The different models presented above present many challenges:
Related to the scientific content
Differences in the underlying health care systems and mechanisms of data generation and collection
Mapping of differing disease coding systems (e.g., the International Classification of Disease, 10th Revision (ICD-10),Read codes, the International Classification of Primary Care (ICPC-2)) and narrative medical information in different languages.
Validation of study variables and access to source documents for validation.
Related to the organisation of the network
Differences in culture and experience between academia, public institutions and private partners.
Differences in the type and quality of information contained within each mapped database.
Different ethical and governance requirements in each country regarding processing of anonymised or pseudo-anonymised healthcare data.
Choice of data sharing model and access rights of partners.
Issues linked to intellectual property and authorship.
Sustainability and funding mechanisms.
|10. Specific topics|
|Annex 1.||Guidance on conducting systematic revies and meta-analyses of completed comparative pharmacoepidemiological studies of safety outcomes|