Frequently Asked Questions
- e-REC (e-reporting of rare conditions): an electronic reporting tool that collects only the number of new cases seen at a centre per month. For the use of the healthcare professional only.
- Core Registry: a registry that collects a set of Common Data Elements for all the diagnoses we cover. Additionally, Patient-Reported outcome measures a condition-specific datasets are collected in this platform. The information collected by the Core Registry is what is expected to be collected during routine clinical care. Healthcare professionals and patients can access and use this platform.
e-REC: any new patient encountered during the reporting period with a diagnosis covered by this platform (see the e-REC conditions and diagnosis dictionary).
Core Registry: any new or known patient with a diagnosis covered by this platform can be entered (see the Core Registry conditions and diagnosis dictionary).
e-REC: patient consent is not required, but participating centres are advised to check if they require local institutional approvals at their centre.
Core Registry: yes, the Centre Lead of the participating centre should make sure that all relevant approvals are in place; this registry also requires patient consent.
This is available at Ethics Approval for European Registries but if you can’t find anything please get in touch with us at registries@lumc.nl.
Can the registries’ team help with the paperwork?
Our team can provide you with several documents like the ethics approval, joint data registry agreement and invitation letter to the registry if needed. As legislation and regulations are different in each country and even within countries the HCP is best placed to understand their local requirements. Please feel free to contact us or attend our drop-in sessions. We can also put you in touch with others in your country who are already using the registries.
No identifiable or partially identifiable personal information is captured in e-REC and individual patient consent is not required.
Informed Consent from the patient is required before their data are entered in the Core Registry.
No, EuRRECa and EuRR-Bone welcome centres caring for the conditions covered by e-REC and the Core Registry platforms including those covered by Endo-ERN and ERN BOND.
No, the registries welcome countries from all over the world. Each centre should check the local regulations regarding participation in registries.
Since endocrine and bone conditions are seen by a wide range of specialties, healthcare professionals from different fields (Endocrinology, Rheumatology, Orthopaedic surgery, etc) and with different titles (physicians, researchers, data managers, nurses) can enter data.
e-REC Reporter: this role allows access to e-REC, can create/modify its own reporting setup, see the selected conditions by other reporters in the same centre, create and submit monthly returns and see and download the reports submitted by the centre.
Core Registry Centre Lead:
Qualifications, responsibilities and role of a Centre Lead (CL):
- The CL must be a permanent member of the clinical staff
- The CL is responsible for local data governance and institutional ethics approvals
- The CL should oversee the reporting of cases in the registry by the local staff
- CL will approve new user requests from the centre
- Cases added by the centre can only be deleted by the CL (e.g. a duplicate record, the record of a patient who requests deletion of its data)
- The CL can edit outcomes created by other clinicians and their centre
- The CL and clinician responsible will be contacted when a study involving data added by the centre is planned
- The CL and clinician responsible will be contacted when a publication involving data added by the centre is planned
Core Registry Clinical Contributor: access to the Core Registry platform, overview of the patients added by the centre, possibility to add patients including common data elements, condition-specific outcomes and patient-reported outcome measures (PROMs). Sending invitations to patients who would like access to the platform. Editing the data of own patients but also of patients added by other contributors from the same centre.
Responsible Clinician: the Responsible Clinician is the clinician who has the overall clinical responsibility for managing the day-to-day care of the case and who is usually responsible for initiating the recruitment process for that case. In addition to the Centre Lead, this Clinician will be contacted when a case under their care is identified at that centre for a study.
Yes, in both, e-REC and the Core Registry, more than one person per centre can enter data. Reporters from the same centre should arrange locally the reporting process.
Useful information about reporting on e-REC:
- To start using e-REC, the reporter must create a reporting setup.
- To avoid double reporting, only one reporter per centre may report on a specific condition for a specific age group. The e-REC platform provides information on the centre’s reporters including their contact details. This is particularly useful when the right to report on a specific condition/age group needs to be transferred between reporters in the same centre. If you face any trouble please contact us.
- When the status of a return is in progress, the reporting setup cannot be changed. The reporter has then 2 options: deleting the return in progress and changing the reporting setup or submitting the return in progress and then changing the reporting setup.
- Returns that have been submitted are final and cannot be changed.
- Reporters can bulk download their own returns or all the returns from the centre after selecting the period of interest.
- The monthly returns are open for a fixed period. The platform provides information on the closing dates and reporters receive reminders of relevant dates by email. Once a return is closed it cannot be reopened.
- If the return of the period you are looking to report is closed, you can report these numbers in the returns of the coming months.
- The status of cases reported as suspected can be changed to either confirmed or excluded at any time.
Adding the mandatory fields within the Common Data Elements takes not more then 5 minutes. Additionally, PROMs and condition-specific modules are available, and the time needed to complete these varies across questionnaires.
Bulk upload of Common Data Elements is possible and can be discussed with the EuRRECa/EuRR-Bone Registries Team, please contact us at: registries@lumc.nl.
A Condition-Specific Module (CSM) is a dataset that includes variables that collect specific data on certain conditions. CSMs have been developed by Study Groups with a specific interest and expertise in a condition.
To obtain data from the Core Registry or e-REC, prospective investigators should have a look at the Data Access Policy, the Publication Plan and complete the Data Request Form and the Data Sharing Agreement. However, before completing these forms, please contact the Registries Team at registries@lumc.nl.
- Data on rare conditions is usually scarce. Patients and healthcare providers might benefit from data collection on the natural history of rare conditions.
- Anyone can apply for data, and the more data the better.
- Co-authorship and acknowledgement in publications for people contributing to the registries with data.
During the consent process for the Core Registry, patients will be asked how they would like to share their data and whether they would like to access the patient platform. Patients choosing to have access will receive an invitation to create an account and upon access, they can view the data their healthcare provider has entered in the registry. Additionally, they can complete questionnaires such as PROMs and condition-specific patient-reported outcomes.
Patients are also involved in the governance of the registries as part of the Steering Committee and Data Access Committee. They are also members of Study Groups.
Signposting health care providers and patients to high quality detailed condition registries is one of the central aims of EuRRECa and EuRR-Bone. We are achieving this aim by developing a list of Affiliate Registries.
If you would like any additional information about our registries, please do not hesitate to contact us at registries@lumc.nl
