Content Comparison

Data Manager or Study Director Home Page

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Level 1: Data Manager or Study Director of Study

Data Manager and Study Director see the same information at Home Pageon the Homepage. It shows summary tables for the current Study such as: 

Subject Enrollment

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For Study

• • Study: Name of SiteStudy
  • Enrolled: Number of Subjects Subjects who met the criteria in the protocol and have have already enrolled at that Sitein the Study.
  • Expected Enrollment: Total number of Subjects expected to enroll at that Sitein the Study, based on preliminary data collected for the Study protocol.
  • Visit Status: Different statuses of visits, for all Visits in the Study or Site.
  • Number of Visits: The number of Visits in the Study or Site having that status.
  • Percentage: The number of Subjects enrolled divided by expected enrollment at that Site.

Study Progress 

• • Percentage: The number of Visits having that status divided by the total number of Visits in the tablefor the Study.

Subject Enrollment By Site: 

• • Site: Name of Site
  • Enrolled: Number of Subjects who met the criteria in the protocol and have already enrolled at that Site
  • Expected Enrollment: Total number of Subjects expected to enroll at that Site, based on preliminary data collected for the Study protocol
  • Percentage: The number of Subjects enrolled divided by expected enrollment at that Site.

Subject Status Count

• Study Subject Status: Available, Signed, Removed
• Number of Study Subjects: The number of Study Subjects currently having that status, including any Subjects removed from the Study.
• Percentage: The number of Subjects that have been Signed/Removed/Available divided by total enrollment for the Study.

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Study Progress 

• • StudyVisit Status: Name of StudyEnrolled: Number of Subjects who met the criteria in the protocol and have already enrolled  Different statuses of Visits, for all Visits in the Study or Site.
  • Expected EnrollmentNumber of Visits: Total The number of Subjects expected to enroll Visits in the Study , based on preliminary data collected for the Study protocolor Site having that status.
  • Percentage: The  The number of Subjects enrolled divided by expected enrollment for the Study.

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• • Visits having that status divided by the total number of Visits in the table

Task Summary: Displays sites which meet the below criteria 

• • New Failed Validation Check
  • Update Failed Validation Check
  • Resolved Failed Validation Check
  • New Query
  • Updated Query
  • Resolved Query
  • Requiring Signature
  • Requiring Verification
  • Requiring Enter Data
  • Ready for lock
  • Ready for freeze
  • Imcoming visit  

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Level 2: Data Manager and Study Director at Site

Data Manager and Study Director will see the same information at Home Pageon the Homepage. It shows summary tables for the current Site such as: 

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• • Visit Status: Different statuses of visitsVisits, for all Visits in the Study or Site.
  • Number of Visits: The number of Visits in the Study or Site having that status.
  • Percentage: The number of Visits having that status divided by the total number of Visits in the table.

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Subject Enrollment For Study is hidden at Site Level

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Task Summary: Displays subject under the current site which meet the below criteria 

• • New Failed Validation Check
  • Update Failed Validation Check
  • Resolved Failed Validation Check
  • New Query
  • Updated Query
  • Resolved Query
  • Requiring Signature
  • Requiring Verification
  • Requiring Enter Data
  • Ready for lock
  • Ready for freeze
  • Imcoming visit  

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CRC, Monitor, and Investigator HomePage

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CRC, Monitor, and Investigator see "Subject Matrix" at Study and Site
Image Removed: can see Study's Information and Task Summary

Study's Information contains:

• Study System Status
• Study Phase
• Protocol Type
• Start Date
• Estimated Completion Date
• Conditions
• Keywords
• Eligibility
• Sex
• Minium Age
• Maximum Age
• Healthy Volunteers Acctepted
• Expected total enrollment 

Task Summary: depends on role , system displays different cretiria. As above section,

• At Study level Task Summary displays sites which meet criteria
• At Site level, Task Summary displays subjects which meet criteria
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