EU-ADR |
Intermediate files that can be shared among partners, analysis will follow |
csv |
Drug safety methodology: comparison of observed drug-event associations with previously classified true and false causal associations; impact on this of different definitions of the derived data |
Mini-Sentinel |
Level of granularity of dataset depends on study needs; always transfer minimum necessary. Some analyses transfer aggregate data, some use highly-summarized patient-level data Intermediate files saved locally by data partners |
csv, SAS datafiles, HTML |
To test code known associations are used. Rapid Response queries include data characterization and are reviewed manually by a data expert and an epidemiologist. Results are also reviewed by data partners. Protocol-based assessments might include chart reviews. |
OMOP |
Final estimates, intermediate files are discarded |
csv, SAS datafiles, SQL tables |
Drug safety methodology: comparison of observed drug-event associations with previously classified true and false causal associations; impact on this of different definitions of the derived data; estimate of residual bias per event by means of known non causal associations. |
MATRICE |
Intermediate files to be used for analysis or report generation |
csv |
Results are reviewed by data partners for comparison with similar analysis performed independently |