Subject and Study Subject used in CheckPad are not the same concept:
- Subject is used to denote individuals participating in a clinical trial in CheckPad. A subject can be enrolled in multiple studies.
- Study subject is a subject participating in a specific study
To reuse subjects among study, user needs to turn on the Person ID configuration in Study Configuration
Contents:
Enroll Subject
Study needs to have "Available" status before enrolling subjects.
Enrolling a study subject also creates a subject in the system if the corresponding subject does not exist
- Choose Enroll from main menu
- Fill in the corresponding information of study subject
- Select one of the following confirmation:
- Save And Assign Study Visit
- Save And Add Next Subject
- Save And Finish: Save and view detailed information of subject
- Cancel
Update Subject
Updating subject information
Study subject is used throughout the system. To change subject's information user needs to have administrative rights
- Access the study subject information page
- Choose 'Edit Record' in 'Standard Information'
- Change subject's information (Person ID, Sex, Date of Birth)
- Choose 'Confirm' to continue
- Choose 'Submit' to finish the process
Update the study subject information
Data entrant can change the study subject's information
- Access the study subject information page
- Choose 'Edit Record' in 'Standard Information'
- Change subject's information (Study Subject ID, Secondary ID, Enrollment Date, Subject Group Class)
- Choose 'Confirm' to continue
- Choose 'Submit' to finish the process