2.2 Body of Home Page

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
  • Resolved 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
  • Resolved 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