DRAFT Data Characteristics Table - Attachment H.xlsx
XLSX spreadsheet 42 KB Posted
- Attached to
- Sentinel 3. 0_2026 Updated Market Research
- Solicitation number
- 75F40126SSN00100
About this file
This is a draft data characteristics table attachment supporting the FDA's Sentinel 3.0 market research initiative. The file serves as a template or reference document that outlines the specifications, categories, and attributes of healthcare data expected to be provided across the contracted tiers (Tiers 1-6 for Data Partners, Tier 7 for the GOCO platform, and Tier 8 for Scientific Support Services). The table is designed to standardize how data characteristics are documented and communicated among potential contractors, including data brokers, platform operators, and scientific service providers involved in the Sentinel 3.0 program.
The data characteristics table functions as an analytical tool to ensure consistency and completeness in data submissions, enabling the FDA to evaluate whether proposed data sources meet the program's requirements for healthcare data acquisition, integration, and accessibility. This attachment directly supports the three-contract structure outlined in the market research notice, particularly informing Contract 1 (Data Partners) regarding what data elements and characteristics must be documented, and Contract 2 (GOCO platform) regarding how data will be characterized within the government-owned repository. The table establishes baseline definitions and organizational frameworks that respondents should reference when describing their data offerings, contributing to the overall market research effort to assess contractor capability and data availability for the updated Sentinel 3.0 program.
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Master Data Chart Table
| Sentinel 3.0: Data Partners IDIQ |
| January 2026 | |
INSTRUCTIONS: Complete the Data Resources Information Table as Applicable to the Proposed Data Source(s)
APPENDIX H
Data Resource Information Table
| Data Resource | Brief description |
| Use the shortest description possible to convey the information. (For any question that does not apply to the services you are proposing, list N/A.) | |
| What data sources are you proposing to support the Sentinel Program? | |
| Population size/characteristics by each proposed data source | |
| Patients currently and cumulatively enrolled (n) | |
| Person time by calendar year | |
| Demographic distribution and geographic diversity of patients, including compeleteness of race and ethnicity data. | |
| Representation of special populations | |
| Demographic comparison of the database population to the larger geographic population | (e.g., state-specific, region-specific, or country-level census data) |
| Rate of patient continuance within database | |
| Description of patients, services, or pharmaceutical products that might not be included in the database | (e.g. elderly or indigent populations; elective procedures; psychiatric or prenatal care or services; acute or chronic conditions treated or services provided outside the health plan; drug or biologic products whose administration, prescription or purchase are not captured in the database; smoking cessation clinic visits; etc.) |
| Total number and validated number of years of data available | Present in table format |
| Overall mean, median and range of observation time for active patients in the database, present in graphical format the number of active patients with in strata based on the number of accrued person-years (e.g., 1-2 years, 2-3 years, 3-4 years, etc.) | |
| How many patients had at least one visit last year? | |
| Lag time between date of service and data availability | |
| Month and year data collection began | |
| Availability of a complete data dictionary (including percentage of missing data) | |
| Describe the extent of missing data over time (i.e., the percentage of data not available for a particular variable of interest) and discuss procedures (e.g., exclusion, imputation) employed to handle this issue | |
| Method and frequency of refreshing/updating each proposed database(s) | |
| What is the number of mother-infant linked records by year? | |
| Geographic distribution of participants | |
| National (US)? | |
| Nationally representative of US? | |
| Patient demographics | |
| Age | Specify method by which age is obtained |
| Gender/Sex | |
| Race and ethnicity | Specify method by which race/ethnicity are obtained |
| For what proportion of patients is race and ethnicity captured? | |
| Unique encrypted patient ID that is constant over time | |
| Patient-specific drug or biologic therapy information | |
| Generic/established name of drug/medical product | |
| Strength | |
| Product form | |
| Dispensed dose | |
| Prescribed dose | |
| Instructions for use | |
| Dates of all dispensed prescriptions | |
| Ability to determine absolute initial versus continuing therapy | Include description of ascertainment of this information |
| Days supply | |
| Prescriber specialty | |
| Anonymized unique prescriber identifier | |
| Quantity dispensed | |
| Indication for drug/medical product therapy | |
| Nonprescription drug product use | |
| Setting of care | |
| Ability to verify that the prescription was dispensed to the patient, rather than merely prescribed. | |
| Serum levels for drug and date measured | |
| Route of administration | |
| Type of coding system(s) used for drugs and medical products (e.g., NDC, RxNorm) | |
| Patient medical diagnostic information | |
| Diagnoses and procedures associated with all ambulatory visits and their dates | |
| Diagnoses and procedures associated with all hospitalizations and their dates | |
| Laboratory tests and dates ordered | |
| Laboratory tests results and their dates | |
| Laboratory - microbiology testing | |
| Laboratory data readiness for analysis | |
| Tobacco use and smoking status | |
| BMI, height and weight | |
| Alcohol use | |
| Cannabis use, duration, quantity per day | |
| Non-medical use of FDA-approved drug use | |
| Blood pressure measurements | |
| Heart rate at time of blood pressure measurements | |
| Medical, past history | |
| Family health history | |
| Description of process for identifying pregnancies and pregnancy outcome after birth | |
| Ability to link maternal with child records and vice versa | |
| Spontaneous abortions, stillbirths, other pregnancy outcomes | |
| Cancer diagnoses | |
| Cancer diagnoses with links to cancer registries | (validated staging, please append list of diagnoses) |
| Linkages with chronic disease registries and pregnancy registries | (please append list) |
| Pathology reports and dates | |
| Inpatient transfusion | |
| Death and cause of death (outside of NDI) | |
| Patients with linked DNA biobank data or biopsy biobank data | |
| Vital statistics data linkages, including | |
| National Death Index linkage, other (specify) | |
| Death certificates | |
| Birth certificates | |
| Electronic Health Record (EHR) Data Source | |
| How many patient lives are represented in your EHR data source? | |
| How many patients contribute both EHR data and claims data to your data source? | |
| What proportion of the claims data is for commercial claims? Medicare claims? Medicaid claims? | |
| What is your approach for linking claims to EHR data? | |
| What tools, methods were used? | |
| Clarify if the linked data needs to be relinked with each analysis given 1) the difference in refresh schedules between the data sources and 2) in case there are no linking identifiers maintained across the claims and EHR data sources over time. | |
| How many pediatric patients contribute both EHR and claims data to your data source(s)? | |
| How does this compare to the number in two years prior? | |
| What are your expectations for how this will compare with the number two years from now? | |
| For patients with both EHR and claims data, how much of a patient’s observation time is overlapping between both EHR and claims data, on average? | |
| On average, how many visits or encounters (e.g., hospitalization, office visit, lab draw) does a patient have in your EHR data source per year? | |
| How many patients have at least one visit in the EHR data in each of the last three years? | |
| Are the following data elements available from your EHR data for analysis? | |
| Coded data using standard terminologies | |
| Extracted clinical concepts from unstructured EHR notes (e.g., using Natural Language Processing technique) | |
| Clinical Notes (e.g., physician, nursing, and other clinical services such as respiratory therapy) | |
| Describe how clinical notes will be made available for analysis | |
| Free text clinical note search (ability to search chart notes for a large cohort of patients simultaneously) | |
| Prescription administration/dispensing information | |
| Lab procedures (test occurred and/or administrative codes) and for what percentage of patients | |
| Lab values (microbiology, chemistries, hematology, inflammatory markers, pregnancy tests, viral respiratory panels) and for what percentage of patients | |
| Vital signs | |
| Death data, death fact and cause of death | |
| Imaging procedures (test occurred and/or administrative codes) | |
| Imaging reports | |
| Pathology procedures (test occurred and/or administrative codes) | |
| Pathology reports (biopsies, tumor grade) | |
| Radiology procedures (test occurred and/or administrative codes) | |
| Radiology reports (pregnancy related ultrasounds, head MRI) | |
| Demographic characteristics | |
| Current diagnoses | |
| Medical history | |
| Allergy diagnoses and treatment | |
| Immunizations history | |
| Provider order entry records (orders) | |
| Procedure notes (surgical procedure notes) | |
| Intraoperative exposures (anesthesia) | |
| Dialysis | |
| Is the time period available different for different locations or providers? | |
| Care settings that are covered: | |
| Inpatient (e.g., Intensive Care Unit (ICU) data, and Pediatric Intensive Care Unit (PICU)) | |
| Outpatient/ambulatory | |
| Telehealth services (health-related services and information via electronic information and telecommunication technologies) | |
| Emergency department | |
| Skilled nursing facility or palliative care | |
| Oncology | |
| Thinking about EHR data that are available for secondary use, how frequently are the research data updated? | |
| Do refreshes vary by the specific field? | |
| What terminologies are available in your EHR data source? | |
| NDC | |
| RXNORM | |
| ICD-9 | |
| ICD-10 | |
| ICD-11 | |
| HCPCS/CPT | |
| ISBT-128 (blood products) | |
| Codabar (blood products) | |
| LOINC | |
| NUCC | |
| SNOMED-CT | |
| Currently available tools or established routine capabilities to address the following | |
| Drug utilization inquiry | |
| Utilization patterns across multiple products | |
| Background rates for adverse events/outcomes | |
| Prevalence and incidence rates | |
| Propensity score analysis | |
| Inverse Probability Treatment Weighting (IPTW) | |
| Signal identification: comparative effectiveness analysis and time to event analysis | |
| Describe the extent that artificial intelligence (AI) tools such as machine learning (ML) and natural language processing (NLP) are used by organization to interrogate your data. | |
| Describe the extent and breadth of any already established and operational Natural Language Processing Tools | |
| Describe the extent and breadth of any outcome codes already validated in these resources (include sensitivity and specificity) | |
| Do you use data standards (e.g., Fast Healthcare Interoperability Resources (FHIR)) in the EHRs or to transfer data to medical claims? | |
| If so, how is it used or how do you project it to be used to support FDA work? | |
| Can medical records be obtained for a portion of your data? | |
| If so, from what source and in what proportion? | |
| If not, what other approaches support more in-depth understanding of the patient's profile and for what proportion? | |
| Can medical records be obtained for a portion of your claims-EHR linked data? | |
| If so, from what source and in what proportion? | |
| Other | |
| Characterize the data quality-control processes used and quality control process of any mapped or transformed data. | |
| Could you provide examples of a published analyses that illustrates your technical capability, capacity, and the strengths of your data sources? | |
| Describe how you will protect patient privacy and Protected Health Information (PHI) (HIPAA compliance) | |
| Describe the frequency and type of any data error corrections or changes in data adjudication policies implemented | |
| Describe the general procedures used to ensure completeness, consistency, and accuracy of data collection and management |
| Describe how the registry data can be used to support Sentinel activities |
| Describe the predefined enrolled population and the prespecified health-related data collected. |
| Describe methods used to identify and retain registry patients and the effect those methods have on the representativeness of the population in the registry. |
| Describe registry outreach strategies for patients who do not maintain contact with the registry or have difficulty doing so. |
| Describe the Contractor’s capability to capture or transform data in a harmonized manner and address semantic interoperability. |
| Describe how the attributes of the registry support the collection of relevant and reliable data, including in situations where the data are from an independent registry not managed or designed by the Contractor. |
| What proportion of Medical Records for patients enrolled in the registry avaiable for review? |
| For Health Information Exchange data, provide all other relevant data chanracteristics |
| Describe the extent to which individual patient profiles could be shared with FDA. |
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