Enroll New Subjects
- Linh Tran (Unlicensed)
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
Data Fields of a Study Subject
Below is the list of data fields of a study subject. These fields are used to add or update study subject information.
Trường dữ liệu | Bắt buộc | Ý nghĩa | Hướng dẫn nhập liệu |
|---|---|---|---|
| Data Field | Required? | Meaning | Filling instructions |
| Site |  | Select site | |
| Study Subject OID | | OID of study subject in study, can be used in a rule | Automatically generated |
| Study Subject ID | | Theo cài đặt trên hệ thống sẽ có một số phương pháp nhập sau: According to system configuration, there are the following input methods:
Maximum 30 characters | |
| Secondary ID | |||
| Person ID | Based on study configuration | ID number for subject on the system | Maximum 255 characters |
| Enrollment Date | | ||
| Sex | Based on study configuration | Select one of the following:
| |
| Date of birth / Year of Bith | Based on study configuration | ||
| Subject Group Classes (Number based on study configuration) | Dependent on whether subject group class is required | Phân loại study subject, có thể tồn tại cùng lúc nhiều nhóm phân loại study subject Classify study subject - there can exist multiple subject group classes | Select patients' categorization criteria ia by list Can be skipped by selecting (--) when inputting data for subject group class which is not required |
View detailed information of study subject
Accessing the dialogue
There are many links to the study subject information page. Below are the 2 most common ways to link to the page:
Method 1: Access via subject label of corresponding subject study page
Method 2: Access via task summary of a site
Content of Study Subject Information Page
- Information of the subject's visists
- Subject's information
- Task summary of current study subject
