ID

19535

Description

Sentinel: Overview and Description of the Common Data Model v6.0 "The primary goal of the Sentinel pilot 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." Sentinel Collaborating Institutions maintain data resources and provide technical, scientific, and methodological expertise as needed to meet the public health surveillance requirements of Sentinel. The Collaborating Institutions also participate as members of the Planning Board, the Safety Science Committee, the Sentinel Operations Center (SOC), and various Sentinel workgroups. Sentinel Common Data Model "The SOC Data Core coordinates the network of Sentinel Data Partners and leads development of the Sentinel Common Data Model (SCDM), a standard data structure that allows Data Partners to quickly execute distributed programs against local data. The SOC Scientific Systems Division manages creation of the Sentinel Distributed Database (SDD) using the SCDM, and maintains complete documentation of the implementation and characteristics of the SDD. The SDD refers to the data held and maintained by the Data Partners in the SCDM format. The SCDM was developed in accordance with the SCDM Guiding Principles and was modeled after the HMO Research Network Virtual Data Warehouse. The SCDM currently includes 13 tables that represent information for the data elements needed for Sentinel activities. Records are linked across tables by a unique person identifier, PatID. Details of the 13 tables are provided in this document. An additional 13 Summary Tables are created from the ""parent tables"" and are also described in this document. Revisions and enhancements to the SCDM are expected, including the addition of clinical information, incorporation of other data types and sources, and revisions based on lessons learned from use of the SDD. This may include adopting variables and formats developed by other programs." This data model is freely available to all. For more information about Sentinel visit the website at: www.sentinelsystem.org For comments and suggestions, please email: info@sentinelsystem.org

Lien

www.sentinelsystem.org

Mots-clés

Versions (5)
  1. 07/01/2017 07/01/2017 -
  2. 29/01/2017 29/01/2017 -
  3. 15/01/2019 15/01/2019 - Sarah Riepenhausen
  4. 02/09/2019 02/09/2019 -
  5. 02/09/2019 02/09/2019 -
Téléchargé le

7 janvier 2017

DOI

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Licence

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

Anglais

Sentinel Common Data Model Enrollment

1 Formulaires  
Enrollment
Description

Enrollment

Alias
UMLS CUI-1
C1516879
Patient ID
Description

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.

Type de données

text

Alias
UMLS CUI [1]
C2348585
Enrollment Start
Description

Date of the beginning of the enrollment period. If the exact date is unknown, use the first day of the month. Enr_Start should not be before January 1, 2000. Note: Adjacent and overlapping enrollment periods with the same PatID, Enr_Start, Enr_End, MedCov, DrugCov, and Chart values should be collapsed. Enrollment periods separated by more than one day should not be bridged. For example, an Enr_End date of 1/31/2005 should be bridged with an Enr_Start date of 2/1/2005, but should not be bridged with an Enr_Start date of 2/2/2005.

Type de données

date

Alias
UMLS CUI [1]
C0808070
Enrollment End
Description

Date of the end of the enrollment period. If the exact date is unknown, use the last day of the month. Note: Adjacent and overlapping enrollment periods with the same PatID, Enr_Start, Enr_End, MedCov, DrugCov, and Chart values should be collapsed. Enrollment periods separated by more than one day should not be bridged. For example, an Enr_End date of 1/31/2005 should be bridged with an Enr_Start date of 2/1/2005, but should not be bridged with an Enr_Start date of 2/2/2005. Enr_End should not be imputed using the date of death found in the Death table.

Type de données

date

Alias
UMLS CUI [1]
C0806020
Medical Care
Description

Mark as "Y" if the health plan has any responsibility for covering medical care for the member during this enrollment period (i.e., if you expect to observe medical care provided to this member during the enrollment period).

Type de données

integer

Alias
UMLS CUI [1]
C0496675
Drugs
Description

Mark as "Y" if the health plan has any responsibility for covering outpatient prescription drugs for the member during this enrollment period (i.e., if you expect to observe outpatient pharmacy dispensings for this member during this enrollment period).

Type de données

integer

Alias
UMLS CUI [1]
C0013227
Are you able to request charts for this member?
Description

Chart abstraction flag to answer the question, "Are you able to request charts for this member?" This flag does not address chart availability. Mark as "Y" if there are no contractual restrictions between you and the member (or sponsor) that would prohibit you from requesting any chart for this member. Note: "Chart variable aims to identify enrollment periods for which medical charts cannot be requested. Potential scenarios include: 1) Charts cannot be requested for Medicare members (all enrollment periods for Medicare members should be assigned Chart='N') 2) Charts cannot be requested for administrative services only (ASO) populations (all ASO enrollment periods should be assigned Chart='N') If there is no definitive information indicating that medical charts cannot be requested for member enrollment period(s), records should be assigned Chart = 'Y'.

Type de données

integer

Alias
UMLS CUI [1]
C3869736
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Similar models

Sentinel Common Data Model Enrollment

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
Enrollment
C1516879 (UMLS CUI-1)
Patient ID
Item
Patient ID
text
C2348585 (UMLS CUI [1])
Start Date
Item
Enrollment Start
date
C0808070 (UMLS CUI [1])
End Date
Item
Enrollment End
date
C0806020 (UMLS CUI [1])
Item
Medical Care
integer
C0496675 (UMLS CUI [1])
Medical Care
Code List
Medical Care
CL Item
"Y"es (1 )
CL Item
"N"o (2 )
CL Item
"U"nknown (3 )
Item
Drugs
integer
C0013227 (UMLS CUI [1])
Drugs
Code List
Drugs
CL Item
"Y"es (1 )
CL Item
"N"o (2 )
CL Item
"U"nknown (3 )
Item
Are you able to request charts for this member?
integer
C3869736 (UMLS CUI [1])
Able to request or review patient chart
Code List
Are you able to request charts for this member?
CL Item
"Y"es (1 )
CL Item
"N"o (2 )
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