1. Contact details
Name of data sourceBig-Pac
Name under which the data source should be displayed in the inventory (e.g short name if one exists)Real Life Data - Big-Pac
Name of organisation
1) Department/research group
2) Organisation/affiliationReal Life Data SLU
Administrative Contact
Title Mr
Last name Enriquez
First name Jose-Luis
Address line 1Cronos, 24
Address line 2
Address line 3
CityMadrid
Postcode28037
CountrySpain
Scientific Contact
Title Dr
Last name Enriquez
First name Jose-Luis
Address line 1Cronos, 24
Address line 2
Address line 3
CityMadrid
Postcode28037
CountrySpain
Alternative Contact
Title Dr
Last name Sicras
First name Antoni
Address line 1Cronos, 24
Address line 2
Address line 3
CityMadrid
Postcode28037
CountrySpain
2. Description/category
Disease/case registry
Prescription event monitoring
Routine primary care electronic patient registry
Pharmacy dispensing database
Prospective studies database
Case-control surveillance database
3.1 Coverage of licensed medicinal products
Licensed Medicinal Product
Comments
Hospital data
Community / general practice data
Vaccines
3.2 ATC code (5th level)
Yes
3.3 Other product dictionaries
CNF (Codigo Nacional Farmaceutico)
3.4 Recording of indication for use
Yes
Is a coding dictionary being used? ICD9,10
4. Coverage of events
Event
Dictionary
Dictionary details
Symptoms/signs
Yes
SNOMED
Diagnosis in primary care
Yes
ICD9,10
Specialist diagnosis
Yes
ICD9,10
Laboratory values
Yes
Standard blood test data (HDL, Hb, etc)
Procedures
Yes
COPD, Ashma
5. Year of establishment
2012
6. Geographical origin of data
EEA/EFTA countries
Spain
7. Demographical extent of data collection
Nation-wide
8. Age groups
17 years and under [Paediatrics]
term newborn infants (0 to 27 days)
infants and toddlers (28 days to 23 months)
children (2 to 11 years)
adolescents (12 to 17 years)
18 to 45 years
46 to 64 years
65 years and over
65 to 75 years
76 years and over
9. Size of the source/catchment population
46,733,038
10 a. Total (cumulative) number of persons with actual data
2,514,323
10 b. Number of persons with active data collection in past calendar year
1,933,466
11. Possibility to obtain additional information on the patient
a) Clinical information from treating physician?
Yes
b) Questionnaire data from the patient?
No
c) Genetic information or samples?
No
12. Possibility of links to other sources of data
No
13. Written policy governing data access
Yes
14. Committee to evaluate requests for data access
Yes
15. Charge/fee for data access
No