Alcedis Plugins: Improved Data Quality in Clinical Studies
Published: 08.16.2021
Collecting and processing data is essential for the success of clinical trials. Plugins from Alcedis help.
Data quality is crucial for the success of clinical trials. In order to collect data efficiently, Alcedis develops plugins that ensure the collection of information and thus guarantee its quality. The following plugins support the collection and documentation of data.
CRF Status for data status view
The Alcedis Plugin CRF Status provides a quick overview of the data status of patients. If the program has all the necessary documents, forms and information for a patient, the patient's name is marked with a green tick. The associated site does not have to worry about any open to-dos.
However, if electronic or manual queries, i.e. queries about the eCRF, are open, a yellow exclamation mark indicates that information is still missing or questionable data is provided. A red X appears as soon as forms or data for the evaluation of primary endpoints, the previously defined, first priority objective of the clinical trial, are missing.
Data managers as well as internal and external project managers can use this Plugin to display a dashboard with an overview of all patients. Various filters also document missing data. Sites also receive this overview, filtered with the appropriate information for their organization. They are also taken directly to the form with the missing information. This makes data cleaning, i.e. the removal and correction of incorrect, duplicate, or incomplete data, much easier.
Long free texts, a lack of medication and complicated documentation are common problems in clinical trials. These five plugins from Alcedis help doctors.
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Simplified data control with the help of Query
The Query Plugin simplifies data control. Data fields with predefined selection options can already be easily entered via the eCRF. However, there are obstacles to electronic processing, particularly with free text fields - for example, if a field contains too much information and it is not clear whether all the information entered is relevant to the clinical trial.
A data manager regularly checks the data that cannot be checked electronically for discrepancies or undocumented data using a manual query in the system. This is done via a chat function that is integrated into the Plugin. This allows the site to check its documentation and send feedback to the data manager via the chat function.
eSignature for electronic signatures
The eSignature Plugin enables the electronic signature of an investigator. This confirms that all available data is correct. This confirmation takes place at regular intervals for longer studies as well as after the end of each study for the respective patient.
Before the investigator's signature, a documentary check is carried out to ensure that all data is complete and free of errors. This is a prerequisite before the investigator submits his signature. In addition, a list can be made available to the investigator via the Plugin, which only lists patients and forms whose CRF status is marked with a green checkmark.
These signatures also contribute significantly to correct remuneration. Only if the investigator confirms the data with his signature will the site’s service be reimbursed.
Monitoring assistance through SDV
The name of the next Alcedis Plugin SDV stands for Source Data Verification. This plugin is closely related to monitoring at the center by the CRA (Clinical Research Associate). For certain studies, the CRA must visit sites and clinics to compare the electronically documented data with the source data in the patient file. These must be synonymous.
The intensity of the review can vary greatly depending on the specifications and study. For example, there are studies in which all recorded data must be checked using a CRA and studies in which, for example, only 50 percent of the data is compared.
The Plugin is used to visualize and monitor progress. The CRA and project management can see at a glance in which forms the comparison still deviates from the clinical trial specifications.
More individual customization with EVA
The EVA (electronic validation acknowledgement) Plugin is used to determine which mandatory fields are deactivated manually by the doctor. For example, if the doctor has no information on a laboratory parameter or if the measured value deviates from a predefined limit value, the doctor can deactivate the message by stating a reason.
This allows processes to be mapped more quickly and the doctor does not have to consult data management every time information is missing. A decision is made at field level as to whether missing data or electronic checks are deactivated. Data for analyzing primary endpoints or patient safety is excluded from this function.
Queries or problems often arise during the operational implementation of clinical trials. Plugins developed by Alcedis support users and customers, making their work easier. Find out more about our solutions in the area of user support.