Can a Data Partner with previous experience in mapping to the OMOP-CDM do (part) of the work using the financial support?
It is allowed that a Data Partner with the appropriate expertise can perform (part) of the data standardisation and analytical tool installation using the financial support. However, we do believe that the help of the certified SMEs will often be needed. This will be assessed on a case-by-case basis and will be part of the workplan that is attached to the sub-grant agreement. We do enforce that a final inspection of the ETL and infrastructure is performed by a certified SME.
How high will the costs when the mapping process is performed by a certified SME?
This is not under control of EHDEN and will be between the Data Partner and the SME. Since this is a pilot round, we cannot provide estimates based on prior experience with the new SME market. We do believe that based on prior mapping experience the provided financial support should be sufficient for the average data source that is already actively used for research. However, we do like to point out that you may have to contribute some of your own resources in the process.
Can a Data Partner be certified like the SMEs to help in the mapping process of other data sources?
Certification is currently envisaged for SMEs so we can build a sustainable market that supports the eco-system across Europe. However, we may consider expanding this to other type of organisations that want to provide a role as certified centre to supports others.
A Data Partner may have multiple data source can they apply separately for each data source?
It is important to realise that there is a maximum amount of funding of 100.000 euro per Data Partner not per Data Source within the duration of the EHDEN project. There will be multiple calls over the next years you can participate in, but the sum of grants cannot exceed the 100.000 euro due to IMI regulations. If you like to apply for multiple now, we suggest you make this clear in the form and clarify the differences between the data sources. If there are other institutes that manage the same data sources with you, you could ask them to apply. Finally, the SMEs will of course also be available for support outside of the EHDEN grants using your own resources.
How long will it take to map my data source?
We will aim for a milestone driven workplan of maximum 7 months (to be included as annex in the sub-grant agreement), but this can be negotiated case by case depending on specific circumstances like the data readiness and complexity. We do want to onboard data sources as quickly as possible but will make sure the execution phase is long enough to ensure the required quality. The duration will of course also depend on the type of activity applied for, i.e. full mapping, extensions, or only inspection.
One of the selection criteria is related to the participation in federated studies. In this case, is it expected that we share data at an individual level?
You do not have to share patient-level data within EHDEN. The goal is to standardise the data to a common structure and terminology system, to improve the interoperability of the data. The financial support we offer in EHDEN is there to initiate the data standardisation and make sure this is done at a high quality. By standardising the data, we can all apply the same tools when we do studies which will bring more reliable evidence quicker to the patients as illustrated in the figure below.
You can participate in research studies initiated by the community following your own data governance and privacy rules. These studies are executed by running an analytical tool locally on the data, you can then approve the aggregated results, and return these to the coordinator. This process is called federated analyses, it is a form of privacy by design in which the data custodian is in full control.
It is expected that a certified SME will inspect data and infrastructure for quality assessment. When do we need to select the SME?
It is not needed to connect with a SME at the application submission stage. Once the Data Partner is selected the Data Partner can connect to certified SMEs. EHDEN will provide a public catalogue of certified SMEs at that time.
Do I have to share patient data with the certified SME?
The SME does not need to have access to the data to build the Extraction, Transform, and Load (ETL) process. In close collaboration with the Data Partner the local data model is studied, and a profile is made to understand the complexity of data structure and the terminology system. Together with the Data Partner the mapping rules are then developed. The implementation of the ETL can be done on simulated data if required by the local governance and privacy rules.
Where can we get the list of EHDEN-certified SMEs?
The SMEs are currently following the training program. We will make the list available on a public website in October 2019.
To select the SME, we may have to follow internal procurement procedures. Will this have impact on the selection process?
This will not have impact on selection process. We fully understand a Data Partner may have to follow procurement procedures. This can be discussed when the working plan is developed as part of the sub-grant agreement. This will have implications for timelines.
Is there a preference for data associated to any particular pathology or geographic area?
No in the pilot call there is no focus on a particular pathology or geographic area. This may change in future calls.
Will EHDEN provide any training for the Data Partners?
Yes, the Data Partners will get access to the EHDEN Academy that contains several courses on the Common Data Model, Vocabularies, ETL, Tools installation etc. The curriculum will grow during the EHDEN project.
If you have additional questions, please send them to firstname.lastname@example.org.
Helpful resources from OHDSI:
- The Book of OHDSI: https://ohdsi.github.io/TheBookOfOhdsi/
- FAQ available at the Common Data Model wiki page: https://github.com/OHDSI/CommonDataModel/wiki/Frequently-Asked-Questions