Dear Colleagues and Friends of the ESID Registry,
Following up on my recent newsletter of July 1st (link see below), I may inform you now that the migration of the ESID registry (database and online electronic data capture platform) from Medical University of Freiburg to Castor-edc, a professional clinical trial operator based in the NL, is ongoing and will be completed very soon.
While this was considered necessary, mainly, in order to keep up with modern security concerns, it should also facilitate decentral substudy creation and YOUR benefits from ESID registry data. Upon login, you will find all the relevant patient data ever entered from your center in the new platform, as we put a lot of effort in migrating all existing data! [Even if some data fields are not shown any longer in the new system, the old data entered there are saved in the background.]
As explained and triple-checked, there is no need to reconsent existing patients! However, we would recommend to file an amendment at your local IRB (verified users will get the amended protocol and PIC as email attachment with this newsletter). Furthermore, to be on the same, current, contractual basis with all participating centers, an updated version of the ESID-Center Agreement (contract and DTA, attached) should be signed from your institution and returned to us. As with any study amendment, from our perspective, the work with the ESID registry should not be interrupted in the meantime. Please find details about the new 2-factor authentication login and other instructions below. If there are questions, please contact us.
On the fly, we, the registry steering committee together with IT/data staff, aimed to simplify the structure a bit and reduce data fields that were not or only very rarely used, and added few new fields of interest, e.g., for organ involvement in IEI/PID as new filter option for research feasibility checks. Soon after the new launch you will also receive your first “automated center dashboard report” containing the most relevant epidemiological and clinical statistics of the patients from your center, compared to your country and to the entire ESID registry. Furthermore, there are many options for data export (and direct usage) on your side. We are truly optimistic that the benefits of the professional new system upgrade outweigh by far the hurdles of a change, which are to be expected of course.
The planned dates and downtimes are:
Shutdown of existing ESID registry (incl. substudies): Nov. 08, 2024
Launch/Go-Live of the new ESID registry at Castor: Nov. 29, 2024
Launch of the APDS substudy within the ESID registry at Castor: provisional date, Dec.19, 2024
In line, also the APDS study is being built in Castor and all existing data will be migrated. During that interim phase, it will NOT be possible to enter APDS data. The UnPad study data will be exported upon closure of the ESID registry, and a prolongation at Castor is planned; we will keep you updated on that and other studies. I am grateful for and looking forward to continuing our fruitful cooperation!
Sincerely yours Markus Seidel
More details:
Newsletter July 2024: please see download (if you missed it): https://www.esid.org/Working-Parties/Registry-Working-Party/News-and-Events
Tutorials @Castoredc.com:
- Login: https://academy.castoredc.com/courses/category/edc-cdms
- Data entry: https://academy.castoredc.com/courses/category/edc-cdms
Data export: https://academy.castoredc.com/courses/category/edc-cdms
Other: https://academy.castoredc.com/courses/category/edc-cdms
…
Attachments (for confidential ESID registry-related use only):
- Center Agreement version 4.4 without SCC [for EU countries; there is another version for countries outside the EU, please contact us by email if you need that]
- Study protocol version 3.0 (= an amendment based on previous version 2.0 or 2.1)
- Patient informed consent (English) version 4.0
- IRB approval for the ESID registry study, substantial amendment July 2024, Graz, Austria (German); plus an official translation in English.
Download the PDF here
