Data Integrity and Privacy in an Electronic Case Report Form
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Julkaisu on tekijänoikeussäännösten alainen. Teosta voi lukea ja tulostaa henkilökohtaista käyttöä varten. Käyttö kaupallisiin tarkoituksiin on kielletty.
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Health records are used to map the overall health of a patient and most information related
to their current status such as existing diseases and medication are usually entered into
these records. These records are generally used to provide to the patient the healthcare
that they need. Electronic health records (EHR), that are used by healthcare professionals
to store the data electronically, are becoming more open in a way that include the patient
in some way as well. EHRs that give the patient the chance to view information related to
their own health, have become more common in the last few years, especially in Finland
where the existence of this type of EHRs was rare just ten years ago.
In addition to using these records in clinical care, they can also be used in healthcare
research. Case report forms are used as source documents to gather or answer specific
questions related to the research study in question. The data that is produced this way is
usually pseudonymized and a lot of it is usually gathered to help with the accuracy of the
study.
Usually when gathering this data, there are researchers and other people entering the data
electronically first before it can analyzed. So that this data can be used more efficiently
and to reduce the risk of inaccurate data, the form where it is entered can be programmed
to monitor the entries to help researchers, and make sure the data is more uniform across
the dataset.
To achieve this kind of validation, two different techniques are researched and executed
in an existing electronic Case Report Form (eCRF) system. The form is changed so that
it gives feedback to the data entry person in real time. The form is also looked at from the
point of data extraction and if some existing problems can be solved.
The new European General Data Privacy Regulation is also looked at and its impacts
on the case eCRF, and what changes must be made to the system for it comply with the
regulation.