The data source contains the following information

Disease information

Does the data source collect information with a focus on a specific disease? This might be a patient registry or other similar initiatives.

Yes

Disease details, other

SCEM methodology facilitates involvement of HCPs from any chosen speciality, depending on the medicinal product being studied. The HCPs can provide any disease information that we request from the patient medical records.

Rare diseases

Are rare diseases captured? In the European Union a rare disease is one that affects no more than 5 people in 10,000.

Yes

Pregnancy and/or neonates

Does the data source collect information on pregnant women and/or neonatal subpopulation (under 28 days of age)?

Yes

Hospital admission and/or discharge

Yes

ICU admission

Is information on intensive care unit admission available?

Yes

Cause of death

Captured

Cause of death vocabulary

Not coded (Free text)
Other

Cause of death vocabulary, other

Based on study requirements.

Prescriptions of medicines

Captured

Prescriptions vocabulary

other

Prescriptions vocabulary, other

Based on study requirements.

Dispensing of medicines

Captured

Advanced therapy medicinal products (ATMP)

Is information on advanced therapy medicinal products included? A medicinal product for human use that is either a gene therapy medicinal product, a somatic cell therapy product or a tissue engineered products as defined in Regulation (EC) No 1394/2007 [Reg (EC) No 1394/2007 Art 1(1)].

Yes

Contraception

Is information on the use of any type of contraception (oral, injectable, devices etc.) available?

Yes

Indication for use

Does the data source capture information on the therapeutic indication for the use of medicinal products?

Captured

Indication vocabulary

Not coded (Free text)
Other

Indication vocabulary, other

Based on study requirements.

Medical devices

Is information on medicinal devices (e.g., pens, syringes, inhalers) available?

Yes

Administration of vaccines

Yes

Procedures

Does the data source capture information on procedures (e.g., diagnostic tests, therapeutic, surgical interventions)?

Captured

Procedures vocabulary

Other

Procedures vocabulary, other

Based on study requirements.

Clinical measurements

Is information on clinical measurements (e.g., BMI, blood pressure, height) available?

Yes

Healthcare provider

Is information on the person providing healthcare (e.g., physician, pharmacist, specialist) available? The healthcare provider refers to individual health professionals or a health facility organisation licensed to provide health care diagnosis and treatment services including medication, surgery and medical devices.

Yes

Genetic data

Are data related to genotyping, genome sequencing available?

Not Captured

Biomarker data

Does the data source capture biomarker information? The term “biomarker” refers to a broad subcategory of medical signs ( objective indications of medical state observed from outside the patient), which can be measured accurately and reproducibly. For example, haematological assays, infectious disease markers or metabolomic biomarkers.

Not Captured

Patient-reported outcomes

Is information on patient-reported outcomes (e.g., quality of life) available?

Yes

Patient-generated data

Is patient-generated information (e.g., from wearable devices) available?

Yes

Units of healthcare utilisation

Are units of healthcare utilisation (e.g., number of visits to GP per year, number of hospital days) available or can they be derived? Units of healthcare utilisation refer to the quantification of the use of services for the purpose of preventing or curing health problems.

Yes

Unique identifier for persons

Are patients uniquely identified in the data source?

Yes

Diagnostic codes

Captured

Diagnosis / medical event vocabulary

Other

Diagnosis / medical event vocabulary, other

Based on study requirements.

Medicinal product information

Captured

Medicinal product information collected

Batch number
Brand name
Dosage regime
Dose
Route of administration

Medicinal product vocabulary

Not coded (Free text)
Other

If 'other,' what vocabulary is used?

Based on study requirements.

Quality of life measurements

Captured

Quality of life measurements vocabulary

other

Quality of life measurements, other

Study specific.

Lifestyle factors

Captured

Lifestyle factors collected

Alcohol use
Diet
Frequency of exercise
Tobacco use

Sociodemographic information

Captured

Sociodemographic information collected

Age
Country of origin
Deprivation index
Ethnicity
Gender
Marital status
Socioeconomic status