A COVID‐19‐ready public health surveillance system: The Food and Drug Administration's Sentinel System

The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national capability to assess post‐market medical product safety. Over more than a decade, Sentinel has become an integral part of FDA's surveil...

Full description

Saved in:
Bibliographic Details
Published inPharmacoepidemiology and drug safety Vol. 30; no. 7; pp. 827 - 837
Main Authors Cocoros, Noelle M., Fuller, Candace C., Adimadhyam, Sruthi, Ball, Robert, Brown, Jeffrey S., Dal Pan, Gerald J., Kluberg, Sheryl A., Lo Re, Vincent, Maro, Judith C., Nguyen, Michael, Orr, Robert, Paraoan, Dianne, Perlin, Jonathan, Poland, Russell E., Driscoll, Meighan Rogers, Sands, Kenneth, Toh, Sengwee, Yih, W. Katherine, Platt, Richard, Measer, Gregory, Cosgrove, Austin, Rosen, Edward, Haffenreffer, Katherine, Kempner, Maria, Back, Soowoo, Horgan, Casie, Jin, Robert, Draper, Christine, Lyons, Jennifer, Shinde, Mayura, Martinez, Ashley, Hou, Laura, Ko, Jenice, Burk, Jillian, Noble, Jennifer, Her, Meg, Kennedy, Adee, Reynolds, Juliane, Ehrmann, Max, Nolan, Bridget, Maynard, Amanda, Martin, Christopher, Nolan, Jamie, Peters, Alexander, Attaya, Samuel, Varma, Neha, Gowda, Abinav, Kolonoski, Joy, Richard, Julie E., Shockro, Laura, Contreras, Tawil, Halbig, Christine Lee, Coronel‐Moreno, Claudia, Nathwani, Neesha, Curtis, Linda, Mai, Alexander, Scarnecchia, Daniel, Nandyala, Sampada, Vigeant, Justin, Carter, Suzanne, Damon, Jolene, Mosley, Jolene, Billings, Monisha, Pratt, Natasha, Bradley, Marie C., Pishko, Allyson, Carbonari, Dena M., Hennessy, Sean, McLean, Laura, Klompas, Michael, Ochoa, Aileen
Format Journal Article
LanguageEnglish
Published Chichester, UK John Wiley & Sons, Inc 01.07.2021
Wiley Subscription Services, Inc
Subjects
COVID-19
electronic health records
Electronic medical records
Health surveillance
medical claims
Medical equipment
Pandemics
Public health
real‐time monitoring
real‐world data
Review
Reviews
surveillance
COVID-19
real-time monitoring
medical claims
real-world data
electronic health records
surveillance
Online AccessGet full text
ISSN1053-8569
1099-1557
1099-1557
DOI10.1002/pds.5240

Cover

Abstract The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national capability to assess post‐market medical product safety. Over more than a decade, Sentinel has become an integral part of FDA's surveillance capabilities and has been used to conduct analyses that have contributed to regulatory decisions. FDA's role in the COVID‐19 pandemic response has necessitated an expansion and enhancement of Sentinel. Here we describe how the Sentinel System has supported FDA's response to the COVID‐19 pandemic. We highlight new capabilities developed, key data generated to date, and lessons learned, particularly with respect to working with inpatient electronic health record data. Early in the pandemic, Sentinel developed a multi‐pronged approach to support FDA's anticipated data and analytic needs. It incorporated new data sources, created a rapidly refreshed database, developed protocols to assess the natural history of COVID‐19, validated a diagnosis‐code based algorithm for identifying patients with COVID‐19 in administrative claims data, and coordinated with other national and international initiatives. Sentinel is poised to answer important questions about the natural history of COVID‐19 and is positioned to use this information to study the use, safety, and potentially the effectiveness of medical products used for COVID‐19 prevention and treatment.
AbstractList The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national capability to assess post‐market medical product safety. Over more than a decade, Sentinel has become an integral part of FDA's surveillance capabilities and has been used to conduct analyses that have contributed to regulatory decisions. FDA's role in the COVID‐19 pandemic response has necessitated an expansion and enhancement of Sentinel. Here we describe how the Sentinel System has supported FDA's response to the COVID‐19 pandemic. We highlight new capabilities developed, key data generated to date, and lessons learned, particularly with respect to working with inpatient electronic health record data. Early in the pandemic, Sentinel developed a multi‐pronged approach to support FDA's anticipated data and analytic needs. It incorporated new data sources, created a rapidly refreshed database, developed protocols to assess the natural history of COVID‐19, validated a diagnosis‐code based algorithm for identifying patients with COVID‐19 in administrative claims data, and coordinated with other national and international initiatives. Sentinel is poised to answer important questions about the natural history of COVID‐19 and is positioned to use this information to study the use, safety, and potentially the effectiveness of medical products used for COVID‐19 prevention and treatment.
The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national capability to assess post‐market medical product safety. Over more than a decade, Sentinel has become an integral part of FDA's surveillance capabilities and has been used to conduct analyses that have contributed to regulatory decisions. FDA's role in the COVID‐19 pandemic response has necessitated an expansion and enhancement of Sentinel. Here we describe how the Sentinel System has supported FDA's response to the COVID‐19 pandemic. We highlight new capabilities developed, key data generated to date, and lessons learned, particularly with respect to working with inpatient electronic health record data. Early in the pandemic, Sentinel developed a multi‐pronged approach to support FDA's anticipated data and analytic needs. It incorporated new data sources, created a rapidly refreshed database, developed protocols to assess the natural history of COVID‐19, validated a diagnosis‐code based algorithm for identifying patients with COVID‐19 in administrative claims data, and coordinated with other national and international initiatives. Sentinel is poised to answer important questions about the natural history of COVID‐19 and is positioned to use this information to study the use, safety, and potentially the effectiveness of medical products used for COVID‐19 prevention and treatment.
The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national capability to assess post-market medical product safety. Over more than a decade, Sentinel has become an integral part of FDA's surveillance capabilities and has been used to conduct analyses that have contributed to regulatory decisions. FDA's role in the COVID-19 pandemic response has necessitated an expansion and enhancement of Sentinel. Here we describe how the Sentinel System has supported FDA's response to the COVID-19 pandemic. We highlight new capabilities developed, key data generated to date, and lessons learned, particularly with respect to working with inpatient electronic health record data. Early in the pandemic, Sentinel developed a multi-pronged approach to support FDA's anticipated data and analytic needs. It incorporated new data sources, created a rapidly refreshed database, developed protocols to assess the natural history of COVID-19, validated a diagnosis-code based algorithm for identifying patients with COVID-19 in administrative claims data, and coordinated with other national and international initiatives. Sentinel is poised to answer important questions about the natural history of COVID-19 and is positioned to use this information to study the use, safety, and potentially the effectiveness of medical products used for COVID-19 prevention and treatment.The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national capability to assess post-market medical product safety. Over more than a decade, Sentinel has become an integral part of FDA's surveillance capabilities and has been used to conduct analyses that have contributed to regulatory decisions. FDA's role in the COVID-19 pandemic response has necessitated an expansion and enhancement of Sentinel. Here we describe how the Sentinel System has supported FDA's response to the COVID-19 pandemic. We highlight new capabilities developed, key data generated to date, and lessons learned, particularly with respect to working with inpatient electronic health record data. Early in the pandemic, Sentinel developed a multi-pronged approach to support FDA's anticipated data and analytic needs. It incorporated new data sources, created a rapidly refreshed database, developed protocols to assess the natural history of COVID-19, validated a diagnosis-code based algorithm for identifying patients with COVID-19 in administrative claims data, and coordinated with other national and international initiatives. Sentinel is poised to answer important questions about the natural history of COVID-19 and is positioned to use this information to study the use, safety, and potentially the effectiveness of medical products used for COVID-19 prevention and treatment.
Author Rosen, Edward
Nathwani, Neesha
Ko, Jenice
Billings, Monisha
Maro, Judith C.
Hou, Laura
Kempner, Maria
Sands, Kenneth
Nolan, Bridget
Coronel‐Moreno, Claudia
Orr, Robert
Attaya, Samuel
Kluberg, Sheryl A.
Nguyen, Michael
Curtis, Linda
Scarnecchia, Daniel
Toh, Sengwee
Reynolds, Juliane
Varma, Neha
Dal Pan, Gerald J.
Lyons, Jennifer
Shinde, Mayura
Bradley, Marie C.
Carbonari, Dena M.
Ball, Robert
Haffenreffer, Katherine
Nandyala, Sampada
Platt, Richard
Paraoan, Dianne
Gowda, Abinav
Halbig, Christine Lee
Burk, Jillian
Mai, Alexander
Poland, Russell E.
Martinez, Ashley
Her, Meg
Klompas, Michael
Horgan, Casie
McLean, Laura
Contreras, Tawil
Perlin, Jonathan
Carter, Suzanne
Cosgrove, Austin
Draper, Christine
Jin, Robert
Richard, Julie E.
Cocoros, Noelle M.
Measer, Gregory
Noble, Jennifer
Martin, Christopher
Damon, Jolene
Ochoa, Aileen
Hennessy, Sean
Fuller, Candace C.
Back, Soowoo
Kennedy, Adee
Pratt, Natasha
Peters, Alexander
Ehrmann, Max
Maynard, Amanda
Nolan, Jamie
Pishko, Allyson
Vigeant, Justin
Adimadhyam, Sruthi
Mosley, Jolene
Shockro, Laura
Yih, W. Kath
AuthorAffiliation 1 Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute Boston Massachusetts USA
3 Division of Infectious Diseases, Department of Medicine, and Center for Pharmacoepidemiology Research and Training, Department of Biostatistics, Epidemiology, and Informatics Perelman School of Medicine, University of Pennsylvania Philadelphia Pennsylvania USA
4 HCA Healthcare Nashville Tennessee USA
2 US Food and Drug Administration Silver Spring Maryland USA
AuthorAffiliation_xml – name: 4 HCA Healthcare Nashville Tennessee USA
– name: 2 US Food and Drug Administration Silver Spring Maryland USA
– name: 3 Division of Infectious Diseases, Department of Medicine, and Center for Pharmacoepidemiology Research and Training, Department of Biostatistics, Epidemiology, and Informatics Perelman School of Medicine, University of Pennsylvania Philadelphia Pennsylvania USA
– name: 1 Department of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute Boston Massachusetts USA
Author_xml – sequence: 1
  givenname: Noelle M.
  orcidid: 0000-0001-7090-2761
  surname: Cocoros
  fullname: Cocoros, Noelle M.
  email: noelle_cocoros@harvardpilgrim.org
  organization: Harvard Medical School and Harvard Pilgrim Health Care Institute
– sequence: 2
  givenname: Candace C.
  surname: Fuller
  fullname: Fuller, Candace C.
  organization: Harvard Medical School and Harvard Pilgrim Health Care Institute
– sequence: 3
  givenname: Sruthi
  surname: Adimadhyam
  fullname: Adimadhyam, Sruthi
  organization: Harvard Medical School and Harvard Pilgrim Health Care Institute
– sequence: 4
  givenname: Robert
  orcidid: 0000-0002-1609-7420
  surname: Ball
  fullname: Ball, Robert
  organization: US Food and Drug Administration
– sequence: 5
  givenname: Jeffrey S.
  surname: Brown
  fullname: Brown, Jeffrey S.
  organization: Harvard Medical School and Harvard Pilgrim Health Care Institute
– sequence: 6
  givenname: Gerald J.
  surname: Dal Pan
  fullname: Dal Pan, Gerald J.
  organization: US Food and Drug Administration
– sequence: 7
  givenname: Sheryl A.
  surname: Kluberg
  fullname: Kluberg, Sheryl A.
  organization: Harvard Medical School and Harvard Pilgrim Health Care Institute
– sequence: 8
  givenname: Vincent
  orcidid: 0000-0001-7955-0600
  surname: Lo Re
  fullname: Lo Re, Vincent
  organization: Perelman School of Medicine, University of Pennsylvania
– sequence: 9
  givenname: Judith C.
  surname: Maro
  fullname: Maro, Judith C.
  organization: Harvard Medical School and Harvard Pilgrim Health Care Institute
– sequence: 10
  givenname: Michael
  surname: Nguyen
  fullname: Nguyen, Michael
  organization: US Food and Drug Administration
– sequence: 11
  givenname: Robert
  surname: Orr
  fullname: Orr, Robert
  organization: US Food and Drug Administration
– sequence: 12
  givenname: Dianne
  surname: Paraoan
  fullname: Paraoan, Dianne
  organization: US Food and Drug Administration
– sequence: 13
  givenname: Jonathan
  surname: Perlin
  fullname: Perlin, Jonathan
  organization: HCA Healthcare
– sequence: 14
  givenname: Russell E.
  surname: Poland
  fullname: Poland, Russell E.
  organization: HCA Healthcare
– sequence: 15
  givenname: Meighan Rogers
  surname: Driscoll
  fullname: Driscoll, Meighan Rogers
  organization: Harvard Medical School and Harvard Pilgrim Health Care Institute
– sequence: 16
  givenname: Kenneth
  surname: Sands
  fullname: Sands, Kenneth
  organization: HCA Healthcare
– sequence: 17
  givenname: Sengwee
  orcidid: 0000-0002-5160-0810
  surname: Toh
  fullname: Toh, Sengwee
  organization: Harvard Medical School and Harvard Pilgrim Health Care Institute
– sequence: 18
  givenname: W. Katherine
  surname: Yih
  fullname: Yih, W. Katherine
  organization: Harvard Medical School and Harvard Pilgrim Health Care Institute
– sequence: 19
  givenname: Richard
  surname: Platt
  fullname: Platt, Richard
  organization: Harvard Medical School and Harvard Pilgrim Health Care Institute
– sequence: 21
  givenname: Gregory
  surname: Measer
  fullname: Measer, Gregory
– sequence: 22
  givenname: Austin
  surname: Cosgrove
  fullname: Cosgrove, Austin
– sequence: 23
  givenname: Edward
  surname: Rosen
  fullname: Rosen, Edward
– sequence: 24
  givenname: Katherine
  surname: Haffenreffer
  fullname: Haffenreffer, Katherine
– sequence: 25
  givenname: Maria
  surname: Kempner
  fullname: Kempner, Maria
– sequence: 26
  givenname: Soowoo
  surname: Back
  fullname: Back, Soowoo
– sequence: 27
  givenname: Casie
  surname: Horgan
  fullname: Horgan, Casie
– sequence: 28
  givenname: Robert
  surname: Jin
  fullname: Jin, Robert
– sequence: 29
  givenname: Christine
  surname: Draper
  fullname: Draper, Christine
– sequence: 30
  givenname: Jennifer
  surname: Lyons
  fullname: Lyons, Jennifer
– sequence: 31
  givenname: Mayura
  surname: Shinde
  fullname: Shinde, Mayura
– sequence: 32
  givenname: Ashley
  surname: Martinez
  fullname: Martinez, Ashley
– sequence: 33
  givenname: Laura
  surname: Hou
  fullname: Hou, Laura
– sequence: 34
  givenname: Jenice
  surname: Ko
  fullname: Ko, Jenice
– sequence: 35
  givenname: Jillian
  surname: Burk
  fullname: Burk, Jillian
– sequence: 36
  givenname: Jennifer
  surname: Noble
  fullname: Noble, Jennifer
– sequence: 37
  givenname: Meg
  surname: Her
  fullname: Her, Meg
– sequence: 38
  givenname: Adee
  surname: Kennedy
  fullname: Kennedy, Adee
– sequence: 39
  givenname: Juliane
  surname: Reynolds
  fullname: Reynolds, Juliane
– sequence: 40
  givenname: Max
  surname: Ehrmann
  fullname: Ehrmann, Max
– sequence: 41
  givenname: Bridget
  surname: Nolan
  fullname: Nolan, Bridget
– sequence: 42
  givenname: Amanda
  surname: Maynard
  fullname: Maynard, Amanda
– sequence: 43
  givenname: Christopher
  surname: Martin
  fullname: Martin, Christopher
– sequence: 44
  givenname: Jamie
  surname: Nolan
  fullname: Nolan, Jamie
– sequence: 45
  givenname: Alexander
  surname: Peters
  fullname: Peters, Alexander
– sequence: 46
  givenname: Samuel
  surname: Attaya
  fullname: Attaya, Samuel
– sequence: 47
  givenname: Neha
  surname: Varma
  fullname: Varma, Neha
– sequence: 48
  givenname: Abinav
  surname: Gowda
  fullname: Gowda, Abinav
– sequence: 49
  givenname: Joy
  surname: Kolonoski
  fullname: Kolonoski, Joy
– sequence: 50
  givenname: Julie E.
  surname: Richard
  fullname: Richard, Julie E.
– sequence: 51
  givenname: Laura
  surname: Shockro
  fullname: Shockro, Laura
– sequence: 52
  givenname: Tawil
  surname: Contreras
  fullname: Contreras, Tawil
– sequence: 53
  givenname: Christine Lee
  surname: Halbig
  fullname: Halbig, Christine Lee
– sequence: 54
  givenname: Claudia
  surname: Coronel‐Moreno
  fullname: Coronel‐Moreno, Claudia
– sequence: 55
  givenname: Neesha
  surname: Nathwani
  fullname: Nathwani, Neesha
– sequence: 56
  givenname: Linda
  surname: Curtis
  fullname: Curtis, Linda
– sequence: 57
  givenname: Alexander
  surname: Mai
  fullname: Mai, Alexander
– sequence: 58
  givenname: Daniel
  surname: Scarnecchia
  fullname: Scarnecchia, Daniel
– sequence: 59
  givenname: Sampada
  surname: Nandyala
  fullname: Nandyala, Sampada
– sequence: 60
  givenname: Justin
  surname: Vigeant
  fullname: Vigeant, Justin
– sequence: 61
  givenname: Suzanne
  surname: Carter
  fullname: Carter, Suzanne
– sequence: 62
  givenname: Jolene
  surname: Damon
  fullname: Damon, Jolene
– sequence: 63
  givenname: Jolene
  surname: Mosley
  fullname: Mosley, Jolene
– sequence: 64
  givenname: Monisha
  surname: Billings
  fullname: Billings, Monisha
– sequence: 65
  givenname: Natasha
  surname: Pratt
  fullname: Pratt, Natasha
– sequence: 66
  givenname: Marie C.
  surname: Bradley
  fullname: Bradley, Marie C.
– sequence: 67
  givenname: Allyson
  surname: Pishko
  fullname: Pishko, Allyson
– sequence: 68
  givenname: Dena M.
  surname: Carbonari
  fullname: Carbonari, Dena M.
– sequence: 69
  givenname: Sean
  surname: Hennessy
  fullname: Hennessy, Sean
– sequence: 70
  givenname: Laura
  surname: McLean
  fullname: McLean, Laura
– sequence: 71
  givenname: Michael
  surname: Klompas
  fullname: Klompas, Michael
– sequence: 72
  givenname: Aileen
  surname: Ochoa
  fullname: Ochoa, Aileen
BackLink https://www.ncbi.nlm.nih.gov/pubmed/33797815$$D View this record in MEDLINE/PubMed
BookMark eNp9kd1q2zAUx8XoWD822BMMwS7WXTiTZcuWdzEIyboVCh0k7FbI0nGj4EipZLf4bo_QZ-yTTE66r7LtRhKc3zn8z0_H6MA6Cwi9TMkkJYS-2-owYTQnT9BRSqoqSRkrD8Y3yxLOiuoQHYewJiTWqvwZOsyysip5yo7Qeopnl1_P5_ff7tIqHh6kHvC2r1uj8Apk261w6P0NmLaVVgEOQ-hg8x4vV4DPnNNYWo3nvr_CU70x1oTOy844-ybgBdjOWGjxYtfzHD1tZBvgxcN9gpZnH5ezz8nF5afz2fQiUXnGSUIlbXTdKKlzgKrhPJVMa94Uqip0ySgpgUhVNBoklXnNaq60lEXDmWxUzbMT9HY_trdbOdzKthVbbzbSDyIlYtQloi4x6orshz0bF96AVjGwl794J434s2LNSly5G8EpIzzP4oDThwHeXfcQOrExQcHoClwfxIgxTipCI_r6Ebp2vbfRRKQyVtCCZmmkXv2e6GeUHz8WgckeUN6F4KERynQ74zGgaf-24-mjhv_oSPborWlh-CcnvswXO_47bzfIFQ
CitedBy_id crossref_primary_10_2196_59024
crossref_primary_10_1136_bmjmed_2022_000421
crossref_primary_10_1093_cid_ciac661
crossref_primary_10_1001_jama_2022_13072
crossref_primary_10_1002_jhm_13068
crossref_primary_10_1007_s40264_022_01158_3
crossref_primary_10_1093_jamia_ocac153
crossref_primary_10_1002_jrsm_1648
crossref_primary_10_1002_cpt_2979
crossref_primary_10_21032_jhis_2023_48_2_148
crossref_primary_10_4018_IJTD_288525
crossref_primary_10_1007_s40264_022_01170_7
crossref_primary_10_1371_journal_pone_0288284
crossref_primary_10_1177_18333583221104213
crossref_primary_10_1002_pds_5440
crossref_primary_10_1080_14760584_2023_2182294
crossref_primary_10_1007_s40264_022_01256_2
crossref_primary_10_1111_irv_12921
crossref_primary_10_1002_pds_5436
crossref_primary_10_2147_CLEP_S448980
crossref_primary_10_2196_40312
Cites_doi 10.1002/pds.2311
10.1056/NEJMp1014427
10.7326/0003-4819-151-5-200909010-00139
10.1002/cpt.320
10.1111/jth.14869
10.1002/pds.2336
10.3201/eid2109.141912
10.1002/pds.3908
10.1093/aje/kwy023
10.1016/j.thromres.2020.04.024
10.2105/AJPH.2018.304526
10.1056/NEJMp1809643
10.1016/j.thromres.2020.04.013
10.1097/CCM.0000000000002316
10.1093/jamiaopen/ooaa061
10.1097/MLR.0b013e3181d9919f
10.1111/irv.12598
10.1056/NEJMoa2021436
10.1093/infdis/jiw376
ContentType Journal Article
Contributor Chai, Grace
Stojanovic, Danijela
Corey, Catherine
Perez-Vilar, Silvia
Hua, Wei
Woods, Corinne
Dutcher, Sarah K
Kit, Brian
Contributor_xml – sequence: 1
  givenname: Catherine
  surname: Corey
  fullname: Corey, Catherine
– sequence: 2
  givenname: Grace
  surname: Chai
  fullname: Chai, Grace
– sequence: 3
  givenname: Sarah K
  surname: Dutcher
  fullname: Dutcher, Sarah K
– sequence: 4
  givenname: Wei
  surname: Hua
  fullname: Hua, Wei
– sequence: 5
  givenname: Brian
  surname: Kit
  fullname: Kit, Brian
– sequence: 6
  givenname: Silvia
  surname: Perez-Vilar
  fullname: Perez-Vilar, Silvia
– sequence: 7
  givenname: Danijela
  surname: Stojanovic
  fullname: Stojanovic, Danijela
– sequence: 8
  givenname: Corinne
  surname: Woods
  fullname: Woods, Corinne
Copyright 2021 John Wiley & Sons Ltd.
2021 John Wiley & Sons, Ltd.
Copyright_xml – notice: 2021 John Wiley & Sons Ltd.
– notice: 2021 John Wiley & Sons, Ltd.
CorporateAuthor And the FDA‐Sentinel COVID‐19 Working Group
And the FDA-Sentinel COVID-19 Working Group
CorporateAuthor_xml – name: And the FDA‐Sentinel COVID‐19 Working Group
– name: And the FDA-Sentinel COVID-19 Working Group
DBID AAYXX
CITATION
NPM
7TK
K9.
7X8
5PM
ADTOC
UNPAY
DOI 10.1002/pds.5240
DatabaseName CrossRef
PubMed
Neurosciences Abstracts
ProQuest Health & Medical Complete (Alumni)
MEDLINE - Academic
PubMed Central (Full Participant titles)
Unpaywall for CDI: Periodical Content
Unpaywall
DatabaseTitle CrossRef
PubMed
ProQuest Health & Medical Complete (Alumni)
Neurosciences Abstracts
MEDLINE - Academic
DatabaseTitleList

MEDLINE - Academic
PubMed
CrossRef
ProQuest Health & Medical Complete (Alumni)
Database_xml – sequence: 1
  dbid: NPM
  name: PubMed
  url: https://proxy.k.utb.cz/login?url=http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed
  sourceTypes: Index Database
– sequence: 2
  dbid: UNPAY
  name: Unpaywall
  url: https://proxy.k.utb.cz/login?url=https://unpaywall.org/
  sourceTypes: Open Access Repository
DeliveryMethod fulltext_linktorsrc
Discipline Pharmacy, Therapeutics, & Pharmacology
Public Health
DocumentTitleAlternate Cocoros et al
EISSN 1099-1557
EndPage 837
ExternalDocumentID 10.1002/pds.5240
PMC8250843
33797815
10_1002_pds_5240
PDS5240
Genre reviewArticle
Journal Article
Review
GrantInformation_xml – fundername: HCA Healthcare
– fundername: US Food and Drug Administration (Department of Health and Human Services Contract Number
  funderid: 75F40119D10037)
– fundername: US Food and Drug Administration (Department of Health and Human Services Contract Number
  grantid: 75F40119D10037)
GroupedDBID ---
.3N
.GA
.Y3
05W
0R~
10A
123
1L6
1OB
1OC
1ZS
31~
33P
3SF
3WU
4.4
50Y
50Z
51W
51X
52M
52N
52O
52P
52R
52S
52T
52U
52V
52W
52X
53G
5VS
66C
702
7PT
8-0
8-1
8-3
8-4
8-5
8UM
930
A01
A03
AAESR
AAEVG
AAHHS
AAHQN
AAIPD
AAMNL
AANHP
AANLZ
AAONW
AASGY
AAXRX
AAYCA
AAZKR
ABCQN
ABCUV
ABEML
ABIJN
ABJNI
ABPVW
ABQWH
ABXGK
ACAHQ
ACBWZ
ACCFJ
ACCZN
ACFBH
ACGFO
ACGFS
ACGOF
ACMXC
ACPOU
ACPRK
ACRPL
ACSCC
ACXBN
ACXQS
ACYXJ
ADBBV
ADBTR
ADEOM
ADIZJ
ADKYN
ADMGS
ADNMO
ADOZA
ADXAS
ADZMN
AEEZP
AEGXH
AEIGN
AEIMD
AENEX
AEQDE
AEUQT
AEUYR
AFBPY
AFFPM
AFGKR
AFPWT
AFRAH
AFWVQ
AFZJQ
AHBTC
AHMBA
AIACR
AIAGR
AITYG
AIURR
AIWBW
AJBDE
ALAGY
ALMA_UNASSIGNED_HOLDINGS
ALUQN
ALVPJ
AMBMR
AMYDB
ASPBG
ATUGU
AVWKF
AZBYB
AZFZN
AZVAB
BAFTC
BDRZF
BFHJK
BHBCM
BMXJE
BROTX
BRXPI
BY8
C45
CS3
D-6
D-7
D-E
D-F
DCZOG
DPXWK
DR2
DRFUL
DRMAN
DRSTM
DU5
EBD
EBS
EJD
EMOBN
F00
F01
F04
F5P
FEDTE
FUBAC
G-S
G.N
GNP
GODZA
GWYGA
H.X
HF~
HGLYW
HHZ
HVGLF
HZ~
IX1
J0M
JPC
KBYEO
KQQ
LATKE
LAW
LC2
LC3
LEEKS
LH4
LITHE
LOXES
LP6
LP7
LSO
LUTES
LW6
LYRES
M6Q
MEWTI
MK4
MRFUL
MRMAN
MRSTM
MSFUL
MSMAN
MSSTM
MXFUL
MXMAN
MXSTM
N04
N05
N9A
NF~
NNB
O66
O9-
OIG
OVD
P2P
P2W
P2X
P2Z
P4B
P4D
PALCI
PQQKQ
Q.N
Q11
QB0
QRW
R.K
RIWAO
RJQFR
ROL
RWI
RX1
RYL
SAMSI
SUPJJ
SV3
TEORI
UB1
V8K
W8V
W99
WBKPD
WHWMO
WIB
WIH
WIJ
WIK
WJL
WOHZO
WQJ
WRC
WUP
WVDHM
WWP
WXI
WXSBR
XG1
XV2
YCJ
ZZTAW
~IA
~WT
AAMMB
AAYXX
AEFGJ
AEYWJ
AGHNM
AGQPQ
AGXDD
AGYGG
AIDQK
AIDYY
AIQQE
CITATION
NPM
7TK
K9.
7X8
5PM
ADTOC
UNPAY
ID FETCH-LOGICAL-c4380-2a2fdbfcad4ee9f881a5dd8f6c96d75207e0ac6fdea2a4b5b8cdaa6f85afcb83
IEDL.DBID UNPAY
ISSN 1053-8569
1099-1557
IngestDate Sun Oct 26 04:10:16 EDT 2025
Tue Sep 30 16:51:02 EDT 2025
Fri Sep 05 09:29:23 EDT 2025
Tue Oct 07 05:52:19 EDT 2025
Thu Apr 03 07:02:32 EDT 2025
Wed Oct 01 05:03:29 EDT 2025
Thu Apr 24 22:56:10 EDT 2025
Wed Jan 22 16:30:05 EST 2025
IsDoiOpenAccess true
IsOpenAccess true
IsPeerReviewed true
IsScholarly true
Issue 7
Keywords COVID-19
real-time monitoring
medical claims
real-world data
electronic health records
surveillance
Language English
License 2021 John Wiley & Sons Ltd.
This article is being made freely available through PubMed Central as part of the COVID-19 public health emergency response. It can be used for unrestricted research re-use and analysis in any form or by any means with acknowledgement of the original source, for the duration of the public health emergency.
LinkModel DirectLink
MergedId FETCHMERGED-LOGICAL-c4380-2a2fdbfcad4ee9f881a5dd8f6c96d75207e0ac6fdea2a4b5b8cdaa6f85afcb83
Notes Funding information
HCA Healthcare; US Food and Drug Administration (Department of Health and Human Services Contract Number, Grant/Award Number: 75F40119D10037)
The protocols described in the text have been posted to the Sentinel System website. One of the projects summarized was presented at ICPE 2020: Validation of Claims‐based Algorithms to Identify Hospitalized COVID‐19 Events within the FDA Sentinel System.
Members of the FDA‐Sentinel COVID‐19 Working Group: Catherine Corey, MSPH; Grace Chai, PharmD; Sarah K. Dutcher, PhD; Wei Hua, MD; Brian Kit, MD; Silvia Perez‐Vilar, PhD; Danijela Stojanovic, PhD; Corinne Woods, MPH.
Prior postings and presentation
ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 14
ObjectType-Review-3
content type line 23
Prior postings and presentation: The protocols described in the text have been posted to the Sentinel System website. One of the projects summarized was presented at ICPE 2020: Validation of Claims‐based Algorithms to Identify Hospitalized COVID‐19 Events within the FDA Sentinel System.
Funding information HCA Healthcare; US Food and Drug Administration (Department of Health and Human Services Contract Number, Grant/Award Number: 75F40119D10037)
ORCID 0000-0001-7090-2761
0000-0002-1609-7420
0000-0002-5160-0810
0000-0001-7955-0600
OpenAccessLink https://proxy.k.utb.cz/login?url=https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/pds.5240
PMID 33797815
PQID 2535626231
PQPubID 105383
PageCount 11
ParticipantIDs unpaywall_primary_10_1002_pds_5240
pubmedcentral_primary_oai_pubmedcentral_nih_gov_8250843
proquest_miscellaneous_2508580902
proquest_journals_2535626231
pubmed_primary_33797815
crossref_citationtrail_10_1002_pds_5240
crossref_primary_10_1002_pds_5240
wiley_primary_10_1002_pds_5240_PDS5240
ProviderPackageCode CITATION
AAYXX
PublicationCentury 2000
PublicationDate July 2021
PublicationDateYYYYMMDD 2021-07-01
PublicationDate_xml – month: 07
  year: 2021
  text: July 2021
PublicationDecade 2020
PublicationPlace Chichester, UK
PublicationPlace_xml – name: Chichester, UK
– name: England
– name: Bethesda
PublicationTitle Pharmacoepidemiology and drug safety
PublicationTitleAlternate Pharmacoepidemiol Drug Saf
PublicationYear 2021
Publisher John Wiley & Sons, Inc
Wiley Subscription Services, Inc
Publisher_xml – name: John Wiley & Sons, Inc
– name: Wiley Subscription Services, Inc
References 2018; 187
2010; 48
2020; 3
2018; 108
2020
2020; 191
2018; 379
2015; 21
2017; 45
2020; 15
2016
2021; 384
2009; 151
2020; 12
2016; 214
2018; 12
2012; 21
2016; 25
2011; 364
2016; 99
2020; 18
e_1_2_7_6_1
US FDA (e_1_2_7_27_1) 2020
e_1_2_7_5_1
e_1_2_7_4_1
e_1_2_7_3_1
e_1_2_7_9_1
e_1_2_7_8_1
e_1_2_7_7_1
e_1_2_7_19_1
e_1_2_7_18_1
e_1_2_7_17_1
e_1_2_7_16_1
e_1_2_7_40_1
e_1_2_7_2_1
e_1_2_7_15_1
e_1_2_7_14_1
e_1_2_7_13_1
e_1_2_7_12_1
e_1_2_7_11_1
e_1_2_7_10_1
Sands KE (e_1_2_7_42_1) 2020; 15
e_1_2_7_26_1
Sands KE (e_1_2_7_41_1) 2020; 12
e_1_2_7_28_1
FRANCISCO EM (e_1_2_7_29_1) 2020
Reagan‐Udall Foundation COVID‐19 Evidence Accelerator (e_1_2_7_31_1) 2020
Reagan‐Udall Foundation COVID‐19 Evidence Accelerator (e_1_2_7_32_1) 2020
Reagan‐Udall Foundation COVID‐19 Evidence Accelerator (e_1_2_7_33_1) 2020
Reagan‐Udall Foundation COVID‐19 Evidence Accelerator (e_1_2_7_35_1) 2020
e_1_2_7_30_1
e_1_2_7_25_1
e_1_2_7_24_1
e_1_2_7_23_1
Reagan‐Udall Foundation COVID‐19 Evidence Accelerator (e_1_2_7_34_1) 2020
e_1_2_7_22_1
e_1_2_7_21_1
e_1_2_7_20_1
e_1_2_7_37_1
Reagan‐Udall Foundation COVID‐19 Evidence Accelerator (e_1_2_7_36_1) 2020
e_1_2_7_39_1
(e_1_2_7_38_1) 2020
References_xml – volume: 21
  start-page: 9
  issue: Suppl 1
  year: 2012
  end-page: 11
  article-title: The US Food and Drug Administration's sentinel initiative: expanding the horizons of medical product safety
  publication-title: Pharmacoepidemiol Drug Saf
– year: 2020
  article-title: Coagulopathy assessment in patients with COVID‐19: a TriNetX analysis [internet]
  publication-title: Sentinel Initiative
– volume: 45
  start-page: e711
  issue: 7
  year: 2017
  end-page: e714
  article-title: Validation of intensive care and mechanical ventilation codes in Medicare data
  publication-title: Crit Care Med
– year: 2020
  article-title: Assessing data source characteristics in multi‐site analyses [internet]
  publication-title: Sentinel Initiative
– volume: 99
  start-page: 265
  issue: 3
  year: 2016
  end-page: 268
  article-title: The FDA's sentinel initiative—a comprehensive approach to medical product surveillance
  publication-title: Clin Pharmacol Ther
– volume: 12
  start-page: 1
  year: 2020
  end-page: 2
  article-title: Changes in hospitalized coronavirus disease 2019 (COVID‐19) patient characteristics and resource use in a system of community hospitals in the United States
  publication-title: Infect Control Hosp Epidemiol
– volume: 18
  start-page: 1743
  issue: 7
  year: 2020
  end-page: 1746
  article-title: High incidence of venous thromboembolic events in anticoagulated severe COVID‐19 patients
  publication-title: J Thromb Haemost
– volume: 384
  start-page: 693
  issue: 8
  year: 2021
  end-page: 704
  article-title: Dexamethasone in hospitalized patients with Covid‐19—preliminary report
  publication-title: N Engl J Med
– volume: 379
  start-page: 2091
  issue: 22
  year: 2018
  end-page: 2093
  article-title: The FDA sentinel initiative—an evolving National Resource
  publication-title: N Engl J Med
– volume: 21
  start-page: 23
  year: 2012
  end-page: 31
  article-title: Design considerations, architecture, and use of the Mini‐Sentinel distributed data system: Use of the mini‐sentinel distributed database
  publication-title: Pharmacoepidemiol Drug Saf
– volume: 187
  start-page: 1269
  issue: 6
  year: 2018
  end-page: 1276
  article-title: Assessment of quadrivalent human papillomavirus vaccine safety using the self‐controlled tree‐temporal scan statistic signal‐detection method in the sentinel system
  publication-title: Am J Epidemiol
– volume: 25
  start-page: 481
  issue: 5
  year: 2016
  end-page: 492
  article-title: Prospective influenza vaccine safety surveillance using fresh data in the Sentinel System
  publication-title: Pharmacoepidemiol Drug Saf
– year: 2020
  article-title: Risk of thromboembolic events with COVID‐19: a sentinel system investigation – update on methods [internet]
  publication-title: Sentinel Initiative
– volume: 191
  start-page: 9
  year: 2020
  end-page: 14
  article-title: Venous and arterial thromboembolic complications in COVID‐19 patients admitted to an academic hospital in Milan
  publication-title: Italy Thromb Res
– year: 2020
  article-title: Descriptive assessment of coagulopathy among COVID‐19 patients: feasibility data review [internet]
  publication-title: Sentinel Initiative
– volume: 12
  start-page: 804
  issue: 6
  year: 2018
  end-page: 807
  article-title: Outpatient influenza antivirals in a distributed data network for influenza surveillance
  publication-title: Influenza Respir Viruses
– year: 2016
– year: 2020
  article-title: Defining COVID‐19 cohorts in real‐world data [internet]
  publication-title: Sentinel Initiative
– year: 2020
  article-title: Risk of thromboembolic events with COVID‐19: a sentinel system investigation – focus on endpoints [internet]
  publication-title: Sentinel Initiative
– volume: 21
  start-page: 1543
  issue: 9
  year: 2015
  end-page: 1550
  article-title: The US influenza hospitalization surveillance network
  publication-title: Emerg Infect Dis
– volume: 364
  start-page: 498
  issue: 6
  year: 2011
  end-page: 499
  article-title: Developing the Sentinel System—a national resource for evidence development
  publication-title: N Engl J Med
– volume: 191
  start-page: 145
  year: 2020
  end-page: 147
  article-title: Incidence of thrombotic complications in critically ill ICU patients with COVID‐19
  publication-title: Thromb Res
– year: 2020
– volume: 108
  start-page: S224
  issue: S3
  year: 2018
  end-page: S226
  article-title: Monitoring and assessment of medical countermeasures as part of a public health emergency response
  publication-title: Am J Public Health
– volume: 48
  start-page: S45
  year: 2010
  end-page: S51
  article-title: Distributed health data networks: a practical and preferred approach to multi‐institutional evaluations of comparative effectiveness, safety, and quality of care
  publication-title: Med Care
– volume: 15
  start-page: 1
  year: 2020
  end-page: 7
  article-title: Patient characteristics and admitting vital signs associated with coronavirus disease 2019 (COVID‐19)‐related mortality among patients admitted with noncritical illness
  publication-title: Infect Control Hosp Epidemiol
– volume: 3
  start-page: 500
  year: 2020
  end-page: 505
  article-title: The FDA MyStudies app: a reusable platform for distributed clinical trials and real‐world evidence studies
  publication-title: JAMIA Open
– volume: 151
  start-page: 341
  issue: 5
  year: 2009
  end-page: 344
  article-title: Design of a National Distributed Health Data Network
  publication-title: Ann Intern Med
– volume: 214
  start-page: S380
  issue: suppl 4
  year: 2016
  end-page: S385
  article-title: Infectious disease surveillance in the big data era: towards faster and locally relevant systems
  publication-title: J Infect Dis
– ident: e_1_2_7_3_1
  doi: 10.1002/pds.2311
– ident: e_1_2_7_37_1
– ident: e_1_2_7_2_1
  doi: 10.1056/NEJMp1014427
– ident: e_1_2_7_20_1
– year: 2020
  ident: e_1_2_7_36_1
  article-title: Coagulopathy assessment in patients with COVID‐19: a TriNetX analysis [internet]
  publication-title: Sentinel Initiative
– ident: e_1_2_7_6_1
  doi: 10.7326/0003-4819-151-5-200909010-00139
– ident: e_1_2_7_4_1
  doi: 10.1002/cpt.320
– ident: e_1_2_7_23_1
  doi: 10.1111/jth.14869
– ident: e_1_2_7_8_1
  doi: 10.1002/pds.2336
– ident: e_1_2_7_26_1
  doi: 10.3201/eid2109.141912
– volume-title: Coronavirus (COVID‐19) Update: FDA Issues Emergency Use Authorization for Potential COVID‐19 Treatment [Internet]
  year: 2020
  ident: e_1_2_7_27_1
– ident: e_1_2_7_11_1
– ident: e_1_2_7_14_1
  doi: 10.1002/pds.3908
– ident: e_1_2_7_15_1
  doi: 10.1093/aje/kwy023
– ident: e_1_2_7_25_1
– ident: e_1_2_7_22_1
  doi: 10.1016/j.thromres.2020.04.024
– ident: e_1_2_7_12_1
  doi: 10.2105/AJPH.2018.304526
– ident: e_1_2_7_17_1
– year: 2020
  ident: e_1_2_7_34_1
  article-title: Risk of thromboembolic events with COVID‐19: a sentinel system investigation – focus on endpoints [internet]
  publication-title: Sentinel Initiative
– ident: e_1_2_7_5_1
  doi: 10.1056/NEJMp1809643
– year: 2020
  ident: e_1_2_7_31_1
  article-title: Descriptive assessment of coagulopathy among COVID‐19 patients: feasibility data review [internet]
  publication-title: Sentinel Initiative
– ident: e_1_2_7_10_1
– ident: e_1_2_7_21_1
  doi: 10.1016/j.thromres.2020.04.013
– volume-title: ACTIV [Internet]
  year: 2020
  ident: e_1_2_7_38_1
– ident: e_1_2_7_39_1
  doi: 10.1097/CCM.0000000000002316
– ident: e_1_2_7_13_1
– ident: e_1_2_7_24_1
– ident: e_1_2_7_30_1
  doi: 10.1093/jamiaopen/ooaa061
– year: 2020
  ident: e_1_2_7_35_1
  article-title: Risk of thromboembolic events with COVID‐19: a sentinel system investigation – update on methods [internet]
  publication-title: Sentinel Initiative
– ident: e_1_2_7_19_1
– ident: e_1_2_7_7_1
  doi: 10.1097/MLR.0b013e3181d9919f
– year: 2020
  ident: e_1_2_7_33_1
  article-title: Defining COVID‐19 cohorts in real‐world data [internet]
  publication-title: Sentinel Initiative
– volume: 15
  start-page: 1
  year: 2020
  ident: e_1_2_7_42_1
  article-title: Patient characteristics and admitting vital signs associated with coronavirus disease 2019 (COVID‐19)‐related mortality among patients admitted with noncritical illness
  publication-title: Infect Control Hosp Epidemiol
– ident: e_1_2_7_18_1
– year: 2020
  ident: e_1_2_7_32_1
  article-title: Assessing data source characteristics in multi‐site analyses [internet]
  publication-title: Sentinel Initiative
– ident: e_1_2_7_9_1
– ident: e_1_2_7_16_1
  doi: 10.1111/irv.12598
– volume-title: COVID‐19: EMA sets up infrastructure for real‐world monitoring of treatments and vaccines [Internet]
  year: 2020
  ident: e_1_2_7_29_1
– volume: 12
  start-page: 1
  year: 2020
  ident: e_1_2_7_41_1
  article-title: Changes in hospitalized coronavirus disease 2019 (COVID‐19) patient characteristics and resource use in a system of community hospitals in the United States
  publication-title: Infect Control Hosp Epidemiol
– ident: e_1_2_7_28_1
  doi: 10.1056/NEJMoa2021436
– ident: e_1_2_7_40_1
  doi: 10.1093/infdis/jiw376
SSID ssj0009994
Score 2.4326775
SecondaryResourceType review_article
Snippet The US Food and Drug Administration's Sentinel System was established in 2009 to use routinely collected electronic health data for improving the national...
SourceID unpaywall
pubmedcentral
proquest
pubmed
crossref
wiley
SourceType Open Access Repository
Aggregation Database
Index Database
Enrichment Source
Publisher
StartPage 827
SubjectTerms COVID-19
electronic health records
Electronic medical records
Health surveillance
medical claims
Medical equipment
Pandemics
Public health
real‐time monitoring
real‐world data
Review
Reviews
surveillance
SummonAdditionalLinks – databaseName: Wiley Online Library - Core collection (SURFmarket)
  dbid: DR2
  link: http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwnZ3LjtMwFIYtNBvYcL8EBmQQ6mwmnVxsN2E3mlINSEDFFDQSi-g4todLlVZNAyorHoFn5Ek4jpNUYQAhNs0iJ26d_if-kxx_JuSxkugDlA78AHTsM26YD4phXsWKp6EMIAX7vOPFS3H8hj0_5adNVaWdC-P4EN0DN5sZ9fXaJjjI8mALDV2qcshxPMLLbxiL-m7q9ZYchb6nfqGMGvMTLtKWOxtEB-2B_ZHonL08XyV5sSqWsPkC83nfydZD0eQKedd2wlWgfBpWaznMv_7Cd_y_Xl4llxuHSg-dpK6RC7q4TgZTh7je7NPZdsZWuU8HdLqFX29ukI-H9OjV22fjH9--hyl-oCdVG-pg2tRNuqRltfqs7WpHKDjqUNJPbLN0slgoCoWi41V1Rvtc372SntjKJuwQdZj1m2Q2eTo7Ovab9Rz83HLt_Qgio6TJUQxapyZJQuBKJUbkqVAjHgUjHUAujNIQAZNcJrkCECbhYHKZxLfITrEo9B1CDUtBoPYED2PGUpUqzSQIZQzHATkPPLLX_rVZ3rDO7ZIb88xRmqMMz2tmz6tHHnaRS8f3-E3MbquOrMnwMot4jNYRzWOITXS7MTftCxco9KKyMWhoE1v56pHbTkzdl8TxyOLGuEdGPZl1AZb73d9TfHhf878T2y6LPfKoE-RffvugltcfA7Lp-MRu7_5r4D1yKbJ1PXXJ8i7ZWa8qfR-N2Vo-qFPwJ5zpOy0
  priority: 102
  providerName: Wiley-Blackwell
Title A COVID‐19‐ready public health surveillance system: The Food and Drug Administration's Sentinel System
URI https://onlinelibrary.wiley.com/doi/abs/10.1002%2Fpds.5240
https://www.ncbi.nlm.nih.gov/pubmed/33797815
https://www.proquest.com/docview/2535626231
https://www.proquest.com/docview/2508580902
https://pubmed.ncbi.nlm.nih.gov/PMC8250843
https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/pds.5240
UnpaywallVersion publishedVersion
Volume 30
hasFullText 1
inHoldings 1
isFullTextHit
isPrint
journalDatabaseRights – providerCode: PRVWIB
  databaseName: Wiley Online Library - Core collection (SURFmarket)
  issn: 1053-8569
  databaseCode: DR2
  dateStart: 19960101
  customDbUrl:
  isFulltext: true
  eissn: 1099-1557
  dateEnd: 99991231
  omitProxy: false
  ssIdentifier: ssj0009994
  providerName: Wiley-Blackwell
link http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwnV1bb9MwFD6C7gFexh0CYzIIdS9LlYudC2_VSjWQGBXr0HiK7NiGQZVWTQMqT_wEfiO_hOM4zQgDhHhJpPjEiZPv5Hyxjz8DPJECeYBUnutxFbqUaepySdGvQslSX3g85aa_4-VRdHhCX5yy06bDzcyFsfoQbYeb8Yz6e20cfCG1_c43o_sBHikHDGPSZdiKGHLxHmydHE2Gb-shTha6CavXtDOjPy4GznijPvvTqd14dIFkXsyVvFIVC77-zGezLp-tA9L4GmSbptg8lI-DaiUG-ZdfVB7_v63XYbvhqmRowXUDLqniJvQnVux6vU-m53O3yn3SJ5NzGez1LfgwJAev3jwfff_6zU9xg-xUromV1SZ2-iUpq-UnZdY9QugRKyr91FRLxvO5JLyQZLSs3pGuwu9eSY5NjhM2iljB9dswHT-bHhy6zcoObm4U7t2AB1oKnSMslEp1kvicSZnoKE8jGbPAi5XH80hLxQNOBRNJLjmPdMK4zkUS3oFeMS_UPSCapjxCFEbMDylNZSoVFTySWjMMzbnnwN7m9WZ5o3puFt-YZVavOcjwuWbmuTrwqLVcWKWP39jsbBCSNb5eZgELkUQijfSxirYYvdQMvfBCzStjg9Q2MTmwDty1gGovEoaxER5jDsQdqLUGRgG8W1Kcva-VwBNTLw0deNyC8i_33q8h9keDbDI6Nvv7_1LbA7gamOyeOnF5B3qrZaUeIj1biV38MXkd7Dae-AOQVEC9
linkProvider Unpaywall
linkToHtml http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwnZ1db9MwFIaPxrgYN-MbAgMMQt3N0uXDdhO4mlaqDrZRsQ7tAilyYnt8VGnVNqByxU_gN_JLOI6bVGGAEDftRU7cOnlP_dY5fgzwVKboA6TyXE-o0KVMU1dIinkVShb7qSdiYeY7jo55_5S-PGNna_C8Wgtj-RD1hJvJjPL32iS4mZDeXVFDJ3LWZjggXYLLlOPfFOOI3qzYUeh8ykfKqDI3YjyuyLNesFud2RyLLhjMi3WSG0U-EYsvYjRqetlyMOpdhXdVN2wNyqd2MU_b2ddfCI__2c9rsLk0qWTPquo6rKn8BrQGlnK92CHD1aKt2Q5pkcGKf724CR_3yP7rtwfdH9---zG-oC2VC2J52sSuuySzYvpZmQ2PUHPE0qSfmWZJbzyWROSSdKfFOWmifbdn5MQUN2GPiCWt34Jh78Vwv-8ut3RwM4O2dwMRaJnqDPWgVKyjyBdMykjzLOaywwKvozyRcS2VCARNWRplUgiuIyZ0lkbhbVjPx7m6C0TTWHCUH2d-SGksY6loKrjUmuGYnHkObFf3NsmWuHOz68YosaDmIMHrmpjr6sDjOnJiER-_idmq5JEsk3yWBCxE94j-0ccm6sOYnuaZi8jVuDAx6GkjU_zqwB2rpvpDwrBjiGPMgU5DZ3WAQX83j-Qf3pcI8Mi0S0MHntSK_Mt3b5X6-mNAMuiemPd7_xr4CDb6w6PD5PDg-NV9uBKYMp-ygnkL1ufTQj1AnzZPH5b5-BMjjD9O
linkToPdf http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwnZ1db9MwFIaPxpBgN3zDAgMMQt3N0uXDTm24mhaqjY9RsQ7tAilyYhs2qrRqGqbuip_Ab-SXYMdNqjBAiJv0IqdOnL6nfuUcPwZ4JlLtA4T0XI_L0MVEYZcLrPMqFIT5qccZN_Mdbw-ivSP86pgcr8CLei2M5UM0E24mM6r_a5PgciLU9pIaOhFFl-gB6RJcxoRRU88Xv1-yo7TzqV4pa5W5lESsJs96wXb9zfZYdMFgXqyTvFrmEz4_46NR28tWg1H_Onysu2FrUL50y1nazc5_ITz-Zz9vwLWFSUU7VlU3YUXmt6AzsJTr-RYaLhdtFVuogwZL_vX8NpzuoN13H_bjH9---0wftC0Vc2R52siuu0RFOf0qzYZHWnPI0qSfm2ZRfzwWiOcCxdPyE2qjfTcLdGiKm3SPkCWt34Fh_-Vwd89dbOngZgZt7wY8UCJVmdaDlExR6nMiBFVRxiLRI4HXkx7PIiUkDzhOSUozwXmkKOEqS2l4F1bzcS7XASnMeKTlFxE_xJgJJiROeSSUInpMzjwHNuvfNskWuHOz68YosaDmINHPNTHP1YEnTeTEIj5-E7NRyyNZJHmRBCTU7lH7R1830ZzW6WneufBcjksToz0tNcWvDtyzamouEoY9QxwjDvRaOmsCDPq7fSY_-VwhwKlpF4cOPG0U-Zd771T6-mNAMogPzef9fw18DFcGcT95s3_w-gGsBabKpypg3oDV2bSUD7VNm6WPqnT8CXmqPtI
linkToUnpaywall http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwnV1Lj9MwEB5B9wAX3o_AggxC3cumysPOg1u1pVqQWCptFy2nyIltXlVatQ2onPgJ_EZ-CTNxmiUsIMQlkeKJEzvfZD7Z488AT1SOPEBpz_WkDl0uDHel4uhXoRKpn3sylTTe8fIoOjzhL07FaTPgRmthrD5EO-BGnlH_r8nBF8rY_3wzux_gldVAYEy6CDuRQC7eg52To8nwTT3FKUI3EfWedjT742LgjLfqsz_d2o1H50jm-VzJS1W5kJvPcjbr8tk6II2vQrZtis1D-Tio1vmg-PKLyuP_t_UaXGm4KhtacF2HC7q8Af2JFbve7LPp2dqt1T7rs8mZDPbmJnwYsoNXr5-Pvn_95qd4QHaqNszKajO7_JKtquUnTfseIfSYFZV-StWy8XyumCwVGy2rt6yr8Lu3YseU44SNYlZw_RZMx8-mB4dus7ODW5DCvRvIwKjcFAgLrVOTJL4USiUmKtJIxSLwYu3JIjJKy0DyXORJoaSMTCKkKfIkvA29cl7qu8AMT2WEKIyEH3KeqlRpnstIGSMwNBeeA3vbz5sVjeo5bb4xy6xec5Bhv2bUrw48ai0XVunjNza7W4Rkja-vskCESCKRRvpYRVuMXkpTL7LU84pskNomlAPrwB0LqPYhYRiT8JhwIO5ArTUgBfBuSfn-Xa0EnlC9PHTgcQvKv7x7v4bYHw2yyeiYzvf-pbb7cDmg7J46cXkXeutlpR8gPVvnDxsf_AERwz_U
openUrl ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=A+COVID+%E2%80%9019%E2%80%90ready+public+health+surveillance+system%3A+The+Food+and+Drug+Administration%27s+Sentinel+System&rft.jtitle=Pharmacoepidemiology+and+drug+safety&rft.au=Cocoros%2C+Noelle+M.&rft.au=Fuller%2C+Candace+C.&rft.au=Adimadhyam%2C+Sruthi&rft.au=Ball%2C+Robert&rft.date=2021-07-01&rft.issn=1053-8569&rft.eissn=1099-1557&rft.volume=30&rft.issue=7&rft.spage=827&rft.epage=837&rft_id=info:doi/10.1002%2Fpds.5240&rft.externalDBID=n%2Fa&rft.externalDocID=10_1002_pds_5240
thumbnail_l http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=1053-8569&client=summon
thumbnail_m http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=1053-8569&client=summon
thumbnail_s http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=1053-8569&client=summon