What is the purpose of the EUROMAC Registry?

There is no cure for muscle glycogenoses, and to date no drug treatment. This is the main reason for setting up this registry. Its goal is to collect clinical data on people with McArdle Disease and the above-mentioned Glycogenoses. In the long-term, we expect to achieve the following objectives:

• Improve the access of patients to specialised care;

• Improve knowledge on McArdle Disease and other rare neuromuscular Glycogenoses;

• Help patients learn or improve to manage their disease; • Avoid delayed or incorrect diagnosis and advice;

• Facilitating inclusion of patients in future clinical and therapeutic trials.

 

 

What are the risks of participating in this registry?

There are no medical risks associated with registry participation, since all assessments captured in the registry are considered to be standard of care for included patients.

Also, there are no costs to you for participating in this registry. Please discuss all disease management activities and their associated risks with your treating physician, as necessary. How can I participate in the Registry? If you want to be included in the EUROMAC registry, you should contact your physician, who will brief you on how to do this and mostly on your rights. You can also access the registry through the EUROMAC website (euromacregistry.eu); this will link to a separate, secure server where you will download all the necessary forms and then enter the registry with your data. In order to allow a correct entry especially relating diagnosis, your first entry will be validated and completed by your physician. Alternatively, you can have your physician entering the whole registry himself.

 

For how long will my data be stored in the registry?

Since Glycogenosis are rare, genetic diseases, it is anticipated the EUROMAC Registry will continue for a number of years in order to enable a comprehensive coverage of patients. However, you will be able to withdraw from it at any time, as detailed below.

 

What are my rights in this registry?

Your participation in the EUROMAC Registry is completely voluntary. You may choose not to participate or to withdraw your authorization at any time without being penalized, being denied treatment, or losing any benefits to which you are otherwise entitled. If you withdraw from the registry, the system will remove your personal code, name, and any linkage to your identity and personal physician from its database and any other associated studies. Your clinical and genetic data will remain in the database for use in anonymised aggregate data reports or statistics. Your physician should also be your first point of contact should you wish to withdraw from the registry. Requests to withdraw must be made in writing to your physician; he/she will then notify the registry in writing, and the system will delete any data linking to your identity within 7 working days.

 

Who funds and regulates the registry?

The EUROMAC registry is funded by the European Commission under contract no. 2012 12 14. Therefore, the owner of the registry is the European Commission, although, as explained above, it will not have access to your identity and you will be able to withdraw from it at any time, so as to have your identifying data permanently removed from it. Data access and processing is regulated in this registry by the European Directive 95/46 on the Protection of Individuals with regard to the processing of personal data and on the free movement of such data. Further information and contact: For any query regarding your condition or your participation in the registry, you should contact your physician, or if you require further assistance, you may visit the EUROMAC website or contact the EUROMAC Coordinator at the following address:

Medical Doctor/ specialist: Dr. Ros Quinlinvan Centre for Neuromuscular Diseases, Box 102, The National Hospital for Neurology & Neurosurgery, Queen Square, London WC1N 3BG, United Kingdom. Tel: +44-203-4488132 e-mail:

EUROMAC coordinator: Dr. Ramon Marti, Institut de Recerca Vall’Hebron, Passeig Vall D’Hebron 119-129, Edifici Mediterranea, Barcelona, Spain. Tel: +34-93-4894054 e-mail:

Registry Coordinator: Miguel Angel Martin, Hospital 12 de Octubre, Madrid, Spain. Tel: 917 79 27 85, e-mail: [email protected]