Summary
The Master Check Report (MCR) is a comprehensive study design style report that provides visibility into study design. It is a report typically used by study designers, monitors, and data management teams to review the setup of a trial. It provides details to areas within activity plans, CRF design, eligibility mapping, informed consent, sample paths, and study lab panels.
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Design
The MCR is a hyperlinked PDF export, with similar design to other CRF style reports. It contains the following outputs:
Cover Page
Activity Plans
Eligibility
Informed Consents
Sample Paths
Study Lab Panels
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Data Mapping
Cover Page
The cover page outputs study metadata:
Study Name / Description
Protocol
Site Name
Date/Time Generated
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Activity Plans
All study specific activity plans are presented in the report. They are organized by cohort type, in the following order:
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Activity Plan approvals will also be provided.
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Eligibility
The setup of eligibility mapping, against the Subject Eligibility form (base type of Eligibility), will be present in the report as well. The report will also indicate if the mapping is currently locked.
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Informed Consents
Informed consent form (ICF) configurations will be based off the currently configured ICF within Study > Configure.
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Sample Paths
Configured sample paths are made visible in this section of the report. The following information is provided:
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Sample pathways can be configured with their own HTML, as this is done by way of the WYSIWG editor with Samples > Configure. This same formatting and presentation of the configured sample pathway is presented in the MCR.
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Study Lab Panels
Study specific lab panels, as they’re configured within Lab > Configure, are present in the MCR.
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