ID
37956
Descrição
Sentinel: Overview and Description of the Common Data Model v7.0.0: "The primary goal ofSentinel 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 SCDM: Enrollment Table Structure: The SCDM Enrollment Table has a start/stop structure that contains records on continuous enrollment periods. Members with medical coverage, drug coverage, or both should be included. A unique combination of PatID, Enr_Start, Enr_End, MedCov, DrugCov, and Chart identifies a unique record. A break in enrollment (of at least one day) or a change in the medical coverage, drug coverage, or chart abstraction flag variables should generate a new record.
Link
Palavras-chave
Versões (5)
- 07/01/2017 07/01/2017 -
- 29/01/2017 29/01/2017 -
- 15/01/2019 15/01/2019 - Sarah Riepenhausen
- 02/09/2019 02/09/2019 -
- 02/09/2019 02/09/2019 -
Titular dos direitos
FDA's Sentinel Initiative
Transferido a
2 de setembro de 2019
DOI
Para um pedido faça login.
Licença
Creative Commons BY-NC-ND 3.0
Comentários do modelo :
Aqui pode comentar o modelo. Pode comentá-lo especificamente através dos balões de texto nos grupos de itens e itens.
Comentários do grupo de itens para :
Comentários do item para :
Para descarregar formulários, precisa de ter uma sessão iniciada. Por favor faça login ou registe-se gratuitamente.
Sentinel Common Data Model Enrollment
Sentinel Common Data Model Enrollment
- StudyEvent: ODM
Similar models
Sentinel Common Data Model Enrollment
- StudyEvent: ODM
C0808070 (UMLS CUI [1,2])
C0806020 (UMLS CUI [1,2])