Existing Codelist Test Name_Code
| Codelist Name | CDISC Submission Value Test Code | CDISC Submission Value Test Name | CDISC Synonym(s) | CDISC Definition | Examples of how this new request will be used | Current Status | Team Notes and Discussion | Batch # | Date Submitted to CDISC CT | Package Number | Final Status | Final Implementation Date |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| MBTEST-CD | SAR2IGG | SARS-CoV-2 IgG Antibody | SARS-CoV-2 IgG Antibody | A measurement of the SARS-CoV-2 IgG antibody in a biological specimen. | Requested by Jozef via new term request system (CDISC-4243): SARS coronavirus 2 Ab.IgG | MB team agrees to add new MBTEST-CD: SARS-CoV-2 IgG Antibody/SAR2IGG | 1 | |||||
| MBTEST-CD | MERSRNA | MERS-CoV RNA | MERS-CoV RNA | A measurement of the MERS-CoV RNA in a biological specimen. | Requested by Jozef via new term request system (CDISC-4243): Middle east respiratory syndrome coronavirus RNA | MB team agrees to add new MBTEST-CD: MERS-CoV RNA/MERSRNA | 1 | |||||
| MBTEST-CD | SAR2IGGM | SARS-CoV-2 IgG/IgM Antibody | SARS-CoV-2 IgG/IgM Antibody | A measurement of the SARS-CoV-2 IgG and/or IgM antibody in a biological specimen. | Requested by Jozef via new term request system (CDISC-4243): SARS coronavirus 2 Ab.IgG+IgM | MB team agrees to add new MBTEST-CD: SARS-CoV-2 IgG/IgM Antibody / SAR2IGGM | 1 | |||||
| MBTEST-CD | SAR2IGM | SARS-CoV-2 IgM Antibody | SARS-CoV-2 IgM Antibody | A measurement of the SARS-CoV-2 IgM antibody in a biological specimen. | Requested by Jozef via new term request system (CDISC-4243): SARS coronavirus 2 Ab.IgM | MB team agrees to add new MBTEST-CD: SARS-CoV-2 IgM Antibody/SAR2IGM They also agreed to add SARS-CoV-2 IgA Antibody/SAR2IGA as an additional term (not in multiple term request file) | 1 | |||||
| MBTEST-CD | SAR2IGA | SARS-CoV-2 IgA Antibody | SARS-CoV-2 IgA Antibody | A measurement of the SARS-CoV-2 IgA antibody in a biological specimen. | Added by MB team based on Jozef request |
MB team agrees to add new MBTEST-CD: SARS-CoV-2 IgM Antibody/SAR2IGM They also agreed to add SARS-CoV-2 IgA Antibody/SAR2IGA as an additional term (not in multiple term request file) | 1 | |||||
| MB Domain | Do not add; use MBTEST = SARS-CoV-2 RNA; MBTESTCD = SAR2RNA (will be published) | Requested by Jozef via new term request system (CDISC-4243): SARS coronavirus 2 E gene | Sent to PGx team for discussion covers LOINC tests 94509-7 and 94315-9 Do not add. If you choose to model this in MB, the TEST would be SARS-CoV-2 RNA/SAR2RNA with appropriate TSTDTL, if you are assessing RNA. The name of the gene or region goes into the NSV --SYM. | n/a | ||||||||
| MB Domain | Do not add; use MBTEST = SARS-CoV-2 RNA; MBTESTCD = SAR2RNA (will be published) | Requested by Jozef via new term request system (CDISC-4243): SARS coronavirus 2 N gene (submitted twice) | Sent to PGx team for discussion covers LOINC tests 94533-7, 94510-5, 94307-6, 94308-4, 94311-8, 94312-6, and 94316-7 covers LOINC codes 94310-0 and 94313-4 Do not add. If you choose to model this in MB, the TEST would be SARS-CoV-2 RNA/SAR2RNA with appropriate TSTDTL, if you are assessing RNA. The name of the gene or region goes into the NSV --SYM. | n/a | ||||||||
| MB Domain | Do not add; use MBTEST = SARS-CoV-2 RNA; MBTESTCD = SAR2RNA (will be published) | Requested by Jozef via new term request system (CDISC-4243): SARS coronavirus 2 ORF1ab region | Sent to PGx team for discussion covers LOINC code 94511-3 Do not add. If you choose to model this in MB, the TEST would be SARS-CoV-2 RNA/SAR2RNA with appropriate TSTDTL, if you are assessing RNA. The name of the gene or region goes into the NSV --SYM. | n/a | ||||||||
| MB Domain | Do not add; use MBTEST = SARS-CoV-2 RNA; MBTESTCD = SAR2RNA (will be published) | Requested by Jozef via new term request system (CDISC-4243): SARS coronavirus 2 RdRp gene | Sent to PGx team for discussion covers LOINC codes 94534-5 and 94314-2 Do not add. If you choose to model this in MB, the TEST would be SARS-CoV-2 RNA/SAR2RNA with appropriate TSTDTL, if you are assessing RNA. The name of the gene or region goes into the NSV --SYM. | n/a | ||||||||
| MB Domain | Do not add; use MBTEST = SARS-CoV-2 RNA; MBTESTCD = SAR2RNA (will be published) | Requested by Jozef via new term request system (CDISC-4243): SARS-like Coronavirus N gene | Sent to PGx team for discussion Do not add. If you choose to model this in MB, the TEST would be SARS-CoV-2 RNA/SAR2RNA with appropriate TSTDTL, if you are assessing RNA. The name of the gene or region goes into the NSV --SYM. | n/a | ||||||||
| MB Domain | Do not add; use MBTEST = SARS-CoV-2 RNA; MBTESTCD = SAR2RNA (will be published) | Requested by Jozef via new term request system (CDISC-4297): SARS coronavirus 2 S gene | Sent to PGx team for discussion covers LOINC test codes 94643-4, 94642-6, 94641-8, 94640-0 Do not add. If you choose to model this in MB, the TEST would be SARS-CoV-2 RNA/SAR2RNA with appropriate TSTDTL, if you are assessing RNA. The name of the gene or region goes into the NSV --SYM. | n/a | ||||||||
| MBTEST-CD | SAR2RNA | SARS-CoV-2 RNA | SARS-CoV-2 RNA | A measurement of the SARS-CoV-2 RNA in a biological specimen. | Requested by Jozef via new term request system (CDISC-4243): SARS coronavirus 2 RNA | MB team agrees to add new MBTEST-CD: SARS-CoV-2 RNA/SAR2RNA | 1 | |||||
| MBTEST-CD | Do not add. More information needed before publication. | Requested by Jozef via new term request system (CDISC-4243): SARS coronavirus+SARS-like coronavirus+SARS coronavirus 2 RNA | MB team reviewed request and has emailed requester for additional information. LOINC code doesn't match what was requested. Emails sent to Regenstrief and the company that makes this panel. No information returned so the team cannot develop this further. Team will wait for information and try to publish this with the June publication. | n/a | ||||||||
| MBTEST-CD | Do not add. More information needed before publication. | Requested by Jozef via new term request system (CDISC-4243): SARS coronavirus+SARS-like coronavirus+SARS coronavirus 2+MERS coronavirus RNA | MB team reviewed request and has emailed requester for additional information. LOINC code doesn't match what was requested. Emails sent to Regenstrief and the company that makes this panel. No information returned so the team cannot develop this further. Team will wait for information and try to publish this with the June publication. | n/a | ||||||||
| MBTEST-CD | Do not add; use MBTEST = SARS-CoV-2 RNA; MBTESTCD = SAR2RNA (will be published) | Requested by SmithaK via email: 2019-nCoV PCR SK: These are for VIRAL DETECTION (Results are more like POSITIVE or NEGATIVE with some quantitative results ). On CRF, I see specimen source as ‘ (e.g. nasopharynx, oropharynx, BAL, sputum, stool, blood, etc.). These are collected as Lab-panel so we mapped to LB. These tests have ‘SEROLOGY’ as LBCAT on CRF form. | Sent to microbiology team for review. Do not add. Use MBTEST = SARS-CoV-2 RNA; MBTESTCD = SAR2RNA (this is a newly approved MBTEST-CD term in package 43, not published yet), PCR should be mapped to MBMETHOD. TSTDTL could be either 'CYCLE THRESHOLD' or 'VIRAL LOAD' depending upon how the test is being assessed. | n/a | ||||||||
| MBTEST-CD | Do not add; use MBTEST = SARS-CoV-2 RNA; MBTESTCD = SAR2RNA (will be published) | Requested by SmithaK via email: SARS-CoV-2 PCR - qualitative SK: These are for VIRAL DETECTION (Results are more like POSITIVE or NEGATIVE with some quantitative results ). On CRF, I see specimen source as ‘ (e.g. nasopharynx, oropharynx, BAL, sputum, stool, blood, etc.). These are collected as Lab-panel so we mapped to LB. These tests have ‘SEROLOGY’ as LBCAT on CRF form. | Sent to microbiology team for review. Do not add. Use MBTEST = SARS-CoV-2 RNA; MBTESTCD = SAR2RNA (this is a newly approved MBTEST-CD term in package 43, not published yet), PCR should be mapped to MBMETHOD. TSTDTL could be either 'CYCLE THRESHOLD' or 'VIRAL LOAD' depending upon how the test is being assessed. | n/a | ||||||||
| MBTEST-CD | Do not add; use MBTEST = SARS-CoV-2 RNA; MBTESTCD = SAR2RNA (will be published) | Requested by SmithaK via email: SARS-CoV-2 PCR – quantitative SK: These are for VIRAL DETECTION (Results are more like POSITIVE or NEGATIVE with some quantitative results ). On CRF, I see specimen source as ‘ (e.g. nasopharynx, oropharynx, BAL, sputum, stool, blood, etc.). These are collected as Lab-panel so we mapped to LB. These tests have ‘SEROLOGY’ as LBCAT on CRF form. | Sent to microbiology team for review. Do not add. Use MBTEST = SARS-CoV-2 RNA; MBTESTCD = SAR2RNA (this is a newly approved MBTEST-CD term in package 43, not published yet), PCR should be mapped to MBMETHOD. TSTDTL could be either 'CYCLE THRESHOLD' or 'VIRAL LOAD' depending upon how the test is being assessed. | n/a | ||||||||
| MBTEST-CD | SARSCOV2 | Severe Acute Resp Syndrome Coronavirus 2 | Severe Acute Resp Syndrome Coronavirus 2; Severe Acute Respiratory Syndrome Coronavirus 2 | A measurement of the severe acute respiratory syndrome Coronavirus 2 in a biological specimen. | Example: Virus Identification | This is in P42 public review but we can expedite its publication with this batch. | 1 | |||||
| MBTEST-CD | Do not add. This is too non-specific as a test. Should use the more specific test related to the microorganism infecting the mother. | From WHO ISARIC Annotated CRF: Demographics tab: Acute Respiratory Infection/ARI | n/a | |||||||||
| MBTEST-CD | CRONAVIR | Coronaviridae | Coronaviridae | A measurement of the coronaviridae in a biological specimen. A measurement of the coronaviridae in a biological specimen. | From WHO ISARIC Annotated CRF: Pathogen Testing Tab | New term request; existing term CORONAVIRIDAE exists for non-specified CoV in the microorganism codelist, but NOT in the MBTEST/CD codelists | 1 | |||||
| MBTEST-CD | RSV | Respiratory Syncytial Virus | Respiratory Syncytial Virus | A measurement of the respiratory syncitial virus in a biological specimen. | From WHO ISARIC Annotated CRF: Pathogen Testing Tab | 1 | ||||||
| MBTEST-CD | ADENOVIR | Adenoviridae | Adenoviridae; Adenovirus | A measurement of the adenoviridae in a biological specimen. | From WHO ISARIC Annotated CRF: Pathogen Testing Tab | 1 | ||||||
| LBTEST-CD | Do not add. Map to C60832 - Already published | Requested by SmithaK via email: Oxygen Saturation: (PaO2) | Sent to lab team for discussion Do not add. This is a synonym to Partial Pressure Oxygen/PO2/C71251. LOINC code = 11556-8 if measured in blood. LOINC code = 2703-7 if measured in arterial blood. | n/a | ||||||||
| LBTEST-CD | Do not add. Map to C71251 - Already published | Requested by SmithaK via email: Oxygen Saturation: (PaO2) | Sent to lab team for discussion Do not add. This is a synonym to Partial Pressure Oxygen/PO2/C71251. LOINC code = 11556-8 if measured in blood. LOINC code = 2703-7 if measured in arterial blood. | n/a | ||||||||
| LBTEST-CD | FLUIDOUT | Fluid Output | Fluid Output | A measurement of the total volume of fluid discharged over a set period of time. | CNEW Request by RebeccaB from the WHO CRF in the vital signs section: "urine flow rate (per hour)" | Lab leadership team agrees that this belongs in LB (considered VS but ultimately chose LB) with a LBTEST of Fluid Output, LBTESTCD of FLUIDOUT, SPEC of URINE, and unit of measure of mL/day. This could map to LOINC 9192-6 if we choose to put LOINC into the example. Lab team agrees to add as an LBTEST and finalizes the definition | 1 | |||||
| SCTEST-CD | INL1YIND | Infant Less Than One Year Indicator | Infant Less Than One Year Indicator | An indication as to whether the subject is less than one year of age. | From WHO ISARIC Annotated CRF: Demographics tab | 1 | ||||||
| SCTEST-CD | ADEVAIND | Appropriate Developmental Age Indicator | Appropriate Developmental Age Indicator; Appropriate Development For Age Indicator | An indication as to whether the subject's chronological age matches their physical, emotional, social, and cognitive functioning. | From WHO ISARIC Annotated CRF: Demographics tab | 1 | ||||||
| RETEST-CD | INTP | Interpretation | Interpretation | An act or process of elucidation; explication, or explanation of the meaning of the event or thing via the assignment of objects from the domain to the constants of a formal language, truth-values to the proposition symbols, truth-functions to the connectives, other functions to the function symbols, and extensions to the predicates, if any. The assignments are result of human logic application and are not native to the symbols of the formal language. | C41255 Imaging – CT Scans, Chest X-Rays (under review through 8 Apr) | general team agrees to add | 1 | |||||
| RETEST-CD | PNEUMIND | Pneumonia Indicator | Pneumonia Indicator | An indication as to whether pneumonia has occurred. | CNEW Imaging – CT Scans, Chest X-Rays (under review through 8 Apr) | General team agrees to ad | 1 | |||||
| RETEST-CD | INFLTIND | Infiltrates Indicator | Infiltrates Indicator | An indication as to whether infiltrates have occurred. | CNEW Imaging – CT Scans, Chest X-Rays (under review through 8 Apr) | General team agrees to ad | 1 | |||||
| VSTEST-CD | CPLRFLT | Capillary Refill Time | Capillary Refill Time | The amount of time it takes for a capillary bed to refill with blood after pressure blanching. | C168165 Example: Vital Signs and Urine Output | Team agrees to add to VS. Team changes TESTCD to CPLRFLT. | 1 | |||||
| TSPARM-CD | EPDISIND | Epi/Pandemic Related Disruption Ind | Epi/Pandemic Related Disruption Ind; Epidemic Related Disruption Indication | An indication as to whether the study disruption was caused by the epidemic or pandemic. | Trial Summary to Provide Pandemic Relationship | Agree to add and update PARM value to be more inclusive of both epidemics and pandemics. | 1 | |||||
| TSPARM-CD | EPIDEMIC | Name of Epi/Pandemic | Name of Epi/Pandemic; Name of Epidemic and/or Pandemic | The literal identifier of the epidemic or pandemic. | Trial Summary to Provide Pandemic Relationship | Agree to add and update PARM value to be more inclusive of both epidemics and pandemics. | 1 |
Existing Codelist New Term
| Codelist Name | CDISC Submission Value | CDISC Synonym(s) | CDISC Definition | Examples of how this new request will be used | Current Status | Team Notes and Discussion | Batch # | Date Submitted to CDISC CT | Package Number | Final Status | Final Implementation Date |
|---|---|---|---|---|---|---|---|---|---|---|---|
| METHOD | Requested by Jozef via new term request system (CDISC-4243): NUCLEIC ACID AMPLIFICATION TEST – PRIMER-PROBE SET N1 | 31 Mar 2020 Sent to PGx team for discussion. Primer Probe Sets go into Device domain yes? | |||||||||
| METHOD | Requested by Jozef via new term request system (CDISC-4243): NUCLEIC ACID AMPLIFICATION TEST – PRIMER-PROBE SET N2 | Sent to PGx team for discussion. Primer Probe Sets go into Device domain yes? | |||||||||
| METHOD | VISUAL ANALOG SCALE (100 MM) | VAS (100 mm) | A questionnaire, rating and scale (QRS) data type using a visual analog scale (VAS) 100 mm scale. | C158268 | Currently published in QRSMETHOD codelist. Add into Method | 1 | |||||
| METHOD | VISUAL ANALOG SCALE (50 MM) | VAS (50 mm) | A questionnaire, rating and scale (QRS) data type using a visual analog scale (VAS) 50 mm scale. | C158269 | Currently published in QRSMETHOD codelist. Add into Method | 1 | |||||
| PROCEDUR | X-RAY | Static X-Ray | A radiographic procedure using the emission of x-rays, a type of penetrating energy wave. | C38101 Imaging – CT Scans, Chest X-Rays (under review through 8 Apr) | Currently in METHOD codelist; add to PROCEDUR codelist | 1 | |||||
| PROCEDUR | RENAL REPLACEMENT THERAPY | RRT | Any of the methods used to supplement or substitute for the blood-filtering function of the kidneys. | C126400 | Agree to add NCI Definition: Treatments that substitute for the blood-filtering function of the kidneys. It includes dialysis (hemodialysis or peritoneal dialysis), hemofiltration, and hemodiafiltration. Kidney transplant may also be considered a renal replacement therapy. | 1 | |||||
| PROCEDUR | HIGH-FLOW NASAL CANNULA OXYGEN THERAPY | HFNC Oxygen Therapy | The delivery of heated, humidified, oxygen enriched gas via nasal cannula at flow rates greater than those typically delivered by standard-flow oxygen devices. | CNEW | Agree to add | 1 | |||||
| PROCEDUR | NON-INVASIVE MECHANICAL VENTILATION | Non-Invasive Ventilation; NIV | A type of mechanical ventilation procedure that uses a non-invasive means, such as a face mask or nasal mask, to deliver oxygenated air into the lungs. | CNEW | Agree to add | 1 | |||||
| PROCEDUR | MECHANICAL VENTILATION | A procedure that mechanically assists or replaces spontaneous breathing in patients by use of a powered device that forces oxygenated air into the lungs. | C70909 | Agree to add | 1 | ||||||
| PROCEDUR | CONTINUOUS POSITIVE AIRWAY PRESSURE VENTILATION | CPAP Ventilation | A type of non-invasive mechanical ventilation procedure that uses continuous positive airway pressure to support spontaneous breathing activity. | C124040 | Agree to add | 1 | |||||
| PROCEDUR | BILEVEL POSITIVE AIRWAY PRESSURE VENTILATION | BPAP Ventilation | A type of non-invasive mechanical ventilation procedure that that uses bilevel positive airway pressure to support spontaneous breathing activity. | CNEW Assisted Ventilation and Oxygen Treatments A form of non-invasive mechanical pressure support ventilation that uses a bilevel positive airway pressure level to support spontaneous breathing activity. | Agree to add | 1 | |||||
| PROCEDUR | TRACHEOSTOMY | Tracheotomy | Creation of a surgical opening into the trachea. | C15341 | Agree to add | 1 | |||||
| PROCEDUR | EXTRACORPOREAL MEMBRANE OXYGENATION | ECMO | A technique that utilizes a device to pump a patient's blood outside of the body, oxygenate it, and return it to the body. | CNEW | Agree to add | 1 | |||||
| MICROORG | SARS-COV-2 | Severe Acute Respiratory Syndrome Coronavirus 2; 2019-nCoV; COVID-19 Virus; SARS2 | Any viral organism that can be assigned to the species severe acute respiratory syndrome Coronavirus 2. | This is in P42 public review but we can expedite its publication with this batch. | 1 | ||||||
| CDISC-Glossary | pandemic | An epidemic occurring worldwide, or over a very wide area, crossing international boundaries, and usually affecting a large number of people. [A dictionary of epidemiology, edited for the International Epidemiological Association by John M. Last, Oxford University Press 2001] | Glossary team final | 1 | |||||||
| CDISC-Glossary | epidemic | The occurrence in a community or region of cases of an illness, specific health-related behavior, or other health-related events clearly in excess of normal expectancy. NOTE The community or region and the period in which the cases occur are specified precisely. The number of cases indicating the presence of an epidemic varies according to the agent, size, and type of population exposed; previous experience or lack of exposure to the disease; and time and place of occurrence. [After A dictionary of epidemiology, edited for the International Epidemiological Association by John M. Last, OXFORD UNIVERSITY PRESS 2001] | Glossary team final | 1 | |||||||
| CDISC-Glossary | endemic disease | The constant presence of a disease or infectious agent within a given geographic area or population group; may also refer to the usual prevalence of a given disease within such area or group. [A dictionary of epidemiology, edited for the International Epidemiological Association by John M. Last, Oxford University Press 2001] | Glossary team final | 1 | |||||||
| CDISC-Glossary | immediately life-threatening disease or condition | A stage of disease in which there is reasonable likelihood that death will occur within a matter of months, or in which premature death is likely without early treatment. [21 CFR 312.300] | Glossary team final | 1 | |||||||
| CDISC-Glossary | medical countermeasure | Pharmaceutical products, such as vaccines, antimicrobials, and antitoxins, and nonpharmaceutical products, such as ventilators, diagnostic tests, personal protective equipment (PPE), and patient (also general) decontamination materials, that may be used to prevent, mitigate, or treat the adverse health effects from a public health emergency. [After National Health Security Strategy 2019-2022] | Glossary team final | 1 | |||||||
| CDISC-Glossary | morbidity rate | A measure of the frequency of occurrence of a specific illness in a defined population during a specified interval. [After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics] | Glossary team final | 1 | |||||||
| CDISC-Glossary | mortality rate | A measure of the frequency of occurrence of death in a well defined population during a specified interval. [After Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics] | Glossary team final | 1 | |||||||
| CDISC-Glossary | pre-approval access | Expanded Access; Compassionate Use | A potential pathway for a patient with an immediately life-threatening condition or serious disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. NOTE: The intent is treatment, as opposed to research. Individual, Intermediate-size, and Widespread Use Expanded Access, also Emergency IND, are all programs administered under FDA guidelines. Additionally, the US Right-to-Try Act, which is independent of FDA, expands access. [FDA Expanded Access: Information for Physicians] | Glossary team final | 1 | ||||||
| CLMETH | ASPIRATION | A technique in which suction is used to remove bodily fluid or tissue. | C15631 Removed from TAUG example but will keep in CT package as this is a valid specimen collection method. | lab team agrees to add. EM to do some work on NCI defs in Protege. | 1 | ||||||
| SPECTYPE | ENDOTRACHEAL FLUID | ETA Fluid; Endotracheal Aspirate Fluid | The fluid collected from the lumen of the trachea. | C13722 | Team discusses whether to use Sputum, Mucus, or Endotracheal Aspirate. CDC and HL7 do use ETA as a distinct specimen type. We think Mucus is not right because it is a component of what is being collected but not the entirety. EVS SME suggests endotracheal aspirate fluid is most correct though sputum could be used. Team ultimately agree to add Endotracheal Fluid as the submission value. We will add the HL7/CDC terms as synonyms to help with mapping. | 1 | |||||
| RACEC | WEST ASIAN | A person having origins in any of the original peoples of the Western Asia. | C153343 | 1 | |||||||
| RACEC | LATIN AMERICAN | A person of Latin American descent. | C126531 From WHO ISARIC annotated CRF: Demographics This term is currently in the Ethnicity as collected codelist. Could this be in both places? | ** | |||||||
| RACEC | ABORIGINAL/FIRST NATION | CNEW This is an overloaded concept. 'First Nation' appears to be used nearly exclusively for Canadian Aboriginals while 'Aboriginals' may also be used for Australian Aboriginals. What is this concept supposed to be capturing? What did WHO mean by this? Any and all aboriginal peoples from anywhere? | ** |
New Codelist Test Name_Code
| Codelist Name | Codelist Description | CDISC Submission Value Test Code | CDISC Submission Value Test Name | CDISC Synonym(s) | CDISC Definition | Examples of how this new request will be used | Current Status | Team Notes and Discussion | Batch # | Date Submitted to CDISC CT | Package Number | Final Status | Final Implementation Date |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
C19FAT-CD/COVID-19 Findings About Test Name/Code | Terminology relevant to the test codes/names that describe findings about COVID-19 related events or interventions. | OCCUR | Occurrence Indicator | Occurrence Indicator | An indication as to whether something has happened, such as an event or incident. | C127786 | agree to add | 1 | |||||
| C19FAT-CD/COVID-19 Findings About Test Name/Code | EPSDNUM | Number of Episodes | Number of Episodes | The total number of episodes that have occurred for the condition. | C124281 | agree to add | 1 | ||||||
| C19FAT-CD/COVID-19 Findings About Test Name/Code | SEV | Severity/Intensity | Severity/Intensity | The degree of something undesirable. | C25676 | agree to add | 1 |
New Codelist New Term
| Codelist Name | Codelist Description | CDISC Submission Value | CDISC Synonym(s) | CDISC Definition | Examples of how this new request will be used | Current Status | Team Notes and Discussion | Batch # | Date Submitted to CDISC CT | Package Number | Final Status | Final Implementation Date |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HODECOD/Health Care Encounters Dictionary Derived Term | A terminology codelist based on the standardized or preprinted name of the healthcare encounter that occurs. | HOSPITAL STAY | Inpatient Hospitalization; Inpatient Hospital Stay | The subject or patient has been admitted as an inpatient to a hospital. | C25179 | Team agrees to create a codelist to support HODECOD. General team agrees on the semantics. | 1 | |||||
| HODECOD | INTENSIVE CARE UNIT STAY | ICU Stay | The subject or patient has been admitted as an inpatient to a intensive care unit. | Hospitalization | Team agrees to create a codelist to support HODECOD. General team agrees on the semantics. | 1 | ||||||
| HODECOD | CARDIAC INTENSIVE CARE UNIT STAY | CICU Stay; Coronary Intensive Care Unit Stay | The subject or patient has been admitted as an inpatient to a cardiac intensive care unit. | From SDTMIG | General team agrees on the semantics. | 1 | ||||||
| HODECOD | SURGICAL INTENSIVE CARE UNIT STAY | SICU Stay | The subject or patient has been admitted as an inpatient to a surgical intensive care unit. | From SDTMIG | General team agrees on the semantics. | 1 | ||||||
| HODECOD | NEURO INTENSIVE CARE UNIT STAY | Neuro-ICU Stay; Neuro-Trauma ICU Stay | The subject or patient has been admitted as an inpatient to a neuro-intensive care unit. | From SDTMIG | General team agrees on the semantics. | 1 | ||||||
| HODECOD | NURSING HOME STAY | The subject or patient has been admitted as an inpatient to a nursing home. | From SDTMIG | General team agrees on the semantics. | 1 | |||||||
| HODECOD | GENERAL WARD STAY | General Medical Unit Stay | The subject or patient has been admitted as an inpatient to a general medical unit of a hospital. | From SDTMIG | General team agrees on the semantics. | 1 | ||||||
| HODECOD | REHABILITATION FACILITY STAY | The subject or patient has been admitted as an inpatient to a rehabilitation facility. | From SDTMIG | General team agrees on the semantics. | 1 | |||||||
| HODECOD | CARDIAC CATHETERIZATION LABORATORY VISIT | The subject or patient has been admitted as an outpatient to a cardiac catheterization laboratory. | From SDTMIG | General team agrees on the semantics. | 1 | |||||||
| HODECOD | PHYSICAL THERAPY FACILITY VISIT | The subject or patient has been admitted as an outpatient to a physical therapy facility. | From TAUG-Schizophrenia | General team agrees on the semantics. | 1 | |||||||
| HODECOD | SKILLED NURSING FACILITY STAY | The subject or patient has been admitted as an inpatient to a skilled nursing facility. | General team agrees on the semantics. | 1 | ||||||||
| HODECOD | PSYCHIATRIC WARD STAY | The subject or patient has been admitted as an inpatient to a psychiatric ward. | General team agrees on the semantics. | 1 | ||||||||
| HODECOD | TELEHEALTH VISIT | The subject or patient has interacted with a healthcare professional remotely, via telecommunication. | General team agrees on the semantics. | 1 | ||||||||
| CNTMODE/Mode of Subject Contact | Terminology relevant to the means by which interaction occurs between the subject and person or entity. | REMOTE AUDIO | A form of remote communication by audio technology. | General team agrees. Erin update submission value in examples. | 1 | |||||||
| CNTMODE | REMOTE AUDIO VIDEO | A form of remote communication by audio video technology. | Audio is not always assumed to be part of video. We think the submission value in red is a better option. General team agrees. Erin update submission value in examples. | 1 | ||||||||
| CNTMODE | TELEPHONE CALL | Communication by way of telephone. | C50212 | Team agrees to add. This is a type of REMOTE AUDIO. Otherwise the example could re-use REMOTE AUDIO as above. Telephone Call is a type of Remote Audio. | 1 | |||||||
| CNTMODE | SHIPMENT CONFIRMED BY SIGNATURE | Receipt of shipped material was confirmed by signature. | CNEW Ex. Drug Accountability Disruption Signature attained that confirms material was shipped to and received by the subject. | General team does not agree that this term belongs in this codelist. The methodology by which you contacted a person seems different than the methodology used to send the tablets to the subject. General team agrees to the updated term and definition. | 1 |
Changes to Existing Terms
| Code | Codelist Name | CDISC Submission Value | CDISC Synonym(s) | CDISC Definition | Reason for Change | Current Status | Team Notes and Discussion | Batch # | Date Submitted to CDISC CT | Package Number | Final Status | Final Implementation Date |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| C38082 | Laboratory Test Code | FIO2 | Fraction of Inspired Oxygen | A relative measurement (ratio or percentage) of the amount of oxygen in the arterial blood to the total oxygen in the inspired air. A measurement of the volumetric fraction of oxygen in the inhaled gas. | Existing definition sounded like FIO2/PAO2 which we have defined elsewhere. | Lab team agrees to update. | 1 | |||||
| C38082 | Laboratory Test Name | Fraction of Inspired Oxygen | Fraction of Inspired Oxygen | A relative measurement (ratio or percentage) of the amount of oxygen in the arterial blood to the total oxygen in the inspired air. A measurement of the volumetric fraction of oxygen in the inhaled gas. | Existing definition sounded like FIO2/PAO2 which we have defined elsewhere. | Lab team agrees to update. | 1 | |||||
| C71251 | Laboratory Test Code | PO2 | Partial Pressure Oxygen; PaO2; pO2 | A measurement of the pressure of oxygen in a biological specimen. | Update to synonyms for easier mapping | Lab team agrees to update. | 1 | |||||
| C71251 | Laboratory Test Name | Partial Pressure Oxygen | Partial Pressure Oxygen; PaO2; pO2 | A measurement of the pressure of oxygen in a biological specimen. | Update to synonyms for easier mapping | Lab team agrees to update. | 1 | |||||
| C67410 | PK Units of Measure | mL/day | mL/24h | A unit of flow rate equal to one milliliter per day. | Update to synonyms for easier mapping | agree to update to conform with WHO CRF. | 1 | |||||
| C67410 | Unit | mL/day | mL/24h | A unit of flow rate equal to one milliliter per day. | Update to synonyms for easier mapping | agree to update to conform with WHO CRF. | 1 |
QRS Content
| Codelist Name | Codelist Description | CDISC Submission Value Test Code | CDISC Submission Value Test Name | CDISC Synonym(s) | CDISC Definition | Examples of how this new request will be used | Current Status | Team Notes and Discussion | Batch # | Date Submitted to CDISC CT | Package Number | Final Status | Final Implementation Date |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| NEWS2 | Terminology finalized and ready for processing. See Excel file below.
| 1 | |||||||||||
| ACVPU | Discussion today about adding this to QRS CT. This is a new scale, not the existing AVPU scale. |
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