Basic conditions | • Selection of a legal body for CRC |
| • Securing sufficient financial resources for ≥3 years |
| • Appointment of a full-time dedicated project manager |
| • Establishment of a contract with an SME specialising in OHDSI, OMOP CDM and mapping |
| • Establishment of a contract with a hands-on statistician with programming skills |
| • Written confirmation from each registry that patients have given written consent to use their medical data for (international) clinical research |
| • Identification for each local registry of named individuals in the following roles: registry owner, legal officer, clinical expert, source data expert IT contact/administrator, translator of medical terminology and platform/system user |
| • Conclusion of collaboration agreements between CRC and registries |
Conceptual aspects | • Production of a document and a PowerPoint presentation explaining the OHDSI/OMOP CDM and the federated approach to all stakeholders |
| • Organisation of a plenary kick-off meeting with all stakeholders |
| • Organisation of regular team meetings for each registry to monitor progress |
Technical aspects | • Provision/hire of a dedicated Linux server for each registry (local data centre or cloud environment) for the installation and set-up of the FAP, with access to a local copy of the source database |
| • Provision to all required parties of access to the Linux registry servers |
| • Testing of the functioning of the FAP on local Linux servers by SME |
Mapping aspects | • Checks source data quality |
| • Provision of registry data dictionary to SME by source data experts |
| • Provision of a representative, but anonymised registry data sample by local team to smoothen the ETL process and avoid “black box mapping” |
| • Assistance by clinical experts in optimising the mapping |
| • Provision by SME to statistician(s) of a codebook of the variables mapped |
Analytical aspects and quality control | • Learning by statistician(s) on the principles of OHDSI and OMOP CDM |
• Provision by SME of access to the FAP for statistician(s) |
| • Creation by statistician of scripts in R (or OHDSI tools) for the production of descriptive summary statistics |
| • Execution by local analyst in each country of the pre-written R script via the FAP |
| • Checks by clinicians on the validity of the output and provision of feedback to statistician and SME |
| • Revision by source data expert and SME of any mapping issues |
| • Creation of a second round of data summaries and a repeat of the quality control process |
| • Production of final OHDSI/OMOP CDM tables |
Research studies | • Creation of research protocol, and approval by CRC, local clinical experts and registry owners |
| • Identification of dedicated local teams for each registry, comprising clinical experts, source data experts and data analysts |
| • Creation of a formal analysis plan by statistician, for review and approval by representatives of all participating registries |
| • Creation by statistician of analysis scripts in R (or OHDSI tools) |
| • Execution by local data analysts of pre-written scripts in R (or OHDSI tools) using the FAP |
| • Fostering of collaboration between best practices for statisticians and data analysts via workshops to discuss issues such as imputation rules, filters and exclusions |
| • Production of final statistical tables and graphics for each registry singly, according to the analysis plan |
| • Meta-analysis by statistician of summary statistics from all registries |
| • Writing and submission of manuscript |