FAQs
We have both asked and answered many questions over the past ten years. We have compiled a list of the most important ones here.
Roadmap
Timeline
How long does it take for a registry project to go from inception to data being input?
This depends to a large extent on the starting situation. Once all content-related, structural and organizational issues have been clarified and no major modifications need to be made to the basic system, a patient registry can be implemented in eight to twelve weeks. As a general rule, you should expect the project to take around six months including time for testing.
How long should a patient registry remain in service?
We recommended a minimum running time of five years. However, the aim from the outset should be to achieve a service life of ten or more years. All of our registries have been designed to run for more than five years.
Resources & competencies
Who should be involved in a registry project?
The project team needs to include at least one medical expert from the beginning. If the registry covers several specialized areas, experts in every field should be involved. We bring our experience and know-how in the areas of project management, design, technical implementation and communication, and advise you in all matters – from the first idea to the development and daily operation of a patient registry.
Who should be the project manager for a registry project?
The scientific project management should be assumed by a medical expert. We take care of the general project management, design and technical implementation.
Which technical competencies do members of the working group need?
The initiators and scientific members of the working group do not require any technical expertise or special qualifications. Even the medical people who maintain the registry during day-to-day operations do not need any technical know-how. We take care of all technical tasks. We are used to communicating with people who are not technicians. All the features of our patient registries – including those in the area of administration – are intuitive and can be used without any knowledge of programming.
Inputting, importing & exporting data
Inputting data
How is the input of data regulated – who can enter data?
Data can only be entered by defined users that have the appropriate user rights.
What know-how is required to input data?
Persons inputting data need the same amount of medical knowledge as is required to transfer clinical data properly from reports. When using websites and web-based services, no more knowledge is necessary than what is required for day-to-day scientific work.
Can data be entered by study nurses as well?
Yes. Data can also be entered by (specially trained) study nurses as well.
Can you help us to input data?
Yes. Our trained personnel can help you to record data for the first time and/or on an ongoing basis.
Can the process of inputting data be interrupted or does a record need to be entered in full?
The process of inputting data can be interrupted at any time and resumed at a later point in time. The data entered are saved and not lost.
What do I do if a record has been entered incorrectly?
During the recording process, records can be overwritten at any time if a mistake is made. If the records have already been locked, only the administrator or the registry coordinator can make changes.
Can it happen that a patient is recorded by several centers and therefore appears several times in the registry?
No. When creating a new patient, a number of data fields are checked to see if the patient has already been recorded in the system. Only if this is not the case can the patient be created. If the patient already exists in the registry, the registry coordinator is automatically informed. They can then either activate the patient for both centers or transfer them to the new center in consultation with the centers concerned.
Is the registry available around the clock (24/7)?
Yes. Apart from just a few hours a year during which planned maintenance work is carried out, the registry is available around the clock (24/7).
Importing data
In which format can data be imported?
Generally speaking, data can be imported from any machine-readable format. If the data are in an unstructured format, they need to be prepared accordingly before being imported for the first time.
Are there any standardized import interfaces?
As the file formats used often vary considerably from source to source and data often only needs to be imported at the start of a registry project, existing data are imported with our help before the registry goes live. Ideally, the data will be in .csv format.
Can data be automatically taken from the old system to begin with?
Yes. Data can be automatically taken from the old system at the beginning – provided they are in a machine-readable format.
Can data be imported from an Excel list?
Yes. Data can be automatically imported from Excel lists.
Can data be imported from an Access database?
Yes. Data can be automatically imported from Access databases.
Analyses
Can I perform my own analyses using the patient registry?
Yes. All analyses offered by the system can be invoked online by authorized users at any time.
Can up-to-date analyses be made with the registry?
Yes. Given that the patient registry is a live system, the most recent data pool is always drawn on for analyses.
Are analyses made by system subject to a charge?
No. All analyses offered by the system can be invoked free of charge by authorized users at any time.
Is it possible to perform special analyses with the system?
Yes. If additional analyses are required, these can be accounted for during the project phase or be added after the system has gone live.
User interface and features
Data quality
How are wrong entries (incorrect values) avoided?
Wrong entries are prevented by automatic validation checks when being keyed in. Explanatory information is available online in case of uncertainty.
What steps are taken to ensure that all data collectors use the same units?
Each input field is accompanied by an information field containing explanatory information (e.g. the units to be used).
Can follow-ups be recorded?
Yes. Follow-ups can be recorded as standard in the basic system.
How many follow-ups can be recorded per patient?
As many follow-ups as necessary can be recorded for each patient.
Technology
Which requirements must data collector PCs fulfill (software and hardware)?
The only requirements are internet access and an up-to-date web browser.
How secure is the computer center from which the registry is operated and where the data are saved?
All patient registries are run in highly secure computer centers that are equipped with state-of-the-art security systems (access control, video surveillance, etc.).
How do you ensure that data cannot be accessed by third parties?
Access to patient registries is protected by personal login details. In addition, the system ensures that users can only see data that they are allowed to see.
What do you do to protect against viruses and cyber attacks?
Firewalls, the latest anti-virus software, sophisticated access protection systems and computer centers that must satisfy banking standards ensure that data are protected.
Security
Registry access
Who gets registry access?
In most cases, the registry board stipulates who is allowed to access the registry and this is set out in the associated contracts or statutes. The registry coordinator creates user accounts in the system and assigns login details.
What data are needed in order to be able to log in?
User ID and password. There is also the option to request additional access information if so desired.
Can a user of one center access the data of another center?
No. Each user can only see the data of their own center.
Who can assign rights?
User rights are assigned directly by the registry coordinator.
Who sees what data?
Each user can see the data of their own center. Only the registry coordinator can see the data of all centers.
Is there an automatic back-up in place?
Yes. All data are automatically backed up in modern security systems.
What steps are taken to prevent the improper use of data?
The measures in place to prevent data being used improperly comprise several interlocking mechanisms. Examples of these include personal login details for users, role-dependent access control, center ownership of own patient data, pseudonymizing data in the registry database, anonymizing when exporting.
Are patients informed that their data are saved in the registry?
Yes. It is normally contractually agreed with the participating centers that patients may only be included in the registry if they have signed a patient declaration of consent.
Is a vote by an ethics commission required for a center to take part?
This depends on individual legal framework conditions. All of the registry projects operated by us have been inspected by the responsible ethics commissions and received positive evaluations.
Resources and budget
What does a patient registry cost?
Costs are broken down into initial and ongoing costs and depend on the project duration, the consultancy services required, the scope of the basic system and the add-ons. To give a ballpark figure, it can be expected that a basic system will require an annual budget of approx. EUR 25,000 excl. VAT (initial and ongoing costs spread over five years) if the project lasts five years and is managed efficiently.
Are there any ongoing costs in addition to the initial costs?
Yes. Costs are incurred for ongoing support and for running the registry.
Are there any license fees?
No.
Which costs can be expected for add-ons?
This depends entirely on the desired add-on and the associated consultancy and implementation services required.
Does the number of users have an impact on the costs?
Our aim is to reach a long-term agreement in which the number of users is not limited.
Does the number of patients have an impact on the costs?
Our aim is to reach a long-term agreement in which the number of patients is not limited.
Does the number of records have an impact on the costs?
Our aim is to reach a long-term agreement in which the number of records is not limited.
Help and support
What kind of training do registry users need?
We recommend short (1-2 hours) user training sessions for the registry in order to ensure that all users have the same amount of information. These courses are held either by the registry coordinator or by us.
Who supports registry users if they have any questions about the registry?
This is usually the registry coordinator or indeed the people that provide support to the centers.
Who helps the registry coordinator if there are any questions about the registry?
Registry coordinators are supported by our specialists and technicians in all matters pertaining to the registry.
How can additional centers be included in the registry?
This task is often assumed by the registry’s coordination office, which is responsible for ensuring a link to other national and international centers. We can also provide support with our experience and introduce supporting communicative measures, for instance.