There are many ways to access, create, or generate reports in ERT Portal. Two areas of the Portal provide report access: the Clinical Data section, and the Reports section.
Most subject level reports can be accessed from the Clinical Data Navigation Tab. Based on your protocol, the following reports may be included:
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Views in the Clinical Data section can also be configured as reports from the screen, based on subject or site data, and customized as needed. Examples of this could be:
drilling down on the Subjects tab, filtering for randomized subjects, and clicking the Export button;
filtering for measurements based on a specific timepoint, such as Pre PFT or Post PFT, and exporting;
drilling down to the visit level to view Questionnaire Data for eCOA studies. Questionnaires can be toggled to view each question and all possible answers, or each question and the subject’s response. Questionnaire Data can also be manipulated on the screen and exported.
Data Status Forms, including Inactivation and Reactivation forms for a visit. Feedback forms are also available for ABPM and Holter Arrhythmia studies as well.
In the Reports section, types of Monitor/Site level reports include the following examples:
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Subject-level reports can also be generated:
eCOA Session Reports
Subject Detail Reports
ECG Data Exports
Accessing through the Reports Navigation Tab allows you to create, generate, read, and save both subject-level and high-level monitoring reports, and also maintain your reports for the lifetime of the study, or until deleted.
Reports are generated in “real time”, and elements of the report are selectable, such as Country, Investigator, date ranges, and data type, in many cases.
Report outputs can often be selected (Excel or PDF).
Reports can be sent to your email account, if so desired.
Continuous Glucose Monitoring (CGM) Reports are available in the Reports section. CGM Reports are provided as PDFs, which can be downloaded to your local drive. CGM has four report categories:
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See Also