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.
If the data being collected is already available in Electronic Patient Records, it may be possible to integrate this system with the EDC to avoid manual data insertion [FAIRopoly].
[Sander… I should look for a source here]
EDC systems may also support electronic questionnaires. Such questionnaires are sent to patients, allowing for the questionnaire to be filled in at home. This saves time and potential mistakes that may occur when digitising answers from paper questionnaires.
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FAIRopoly
Data collection is a crucial step for a patient registry, make sure to discuss with your team and define the clinical implementation workflow including roles assignment.
Aim for integrations between Electronic Patient Records and Electronic Data Capture Systems or the Registry System, to avoid manual data insertion.
De Novo
Currently, data collection for the VASCA registry is a manual process, where data from the EHR is entered into the eCRF. Here, the symptoms described by the clinicians in natural language were manually converted into terms from HPO by using the HPO website [11].
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.
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.
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.”