Metroline Step: Apply common data elements

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 

Ines:

• short background: what are common data elements. What it means apply common data elements.

• Why is it important: would focus more on interoperability im assuming

• how to: I was thinking in linking and promoting people to look for existing initiatives that make their data known in the first place or look into their own field to look for what are commonly used data elements; Implement them in ecrf (ig this would be where the pages would relate?)

• examples of the community: European Comission (Common Data Element) + NIH also has some common data elements proposed for some areas that could be included here? or on tools

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 - Title of the step

  • Step 2 - Title of the step

  • 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 

Describes the expertise that may be necessary for this step. Should be based on the expertise described in the Metroline: Build the team step.

Practical examples from the community 

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

Training

If you have great suggestions for training material, add links to these resources here. Since the training aspect is still under development, currently many steps have “Relevant training will be added soon.”

Suggestions

This page will be developed in the future. Learn more about the contributors here and explore the development process here. If you have any suggestions, visit our How to contribute page to get in touch.