Skip to end of metadata
Go to start of metadata

You are viewing an old version of this content. View the current version.

Compare with Current View Version History

« Previous Version 12 Current »

What you see in the body of the home page is based on your user Role in Site/Study

Data Manager or Study Director Home Page

Level 1: Data Manager or Study Director of Study

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

Subject Enrollment For Study

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

Study Progress 

    • 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 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
    • Answered Query
    • Requiring Signature
    • Requiring Verification
    • Requiring Enter Data
    • Ready for lock
    • Ready for freeze
    • Imcoming visit  

Level 2: Data Manager and Study Director at Site

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

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.

Study Progress 

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

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.

Subject Enrollment For Study is hidden at Site Level

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
    • Answered Query
    • Requiring Signature
    • Requiring Verification
    • Requiring Enter Data
    • Ready for lock
    • Ready for freeze
    • Imcoming visit  

CRC, Monitor, and Investigator HomePage

CRC, Monitor, and Investigator : 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
  • No labels