ID

37789

Beskrivning

Sentinel: Overview and Description of the Common Data Model v7.0.0: "The primary goal of Sentinel is to build and operate a national public health surveillance system to monitor the safety of FDA-regulated medical products, including drugs, biologics, and devices. Sentinel is part of the Sentinel Initiative, the FDA’s response to a congressional mandate to create an active surveillance system using electronic health data.The Sentinel program will undertake three major types of activities: (1) prospective evaluation of accumulating experience about specific medical products and specific suspected safety problems; (2) evaluation of the impact of FDA actions (e.g., labeling changes) on medical practice and health outcomes; and (3) rapid assessment of past experience in response to FDA questions about specific exposures and outcomes." For more information about Sentinel visit the website at: www.sentinelsystem.org For comments and suggestions, please email: info@sentinelsystem.org The SCDM Demographic Table contains one record per PatID with the most recent information on birth date, sex, race/ethnicity, and ZIP code.

Länk

www.sentinelsystem.org

Nyckelord

Versioner (1)
  1. 2019-08-25 2019-08-25 -
Rättsinnehavare

FDA's Sentinel Initiative

Uppladdad den

25 augusti 2019

DOI

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Licens

Creative Commons BY-NC-ND 3.0
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Sentinel Common Data Model

Engelsk

Inpatient Tranfusion

1 Formulär  
  1. StudyEvent: ODM
    1. Inpatient Tranfusion
Inpatient Transfusion
Beskrivning

Inpatient Transfusion

Alias
UMLS CUI-1
C0021562
UMLS CUI-2
C0005841
Patient ID
Beskrivning

Arbitrary person-level identifier. Used to link across tables. A new enrollment period generates a new record, but the same person should have the same PatID on subsequent records. Note: PatID is a pseudoidentifier with a consistent crosswalk to the true identifier retained by the source Data Partner. For analytical data sets requiring patient-level data, only the pseudoidentifier is used to link across all information belonging to a patient.

Datatyp

text

Alias
UMLS CUI [1]
C2348585
Encounter ID
Beskrivning

A unique combination of PatID, ADate, Provider and EncType. Used to link the Encounter, Diagnosis, and Procedure tables. Note: Medical utilization data is captured in 3 tables: Encounter: the encounter record that characterizes the outpatient visit or hospital stay Diagnosis: the diagnosis or other clinical code(s) associated with the encounter record Procedure: the procedure code(s) associated with the encounter record These 3 tables and the Inpatient Pharmacy, Inpatient Transfusion, and Vital Signs table are linked by EncounterID. All diagnoses and procedures for an encounter should have the same EncounterID. It is allowable to have "orphan" diagnosis or procedure records with EncounterIDs that do not have a match in the Encounter table.

Datatyp

text

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C1300638
Transfusion ID
Beskrivning

Unique transfusion administration identifier. Retain b/c useful to map back to source data

Datatyp

text

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C0600091
Transfusion Code
Beskrivning

Code value for an infusion product. Must be paired with the correct TransCode_Type

Datatyp

text

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C0805701
Transfusion Code Type
Beskrivning

Transfusion product code type. This variable combined with the TransCode variable should be used to capture any type of Inpatient Infusion product in the source data. Other code types will be added as new terminologies are used.

Datatyp

text

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C0805701
UMLS CUI [1,3]
C0332307
Original Transfusion Product
Beskrivning

Original product name/mneumonic. Name of product within Data Partner

Datatyp

text

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C0205313
UMLS CUI [1,3]
C1514468
Blood Type
Beskrivning

Blood type and Rh factors, left-justified. Convert any text Rh factor to symbols (e.g., “pos” to “+”, “negative” to “-“). Rh factor can be blank. A, B, O, AB (upper case) with RH factor (+, -, or null only). Example: AB+

Datatyp

text

Alias
UMLS CUI [1]
C0005810
Transfusion Start Date
Beskrivning

Administration start date.

Datatyp

date

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C0808070
Transfusion Start Time
Beskrivning

Administration start time

Datatyp

time

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C1301880
Transfusion End Date
Beskrivning

Administration end date

Datatyp

date

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C0806020
Transfusion End Time
Beskrivning

Administration end time

Datatyp

time

Alias
UMLS CUI [1,1]
C0005841
UMLS CUI [1,2]
C1522314
Encounter Type
Beskrivning

Ambulatory Visit = Includes visits at outpatient clinics, same day surgeries, urgent care visits, and other same-day ambulatory hospital encounters, but excludes emergency department encounters. Emergency Department = Includes ED encounters that become inpatient stays (in which case inpatient stays would be a separate encounter). Excludes urgent care visits. ED claims should be pulled before hospitalization claims to ensure that ED with subsequent admission won't be rolled up in the hospital event. Inpatient Hospital Stay = Includes all inpatient stays, same-day hospital discharges, hospital transfers, and acute hospital care where the discharge is after the admission date. Non-Acute Institutional Stay = Includes hospice, skilled nursing facility (SNF), rehab center, nursing home, residential, overnight non-hospital dialysis and other non-hospital stays. Other Ambulatory Visit = Includes other non overnight AV encounters such as hospice visits, home health visits, skilled nursing facility visits, other non-hospital visits, as well as telemedicine, telephone and email consultations.

Datatyp

text

Alias
UMLS CUI [1,1]
C0545082
UMLS CUI [1,2]
C0332307
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Similar models

Inpatient Tranfusion

1 Formulär
  1. StudyEvent: ODM
    1. Inpatient Tranfusion
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Inpatient Transfusion
C0021562 (UMLS CUI-1)
C0005841 (UMLS CUI-2)
PatID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
EncounterID
Item
Encounter ID
text
C1512346 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
TransID
Item
Transfusion ID
text
C0005841 (UMLS CUI [1,1])
C0600091 (UMLS CUI [1,2])
TransCode
Item
Transfusion Code
text
C0005841 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
Item
Transfusion Code Type
text
C0005841 (UMLS CUI [1,1])
C0805701 (UMLS CUI [1,2])
C0332307 (UMLS CUI [1,3])
Transfusion Code Type
Code List
Transfusion Code Type
CL Item
CODABAR (CD)
CL Item
ISBT (IS)
Orig_TransProd
Item
Original Transfusion Product
text
C0005841 (UMLS CUI [1,1])
C0205313 (UMLS CUI [1,2])
C1514468 (UMLS CUI [1,3])
BloodType
Item
Blood Type
text
C0005810 (UMLS CUI [1])
TDate_Start
Item
Transfusion Start Date
date
C0005841 (UMLS CUI [1,1])
C0808070 (UMLS CUI [1,2])
TTime_Start
Item
Transfusion Start Time
time
C0005841 (UMLS CUI [1,1])
C1301880 (UMLS CUI [1,2])
TDate_End
Item
Transfusion End Date
date
C0005841 (UMLS CUI [1,1])
C0806020 (UMLS CUI [1,2])
TTime_End
Item
Transfusion End Time
time
C0005841 (UMLS CUI [1,1])
C1522314 (UMLS CUI [1,2])
Item
Encounter Type
text
C0545082 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Encounter Type
Code List
Encounter Type
CL Item
Emergency Department  (ED)
CL Item
Inpatient Hospital Stay (IP)
CL Item
Non-Acute Institutional Stay  (IS)
CL Item
Other Ambulatory Visit (OA)
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