ID

37793

Description

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 One record per unique combination of PatID, NDC, RxADate, RxATime. Each record represents a unique inpatient pharmacy dispensing. Note: Only one Sentinel Data Partner is expected to populate the Inpatient Pharmacy Table.

Lien

www.sentinelsystem.org

Mots-clés

Versions (3)
  1. 29/01/2017 29/01/2017 -
  2. 25/08/2019 25/08/2019 -
  3. 25/08/2019 25/08/2019 -
Détendeur de droits

FDA's Sentinel Initiative

Téléchargé le

25 août 2019

DOI

Pour une demande vous connecter.

Licence

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

Anglais

Sentinel Common Data Model Inpatient Pharmacy

1 Formulaires  
Inpatient Pharmacy
Description

Inpatient Pharmacy

Alias
UMLS CUI-1
C3242769
Patient ID
Description

Arbitrary person-level identifier. Used to link across tables. Derivative of HCA Patient Account Number. 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.

Type de données

text

Alias
UMLS CUI [1]
C2348585
Encounter ID
Description

A unique combination of PatID, ADate, Provider and EncType. Used to link the Encounter, Diagnosis, Procedure, Inpatient Pharmacy, Inpatient Transfusion, and Vital Signs tables. Note: The Encounter, Diagnosis, Procedure, Inpatient Transfusion, Inpatient Pharmacy, and Vital Signs tables are linked by EncounterID. All diagnoses and procedures for an encounter should have the same EncounterID.

Type de données

text

Alias
UMLS CUI [1,1]
C1512346
UMLS CUI [1,2]
C1300638
National Drug Code
Description

Please expunge any place holders (e.g., ‘-‘ or extra digit)

Type de données

text

Alias
UMLS CUI [1]
C1708005
Administration ID
Description

Useful to map back to source data

Type de données

text

Alias
UMLS CUI [1]
C3258054
Administration Date
Description

Rx Administration date

Type de données

date

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0011008
Administration time
Description

Rx Administration time

Type de données

time

Alias
UMLS CUI [1,1]
C1533734
UMLS CUI [1,2]
C0040223
Administration Route
Description

Actual/administered route. Standard list of allowable values under development.

Type de données

text

Alias
UMLS CUI [1]
C0013153
Dosage
Description

Numeric digits with or without a decimal. Actual/administered dose. Intended to be analyzed in conjunction with the RxUOM (unit of measure) field and product strength data associated with the NDC (available from drug databases). Format captures maximum # of whole and decimal digits allowed by software technology for numeric data.

Type de données

float

Alias
UMLS CUI [1]
C0178602
Unit of Measure
Description

Actual/administered unit of measure. Intended to be analyzed in conjunction with the RxDose field and product strength data associated with the NDC (available from drug databases). Standard list of allowable values under development.

Type de données

text

Alias
UMLS CUI [1]
C1519795
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Similar models

Sentinel Common Data Model Inpatient Pharmacy

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Inpatient Pharmacy
C3242769 (UMLS CUI-1)
PatID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
EncounterID
Item
Encounter ID
text
C1512346 (UMLS CUI [1,1])
C1300638 (UMLS CUI [1,2])
NDC
Item
National Drug Code
text
C1708005 (UMLS CUI [1])
RxID
Item
Administration ID
text
C3258054 (UMLS CUI [1])
RxADate
Item
Administration Date
date
C1533734 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
RxATime
Item
Administration time
time
C1533734 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
RxRoute
Item
Administration Route
text
C0013153 (UMLS CUI [1])
RxDose
Item
Dosage
float
C0178602 (UMLS CUI [1])
RxUOM
Item
Unit of Measure
text
C1519795 (UMLS CUI [1])
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