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.
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
Data Mapping
Cover Page
The cover page outputs study metadata:
Study Name / Description
Protocol
Site Name
Date/Time Generated
Activity Plans
All study specific activity plans are presented in the report. They are organized by cohort type, in the following order:
No cohort type
Screening
Lead-In
Randomization
Each activity plan in the report provides the following details:
Activity Plan state
Cohort Type
Date Last Updated
Study Events
Form Names
Timepoints (for timed plans)
Example Reference Times (with configured timezone)
Scheduled Activity Status
The Status column will provide details about each scheduled activity and applicable form, such as:
Hidden based on visibility conditions
Role restrictions
Scheduled order enforcement
Pre & Post Window times
Sample paths (hyperlinked)
Study Lab Panels (hyperlinked)
Item soft ranges
Activity Plan approvals will also be provided.
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.
Informed Consents
Informed consent form (ICF) configurations will be based off the currently configured ICF within Study > Configure.
Sample Paths
Configured sample paths are made visible in this section of the report. The following information is provided:
Sample Processing Steps
Locked status
Date Last modified
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.
Study Lab Panels
Study specific lab panels, as they’re configured within Lab > Configure, are present in the MCR.
The following details will be presented with each panel:
Lab Panel Contents (Tests)
Locked status
Lab Interface
Date last modified
Hyperlinks to these panels are present with each applicable form within the Activity Plan section of the report as well.
