What is Research?
The ‘Research’ tab focuses on patients on clinical trials, allowing the research coordinator to closely monitor events that might influence the outcome of a clinical trial.
Note: This feature is available for Oncology Clients.
When the user navigates to the “Research” tab in a patient’s clinical section, they can view a list of all clinical trials the patient is currently enrolled in or has participated in previously.
- Archive Clinical Trials
The user can archive active trials by clicking the “Archive” button found in each trial entry.
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2. View Trial Details
Users can delve deeper into specific trial details by accessing sections like Adverse Events, Concomitant Medications, and History. This facilitates a more detailed data management and tracking within trials. To access these details, users click the ‘Trial Details’ link available in the trial band.
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Clicking on this link displays trial details in their separate dedicated tabs.
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Each individual section allows for importing of data, printing of detailed reports, and requesting sign-offs, which are essential for maintaining rigorous documentation and ensuring compliance in clinical trials.
- Import Clinical Trial Data
Users with “Import/Add” permissions can import adverse events, concomitant medications, and histories and link them to the currently open trial. This can be done by clicking the ‘Existing Adverse Events/Concomitant Medication/History’ button.
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This displays a list of available data, allowing users to select items for import by checking the corresponding checkbox and then clicking the ‘Import’ button to proceed.
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b. Remove Clinical Data
To remove adverse events, concomitant medications, or histories associated with a current clinical trial, users can select these items using checkboxes and then click the “Remove” button. A confirmation prompt appears, and upon clicking “Yes,” the selected items are successfully disassociated from the trial.
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c. Print Reports
To print preview reports for data within a specific section, users can click the “Print” button.
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They can choose to print all the information or select specific details. After reviewing the selections in a print preview, clicking the “Print” button within the preview executes the printing of the report.
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d. Request Sign-off on Clinical Data
To obtain sign-off against any added information, users can select the checkboxes for relevant records and click the ‘Request Sign-Off’ button.
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On the ‘Request Sign-Off’ screen, the information pending sign-off is displayed.
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Users also have the option to assign tasks to specific users or roles, ensuring they are notified that their sign-off is required. Assigning of tasks can be done by clicking the user icon available at the top of this screen.
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e. Approve Sign-off Requests
Once a sign-off request is submitted, users with sign-off authority can approve and sign off on the requested information by clicking the ‘Sign off’ button.
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The information that has been signed off is then marked as ‘Signed’ in the listing.
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Users access the Tumor Assessment section within the “Research” tab of a patient’s clinical details by clicking the “Tumor Assessment” button.
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This directs the user to the specific Tumor Assessment section associated with the clinical trial open in context. Users with “Import/Add” permissions can import tumor assessment data by clicking the ‘Import Existing Tumor Assessment’ button, displaying a list of available data. Users select items by checking the corresponding checkboxes and click “Import” to proceed.
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To remove tumor assessments linked to the current clinical trial, users select the relevant items and click the “Remove” button.
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A confirmation prompt appears, and the user confirms by selecting “Yes” to disassociate the selected items from the trial.
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Users can request sign-off by selecting relevant records and clicking the ‘Request Sign-Off’ button.
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The pending sign-off information is displayed on the ‘Request Sign-Off’ screen, and users can assign tasks to specific individuals by clicking the user icon.
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Once submitted, users with sign-off authority can approve by clicking the ‘Sign off’ button, after which the record is marked as ‘Signed.’
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To print a report, users click the “Print” button, review the selections in the print preview, and click “Print” again to execute the printing process.
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