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Cellular Therapy Data Collection in Castor

At the first Registry Annual Data Management Educational Event (10-11 November 2021), the registry team presented a new database for cellular therapy, called Castor.

Background information

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 cellulartherapyhelpdesk@ebmt.org

Will the cellular therapy form be updated?

Yes, the registry team is currently working on a new version of the cellular therapy form. Once this is finalized, it will be put on the EBMT website together with an updated manual.

Will there be more training sessions for data managers?

Currently, training is being given to the national registries and centres from countries without a national registry. Furthermore, a Castor course will be available at EBMT's e-learning platform, where it is possible to obtain a certificate proving the successful completion of the course.

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 will be 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?

When the database is finished, you will receive an invitation with instructions. Creating an account will also be explained in the Castor manual.

When will the Castor manual be available?

The Castor manual is ready to be distributed and can be found on our Website by clicking HERE.

Furthermore, the Castor manual will be available in the e-course at EBMT's e-learning platform.

Will the database structure in ProMISe be changed?

No, nothing will be changed in ProMISe.

Will the CAR-T data that is in ProMISe be transferred to Castor?

Currently, the Castor cellular therapy study covers all the stages from Pre-Infusion Registration to Follow up forms. However, Diagnosis, previous treatments and subsequent HSCTs will still be collected and stored in ProMISe. All the information about the stages covered in Castor is copied from ProMISe.

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.