinicaltrials.gov) Intervention Model C98746 Intervention Model
63 2020-03-27 TSPARM Intervention Type     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The kind of product or procedure studied in a trial. Intervention Type C98747 Intervention Type
64 2020-03-27 TSPARM Investigational Therapy or Treatment     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The investigational product under study. Investigational Therapy or Treatment C41161 Protocol Agent
65 2020-03-27 TSPARM Multiple Site EU State Trial Indicator     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An indication as to whether the clinical study is being conducted at multiple sites within the European Union member state concerned by the application. Multiple Site EU State Trial Indicator C127794 Multiple Site European Union State Trial Indicator
66 2020-03-27 TSPARM Number of Groups/Cohorts     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The number of groups or cohorts that are part of the study. Number of Groups/Cohorts C126063 Number of Groups or Cohorts
67 2020-03-27 TSPARM Number of Trial Sites EU State     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The total number of trial sites within the European Union member state concerned by the application. Number of Trial Sites EU State C127795 Number of Trial Sites within European Union State
68 2020-03-27 TSPARM Obs Study Population Description     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology A description of the population from which the groups or cohorts will be selected within an observational study. Obs Study Population Description C126066 Observational Study Population Description
69 2020-03-27 TSPARM Obs Study Sampling Method Description     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology A textual description of the sampling method used to assign study participants into groups or cohorts within an observational study. Obs Study Sampling Method Description C126068 Observational Study Sampling Method Description
70 2020-03-27 TSPARM Observational Model     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The trial design developed to compare biomedical and/or health outcomes in pre-defined and non-assigned groups of individuals. Observational Model C126064 Observational Model
71 2020-03-27 TSPARM Observational Study Sampling Method     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The sampling method used to assign study participants into groups or cohorts within an observational study. Observational Study Sampling Method C126067 Observational Study Sampling Method
72 2020-03-27 TSPARM Observational Time Perspective     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The temporal relationship between the observation period and time of subject enrollment. (ClinicalTrials.gov) Observational Time Perspective C126065 Observational Time Perspective of Study
73 2020-03-27 TSPARM Pediatric Investigation Plan Indicator     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An indication as to whether the trial is part of a pediatric investigation plan (PIP). Pediatric Investigation Plan Indicator C126069 Pediatric Investigation Plan Indicator
74 2020-03-27 TSPARM Pediatric Postmarket Study Indicator     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An indication as to whether the study is a pediatric postmarket study. Pediatric Postmarket Study Indicator C123631 Pediatric Postmarket Study Indicator
75 2020-03-27 TSPARM Pediatric Study Indicator     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An indication as to whether the study is a pediatric study. Pediatric Study Indicator C123632 Pediatric Study Indicator
76 2020-03-27 TSPARM Pharmacologic Class     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The pharmacological class of the investigational product. Pharmacologic Class C98768 Pharmacological Class of Investigational Therapy
77 2020-03-27 TSPARM Planned Country of Investigational Sites     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The country name of planned study facility which has received IRB approval. Planned Country of Investigational Sites C98770 Planned Country of Investigational Site
78 2020-03-27 TSPARM Planned Maximum Age of Subjects     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The anticipated maximum age of the subjects to be entered in a clinical trial. (NCI) Planned Maximum Age of Subjects C49694 Planned Maximum Age of Subjects
79 2020-03-27 TSPARM Planned Minimum Age of Subjects     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The anticipated minimum age of the subjects to be entered in a clinical trial. (NCI) Planned Minimum Age of Subjects C49693 Planned Minimum Age of Subjects
80 2020-03-27 TSPARM Planned Number of Arms     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The planned number of intervention groups. Planned Number of Arms C98771 Planned Number of Arms
81 2020-03-27 TSPARM Planned Number of Subjects     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The planned number of subjects to be entered in a clinical trial. (NCI) Anticipated Enrollment; Planned Enrollment; Planned Number of Subjects; Target Enrollment C49692 Planned Subject Number
82 2020-03-27 TSPARM Planned Treatment Duration     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The period of time during which the treatment is intended to be given. Planned Treatment Duration C139276 Planned Treatment Duration
83 2020-03-27 TSPARM Planned Trial Duration     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The approximate period of time over which the clinical trial is expected to occur. Planned Trial Duration C127796 Planned Trial Duration
84 2020-03-27 TSPARM Post Authorization Safety Study Ind     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An indication as to whether the clinical study is a post authorization safety study. Post Authorization Safety Study Ind C139275 Post Authorization Safety Study Indicator
85 2020-03-27 TSPARM Primary Outcome Measure     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The outcome measure(s) of greatest importance specified in the protocol, usually the one(s) used in the power calculation, to evaluate the primary endpoint(s) associated with the primary study objective(s). (After Clinicaltrials.gov) Primary Outcome Measure C98772 Primary Outcome Measure
86 2020-03-27 TSPARM Protocol Keyword     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology A word or small set of words designed to convey the focus of the protocol. Protocol Keyword C126062 Protocol Keyword
87 2020-03-27 TSPARM Protocol Risk Assessment     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The potential future harm that may arise from a protocol-related activity. Protocol Risk Assessment C139277 Protocol Risk Assessment
88 2020-03-27 TSPARM PubMed ID for Citation Used in Study     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology A globally unique identifier for a biomedical article, as assigned by PubMed. PubMed ID for Citation Used in Study C127797 PubMed Identifier for Citation Used in Study
89 2020-03-27 TSPARM Randomization Quotient     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The randomization quotient is the number of planned subjects to be exposed to investigational therapy, independent of dose or other factors, divided by the total number of planned subjects. Randomization Quotient C98775 Randomization Quotient
90 2020-03-27 TSPARM Rare Disease Indicator     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An indication as to whether the condition under study is considered a rare disease. Rare Disease Indicator C126070 Rare Disease Indicator
91 2020-03-27 TSPARM Registry Identifier     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology Identification numbers assigned to the protocol by clinicaltrials.gov, EudraCT, or other registries. Registry Identifier C98714 Clinical Trial Registry Identifier
92 2020-03-27 TSPARM Relapse Criteria     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology A standard from which a judgment concerning a disease relapse can be established. Relapse Criteria C117961 Relapse Criteria
93 2020-03-27 TSPARM Request for XML Copy of Study Indicator     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An indication as to whether the registrant would like to receive an XML copy of their study as saved on EudraCT. Request for XML Copy of Study Indicator C127798 Study Saved as XML Indicator
94 2020-03-27 TSPARM Resubmission Letter     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An alphabetic character that describes the incremental order of trial resubmissions. Resubmission Letter C126071 Resubmission Letter
95 2020-03-27 TSPARM Retained Biospecimen Description     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology A textual description of the specimen types that are retained as reserve samples. Retained Biospecimen Description C126072 Retained Biospecimen Description
96 2020-03-27 TSPARM Route of Administration     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The course by which a substance is administered in order to reach the site of action in the body. Route of Administration C38114 Route of Administration
97 2020-03-27 TSPARM SDTM IG Version     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The version of the CDISC Study Data Tabulation Model implementation guide that is being used in the study submission. SDTM IG Version; SDTM Implementation Guide Version C156604 Study Data Tabulation Model Implementation Guide Version
98 2020-03-27 TSPARM SDTM Version     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The version of the CDISC Study Data Tabulation Model that is being used in the study submission. SDTM Version C156605 Study Data Tabulation Model Version
99 2020-03-27 TSPARM SUSAR Reporting to EVCTM Indicator     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An indication as to whether suspected unexpected serious adverse reactions (SUSAR) will be reported to a EudraVigiliance clinical trial module (EVCTM). SUSAR Reporting to EVCTM Indicator C126073 SUSAR Reporting to EudraVigiliance Clinical Trial Module Indicator
100 2020-03-27 TSPARM SUSAR Reporting to NCA Indicator     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An indication as to whether suspected unexpected serious adverse reactions (SUSAR) will be reported to national competent authorities (NCA). SUSAR Reporting to NCA Indicator C126074 SUSAR Reporting to National Competent Authority Indicator
101 2020-03-27 TSPARM Secondary Outcome Measure     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The outcome measure(s) that is part of a pre-specified analysis plan used to evaluate the secondary endpoint(s) associated with secondary study objective(s) and/or used to evaluate any measure(s) ancillary to the primary or secondary endpoint(s). (After Clinicaltrials.gov). Secondary Outcome Measure C98781 Secondary Outcome Measure
102 2020-03-27 TSPARM Secure Delivery XML Required Indicator     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An indication as to whether the XML copy of the EudraCT application requires secure E-mail delivery. Secure Delivery XML Required Indicator C127799 Requires Secure Email Delivery of XML Indicator
103 2020-03-27 TSPARM Severity Criteria     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology A standard from which a judgment concerning the severity of an event, disease or condition can be established. Severity Criteria C117962 Severity Criteria
104 2020-03-27 TSPARM Sex of Participants     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The specific sex, either male, female, or mixed of the subject group being studied. (NCI) Sex of Participants C49696 Sex of Study Group
105 2020-03-27 TSPARM Single Site EU State Trial Indicator     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An indication as to whether the clinical study is being conducted at only one site within the European Union member state concerned by the application. Single Site EU State Trial Indicator C127800 Single Site European Union State Trial Indicator
106 2020-03-27 TSPARM Stable Disease Minimum Duration     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The protocol specified minimum amount of time needed to meet the definition of stable disease. Stable Disease Minimum Duration C98783 Stable Disease Minimum Duration
107 2020-03-27 TSPARM Stratification Factor     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology Selected factors that are used during randomization to ensure there is balance of these factors across all subjects within each arm of a study. The subject level values of these factors may be used as fixed effects in statistical models and for sensitivity analyses. Stratification Factor C16153 Stratification Factors
108 2020-03-27 TSPARM Study End Date     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The date on which the final data item for a clinical study was collected from the last study participant (that is, last subject, last visit, or as otherwise defined in the study protocol). (CDISC Glossary) Study End Date C90462 Clinical Study End Date
109 2020-03-27 TSPARM Study Start Date     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The earliest date of informed consent among any subject (Date/Time of Informed Consent, RFICDTC) that enrolled in the study. For studies conducted without informed consent (ie. emergency use) use the date of treatment. Dates for subjects who were screen failures are not included. Study Start Date C69208 Study Start Date
110 2020-03-27 TSPARM Study Stop Rules     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The rule, regulation and/or condition that determines the point in time when a clinical trial will be terminated. (NCI) Study Stop Rules C49698 Study Stop Rule
111 2020-03-27 TSPARM Study Type     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology Describes the role the study plays in determining the interventions a subject receives. Study Type C142175 Study Type
112 2020-03-27 TSPARM Substudy Details     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology A textual description of the substudy. Substudy Details C126075 Substudy Details
113 2020-03-27 TSPARM Substudy Planned Indicator     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology An indication as to whether a study performed on a subgroup of subjects included in the original trial (substudy) is planned for the current study. Substudy Planned Indicator C126076 Substudy Planned Indicator
114 2020-03-27 TSPARM Target Follow-Up Duration     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The anticipated time period over which each study participant is to be followed. (ClinicalTrials.gov) Target Follow-Up Duration C126077 Planned Follow-Up Duration
115 2020-03-27 TSPARM Therapeutic Area     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology A knowledge field that focuses on research and development of specific treatments for diseases and pathologic findings, as well as prevention of conditions that negatively impact the health of an individual. (NCI) Therapeutic Area C101302 Therapeutic Area
116 2020-03-27 TSPARM Trial Blinding Schema     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The type of experimental design used to describe the level of awareness of the clinical trial subjects and/or investigators of the intervention(s) that they are receiving and/or administering. Trial Blinding Schema C49658 Trial Blinding Schema
117 2020-03-27 TSPARM Trial Disease/Condition Indication     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The condition, disease or disorder that the clinical trial is intended to investigate or address. Trial Disease/Condition Indication C112038 Trial Indication
118 2020-03-27 TSPARM Trial Exploratory Objective     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The exploratory purpose of the trial. Trial Exploratory Objective C163559 Trial Exploratory Objective
119 2020-03-27 TSPARM Trial Intent Type     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The planned purpose of the therapy, device, or agent under study in the clinical trial. Trial Intent Type C49652 Clinical Study by Intent
120 2020-03-27 TSPARM Trial Length     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology Planned length of observation for a single subject. Trial Length C49697 Trial Length
121 2020-03-27 TSPARM Trial Phase Classification     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology Any defined stage in the lifecycle of a clinical trial. Trial Phase Classification C48281 Trial Phase
122 2020-03-27 TSPARM Trial Primary Objective     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The principal purpose of the trial. Trial Primary Objective C85826 Trial Primary Objective
123 2020-03-27 TSPARM Trial Secondary Objective     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The auxiliary purpose of the trial. Trial Secondary Objective C85827 Trial Secondary Objective
124 2020-03-27 TSPARM Trial Title     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The name of a clinical trial. (NCI) Trial Title C49802 Trial Title
125 2020-03-27 TSPARM Trial Type     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The type of primary outcome or endpoint that the protocol is designed to evaluate. (clinicaltrials.gov) Trial Scope; Trial Type C49660 Trial Type
126 2020-03-27 TSPARM Trial is Randomized     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. NOTE: Unequal randomization is used to allocate subjects into groups at a differential rate; for example, three subjects may be assigned to a treatment group for every one assigned to the control group. [ICH E6 1.48] See also balanced study. (CDISC glossary) Trial is Randomized C25196 Randomization
127 2020-03-27 TSPARM URL Related to Study     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology The uniform resource locator (URL) related to a particular study. URL Related to Study C127801 Study Protocol Uniform Resource Locator
128 2020-03-27 TSPARM URL Related to Study Description     .   C67152 Trial Summary Parameter Test Name Yes CDISC SDTM Trial Summary Parameter Long Name Terminology A textual description of the uniform resource locator (URL) related to a particular study. URL Related to Study Description C127802 Study Protocol Uniform Resource Locator Description
129 2020-03-27 TSPARMCD ACTSUB     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology Actual number of subjects enrolled; may include subjects who were not randomized. Actual Number of Subjects C98703 Actual Subject Number
130 2020-03-27 TSPARMCD ADAPT     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology Indicate if the study includes a prospectively planned opportunity for modification of one or more specified aspects of the study design and hypotheses based on analysis of data (usually interim data) from subjects in the study. Adaptive Design C146995 Adaptive Study Design Indicator
131 2020-03-27 TSPARMCD ADDON     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The addition of a therapeutic product to the existing regimen in a clinical trial, where both entities remain as discrete products. Added on to Existing Treatments C49703 Test Product Added to Existing Treatment
132 2020-03-27 TSPARMCD AGEMAX     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The anticipated maximum age of the subjects to be entered in a clinical trial. (NCI) Planned Maximum Age of Subjects C49694 Planned Maximum Age of Subjects
133 2020-03-27 TSPARMCD AGEMIN     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The anticipated minimum age of the subjects to be entered in a clinical trial. (NCI) Planned Minimum Age of Subjects C49693 Planned Minimum Age of Subjects
134 2020-03-27 TSPARMCD BIOSPRET     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology A textual description as to whether a biospecimen is retained and/or contains DNA. Biospecimen Retention Contains DNA C126058 Biospecimen Retained and/or Contains DNA Indicator
135 2020-03-27 TSPARMCD CITNSTDY     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology A bibliographical reference related to a particular study. Citation Used in Study C127788 Clinical Study Citation
136 2020-03-27 TSPARMCD CMSPSTAT     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The state or condition of the sponsor as pertains to whether the sponsor is considered a commercial entity. Commercial Sponsor Status C127789 Sponsor Commercial Status
137 2020-03-27 TSPARMCD COMPTRT     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology A therapeutically active agent that is intended to provide reference measurements for the experimental protocol of a clinical trial. Comparative Treatment Name C68612 Active Comparator Drug
138 2020-03-27 TSPARMCD CRMDUR     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The protocol specified minimum amount of time needed to meet the definition of a confirmed response to treatment. Confirmed Response Minimum Duration C98715 Confirmed Response Minimum Duration
139 2020-03-27 TSPARMCD CSRARDTC     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The date when the clinical study report was archived. Clinical Study Report Archive Date C139273 Clinical Study Report Archive Date
140 2020-03-27 TSPARMCD CTAUG     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The name and version of the CDISC therapeutic area user guide that is being used in the study submission. CDISC Therapeutic Area User Guide C156602 CDISC Therapeutic Area User Guide Name and Version
141 2020-03-27 TSPARMCD CURTRT     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The literal identifier of the therapy or medication that is currently being given per protocol. Current Therapy or Treatment C85582 Current Therapy
142 2020-03-27 TSPARMCD DCUTDESC     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology Text that describes the cutoff date. Data Cutoff Description C98718 Data Cutoff Date Description
143 2020-03-27 TSPARMCD DCUTDTC     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology A date which indicates any data collected by this date will be used for analysis. Data Cutoff Date C98717 Data Cutoff Date
144 2020-03-27 TSPARMCD DGFCRIT     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology A standard by which the determination of delayed graft function (DGF) is established. Delayed Graft Function Diagnostic Criteria; Delayed Graft Function Dx Criteria C135514 Delayed Graft Function Diagnostic Criteria Name
145 2020-03-27 TSPARMCD DMCIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An indication as to whether the clinical trial has an appointed data monitoring committee. Data Monitoring Committee Indicator C127790 Data Monitoring Committee Indicator
146 2020-03-27 TSPARMCD DOSE     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The amount of drug administered to a patient or test subject at one time or the total quantity administered. [AMA Manual of Style] (CDISC Glossary) Dose Level; Dose per Administration C25488 Dose
147 2020-03-27 TSPARMCD DOSFRM     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The pharmaceutical dosage form of the drug administered. Dose Form C42636 Pharmaceutical Dosage Form
148 2020-03-27 TSPARMCD DOSFRQ     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The number of doses administered per a specific interval. Dosing Frequency C89081 Dose Frequency
149 2020-03-27 TSPARMCD DOSRGM     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The planned schedule for the administration of an agent (such as a drug, substance or radiation). Dose Regimen C71137 Dose Regimen
150 2020-03-27 TSPARMCD DOSU     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The unit of measure for the dosage form. Dose Units C73558 Dosage Form Unit
151 2020-03-27 TSPARMCD DXCRIT     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology A standard from which a judgment concerning a medical diagnosis can be established. Diagnostic Criteria C117960 Diagnostic Criteria
152 2020-03-27 TSPARMCD EGBLIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology Indicates whether assessors of ECGs for this study were blinded to subject identity, timing and treatment. ECG Reading Blinded C119560 ECG Evaluator Blinding Parameters
153 2020-03-27 TSPARMCD EGCTMON     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology Indicates whether the 10-second ECGs for this study were extracted from a continuous recording. ECG Continuous Monitoring C119561 ECG Continuous Monitoring Indicator
154 2020-03-27 TSPARMCD EGLEADPR     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The ECG lead which was planned to be used for ECG interval measurements for this study. ECG Planned Primary Lead C119562 ECG Planned Primary Lead for Study
155 2020-03-27 TSPARMCD EGLEADSM     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology Indicates whether all ECG interval measurements for the study were based on the same lead. ECG Used Same Lead C119563 ECG Used Same Lead Indicator
156 2020-03-27 TSPARMCD EGRDMETH     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The degree of automation involved in assessing the ECGs for this study. ECG Read Method C119564 ECG Read Method Degree of Automation
157 2020-03-27 TSPARMCD EGREPLBL     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology Indicates whether this study includes replicate ECGs for time points during the baseline portion of the study. ECG Replicates at Baseline C119565 ECG Replicates at Baseline Indicator
158 2020-03-27 TSPARMCD EGREPLTR     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology Indicates whether this study includes replicate ECGs for time points during the on-treatment portion of the study. ECG Replicates On-Treatment C119566 ECG Replicates On-Treatment Indicator
159 2020-03-27 TSPARMCD EGTWVALG     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The algorithm used to identify the end of the T wave for ECGs for this study. ECG Twave Algorithm C119582 ECG T Wave Algorithm
160 2020-03-27 TSPARMCD EMAILXML     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The Email address to which copies of the XML format of the EudraCT application should be sent. Email Address for XML File C127791 E-mail Address for XML File Feedback
161 2020-03-27 TSPARMCD EMPIPDCN     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An alphanumeric code assigned by the European Medicines Agency (EMA) to an EMA regulatory decision for a pediatric investigation plan (PIP). EMA Decision Number for PIP C126059 EMA Decision Number for Pediatric Investigation Plan
162 2020-03-27 TSPARMCD EURSBIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An indication as to whether the trial being submitted to the EudraCT is a trial that has been previously submitted to the EudraCT system. EudraCT Resubmission Indicator C126060 EudraCT Resubmission Indicator
163 2020-03-27 TSPARMCD EVSNDID     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology A unique identifier assigned to the organization that is transmitting an adverse drug reaction report to the EudraVigilance system. EudraVigilance Sender ID C126061 EudraVigilance Sender Identifier
164 2020-03-27 TSPARMCD EVSNDORG     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The name of the group or institution that is transmitting an adverse drug reaction report to the EudraVigilance system. EudraVigilance Sender Organization C126090 EudraVigilance Sender Organization
165 2020-03-27 TSPARMCD EXPARECN     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The unique alphanumeric identifier for the study with associated expanded access record, as assigned by the clinicaltrials.gov protocol registration and results system (PRS). Expanded Access Record NCT Number C127792 Clinicaltrials.gov NCT Number for the Expanded Access Record
166 2020-03-27 TSPARMCD EXPASTAT     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology Status indicating availability of an experimental drug or device outside any clinical trial protocol. (clinicaltrials.gov) Expanded Access Status C127793 Trial Expanded Access Status
167 2020-03-27 TSPARMCD EXTTIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An indication as to whether the clinical trial is an extension trial. Extension Trial Indicator C139274 Extension Trial Indicator
168 2020-03-27 TSPARMCD FCNTRY     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The country name of planned study facility which has received IRB approval. Planned Country of Investigational Sites C98770 Planned Country of Investigational Site
169 2020-03-27 TSPARMCD FDADEIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An indication as to whether the study involves an FDA-regulated device. FDA-Regulated Device Study Indicator C123629 FDA-Regulated Device Study Indicator
170 2020-03-27 TSPARMCD FDADRIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An indication as to whether the study involves an FDA-regulated drug. FDA-Regulated Drug Study Indicator C123630 FDA-Regulated Drug Study Indicator
171 2020-03-27 TSPARMCD FDATCHSP     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The name and version of the FDA technical specification that is being used in the study submission. FDA Technical Specification C156603 FDA Technical Specification Name and Version
172 2020-03-27 TSPARMCD HLTSUBJI     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology Indicate if persons who have not had the condition(s) being studied or otherwise related conditions or symptoms, as specified in the eligibility requirements, may participate in the study. Healthy Subject Indicator C98737 Healthy Subject Indicator
173 2020-03-27 TSPARMCD INDIC     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The condition, disease or disorder that the clinical trial is intended to investigate or address. Trial Disease/Condition Indication C112038 Trial Indication
174 2020-03-27 TSPARMCD INTMODEL     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The general design of the strategy for assigning interventions to participants in a clinical study. (clinicaltrials.gov) Intervention Model C98746 Intervention Model
175 2020-03-27 TSPARMCD INTTYPE     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The kind of product or procedure studied in a trial. Intervention Type C98747 Intervention Type
176 2020-03-27 TSPARMCD KEYWORD     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology A word or small set of words designed to convey the focus of the protocol. Protocol Keyword C126062 Protocol Keyword
177 2020-03-27 TSPARMCD LENGTH     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology Planned length of observation for a single subject. Trial Length C49697 Trial Length
178 2020-03-27 TSPARMCD MNFCNTRY     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The name of the country within which the final product under study is produced. Country of Manufacture C124455 Country of Manufacture
179 2020-03-27 TSPARMCD MSEUTIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An indication as to whether the clinical study is being conducted at multiple sites within the European Union member state concerned by the application. Multiple Site EU State Trial Indicator C127794 Multiple Site European Union State Trial Indicator
180 2020-03-27 TSPARMCD NARMS     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The planned number of intervention groups. Planned Number of Arms C98771 Planned Number of Arms
181 2020-03-27 TSPARMCD NCOHORT     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The number of groups or cohorts that are part of the study. Number of Groups/Cohorts C126063 Number of Groups or Cohorts
182 2020-03-27 TSPARMCD NUMSEUST     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The total number of trial sites within the European Union member state concerned by the application. Number of Trial Sites EU State C127795 Number of Trial Sites within European Union State
183 2020-03-27 TSPARMCD OBJEXP     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The exploratory purpose of the trial. Trial Exploratory Objective C163559 Trial Exploratory Objective
184 2020-03-27 TSPARMCD OBJPRIM     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The principal purpose of the trial. Trial Primary Objective C85826 Trial Primary Objective
185 2020-03-27 TSPARMCD OBJSEC     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The auxiliary purpose of the trial. Trial Secondary Objective C85827 Trial Secondary Objective
186 2020-03-27 TSPARMCD OBSMODEL     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The trial design developed to compare biomedical and/or health outcomes in pre-defined and non-assigned groups of individuals. Observational Model C126064 Observational Model
187 2020-03-27 TSPARMCD OBSTIMP     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The temporal relationship between the observation period and time of subject enrollment. (ClinicalTrials.gov) Observational Time Perspective C126065 Observational Time Perspective of Study
188 2020-03-27 TSPARMCD OBSTPOPD     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology A description of the population from which the groups or cohorts will be selected within an observational study. Obs Study Population Description C126066 Observational Study Population Description
189 2020-03-27 TSPARMCD OBSTSMM     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The sampling method used to assign study participants into groups or cohorts within an observational study. Observational Study Sampling Method C126067 Observational Study Sampling Method
190 2020-03-27 TSPARMCD OBSTSMMD     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology A textual description of the sampling method used to assign study participants into groups or cohorts within an observational study. Obs Study Sampling Method Description C126068 Observational Study Sampling Method Description
191 2020-03-27 TSPARMCD OUTMSADD     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology Additional key measures that will be used to evaluate the intervention(s) or, for observational studies, that are a focus of the study. These are the outcome measures not used to assess primary or secondary objectives. Additional Outcome Measure C156601 Additional Outcome Measure
192 2020-03-27 TSPARMCD OUTMSEXP     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The outcome measure(s) that is part of a pre-specified analysis plan used to evaluate the exploratory endpoint(s) associated with exploratory study objective(s) and/or any other measures, excluding post-hoc measures, that are a focus of the study. (After clinicaltrials.gov) Exploratory Outcome Measure C98724 Exploratory Outcome Measure
193 2020-03-27 TSPARMCD OUTMSPRI     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The outcome measure(s) of greatest importance specified in the protocol, usually the one(s) used in the power calculation, to evaluate the primary endpoint(s) associated with the primary study objective(s). (After Clinicaltrials.gov) Primary Outcome Measure C98772 Primary Outcome Measure
194 2020-03-27 TSPARMCD OUTMSSEC     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The outcome measure(s) that is part of a pre-specified analysis plan used to evaluate the secondary endpoint(s) associated with secondary study objective(s) and/or used to evaluate any measure(s) ancillary to the primary or secondary endpoint(s). (After Clinicaltrials.gov). Secondary Outcome Measure C98781 Secondary Outcome Measure
195 2020-03-27 TSPARMCD PASSIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An indication as to whether the clinical study is a post authorization safety study. Post Authorization Safety Study Ind C139275 Post Authorization Safety Study Indicator
196 2020-03-27 TSPARMCD PCLAS     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The pharmacological class of the investigational product. Pharmacologic Class C98768 Pharmacological Class of Investigational Therapy
197 2020-03-27 TSPARMCD PDPSTIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An indication as to whether the study is a pediatric postmarket study. Pediatric Postmarket Study Indicator C123631 Pediatric Postmarket Study Indicator
198 2020-03-27 TSPARMCD PDSTIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An indication as to whether the study is a pediatric study. Pediatric Study Indicator C123632 Pediatric Study Indicator
199 2020-03-27 TSPARMCD PIPIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An indication as to whether the trial is part of a pediatric investigation plan (PIP). Pediatric Investigation Plan Indicator C126069 Pediatric Investigation Plan Indicator
200 2020-03-27 TSPARMCD PLANSUB     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The planned number of subjects to be entered in a clinical trial. (NCI) Anticipated Enrollment; Planned Enrollment; Planned Number of Subjects; Target Enrollment C49692 Planned Subject Number
201 2020-03-27 TSPARMCD PLNTRDUR     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The approximate period of time over which the clinical trial is expected to occur. Planned Trial Duration C127796 Planned Trial Duration
202 2020-03-27 TSPARMCD PROTRSK     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The potential future harm that may arise from a protocol-related activity. Protocol Risk Assessment C139277 Protocol Risk Assessment
203 2020-03-27 TSPARMCD PTRTDUR     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The period of time during which the treatment is intended to be given. Planned Treatment Duration C139276 Planned Treatment Duration
204 2020-03-27 TSPARMCD PUBMEDID     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology A globally unique identifier for a biomedical article, as assigned by PubMed. PubMed ID for Citation Used in Study C127797 PubMed Identifier for Citation Used in Study
205 2020-03-27 TSPARMCD RANDOM     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias. NOTE: Unequal randomization is used to allocate subjects into groups at a differential rate; for example, three subjects may be assigned to a treatment group for every one assigned to the control group. [ICH E6 1.48] See also balanced study. (CDISC glossary) Trial is Randomized C25196 Randomization
206 2020-03-27 TSPARMCD RANDQT     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The randomization quotient is the number of planned subjects to be exposed to investigational therapy, independent of dose or other factors, divided by the total number of planned subjects. Randomization Quotient C98775 Randomization Quotient
207 2020-03-27 TSPARMCD RDIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An indication as to whether the condition under study is considered a rare disease. Rare Disease Indicator C126070 Rare Disease Indicator
208 2020-03-27 TSPARMCD REGID     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology Identification numbers assigned to the protocol by clinicaltrials.gov, EudraCT, or other registries. Registry Identifier C98714 Clinical Trial Registry Identifier
209 2020-03-27 TSPARMCD RESUBLTR     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An alphabetic character that describes the incremental order of trial resubmissions. Resubmission Letter C126071 Resubmission Letter
210 2020-03-27 TSPARMCD RLPSCRIT     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology A standard from which a judgment concerning a disease relapse can be established. Relapse Criteria C117961 Relapse Criteria
211 2020-03-27 TSPARMCD ROUTE     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The course by which a substance is administered in order to reach the site of action in the body. Route of Administration C38114 Route of Administration
212 2020-03-27 TSPARMCD RTSPCDES     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology A textual description of the specimen types that are retained as reserve samples. Retained Biospecimen Description C126072 Retained Biospecimen Description
213 2020-03-27 TSPARMCD RXMLCIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An indication as to whether the registrant would like to receive an XML copy of their study as saved on EudraCT. Request for XML Copy of Study Indicator C127798 Study Saved as XML Indicator
214 2020-03-27 TSPARMCD SDMDUR     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The protocol specified minimum amount of time needed to meet the definition of stable disease. Stable Disease Minimum Duration C98783 Stable Disease Minimum Duration
215 2020-03-27 TSPARMCD SDTIGVER     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The version of the CDISC Study Data Tabulation Model implementation guide that is being used in the study submission. SDTM IG Version; SDTM Implementation Guide Version C156604 Study Data Tabulation Model Implementation Guide Version
216 2020-03-27 TSPARMCD SDTMVER     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The version of the CDISC Study Data Tabulation Model that is being used in the study submission. SDTM Version C156605 Study Data Tabulation Model Version
217 2020-03-27 TSPARMCD SDXMLIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An indication as to whether the XML copy of the EudraCT application requires secure E-mail delivery. Secure Delivery XML Required Indicator C127799 Requires Secure Email Delivery of XML Indicator
218 2020-03-27 TSPARMCD SENDTC     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The date on which the final data item for a clinical study was collected from the last study participant (that is, last subject, last visit, or as otherwise defined in the study protocol). (CDISC Glossary) Study End Date C90462 Clinical Study End Date
219 2020-03-27 TSPARMCD SEVCRIT     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology A standard from which a judgment concerning the severity of an event, disease or condition can be established. Severity Criteria C117962 Severity Criteria
220 2020-03-27 TSPARMCD SEXPOP     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The specific sex, either male, female, or mixed of the subject group being studied. (NCI) Sex of Participants C49696 Sex of Study Group
221 2020-03-27 TSPARMCD SPONSOR     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An entity that is responsible for the initiation, management, and/or financing of a clinical study. Clinical Study Sponsor; Sponsor; Study Sponsor C70793 Clinical Study Sponsor
222 2020-03-27 TSPARMCD SREVIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An indication as to whether suspected unexpected serious adverse reactions (SUSAR) will be reported to a EudraVigiliance clinical trial module (EVCTM). SUSAR Reporting to EVCTM Indicator C126073 SUSAR Reporting to EudraVigiliance Clinical Trial Module Indicator
223 2020-03-27 TSPARMCD SRNCAIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An indication as to whether suspected unexpected serious adverse reactions (SUSAR) will be reported to national competent authorities (NCA). SUSAR Reporting to NCA Indicator C126074 SUSAR Reporting to National Competent Authority Indicator
224 2020-03-27 TSPARMCD SSEUTIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An indication as to whether the clinical study is being conducted at only one site within the European Union member state concerned by the application. Single Site EU State Trial Indicator C127800 Single Site European Union State Trial Indicator
225 2020-03-27 TSPARMCD SSTDTC     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The earliest date of informed consent among any subject (Date/Time of Informed Consent, RFICDTC) that enrolled in the study. For studies conducted without informed consent (ie. emergency use) use the date of treatment. Dates for subjects who were screen failures are not included. Study Start Date C69208 Study Start Date
226 2020-03-27 TSPARMCD SSTDYDTL     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology A textual description of the substudy. Substudy Details C126075 Substudy Details
227 2020-03-27 TSPARMCD SSTDYIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology An indication as to whether a study performed on a subgroup of subjects included in the original trial (substudy) is planned for the current study. Substudy Planned Indicator C126076 Substudy Planned Indicator
228 2020-03-27 TSPARMCD STOPRULE     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The rule, regulation and/or condition that determines the point in time when a clinical trial will be terminated. (NCI) Study Stop Rules C49698 Study Stop Rule
229 2020-03-27 TSPARMCD STRATFCT     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology Selected factors that are used during randomization to ensure there is balance of these factors across all subjects within each arm of a study. The subject level values of these factors may be used as fixed effects in statistical models and for sensitivity analyses. Stratification Factor C16153 Stratification Factors
230 2020-03-27 TSPARMCD STYPE     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology Describes the role the study plays in determining the interventions a subject receives. Study Type C142175 Study Type
231 2020-03-27 TSPARMCD TBLIND     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The type of experimental design used to describe the level of awareness of the clinical trial subjects and/or investigators of the intervention(s) that they are receiving and/or administering. Trial Blinding Schema C49658 Trial Blinding Schema
232 2020-03-27 TSPARMCD TCNTRL     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology Comparator against which the study treatment is evaluated. Control Type C49647 Control Type
233 2020-03-27 TSPARMCD TDIGRP     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology A grouping of individuals on the basis of a shared procedure or disease, or lack thereof. Diagnosis Group C49650 Diagnosis Group
234 2020-03-27 TSPARMCD THERAREA     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology A knowledge field that focuses on research and development of specific treatments for diseases and pathologic findings, as well as prevention of conditions that negatively impact the health of an individual. (NCI) Therapeutic Area C101302 Therapeutic Area
235 2020-03-27 TSPARMCD TINDTP     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The planned purpose of the therapy, device, or agent under study in the clinical trial. Trial Intent Type C49652 Clinical Study by Intent
236 2020-03-27 TSPARMCD TITLE     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The name of a clinical trial. (NCI) Trial Title C49802 Trial Title
237 2020-03-27 TSPARMCD TPHASE     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology Any defined stage in the lifecycle of a clinical trial. Trial Phase Classification C48281 Trial Phase
238 2020-03-27 TSPARMCD TRGFUDUR     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The anticipated time period over which each study participant is to be followed. (ClinicalTrials.gov) Target Follow-Up Duration C126077 Planned Follow-Up Duration
239 2020-03-27 TSPARMCD TRT     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The investigational product under study. Investigational Therapy or Treatment C41161 Protocol Agent
240 2020-03-27 TSPARMCD TTYPE     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The type of primary outcome or endpoint that the protocol is designed to evaluate. (clinicaltrials.gov) Trial Scope; Trial Type C49660 Trial Type
241 2020-03-27 TSPARMCD URLSTDY     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology The uniform resource locator (URL) related to a particular study. URL Related to Study C127801 Study Protocol Uniform Resource Locator
242 2020-03-27 TSPARMCD URLSTDYD     .   C66738 Trial Summary Parameter Test Code Yes CDISC SDTM Trial Summary Parameter Short Name Terminology A textual description of the uniform resource locator (URL) related to a particular study. URL Related to Study Description C127802 Study Protocol Uniform Resource Locator Description

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1 2020-03-27 DICTNAM Single CDISC CT       .   C163415 C66788   Yes   Dictionary Name    
2 2020-03-27 DICTNAM Single COSTART       .   C49471 C66788   Yes   Dictionary Name    
3 2020-03-27 DICTNAM Single CTCAE       .   C49704 C66788   Yes   Dictionary Name    
4 2020-03-27 DICTNAM Single D-U-N-S NUMBER       .   C134003 C66788   Yes   Dictionary Name    
5 2020-03-27 DICTNAM Single ICD       .   C49474 C66788   Yes   Dictionary Name    
6 2020-03-27 DICTNAM Single LOINC       .   C49476 C66788   Yes   Dictionary Name    
7 2020-03-27 DICTNAM Single MED-RT       .   C163416 C66788   Yes   Dictionary Name    
8 2020-03-27 DICTNAM Single MedDRA       .   C43820 C66788   Yes   Dictionary Name    
9 2020-03-27 DICTNAM Single SNOMED       .   C53489 C66788   Yes   Dictionary Name    
10 2020-03-27 DICTNAM Single UNII       .   C163417 C66788   Yes   Dictionary Name    
11 2020-03-27 DICTNAM Single WHO ATC CLASSIFICATION SYSTEM       .   C154331 C66788   Yes   Dictionary Name    
12 2020-03-27 DICTNAM Single WHOART       .   C49468 C66788   Yes   Dictionary Name    
13 2020-03-27 DICTNAM Single WHODD       .   C49475 C66788   Yes   Dictionary Name    
14 2020-03-27 TSPARMCD Paired ACTSUB Actual Number of Subjects     .   C98703 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
15 2020-03-27 TSPARMCD Paired ADAPT Adaptive Design     .   C146995 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
16 2020-03-27 TSPARMCD Paired ADDON Added on to Existing Treatments     .   C49703 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
17 2020-03-27 TSPARMCD Paired AGEMAX Planned Maximum Age of Subjects     .   C49694 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
18 2020-03-27 TSPARMCD Paired AGEMIN Planned Minimum Age of Subjects     .   C49693 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
19 2020-03-27 TSPARMCD Paired BIOSPRET Biospecimen Retention Contains DNA     .   C126058 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
20 2020-03-27 TSPARMCD Paired CITNSTDY Citation Used in Study     .   C127788 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
21 2020-03-27 TSPARMCD Paired CMSPSTAT Commercial Sponsor Status     .   C127789 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
22 2020-03-27 TSPARMCD Paired COMPTRT Comparative Treatment Name     .   C68612 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
23 2020-03-27 TSPARMCD Paired CRMDUR Confirmed Response Minimum Duration     .   C98715 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
24 2020-03-27 TSPARMCD Paired CSRARDTC Clinical Study Report Archive Date     .   C139273 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
25 2020-03-27 TSPARMCD Paired CTAUG CDISC Therapeutic Area User Guide     .   C156602 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
26 2020-03-27 TSPARMCD Paired CURTRT Current Therapy or Treatment     .   C85582 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
27 2020-03-27 TSPARMCD Paired DCUTDESC Data Cutoff Description     .   C98718 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
28 2020-03-27 TSPARMCD Paired DCUTDTC Data Cutoff Date     .   C98717 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
29 2020-03-27 TSPARMCD Paired DGFCRIT Delayed Graft Function Dx Criteria     .   C135514 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
30 2020-03-27 TSPARMCD Paired DMCIND Data Monitoring Committee Indicator     .   C127790 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
31 2020-03-27 TSPARMCD Paired DOSE Dose per Administration     .   C25488 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
32 2020-03-27 TSPARMCD Paired DOSFRM Dose Form     .   C42636 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
33 2020-03-27 TSPARMCD Paired DOSFRQ Dosing Frequency     .   C89081 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
34 2020-03-27 TSPARMCD Paired DOSRGM Dose Regimen     .   C71137 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
35 2020-03-27 TSPARMCD Paired DOSU Dose Units     .   C73558 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
36 2020-03-27 TSPARMCD Paired DXCRIT Diagnostic Criteria     .   C117960 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
37 2020-03-27 TSPARMCD Paired EGBLIND ECG Reading Blinded     .   C119560 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
38 2020-03-27 TSPARMCD Paired EGCTMON ECG Continuous Monitoring     .   C119561 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
39 2020-03-27 TSPARMCD Paired EGLEADPR ECG Planned Primary Lead     .   C119562 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
40 2020-03-27 TSPARMCD Paired EGLEADSM ECG Used Same Lead     .   C119563 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
41 2020-03-27 TSPARMCD Paired EGRDMETH ECG Read Method     .   C119564 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
42 2020-03-27 TSPARMCD Paired EGREPLBL ECG Replicates at Baseline     .   C119565 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
43 2020-03-27 TSPARMCD Paired EGREPLTR ECG Replicates On-Treatment     .   C119566 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
44 2020-03-27 TSPARMCD Paired EGTWVALG ECG Twave Algorithm     .   C119582 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
45 2020-03-27 TSPARMCD Paired EMAILXML Email Address for XML File     .   C127791 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
46 2020-03-27 TSPARMCD Paired EMPIPDCN EMA Decision Number for PIP     .   C126059 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
47 2020-03-27 TSPARMCD Paired EURSBIND EudraCT Resubmission Indicator     .   C126060 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
48 2020-03-27 TSPARMCD Paired EVSNDID EudraVigilance Sender ID     .   C126061 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
49 2020-03-27 TSPARMCD Paired EVSNDORG EudraVigilance Sender Organization     .   C126090 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
50 2020-03-27 TSPARMCD Paired EXPARECN Expanded Access Record NCT Number     .   C127792 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
51 2020-03-27 TSPARMCD Paired EXPASTAT Expanded Access Status     .   C127793 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
52 2020-03-27 TSPARMCD Paired EXTTIND Extension Trial Indicator     .   C139274 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
53 2020-03-27 TSPARMCD Paired FCNTRY Planned Country of Investigational Sites     .   C98770 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
54 2020-03-27 TSPARMCD Paired FDADEIND FDA-Regulated Device Study Indicator     .   C123629 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
55 2020-03-27 TSPARMCD Paired FDADRIND FDA-Regulated Drug Study Indicator     .   C123630 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
56 2020-03-27 TSPARMCD Paired FDATCHSP FDA Technical Specification     .   C156603 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
57 2020-03-27 TSPARMCD Paired HLTSUBJI Healthy Subject Indicator     .   C98737 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
58 2020-03-27 TSPARMCD Paired INDIC Trial Disease/Condition Indication     .   C112038 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
59 2020-03-27 TSPARMCD Paired INTMODEL Intervention Model     .   C98746 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
60 2020-03-27 TSPARMCD Paired INTTYPE Intervention Type     .   C98747 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
61 2020-03-27 TSPARMCD Paired KEYWORD Protocol Keyword     .   C126062 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
62 2020-03-27 TSPARMCD Paired LENGTH Trial Length     .   C49697 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
63 2020-03-27 TSPARMCD Paired MNFCNTRY Country of Manufacture     .   C124455 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
64 2020-03-27 TSPARMCD Paired MSEUTIND Multiple Site EU State Trial Indicator     .   C127794 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
65 2020-03-27 TSPARMCD Paired NARMS Planned Number of Arms     .   C98771 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
66 2020-03-27 TSPARMCD Paired NCOHORT Number of Groups/Cohorts     .   C126063 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
67 2020-03-27 TSPARMCD Paired NUMSEUST Number of Trial Sites EU State     .   C127795 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
68 2020-03-27 TSPARMCD Paired OBJEXP Trial Exploratory Objective     .   C163559 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
69 2020-03-27 TSPARMCD Paired OBJPRIM Trial Primary Objective     .   C85826 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
70 2020-03-27 TSPARMCD Paired OBJSEC Trial Secondary Objective     .   C85827 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
71 2020-03-27 TSPARMCD Paired OBSMODEL Observational Model     .   C126064 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
72 2020-03-27 TSPARMCD Paired OBSTIMP Observational Time Perspective     .   C126065 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
73 2020-03-27 TSPARMCD Paired OBSTPOPD Obs Study Population Description     .   C126066 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
74 2020-03-27 TSPARMCD Paired OBSTSMM Observational Study Sampling Method     .   C126067 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
75 2020-03-27 TSPARMCD Paired OBSTSMMD Obs Study Sampling Method Description     .   C126068 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
76 2020-03-27 TSPARMCD Paired OUTMSADD Additional Outcome Measure     .   C156601 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
77 2020-03-27 TSPARMCD Paired OUTMSEXP Exploratory Outcome Measure     .   C98724 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
78 2020-03-27 TSPARMCD Paired OUTMSPRI Primary Outcome Measure     .   C98772 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
79 2020-03-27 TSPARMCD Paired OUTMSSEC Secondary Outcome Measure     .   C98781 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
80 2020-03-27 TSPARMCD Paired PASSIND Post Authorization Safety Study Ind     .   C139275 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
81 2020-03-27 TSPARMCD Paired PCLAS Pharmacologic Class     .   C98768 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
82 2020-03-27 TSPARMCD Paired PDPSTIND Pediatric Postmarket Study Indicator     .   C123631 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
83 2020-03-27 TSPARMCD Paired PDSTIND Pediatric Study Indicator     .   C123632 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
84 2020-03-27 TSPARMCD Paired PIPIND Pediatric Investigation Plan Indicator     .   C126069 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
85 2020-03-27 TSPARMCD Paired PLANSUB Planned Number of Subjects     .   C49692 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
86 2020-03-27 TSPARMCD Paired PLNTRDUR Planned Trial Duration     .   C127796 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
87 2020-03-27 TSPARMCD Paired PROTRSK Protocol Risk Assessment     .   C139277 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
88 2020-03-27 TSPARMCD Paired PTRTDUR Planned Treatment Duration     .   C139276 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
89 2020-03-27 TSPARMCD Paired PUBMEDID PubMed ID for Citation Used in Study     .   C127797 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
90 2020-03-27 TSPARMCD Paired RANDOM Trial is Randomized     .   C25196 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
91 2020-03-27 TSPARMCD Paired RANDQT Randomization Quotient     .   C98775 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
92 2020-03-27 TSPARMCD Paired RDIND Rare Disease Indicator     .   C126070 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
93 2020-03-27 TSPARMCD Paired REGID Registry Identifier     .   C98714 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
94 2020-03-27 TSPARMCD Paired RESUBLTR Resubmission Letter     .   C126071 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
95 2020-03-27 TSPARMCD Paired RLPSCRIT Relapse Criteria     .   C117961 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
96 2020-03-27 TSPARMCD Paired ROUTE Route of Administration     .   C38114 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
97 2020-03-27 TSPARMCD Paired RTSPCDES Retained Biospecimen Description     .   C126072 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
98 2020-03-27 TSPARMCD Paired RXMLCIND Request for XML Copy of Study Indicator     .   C127798 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
99 2020-03-27 TSPARMCD Paired SDMDUR Stable Disease Minimum Duration     .   C98783 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
100 2020-03-27 TSPARMCD Paired SDTIGVER SDTM IG Version     .   C156604 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
101 2020-03-27 TSPARMCD Paired SDTMVER SDTM Version     .   C156605 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
102 2020-03-27 TSPARMCD Paired SDXMLIND Secure Delivery XML Required Indicator     .   C127799 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
103 2020-03-27 TSPARMCD Paired SENDTC Study End Date     .   C90462 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
104 2020-03-27 TSPARMCD Paired SEVCRIT Severity Criteria     .   C117962 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
105 2020-03-27 TSPARMCD Paired SEXPOP Sex of Participants     .   C49696 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
106 2020-03-27 TSPARMCD Paired SPONSOR Clinical Study Sponsor     .   C70793 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
107 2020-03-27 TSPARMCD Paired SREVIND SUSAR Reporting to EVCTM Indicator     .   C126073 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
108 2020-03-27 TSPARMCD Paired SRNCAIND SUSAR Reporting to NCA Indicator     .   C126074 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
109 2020-03-27 TSPARMCD Paired SSEUTIND Single Site EU State Trial Indicator     .   C127800 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
110 2020-03-27 TSPARMCD Paired SSTDTC Study Start Date     .   C69208 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
111 2020-03-27 TSPARMCD Paired SSTDYDTL Substudy Details     .   C126075 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
112 2020-03-27 TSPARMCD Paired SSTDYIND Substudy Planned Indicator     .   C126076 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
113 2020-03-27 TSPARMCD Paired STOPRULE Study Stop Rules     .   C49698 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
114 2020-03-27 TSPARMCD Paired STRATFCT Stratification Factor     .   C16153 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
115 2020-03-27 TSPARMCD Paired STYPE Study Type     .   C142175 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
116 2020-03-27 TSPARMCD Paired TBLIND Trial Blinding Schema     .   C49658 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
117 2020-03-27 TSPARMCD Paired TCNTRL Control Type     .   C49647 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
118 2020-03-27 TSPARMCD Paired TDIGRP Diagnosis Group     .   C49650 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
119 2020-03-27 TSPARMCD Paired THERAREA Therapeutic Area     .   C101302 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
120 2020-03-27 TSPARMCD Paired TINDTP Trial Intent Type     .   C49652 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
121 2020-03-27 TSPARMCD Paired TITLE Trial Title     .   C49802 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
122 2020-03-27 TSPARMCD Paired TPHASE Trial Phase Classification     .   C48281 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
123 2020-03-27 TSPARMCD Paired TRGFUDUR Target Follow-Up Duration     .   C126077 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
124 2020-03-27 TSPARMCD Paired TRT Investigational Therapy or Treatment     .   C41161 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
125 2020-03-27 TSPARMCD Paired TTYPE Trial Type     .   C49660 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
126 2020-03-27 TSPARMCD Paired URLSTDY URL Related to Study     .   C127801 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name
127 2020-03-27 TSPARMCD Paired URLSTDYD URL Related to Study Description     .   C127802 C66738 C67152 Yes Yes Trial Summary Parameter Test Code TSPARM Trial Summary Parameter Test Name