At the first Registry Annual Data Management Educational Event (10-11 November 2021), the registry team presented a new database for cellular therapy, Castor EDC.
Since EBMT discontinued the development of Macro and cell therapy data collection possibilities in ProMISe are unsatisfactory, an alternative method of collecting cell therapy data was necessary.
The current ProMISe cellular therapy form holds only a small fraction of the items that are relevant for cellular therapies. The implemented form dates from 2018, and an update is necessary. Particularly the data that is important for the Post-Authorisation Safety and efficacy Studies (PAS) cannot be entered into ProMISe sufficiently at this moment.
As the availability of ProMISe ends soon and finding a replacement is a time-consuming process, the decision was made to use Castor. Castor is a data management platform used by various institutes to perform clinical studies. It conforms to all international regulations regarding data safety (ISO 27001, GDPR).
What does this mean for your center?
Centers still enter the diagnosis, HSCT, and pre-treatment information in ProMISe. To do this, instruction documents will be provided. Cell therapy, the infusion unit, infusion episode and follow-up including complications and infections will be entered into Castor.
Frequently asked questions
Will Castor have a specific Help Desk?
Yes, currently, the help desk address for cellular therapy data collection related issues is email@example.com
Will there be more training sessions for data managers?
The new e-learning course for Castor is available at the EBMTs e-learning platform. In the course, you will:
- Learn about the collection of cellular therapy data in Castor
- Learn how to enter, modify and update data in Castor
- Learn how to export data from Castor
- Learn about quality control in Castor
After completing the course, a certification that allows access to the platform is achieved!
Find more information about the course here.
Our center downloads data from ProMISe for analyses. Is that functionality available in Castor?
Yes, you will be able to export all the data related to your center in xlsx-, csv- and sav format, selecting which variables or sections of the study you need. All these details will be explained in the manual.
In the Q&A it was mentioned that there is no training database available for cellular therapy. How can we practice working with the system?
In the e-course available in EBMT's e-learning platform there is a document containing the Castor cellular therapy study.
During the course, the user will be taught to create and import its own version of the cellular therapy study to practice with the system.
Furthermore, there is Castor Academy where you can watch free training videos of Castor: https://academy.castoredc.com/
How can I get an account for Castor?
In order to get an account and access to Castor, a certification proving the necessary skills is required. The certificate can be obtained through:
- Online trainings given during the first half of 2022.
- Access to ProMISe.
- Completing the e-learning course available at EBMTs e-learning platform.
Once the certification is obtained, access to Castor can be granted to the user.
What are the educational resources available?
- The Cellular Therapy Data collection Handbook for Castor EDC
- The Cellular Therapy Forms Manual - A guide to the completion of the EBMT Cellular Therapy Forms
You can access the Handbook and Manual by clicking on the blue button at the top of this webpage.
Will the database structure in ProMISe be changed?
No, nothing will be changed in ProMISe.
Is the CAR-T data that was in ProMISe now transferred to Castor?
The data migration was executed in April and a complete validation of all data migrated to the Castor database has been performed. In addition, on Friday 29 July a second import of patient data took place of all newly entered CAR-T treatments added in ProMISe after the migration in April.
Does Castor save automatically?
Yes, Castor saves after every completed field.
After how long of inactivity does the system log you out?
A session in Castor EDC automatically expires after 20 minutes of inactivity.