Frequently Asked Questions (FAQs)

How can I arrange a collaboration with Sentinel?

• Sentinel partners with a broad range of Data and Academic Partners. This network of collaborating institutions provides access to both healthcare data and scientific, technical, and organizational expertise, and may involve data expansion, tool development, or querying activities.
• Regulatory agencies, including Federal, State, and international partners, are encouraged to send proposals to Sentinel via info@sentinelsystem.org.
• At this time, Sentinel does not have a mechanism to support research collaborations initiated by independent investigators.

How can I request data from Sentinel?

Access to the Sentinel Distributed Database is currently only available to contracted partners, the FDA, or through the Innovation in Medical Evidence Development and Surveillance (IMEDS). IMEDS provides access for private-sector entities, such as regulated industries, academic institutions, and non-profit organizations, to be able to ask a question utilizing the Sentinel Distributed Database. 

Does Sentinel have a standard code that I can use to transform my data into the Sentinel Common Data Model?

• Sentinel collaborates with each individual Data Partner to leverage their knowledge of their underlying data. The Sentinel Operations Center and Data Partners jointly develop and maintain site-specific translational code, and universal data source translation code is not available at this time. 
• Other resources are available related to publicly available data:
  • SAS code for transforming Merative™ MarketScan® Research Databases into the Sentinel Common Data Model
    • If your organization currently licenses for the Merative™ MarketScan® Commercial and/or Medicare Databases and wishes to leverage the analytic infrastructure developed by Sentinel by transforming these data into the Sentinel Common Data Model, please email info@sentinelsystem.org and the Sentinel Operations Center will send you a MarketScan License Verification form. Contingent on license validation by Merative, Sentinel will share the SAS code and documentation with your organization.
  • The Centers for Medicare and Medicaid Services (CMS): Medicare Fee-For-Service (FFS) Claims in Sentinel Common Data Model Format
    • Sentinel has released the Sentinel CMS DataMart, containing 100% Medicare FFS administrative claims data housed in the Center for Medicare and Medicaid Services' CMS Virtual Research Data Center (VRDC). Duke University Department of Population Health Sciences (DPHS) serves as the Sentinel Data Partner in accessing the source data in the VRDC, transforming it into a Sentinel Common Data Model (SCDM) compliant database, executing queries, and returning results to the Sentinel Operations Center (SOC). There are three components made available to the public: (1) Program Specifications; (2) Code pack; and (3) User Guide.
  • CMS 2008-2010 Data Entrepreneurs’ Synthetic Public Use Files (SynPUFs) in the Sentinel Common Data Model (SCDM) format
    • This transformation of data allows for the running of Sentinel's Routine Querying System tools, including the Cohort Identification and Descriptive Analysis (CIDA) tool, on the SynPUFs data. The CMS SynPUFs are available in the form of 20 mutually exclusive datasets, which together make up a 5% sample of the entire CMS database from 2008-2010. Each of the 20 datasets contains about 110,000 members. The intended use of these data in SCDM format is to generate familiarity with the CIDA tool and its capabilities and to allow for methodological expansion. 

May I add a link to my work on the Sentinel website?

The Sentinel website is devoted exclusively to information that is related to the FDA Sentinel Initiative, and has been approved by FDA for posting. Consequently, we are not able to accommodate these requests.

A document is posted for public comment and I have feedback to submit. Where do I send it?

Please email info@sentinelsystem.org and the Scientific Communications team will forward your comments to the project lead for consideration. If changes are made to the document, they will be noted in the change log of the revised version when it is posted to the Sentinel website.

How do I cite Sentinel works?

Please cite Sentinel works in the following manner:

• Modular Programs and Summary Tables:
  Report Title. Sentinel Initiative; Year. URL. Accessed Month Day, Year.
   
• Reports, Protocols, and Surveillance Plans: 
  Lastname AA, Lastname BB, Lastname CC, et al. Report Title. Sentinel Initiative; Year. URL. Accessed Month Day, Year.
   
• Technical and User Documentation:
  Document Title. Sentinel Initiative; Year. URL. Accessed Month Day, Year.
   
• Data Model:
  Sentinel Common Data Model vX.X.X. Sentinel Initiative; Year. URL. Accessed Month Day, Year.
   
• Programs and Datasets:
  Dataset Name. Sentinel Initiative; Year. URL. Accessed Month Day, Year
   
• Webpage:
  Webpage Title. Sentinel Initiative. URL. Published Month Day, Year. Accessed Month Day, Year.
   
• Sentinel Website
  Sentinel Iniative. URL. Accessed Month Day, Year.

As a media representative, who do I contact to set up an interview with a Sentinel team member?

Please contact the FDA Office of Media Affairs, which oversees all contact with the media concerning our work on Sentinel.

How do I stay informed about Sentinel

• Subscribe to the RSS feed to stay up-to-date on medical product safety surveillance information posted to the Sentinel website.