Summary
This article covers the default fields available on the project plan form.
Table of Contents
The plans for the study, site and patient status are managed through the Project Plan form. It is from this screen that relevant information concerning the number of Countries, Sites Evaluated, Sites Initiated, Number of CRAs, eCRFs and SAEs, Patient Status can be tracked for the Expected versus Actual numbers. Additional fields can be added to each table to allow tracking of expected versus actual status as needed for each study. Each study contains the Project Plan form (labeled Project Planning).
Access Project Plan Form
The Project Plan form for existing studies can be accessed by clicking Project Plan under the Clinical Plans sub-menu for the study.
Default Fields
The Project Plan form contains by default the Site Setup, Additional Site Setup, Study Setup, Additional Study Setup, Patient Status and Additional Patient Status tables.
The Site Setup, Study Setup, and Patient tables automatically provide the Actual figures by calculating the actuals from other sections of the study. For the Additional Site Setup, Additional Study Setup, and Additional Patient Status tables the Actual figures have to be entered to report on expected versus actual.
Site Setup Table
The Site Setup Table will display Countries, Sites Evaluated and Sites Initiated.
| Status | Expected | Actual |
|---|---|---|
| Countries | List the number of countries expected for the study. | The Actual field auto-populates based on the number of countries added on the Edit Study Countries field. |
| Sites Evaluated | List the number of expected Site Evaluation visits. | The Actual field auto-populates based on the number of Study Sites that have been defined as Evaluated for Site Status. |
| Sites Initiated | List the number of Site Initiated. | The Actual field auto-populates based on the number of Study Sites that have been defined as Initiation for Site Status. |
Study Setup Table
The Study Setup Table will display Active CRA Count, Duration in Months, Total eCRFs, and Unique eCRFs.
| Status | Expected | Actual |
|---|---|---|
| Active CRA Count | List the number CRAs that are expected to monitor the study. | The Actual field auto-populates based on the number of personnel added with the role of CRA on the Study Personnel screen that do not contain a Stop Date. |
| Duration in Months | List the number of months the trial is expected to occur. | The Actual field auto-populates based on the number of months between the earliest Actual Date and the latest Actual Date defined on the Study Milestones. |
| Total eCRFs | List the number of total eCRFs expected in the casebook. | The Actual field auto-populates based on the Actual Number of Total eCRFs defined on the Data Management Plan |
| Unique eCRFs | List the number of unique eCRFs expected in the casebook. | The Actual field auto-populates based on the Actual Number of Unique eCRFs defined on the Data Management Plan. |
Patient Status Table
The Patient Status Table will display a row for each Patient Status defined on the Visit Schedule.
| Status | Expected | Actual |
|---|---|---|
| Will display the Patient Status defined on the Visit Schedule. | List the number of patients expected for the Patient Status. | The Actual field auto-populates based on the number of patients at each site that has data for the Patient Status field. |
Additional Tables
The Additional Site Setup, Additional Study Setup, and Additional Patient Status Tables allow the users to select the “Add Row” button to add a new row to collect additional status for each table.
Once a new row is added and saved the additional row will display a delete icon. Select the delete icon to remove the additional row.
Additional Study Setup Table
The Additional Study Setup table will display SAEs by default.
Save Actions
Save Button
When the Save button is selected the data entered for the questions will be saved and the user will be directed to the Project Planning form with the saved data entered.
Cancel Button
When the Cancel button is selected the data entered for the questions will not be saved and the user will be directed back to the Project Planning form with the saved data displayed.
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