FAQs

This is available at Documents for Institutional Approval but if you can’t find anything please get in touch with us.

Can the GloBE-Reg team help centres with obtaining local approvals?

The GloBE-Reg team will help as much as possible with the processes. The team can help translate any of the documents that are required and provide any documents. Please feel free to contact us or attend our drop in sessions.

Registry User Roles

What is the role/responsibility of the Centre Lead?

Each centre has one Centre Lead and this clinician has responsibility for ensuring that the centre is adhering to the highest level of governance for research, ethics and data governance. The Centre Lead approves another users at the centre and can also delete cases at the centre. The Centre Lead and the Clinician Responsible for the case will be contacted when an eligible case is identified at the that centre for a study.

What is the role/responsibility of the 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 when a case under their care is identified at that centre for a study.

Create an Account

How do I create an account to use the Registry?

To use the Registry, please use the self-registration form at Registry. If your centre is not in the listed centres, then there is no Centre Lead and you may want to consider acting as Centre Lead. Your request will come to the Registries team and we will contact you before activating your account. If your centre is already listed, we will ask your Centre Lead to provide approval.

Recruiting patients

Can I recruit existing cases as well as new cases?

Yes. The Registry can collect information on existing cases as well as new cases.

What conditions should I target?

This will depend on what study do you want to help with. It is expected that the number of active studies will increase over time and may also be guided by the range of conditions that are recruited. At the moment GloBE-Reg is only focussing on rhGH therapy in children. Our advice is to do what is manageable for the centre. For helping with the rhGH studies, ideally we would like centres to target all children who are receiving rhGH therapy.

What type of rhGH therapy patients should I recruit?

To maximise the long-term value of the Registry, we are interested in collecting cases on all forms of rhGH. However, this will also depend on the active studies that are listed on the GloBE-Reg website. Please look at the recruitment criteria.

What data fields should be completed in those who are recruited?

All cases that are recruited will need a handful (literally speaking) of mandatory fields completed to create a record and generate a Registry ID. After these fields are completed for as many cases as possible, we recommend that Centres should consult the studies page to understand the individual requirements of specific studies and complete the fields that are required for the study.

If the case is in another registry or study, can they be added to this registry?

Yes, they can be added but it is possible that you will need to ensure that the local regulatory approvals that were obtained to enter the patient into the original registry apply for GloBE-Reg too. If that is not the case, then the original process needs to be changed or the case needs to specifically approve inclusion in GloBe-Reg. GloBE-Reg has a field in the core dataset which allows you to include the details of the other database.

If the case is in GloBE-Reg, can they be added in to another registry in the future?

Yes, the GloBE-Reg consent allows data to be shared with other approved registries.

Is there a minimum number of cases that need to be recruited?

This will depend on what study do you want to help with. It is expected that the number of active studies will increase over time and may also be guided by the range of conditions that are recruited. At the moment GloBE-Reg is only focussing on rhGH therapy in children. Our advice is to do what is manageable for the centre. For helping with the rhGH studies, ideally we would like centres to target all children who are receiving rhGH therapy.

How can I avoid manual double entry into two registries?

We have developed a bulk upload facility. More information is available at Bulk Upload

What are the recruitment timelines for the study?

This will depend on the specific protocol of the active studies that GloBe-Reg is supporting.

Data Entry

What kind of support does GloBe-Reg offer with Data Entry?

GloBE-Reg offers participating centres a variety of support. Other than providing a free platform and opportunities for global collaboration within a robust regulatory framework, it is also providing funding through a grant application process which will allow centres to receive some support for setting up as a GloBE-Reg Collaborative Centre. GloBE-Reg will also provide support through its grant process to Collaborative Centres that support existing studies and it will provide small travel grants to Centres for GloBE-Reg related activity.

How often are data collected for each participant and over what time span?

This will depend on the specific protocol of the active studies that GloBe-Reg is supporting.

Is the GloBE-Reg on the NHS portfolio in the UK?

Our other existing registry projects are on the ‘portfolio and we are looking into this for GloBE-Reg too; if you would like an update, please get in touch with us.

Further Information

How can I find out more?

There is a lot of information on the GloBE-Reg website. You can also come to one of our drop-ins or just contact us.

I want to remain in touch with GloBE-Reg activity but not use the Registry.

If you want to stay in touch with us, please provide your details at contact and we will put you on our mailing list for newsletters and any other notifications. You can also follow GloBE-Reg on twitter

Data collection and analysis

Who does the data analysis?

For clinical investigators who propose a study, we aim to perform the analysis in-house in GloBE-Reg under the direction of the investigators. However, we can also provide identified raw data if required. Our previous experience with other rare disease registries has taught us that investigators who are not familiar with the data structure find the process of longitudinal analysis very complex.

What information does the GloBE-Reg registry collect?

All the information that is collected in GloBE-Reg can be viewed in the data dictionary. The information can be broadly divided into the Core Dataset and the Drug and Condition Specific Dataset . The Core Dataset that is collected has several data fields that are common to many international rare disease registries. The Drug and Condition Specific Dataset allow the creation of customised case report forms (CRFs) that collect information on the diagnosis, therapy, clinician reported outcomes and patient reported outcomes.

How often should the CRFs be completed and will there be reminders for these?

The frequency of completion of the CRFs shall depend on the study. There will be no reminders sent to the user but there are visual indicators on the user dashboard which indicate over due CRFs.

What committees have industry representatives in all the committee?

Members of industry who are actively involved in funding GloBE-Reg are represented in the Steering Committee, Data Access Committee and in the appropriate Scientific Study Groups Committee. They are also present in the Grants Review Panel but simply as observers. Patient members sit in the DAC, the SSC and the SSG

What committees have patient representatives?

At the moment, patient representatives are present in the Data Access Committee, the generic GloBE-Reg Scientific Study Group and the Scientific Study Groups Committee. We anticipate that over time, these patient representatives will create an advisory group from which a member will rotate into the Steering Committee

How have the members of the Committees chosen?

At the inception of the project, several regional paediatric endocrine societies were approached to nominate a representative to join the Steering Committee. Advice from the members of the Steering Committee was obtained to create the other committees. In time, as the project matures, all the members of the committees and study groups will consist of active users from a GloBE-Reg Collaborative Centre. If you would like to join any of the committees please let us know.

What is the duration of the committee’s tenures?

Committee members are nominated and serve fixed tenures. Members of industry will remain on the committees while the industry continues to fund the project.

What if a patient/parent does not want their data added in GloBE-Reg?

Data will only be added into the the GloBE-Reg following consent from the patient/ parent

What is the role of patients in GloBE-Reg?

Patients and patient representatives can play several important roles in GloBE-Reg but we have to be careful that their time is used as constructively as possible. They are present in several committees ensuring that the activities of GloBE-Reg are relevant to those who are affected by the conditions that are being studied. Patients and parents who participate in the registry can also access their own data. The Registry also has the option for patients to provide patient reported outcomes when these are required in a study.

How many centres and members do you have with GloBE-Reg?

This information will be available in the annual reports that will be available for the project on its website.

When users login to the registry platform, are patient’s data from other centres available?

No, only data from the user’s own centre are available for them to see. To look at other data, an application has to be submitted to the Data Access Committee

Data Sharing & Ownership

Will GloBE-Reg ask the Centre’s permission to use any of the Registry cases in a study?

Yes, once a study is launched after approval by the Data Access Committee, the GloBE-Reg team will search the Registry for eligible cases and and ask centres if they would like to join the study.

Who own’s the data in the Registry?

There are several levels of ownership and these are outlined in detail in the GloBE-Reg Management Protocol. The patient participant and/or the legal guardian, is the primary owner of the data. The Office for Rare Conditions at the University of Glasgow is the owner of the database platform. The institution of the clinician who has entered the data is the owner of the aggregated data of that patient participant. When processed, the data become research data and are then the intellectual property of the investigator who requests the data. – The Office for Rare Conditions at the University of Glasgow and the Globe-Reg Project Lead is the custodian of the data and is responsible for the protection of the data, its storage, use and access.

How will the help of Centres be acknowledged in future publications?

GloBE-Reg has a Publication Plan which recommends that all Centres who contribute cases should be involved in providing input into any resulting publication and should, therefore, be involved as co-authors. There are a number of ways this can be done and these are detailed in the Publication Plan. All prospective investigators are advised to look at this and clarify their publication plan when requesting data access. This publication plan for the study is shared with the Centres with eligible cases at the launch of the study.

Where is the GloBE-Reg project based?

The GloBE-Reg project is based at the Office for Rare Conditions at the University of Glasgow, Scotland, UK

Where does GloBE-Reg receives its funding and support from?

The GloBE-Project receives infrastructural support from the University of Glasgow and its team is employed by the University. The project is funded almost exclusively by industry and its current industry funders include GenSci and Novo Nordisk.

In the Core Dataset does “Drug” mean what the patient is currently taking at time of consent?  Or what medication they started on when first starting GH?

The ‘Drug’ is the actual brand of GH they are currently taking. You can change this on teh core datset and a history be retained of the changes. The ‘Drug’, in addition, to the ‘Diagnosis’, allows the creation of customised Case Report Forms, so its good to have the right ‘Drug’ to create the most appropriate CRF.

Our patients end up switching GH brands quite a bit due to insurance coverage year to year.  How will this be captured?

The GH Brand can just be changed in the Core Dataset and this will be recorded over there.

In the Diagnosis section, what does the past medical history “assessment date” refer to?

The date is when the assessment of these features in the history is being performed for entry in the registry

Often Imaging is performed in steps. Do you want the most recent imaging if more than one occurred, or are you looking for the imaging at time of diagnosis?

Imaging at diagnosis is important and subsequent imaging will also be important if there have been any material changes that are relevant to the case. These can all be entered by creating multiple Diagnosis CRFs. 

In the Diagnosis section, what are “Associated Conditions”? 

Associated conditions are any other health conditions in the patient, related or unrelated to the diagnosis in the registry 

Will we be notified somehow when there are updates made to the database? Also, will the data dictionary posted on the website be updated? 

In the next version of the registry, there will be a version number on the landing (login) page at the bottom with the format 2023.03.31 (effectively the date of publication of that version of the registry).  There will be a corresponding update of the Data Dictionary to reflect the changes to the fields collected and it will have the same version date.