Principles & Policies: Communications

Release of Information by FDA

The FDA reserves the right to release the results of contracted analyses at any time if it considers such action to be in the best interest of the public. To the extent feasible, FDA will authorize posting of query and assessment reports on the Sentinel website in advance of all related presentations or safety communications.

Safety Communications

Upon receipt of an advance notice for a planned FDA safety communication (typically 24 hours or less prior to FDA posting) that mentions or otherwise refers to an assessment or query done within the Sentinel System, the SOC will forward the notice via email to the project lead of the relevant workgroup and a representative from each of the Data Partners that participated in the assessment or query. If the notice is received during business hours, it will be sent the same day; if the notice is received after the close of business, it will be sent by 11am the following day. The SOC will:

• Include a brief note referencing the relevant Sentinel project and project leader
• Instruct recipients that the advance information is for internal use only within the recipient's organization and confidential until the information is made publicly available by the FDA
• Provide a link to additional information on the Sentinel website (if available)

Modular Program and Summary Table Assessments

Modular programs and summary tables facilitate rapid querying of the data to glean information such as counts of enrollment, diagnoses, procedures, drug, device, biologic utilization, and other cohort size measures.

At the present time, results of summary table queries and non-sequential modular program assessments, also known as modular program Level 1 and Level 2 assessments, aggregated across Data Partners, are posted on the Sentinel website if the results will be released publicly (e.g., presentations, manuscripts, etc.) or at the Agency’s discretion. At the Agency’s discretion, summary table and modular program Level 1 and Level 2 queries that are part of sequential surveillance or protocol-based assessments (see Sequential Surveillance and Protocol-Based Assessments), or other larger projects, may not be posted until after final reports from those projects have been accepted and deemed final by FDA.

Sequential Surveillance and Protocol-Based Assessments

Sequential surveillance assessments, also known as modular program Level 3 queries, perform active safety surveillance of medical products in a prospective and semi-automated manner. Sequential assessments use a small number of automated study designs and analytical methods that can be modified to accommodate specific products, outcomes, populations, and time periods for evaluation. The assessment parameters and surveillance plan are outlined in sequential surveillance plans created by the assessment team or project workgroup.

Protocol-based assessments use detailed plans for assessing medical product safety that adjust for anticipated complications in the data. These assessments formally evaluate medical product-outcome associations using study designs and analytical methods that are tailored to accommodate specific products, outcomes, populations, and time periods for evaluation. The assessment parameters and analysis plans are outlined in study protocols created by the assessment team or project workgroup.

First drafts of sequential surveillance plans and protocols are posted on the Sentinel website for two weeks for public review and comment. Workgroup leaders are required to consider but not to accept or respond to comments.

The FDA reserves the right to determine whether sequential surveillance plans and protocols will be implemented as written or with modifications, including those based on available resources or Agency priorities. Upon this determination, if changes are made prior to or during implementation, a revised version will be posted on the Sentinel website. Revised plans/protocols do not require a public comment period.

Results of completed sequential surveillance and protocol-based assessments are posted on the Sentinel website following acceptance of the final report by the FDA. The FDA may delay posting if the Agency determines that a delay is in the public interest.

After the FDA has had 30 days to review (as further discussed in FDA Review), Sentinel Collaborators are encouraged to present and publish results that do not include Non-Public or Confidential Information as defined in Confidentiality. Collaborators must inform the SOC and the FDA when a manuscript or other written material is published and furnish a copy of it as finally published to the SOC. Collaborators are required to provide the SOC with links to publications, presentations, and related materials for posting on the Sentinel website.

Data Checking

Collaborators who choose to submit results of completed protocols for publication or presentation in public forums must first satisfy Sentinel standard data checks and evaluations, as determined by the Infrastructure Division.

Authorship

Workgroup participants identify potential publications and presentations and assign authorship roles among themselves. Ideally, this will occur early during the collaboration before analyses occur. Sentinel authorship guidelines are defined by the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals.1 Participants may include FDA staff members, who are required to adhere to FDA policies regarding authorship.

• 1International Committee of Medical Journal Editors, Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals. Updated December 2019. http://www.icmje.org/recommendations/, accessed 6 April 2021.

Risk Disclaimers

Sentinel website postings related to assessments of exposures to medical products linked to health outcomes of interest must include the following disclaimers:

Assessments - Information for Patients and Consumers

The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from the Sentinel System in the public domain as soon as possible.

Much of the content on this site is technical and intended for use by scientists in various areas of expertise.

The fact that FDA requests and receives data on a particular product through Sentinel does not necessarily mean there is a safety issue with the product.

FDA may access the data available through Sentinel for a variety of reasons beyond assessing potential safety risks for a specific product. Some examples include determining a rate or count of an identified health outcome of interest, examining medical product use, or seeking to better understand the capabilities of the Sentinel System.

When evaluating a potential safety issue, FDA scientists consider the data obtained through Sentinel with information from various other data sources, such as adverse event reports, published study results, and clinical trials, to help make the most informed decisions possible.

FDA communicates its interpretation of Sentinel activities through existing channels, such as FDA's press announcements, MedWatch Alerts, and Drug Safety Communications, rather than on this website.

Information from this site should not affect your use of a medical product in any way. Patients who have questions about the use of a medical product should contact their health care professional.

Assessments - Information for Industry

The information contained on this website is provided as part of FDA's commitment to place knowledge acquired from Sentinel in the public domain as soon as possible. To most effectively interpret results from observational studies, it is important to consider not only the studies that supported a hypothesis, but also the studies that did not. The website serves as a public data repository that archives all the activities of Sentinel and provides important context to those seeking to understand the significance of any specific activity. This information is being provided to the public in the interest of transparency and for purposes of demonstrating the extent of use and the various ways FDA is utilizing the Sentinel System. While the data posted here may contribute to important overall conclusions, FDA relies on other mechanisms for communicating such conclusions to the public.

When reviewing this information please be aware that there are times when FDA may access the data available through Sentinel for a variety of reasons beyond seeking direct access to information that can help assess potential safety risks for a specific product. Some examples include determining a rate or count of an identified health outcome of interest, examining medical product use, exploring the feasibility of future, more detailed analyses within Sentinel, and seeking to better understand the capabilities of the Sentinel System.

Data obtained through Sentinel are intended to complement other types of data and information compiled by FDA scientists, such as adverse event reports, published study results, and clinical trials, which can be combined with Sentinel data and used by FDA to inform regulatory decisions regarding medical product safety. However, data obtained from the Sentinel System are not necessarily used by FDA to take regulatory actions or to make safety decisions. Any public health actions taken by FDA regarding products involved in Sentinel queries and protocols are communicated through existing channels.

FDA also wants to emphasize the fact that the Agency may access data and report findings from the Sentinel System for a number of reasons. Such activity does not necessarily lead to an Agency recommendation regarding the use of the drug. Patients who have questions about the use of an identified medical product should contact their health care professional.

Endorsement Disclaimer

Publications and presentations resulting from work performed under the Sentinel contract must include the following disclaimer:

The views expressed in written conference materials or publications and by speakers and moderators at conferences do not necessarily reflect the official policies of the Department of Health and Human Services, nor does mention of trade names, commercial practices, or organizations imply endorsement by the U.S. government.

Sentinel Logo

Collaborators are expected to use the Sentinel logo on all presentations, reports, and other written materials that are products of Sentinel. Collaborators may not display the Sentinel logo on any conference materials or publications unless authorized by the FDA.

Collaborators' Logos

By participating in Sentinel, Collaborators authorize the use of their institutional logos by the FDA, the SOC, and other Collaborators solely for the purposes of Sentinel related presentations, reports, and other written materials and so long as such uses do not denigrate the respective institutions unless otherwise authorized by those institutions.

FDA Logo

Collaborators may not display the FDA logo on any conference materials or publications unless authorized by the FDA.

HHS Logo

Collaborators may not display the Health and Human Services (HHS) logo on any conference materials or publications unless authorized by the FDA.

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