SMArtCAREFollow-up observation and therapy evaluation in spinal muscular atrophy

What does SMArtCARE offer you as a treatment centre?

We have developed suggestions for follow-up examinations in SMA, and provide the centres participating in SMArtCARE with corresponding documentation forms.

SMArtCARE compensates the additional effort incurred by the centres for the documentation of the patient data in the database.

Our physiotherapists and the medical team offer further education on motor function tests as well as a programme of regular lectures on SMA for the staff of the participating centres.

In addition, SMArtCARE aims to provide a network for clinical research. If you have your own research ideas or would like to validate new evaluation instruments, please contact us. You may be able to use the infrastructure of SMArtCARE for your project and thus avoid unnecessary extra work.

The Federal Joint Committee has commissioned a anwendungsbegleitende Datenerhebung the application for the drug treatment of spinal muscular atrophy with onasemnogen Abeparvovec (Zolgensma®) and Risdiplam (Evrysdi®). These data collections are carried out via the SMArtCARE Register. In order to enable the most complete data collection possible, these drugs may therefore only be prescribed by centers that participate in the SMArtCARE data collection. The corresponding decisions can be found here: Onasemnogen Abeparvovec, Risdiplam.

How can I participate in the SMArtCARE Registry as a treatment centre?

Before you are allowed to document patient data in the SMArtCARE database, the following conditions must be met:

1. A centre contract must be concluded between your centre and the University Medical Centre Freiburg, as well as an agreement in accordance with Article 26 (1) p. 1 of the General Data Protection Regulation on joint data processing.
2. Your responsible ethics committee must approve your application. We will gladly take care of the submission to your responsible ethics committee for you.
3. You must take part in a one-hour initiation session, during which you will learn the most important information about SMArtCARE and get to know the database.
4. You need the consent of the patients whose data you will enter into the SMArtCARE registry. For this purpose, SMArtCARE provides you with centre- and age-specific patient consent forms.

If you are a treatment centre interested in participating in data collection, please contact us, most easily at SMArtCARE@uniklinik-freiburg.de. We will be happy to answer your questions and send you the necessary documents for your participation.

Please also point your patients and their families to the Treat-NMD Registry for patients with Spinal Muscular Atrophy, where patients or families can self-register.