2.2 Enroll Subject Help

This section allows you to enroll a new subject for your current study. You are presented with a graphical model as well as written instructions detailing the two steps necessary to enroll a subject. The latter step is subdivided into five individual steps in order to create new study event for your newly enrolled subject.

 

Step 1: Enroll Subject

Here you can enter the Subject information. At minimum, please fill in the fields titled Unique Identifier, Date of Enrollment for Study, Gender, and Date of Birth. Upon completion, please click the Enroll and Add Study Event button to continue.

You can also choose to click the Enroll and Add Another button if you wish to enroll other subjects at this time.

You can also choose to click the Enroll and Finish button if you would like to add a study event for your subject at a later time.

 

Step 2: Add Study Event

Here you can create a new study event for your newly enrolled subject. At minimum, please fill in the fields titled Study Event Definition, Location, and Start Date/Time. Upon completion, please click the Proceed to Enter Data button to continue.

 

Step 2 (a): Study Event Overview

Here you are presented with a Study Event overview. This section allows you to view all the CRFs included in your particular Study Event.

1. CRF Name

This cell indicates the name of each CRF.

2. Version

This cell indicates the version of each CRF.

3. Status

This cell indicates the current status of each CRF.

4. Initial Data Entry

This cell indicates the initial data entry for each CRF.

5. Validation

This cell indicates if the CRF has been validated.

6. Actions

Enter Data

Clicking on the Enter Data button will allow you to enter data into the particular CRF. It also allows you to continue with the creation of a new Study Event.

 

Step 2 (b): Event CRF Properties

Here you can view the details of the Interview as well as submit CRF data.

Note: Fill in the fields titled Interviewer Name and Interview Date before proceeding to enter data for each section of the subject’s Event CRF. Upon completion, please click the Confirm Interviewer Info button.

1. Title

This cell indicates the title of the Event CRF.

2. Incomplete Items

This cell indicates the number of incomplete Items in the Event CRF.

3. Completed Items

This cell indicates the number of completed Items in the Event CRF.

4. Total Items

This cell indicates the total number of Items in the Event CRF.

5. Actions

Enter Data (Paper & Pencil Icon)

Clicking on the Enter Data button will allow you to enter data into the Event CRF regarding your newly enrolled subject.

 

Step 2 (c): Data Entry

Here you can enter data for the items in the Event CRF.

Note: It is not necessary to complete the Event CRF in one sitting. You can click the Save and Resume Later button on the top or bottom of the page to return to it at a later time. You will be prompted with an error message indicating that all the items are not complete. You can override this message by clicking the Confirm values and Resume Later button. You will be directed back to the Event CRF properties page.

 

Step 2 (d): Mark Event CRF Complete

Clicking on the Mark this Event CRF Complete button finalizes the data entry process for your specific Event CRF. Only after you have completed the Data Entry process in Step 2(c), should you click the Mark this Event CRF Complete button.


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