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Short description
When a patient visits the clinic, data can be entered into an eCRF by, for example, a research nurse. Some information being collected, however, may become available only at a later point [De novo]. Hence, a crucial aspect for collecting the data is the underlying clinical workflow [FAIRopoly]. For example, while blood can perhaps be drawn during the initial visit, results from a genetic test may still need to be performed and will have to be entered at a later time. Thus, it is important to keep the practical side in mind and discuss this with your team while setting up the EDC and the eCRFs and to clearly define roles and responsibilities.
...
The CDEs are static data elements, meaning that they do not include (changes over) time. Therefore, most data were collected and entered in the eCRF at the first contact in our centre. However, not all information is available at this point. For example, diagnostic imaging and genetic tests may still need to be performed. The results from these tests may provide new insights, thereby affecting CDEs such as genetic diagnosis, phenotype and age at which diagnosis was made. To include missing data or update data elements, we built in a six-month check, conducted six months after inclusion. At this point, data collected for the CDEs may be updated based on (newly) available information in the EHR.
Why is this step important
To be able to make data FAIR you need to actually have data, so collecting data is an important step. It is crucial to define who is responsible for which parts of the data collection, decide how quality of the data will be monitored and how and when this data will be collected to ensure you end up with high quality data.
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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.
How to
If possible, try to prevent manual entry of data by integrating the Electronic Patient Records and the EDC [FAIRopoly].
It is important to properly design the general workflow for the patient’s healthcare journey, as this will provide the necessary insights on the logistics which need to be set up, but also defines, for example, when a patient will visit the hospital for baseline and follow-up events.
Practical Examples from the Community
This section should show the step applied in a real project. Links to demonstrator projects.
References & Further reading
<since the descriptions are mostly based on the references below, I put them in the template...>
[FAIRopoly] FAIRopoly https://www.ejprarediseases.org/fairopoly/
[Generic] A Generic Workflow for the Data FAIRification Process: https://direct.mit.edu/dint/article/2/1-2/56/9988/A-Generic-Workflow-for-the-Data-FAIRification
[Elixir] https://faircookbook.elixir-europe.org/content/recipes/introduction/fairification-process.html
[Elixir2] A framework for FAIRification processes: https://faircookbook.elixir-europe.org/content/recipes/introduction/metadata-fair.html
[GOFAIR] https://www.go-fair.org/fair-principles/f2-data-described-rich-metadata/
[RDMkit] https://rdmkit.elixir-europe.org/machine_actionability.html
[De Novo] https://ojrd.biomedcentral.com/articles/10.1186/s13023-021-02004-y
[hri] https://www.health-ri.nl/electronic-data-capture-edc-or-electronic-case-record-form-ecrf-systems
Authors / Contributors
Experts who contributed to this step and whom you can contact for further information 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;
contain custom recipes/best-practices written by/together with experts from the field if necessary.
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
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.”
Suggestions
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