FAQs

Where can I find the paperwork to support local approvals?

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

The Project Management Group (PMG) will help as much as possible with the processes. The PMG can help translate any of the documents that are required. Please feel free to contact us or attend our drop-in sessions.

What committees have industry representatives as members?

Members of industry who are actively involved in funding GloBE-Reg are represented in the Steering Committee, Data Access Committee and in the appropriate Expert Working Groups.

What committees have patient representatives as members?

Patient members sit in the Steering Committee, the Data Access Committee, the Expert Working Groups and the Patient Advisory Group.

How have the members of the Committees been chosen?

Members are representatives who support GloBE-Reg by actively participating in registry-related activities or by being nominated by members of existing GloBE-Reg Committees. If you would like to join any of the committees, please contact us.

What is the duration of the committee’s tenures?

Committee members are nominated and serve fixed tenures usually for 3 years with 1 additional optional year. Further details of the Committees are available on their webpages.

Where is the GloBE-Reg project based?

The GloBE-Reg project is based at the Office for Rare Conditions - Registries 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 currently the platform receives support from GenSci, Novo Nordisk and Pfizer. It has also received some funding from the GH Research Society and Merck Serono.

What is the role/responsibility of users?

There are several types of users and these as well as their roles are explained at GloBE-Reg User Roles.

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. Please look at GloBE-Reg User Roles to understand the role of the Centre Lead. Your registration request will come to the Project Management Group (PMG), and we will contact you before activating your account. If your centre is already listed, your registration request will automatically be direct to the Centre Lead for approval.

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

This information is available in the Annual Reports that are available at Activity Report

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

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. More details can be found at Obtaining Registry Data for Research.

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

Yes, once a new study is launched after approval by the Data Access Committee, the Project Management Group (PMG) will search the Registry for eligible cases and ask centres if they would like to join the study. Every time new cases are identified following the launch of the study, centres will be asked for approval.  Only if permission is granted will the centre’s data be shared.

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 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 has received the data. The Office for Rare Conditions - Registries at the University of Glasgow and the GloBE-Reg Project Lead owns the GloBE-Reg platform and 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 of each study. All prospective investigators are advised to look at this and clarify their publication plan when requesting data access. The publication plan of individual studies is included in the Study Details on the Studies webpage. Centres are also advised to contact the investigators whose details are on the Studies webpage to clarify how the Centres will be acknowledged in any future outputs.

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 cases and conditions should I target?

This will depend on which studies 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. Our advice is to do what is manageable for the centre.

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 and your local capacity to become involved. 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 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. When a study is active, the Project Management Group (PMG) will identify eligible cases and invite centres with these cases to complete more detailed data.

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

Yes. 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 registries. GloBE-Reg does not share data directly with other registries without your approval. You can also download the data yourself from GloBE-Reg and share the data with the other registry.

How can I avoid manual double entry into two registries?

Data can be uploaded in bulk by yourself using templates that we provide. 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. We recommend that Centres should consult the studies page to understand the individual requirements of specific studies.

The data tranches for studies are provided in March and September. Centres should therefore ensure that eligible cases are recruited and data are entered in sufficient time to meet the relevant data submission deadline for the study.

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

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

What are the roles 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.

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 also provides funding through a grant application process which will allow centres to receive some support for setting up as a GloBE-Reg Centre. GloBE-Reg will also provide support through its grant process to Centres that support existing studies and it will provide small travel grants and student grants to Centres for GloBE-Reg related activity. You can find out more at GloBE-Reg Collaborative Centre Grants

Who does the data analysis?

For clinical investigators who propose a study, we can provide the raw data to the investigators. Our previous experience with rare disease registries has taught us that investigators who are not familiar with the data structure find the process of longitudinal analysis very complex. Our advice is that the investigator team should have dedicated resources for data analysis. We will provide a Data Orientation meeting with the investigator team following data provision to help them understand the data structure and make effective use of the data.

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 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 (includes adverse events), 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.

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 the core dataset and a history will be retained of the changes in Core Data Hostory. The 'Drug', in addition, to the 'Diagnosis', allows the creation of customised Case Report Forms, so it’s 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.

Core Data History

Core Data History has been introduced to capture the period covered by any retrospective condition- or drug-specific histories, ensuring that the appropriate case report forms are completed for the relevant retrospective period.

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?

There is a version number on the landing (login) page at the bottom with the format 2024.08 (effectively the date of publication of that version of the registry).  If applicable, there is a corresponding update of the Data Dictionary to reflect the changes to the fields collected and it will have the same version date. There is also a webpage that lists Latest Modifications that have been made to the platform.

How should I state dates (DoB, Assessment date) in the registries if the exact day or month is unknown?

When recording dates in the registries, please follow these guidelines if the exact day or month is unknown:
If the month is known but not the exact date: Use the 15th of the month.
Example: If you know it occurred in March 2024, but not the exact day, record the date as 15th March 2024.
If the month is unknown but the year is known: Use 15th June of the known year.
Example: If you know it occurred in 2023 but not the exact month or day, record the date as 15th June 2023.

Do I need to report AEs/SAEs within 24 hours of becoming aware of them?

GloBE-Reg does not require sites to report AEs or SAEs within 24 hours. You can record these in the registry at the next data update for the patient (e.g., after their next clinic appointment).

Do I need to document AEs and SAEs in patient notes?

This is a local matter and should follow your internal processes. However, it is good practice to ensure that any data entered into GloBE-Reg can be verified from source documents in case of a future quality assurance review.

How will GloBE-Reg use the AE/SAE data?

AE/SAE reporting in GloBE-Reg is not expedited. Data are collected when you update the patient record and may be provided to investigators if required for a study.

What other pharmacovigilance systems should I be aware of?
Centres should consider using recognised pharmacovigilance schemes, such as:

  • WHO Programme for International Drug Monitoring
  • Yellow Card Scheme (UK)
  • EudraVigilance (EU)
  • FDA MedWatch (US)

Is completion of the UK MHRA Yellow Card necessary? (UK Only)

Completion of the Yellow Card (or equivalent scheme) is only required when a drug is suspected to be a potential cause of the adverse event.
For more information on the Yellow Card Scheme, visit: https://yellowcard.mhra.gov.uk/
GloBE-Reg does not advise on what should or should not be reported—please follow your local clinical guidance.

Can the Set-Up Grant be applied for more than once during participation in GloBE-Reg?

The Set-Up Grant can be applied for only once, at the initiation of participation in GloBE-Reg.

When is the deadline to apply for the Set-Up Grant?

The Set-Up Grant application deadline is the last day of each quarter: March 31, June 30, September 30, and December 31. Applications can be submitted at any time but will only be reviewed by the Grants Review Panel after these deadlines.

What is the duration of the centre support grant?

The Centre Support Grant covers a two-year period, as outlined in the Support Grant guidelines.

Can the Support Grant be applied for annually?

Each awarded Support Grant covers a two-year period, and only one Support Grant can be held at a time. However, the Centre Support Grant may be applied for multiple times.

When is the deadline to apply for the Support Grant?

The Support Grant application deadlines are the last day of Q1 (March) and Q3 (September). Applications are reviewed after each of these deadlines.

Who is eligible for the Student Scholarship? Can other staff, such as sub-investigators or study coordinators, apply?

The Student Scholarship is exclusively available to students. Full details and eligibility criteria are outlined in the Student Scholarship Form.

Can the Student Scholarship be used to cover personnel labour fees?

Yes, the Student Scholarship covers personnel fees related to student efforts in GloBE-Reg activities, and funds are paid directly to the student.

How long does it take to be notified of grant approval after submitting an application?
Award notifications are typically issued 4 to 6 weeks after the submission deadline.

If the grant is approved, how long will it take to receive the first payment?

The first payment generally takes about 2 to 3 months, depending on the promptness of the financial paperwork submission.

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 subscribe to our mailing list for newsletters and any other notifications.

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