Site Data Entry

Creating a Subject

1.  To create a new subject, select the Subject List tab within the appropriate site.

2. Select "+Add Subject"

3. Enter the Subject ID and click save.

Note: The subject ID can be updated at anytime by using the "edit" button next to the subject

Starting a Visit

1. Click on the visit name to start a visit.

2. Confirm Visit and Enter Date.  

   You will be prompted to confirm that the visit indicated should be added for the subject.  To set the date for a visit, specify the date and time that the visit occurred. Start the visit by clicking the Submit button. Once a visit is started, the action cannot be undone. However, the actual visit date can be updated by clicking on the the pencil icon next to the visit name.

   If the visit time is unknown, we suggest using the time that the first procedure started or 12:00 AM as a default.

Visit Outside Window

The system provides a standard, built-in workflow for handling data entry values that may be considered protocol exceptions, including visits noted as occurring outside of the expected window.  If a visit date is noted as outside window, the exception workflow will be initiated.

Users can either select an exception that was previously entered, or create a new exception to associate with a visit occurring outside window.  To create a new exception, enter the appropriate information for the exception after selecting "+New Entry." This new exception will then be available from the dropdown menu.

The visit will then be marked on the visit schedule indicating the visit was out of window.

Procedure Selection

To view or enter data for a procedure:

1.  Select the Subject and Visit.  Once a Visit is initiated, all procedures available for the visit will appear

2.  Select the Procedure, indicate whether it was performed, and select "Go".

3.  All fields associated with the procedure are available for data entry.  If available, Certified Copies can also be uploaded.

Unscheduled Visits

Unscheduled Visits

Procedures and assessments occurring outside of a scheduled visit should be recorded using the Unscheduled Visit option.  To initiate an Unscheduled Visit, select the Unscheduled Visit type (if applicable), enter the Visit Date, and select "+Add".

All procedures for an Unscheduled Visit will be available, however only the procedures that occurred need to be entered.

Subject Logs

1. To create a new log entry for a subject, select the Subject Logs tab within the appropriate subject

2. Select the Subject Log

3. Select "New Event"

4. Follow the Data Entry fields to enter information and upload source necessary. Subject Logs can continue to be modified until they’ve been submitted for CRA Review.  Similar to Visit procedures (CRFs), Subject logs are automatically saved.