Real world challenges


Most stakeholders have limited experience in designing a registry. They can be misled by the promises of advanced technology promoted by IT teams in academia. These projects are typically assigned to PhD students with no experience in rare diseases. This can lead to what we classify as “Professorware”.


Academics typically hope to publish a paper highlighting the unique technology employed in the registry. However, stakeholders looking for a useful and flexible European registry have fundamentally different goals.


There is currently significant research interest in making registries “FAIR”. This is where registries are upgraded to allow patient data to be Findable Accessible, Interoperable and Reusable.


The technology to make a registry “FAIRified” is complex and unlikely to be understood by most clinicians. This leads to a “black box” design that makes upgrades and customizations challenging. Additionally, the automation features of FAIR would probably need a new consent agreement signed by each patient and a fresh application to each ERB. 


In our view the ERN approach to sharing common data elements provides most of the FAIR benefits without the technology overhead. 

Why REDcap?

We recommend REDCap to develop a cost effective and flexible open-source registry that patients own and can easily modify to meet their evolving needs.


REDCap was designed to address data collection problems for biomedical researchers and was developed under a grant from the National Institute of Health (NIH) in the US. It was first released in 2004 and is free for hospitals and research organizations to license. 


REDCap is a rapid application development (RAD) platform. The key benefit of an agile RAD approach is fast project turnaround. In practice this means that changes requested by clinicians can be implemented within days instead of weeks or months. 


As this map shows, nearly every major research hospital in Europe is already a licensed user of REDCap.  Click tthe button below to see the current  REDCap licensees in any country: 
REDCap Sites

REDCap’s spreadsheet structure allows clinicians to modify and extend its design without requiring dedicated programming staff. A complex 60 page technical specification taking 6 months for stakeholders to specify and a further 6 months to develop is replaced by an evolving prototype. 


REDCap has been constantly upgraded since its launch and now supports all the feature required in advanced eCRF (electronic case report form) clinical trials software. This includes: 


  • Multi-arm studies 
  • Subject randomization 
  • Full audit trails
  • Role based security
  • Custom dashboards 
  • Automatic data validation 
  • Data quality checks
  • E-signatures 
  • Patient surveys
  • HIPAA and GDPR compliance



REDCap has an important number of less obvious advantages over using a proprietary software platform. Such as:


  1. Cloud hosting challenges are removed because hospitals are already hosting REDCap. 
  2. ERB approval is simplified as the hosting hospital will already have approved REDCap projects.
  3. As a not-for-profit platform, REDCap includes a free license for most clinical ontologies such as ORPHAcode, ICD-10, MedDRA, ATC. A commercial proprietary solution would have to pay significant license fees to use these ontologies. 
  4. There are no requirements for complex IP ownership and licensing agreements.
  5. There are no requirements for expensive annual Service Level Agreements (SLA) with defined minimum performance levels and escrow access to proprietary source code.
  6. The registry source code can be easily modified by any REDCap licensee. This encourages co-operation between researchers and pharma. It also allows national registries and pharma to add their own registry extensions to meet regulator and research requirements.

The net effect is that REDCap substantially reduces the cost, risk, and time to develop any registry or RWD project. 
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