Registry in a Box

About

The registry landscape is fragmented. Existing registries suffer from a lack of interoperability with other sources of information and new initiatives lose time and money reinventing the wheel due to a lack of startup guidance.

The aim of Registry in a Box (RIB) is to unburden the startup of new ‘FAIR’ registries as well as improve the FAIRness of existing registries, increasing their reusability. 
In collaboration with experts in the field, RIB has been working on a multitude of projects, which are now available.

The RIB getting started chapter describes each project in more detail.

• The RIB Wizard – guides starting registries through the essentials, such as Defining the goal of the Registry, Setting up the data collection (standards and technical aspects), Governance considerations, etc.
• The iCRF Generator – a tool to help you to create interoperable case report forms for Castor, REDCap and OpenClinica 3, using online codebooks such as the Basic Health Data Set.
• The ELSI Informed Consent Wizard - a guidance that can help decide whether data/material can be reused, or whether a patient has to be approached for consent.
• Data/Material Agreement Guidance – a guidance that can help you decide what type of agreement is necessary when exchanging data/material.
• Software and Standards Guidance – a guidance that can help you determine which standard and which tool is suitable for your datatype.
• ART-DECOR Codebook Generator – a tool that can transform an Excel codebook to an XML file suitable for import in ART-DECOR.
• PALGA Data Translator – a tool that uses online codebooks from PALGA Protocols to translate Dutch PALGA Protocol data to English (currently available for the colon biopsy and colon resection protocols).

Getting started

The RIB Wizard

Ten chapters of the RIB Wizard guide existing and startup registries on “Governance”, “Technical Aspect” and “Registering the Registry” . For a full description of the available chapters, and to use the wizard, go to this page.

The iCRF Generator

The iCRF Generator is an easy to use JAVA tool, which you can use to create (the basis of) interoperable case report forms for three major EDCS (Castor, REDCap and OpenClinica 3) using codebooks available from ART-DECOR such as the Basic Health Data Set (Basisgegevensset Zorg). Check the iCRF Generator webpage.

The ELSI Informed Consent Flowchart

ELSI Toestemmingsprocedures Stroomdiagram

Deciding whether informed consent is necessary for the use of data and material, is crucial. Given the multitude of applicable legislations and codes of conduct, RIB and the national ELSI Servicedesk developed a guidance that can help researchers with this complicated process. This guidance is currently available as a dynamic flowchart on the ELSI website. You can find it here.

Data/Material Agreement Guidance

When exchanging materials and/or data with another party, some form of agreement may be necessary or even required by legislation (e.g. Material Transfer Agreement, Data Sharing Agreement, Data Processing Agreement, etc.). By setting up an agreement 1) you can prove that you are taking safety of the data seriously; and 2) you can setup the rules about what may and may not be done with the data by the receiving party.

This guidance helps you decide what type of agreement is necessary. You can find it on the Health-RI ELSI Servicedesk website, in the form of a dynamic flowchart here.

Software and Standards Guidance

To make data interoperable, standardisation is necessary. Unfortunately, finding the appropriate standard for a specific data type can be complicated. Furthermore, the standard may depend on the specific tool which will host the data.

This Guidance aims at:

• Helping you select an appropriate standard for your data
• Helping you find an appropriate tool for your data collection

You can find it here. Please note, that this is a version from 2019, and that some of the advice might change over time. 

ART-DECOR Codebook Generator

Definitions of (clinical) datasets, so called codebooks, not only allow other people to understand your data, but also allow them to reuse your definitions, facilitating interoperability. Optimally, such codebooks are nationally endorsed, such as the Basic Health Data Set (Basisgegevensset Zorg). Furthermore, its items should be mapped to medical thesauri, such as SNOMED CT and the NCI thesaurus, as this further improves the data’s interoperability.

Nictiz, the centre of expertise for eHealth and the Dutch SNOMED-CT release centre, facilitates ART-DECOR, an open-source tool suite that supports the creation and maintenance of HL7 templates and allows the storage of dataset definitions. One method to make a codebook available in ART-DECOR is by providing Nictiz with an XML file, which they can then import into ART-DECOR.

RIB will provide you with a tool that can transform an Excel codebook into the required XML. For more information, please contact S. de Ridder or J.A.M. Beliën

PALGA Data Translator

PALGA, the pathology registry of the Netherlands, stores millions of pathology excerpts. A large portion of this data was collected using the PALGA Modules for synaptic reporting - the PALGA protocols. Usage of these protocols ensures that data is nationally collected in a standardised way, thereby ensuring high quality data, making it an extremely valuable resource for research. However, the data is only available in Dutch, limiting its usability to the Netherlands, unless it is translated first.

In a collaboration between the NKI, VUmc and PALGA, two PALGA codebooks (colon biopsy and colorectum carcinoma) were translated and made available online using the ART-DECOR Codebook Generator. More translated PALGA protocols will become available in the future.

To translate your PALGA protocol data using these online codebooks, RIB will provide you with the PALGA Data Translator. For more information on this easy to use Java tool, please contact S. de Ridder or J.A.M. Beliën (a.deridder1@amsterdamumc.nl , jam.belien@amsterdamumc.nl).

Further information

The Registry in a Box Guidances and Tools were designed and created by:
Amsterdam UMC - VUmc: Sander de Ridder, Jeroen Beliën

Acknowledgements
We would like to specifically thank Gerrit Meijer (NKI / Health-RI) and Jan-Willem Boiten (Lygature / Health-RI) for making this project possible.

RIB-Wizard
Netherlands Cancer Institute: Mariska Bierkens, Annemieke Hiemstra
Lygature: Rita Azevedo, Jan-Willem Boiten
SURFSara: Ruud Ross
Dutch Techcentre for Life Science: Rob Hooft
Trial Data Solutions: Gerben Rienk Visser

The iCRF Generator
Trial Data Solutions: Gerben Rienk Visser
UMCG: Wessel Sloof (REDCap testing)

The ELSI Informed Consent Wizard
ELSI Servicedesk: Susanne Rebers, Miriam Beusink
IT’s Security: Marie-Jose Bonthuis <even nakijken>

Data/Material Agreement Guidance
Innovation Exchange Amsterdam: Misja Leikin
ELSI Servicedesk: Susanne Rebers, Miriam Beusink
IT’s Security: Marie-Jose Bonthuis <even nakijken>

Software and Standards Guidance
Netherlands Cancer Institute: Mariska Bierkens
Lygature: Jan-Willem Boiten, Sofie Hansen

ART-DECOR Codebook Generator
Nictiz: Maarten Ligtvoet, Elze de Groot, Alexander Henket

PALGA Data Translator
PALGA: Quirinus Voorham
Nictiz: Maarten Ligtvoet, Elze de Groot, Alexander Henket
Netherlands Cancer Institute: Petur Snaebjornsson

Funding

Registry in a Box was funded by the Dutch Cancer Society (KWF) TraIT2HealthRI (grant 8166).