Registry Onboarding has started

30 January 2024

Registry Onboarding has started

The ERN EURO-NMD Registry Hub intends to collect data from the patients seen by the HCPs participating in the network. Read the registry information letter here: click to open in a new tab

Download the the Data Sharing Agreement in English and the Informed Consent Form in English.

We are delighted that the onboarding procedure will start on March 2024 with 3 pilot centres: HCPs FR01 APHP Pitié Salpêtrière, NL09 Radboud University Medical Center Nijmegen and DE38 Universitätsklinikum Freiburg. All HCPs are welcome to declare their readiness to begin the process as well. A shared calendar will indicate the schedule for the onboarding of each HCP: click to open a new tab.

In the next steps, you will find the procedure on how to forward your HCP’s expression of interest for the onboarding process.

Onboarding procedure

a) SIGN-UP PROCESS: It will be activated by the HCP Main Contact Person [by default, will be also the HCP Registry Representative (HCP Rep)]

HCP Rep identifies him/herself through the Registry Onboarding Form (https://forms.office.com/e/5CPXG7frQy) and indicates if there will be a backup Registry Representative
Through the Form, the representative will indicate the need or not to create “Data access groups” for sites or units – see definitions in Glossary below. This is only necessary for Units or Sites that intend to upload and access independently their own data. Each identified Unit or Site needs to have a Unit / Site Registry Representative
The request for access and following actions will be effective after the Registry Coordination Team in Paris receives the signed Data Sharing Agreement and the adopted Informed Consent form from the HCP Representative.
For the effects of point 3, the Coordination Team will send a confirmatory email to the Registry Team in Freiburg with the data collected through the form and adding the corresponding Data Access Level for each HCP/Unit/Site Representative. We will copy the HCP representative(s) in the email.2The Coordination Team will organize a short call with the HCP representative(s) to answer questions, hand out documentation and choose an adequate date for the start of data entry

b) Roles of the HCP Registry Representative (HCP Rep):

Designation of a Registry representative for your Healthcare Provider – HCP: by default the HCP board representative is also the Registry Representative, but may delegate the function.
Identification of all Units of a non-Consortium HCP or all Sites of a Consortium HCP. Units and Sites only need to be named in the Registry if they are going to do local upload of data and need to gain a Data Access Group statute for that purpose (see Glossary at the end of the page)
Validate the access requests to the registry from his/her team members and therefore know the staff at their Unit or Site who work with the registry;
Answer all registry-related questions in representation of the HCP. The representative does not have to be a domain expert for neuromuscular diseases nor a legal or ethical expert but is responsible for relaying the communications inside the HCP to the adequate intervenients.
When required, contact the Registry Coordination Office using a dedicated form: https://forms.office.com/e/yv1J7wX2Kb

Glossary of Definitions: based on the ERN EURO-NMD structure and validated by the EC

HCP or Healthcare Providers = entities that applied to be part of the ERN (Single hospitals or consortia of hospitals)
UNIT = services/departments inside an hospital ( e.g. paediatric and adult) – only distinguish in case the upload of data is done at each UNIT and not centraly.

This applies mostly when 1 HCP = 1 Hospital

it should be reduced to a minimum and discussed with the HCP representative

e.g. HCP CHU Porto:

1) a Multidisciplinary Neuromuscular Unit, with Paediatric and Adult

2) a Multidisciplinary Outpatient Clinic dedicated to ATTRv