Metroline Step: Apply common data elements

Owned by Sander de Ridder
Last updated: Aug 08, 2024
2 min read

status: Future work

Short description 

Common Data Elements (CDEs) are standardised, precisely defined question paired with specific allowable responses. These CDEs can be used systematically across different sites, studies, or clinical trials to ensure consistent data collection [NIH]. These CDEs can be annotated with an ontological model to define their meaning and facilitate integration of CDEs from different registries [De Novo]. The ontological model is essential for computers to assess that common data elements are indeed common [De Novo]. 

By openly publishing the CDEs and the ontologies to annotate them, they can be reused to build case report forms for data collection [De Novo].  See the Register record level metadata step?

 

[NIH] https://www.nlm.nih.gov/oet/ed/cde/tutorial/03-100.html 

Why is this step important 

By using common data elements, it is ensured that the data being collected uses the exact same definitions and, if annotated, ontological model. This is an important step for the interoperability of the data. 

How to 

[De Novo]

Furthermore, we have made our eCRF interoperable and reusable, as the codebook describing the eCRF templates containing the CDEs and the ontologies to annotate them is openly available in ART-DECOR [34]. Via the openly available iCRF Generator tool [35], the codebook can be directly implemented in other EDC systems such as OpenClinica and REDcap. 

 

We could add something about creating and publishing codebooks?

We could say something about setting up new CDEs and reusing existing ones?

 

The How to section should:

  • be split into easy to follow steps;

    • Step 1

    • Step 2

    • etc.

  • help the reader to complete the step;

  • aspire to be readable for everyone, but, depending on the topic, may require specialised knowledge;

  • be a general, widely applicable approach;

  • if possible / applicable, add (links to) the solution necessary for onboarding in the Health-RI National Catalogue;

  • aim to be practical and simple, while keeping in mind: if I would come to this page looking for a solution to this problem, would this How-to actually help me solve this problem;

  • contain references to solutions such as those provided by FAIR Cookbook, RMDkit, Turing way and FAIR Sharing;

  •  

Expertise requirements for this step 

This section could describe the expertise required. Perhaps the Build Your Team step could then be an aggregation of all the “Expertise requirements for this step” steps that someone needs to fulfil his/her FAIRification goals.  

Practical examples from the community 

Examples of how this step is applied in a project (link to demonstrator projects).  

Training

Add links to training resources relevant for this step. Since the training aspect is still under development, currently many steps have “Relevant training will be added in the future if available.”

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