Summary

This article covers how to add personnel using the study personnel form.

Table of Contents

• Access Study Personnel Form
• Add Study Personnel
  • Role Field
  • Level Field
  • Country Field
  • Site Field
  • Start Date Field
  • Save Actions
    • Clear All
    • Back
    • Save Button
    • Cancel Button
• Personnel Form
  • Roles
  • Country
  • Sites
  • Start Date
  • Stop Date
  • Delete
  • Save Actions
    • Save Button
    • Cancel Button
• Importing Study Personnel
  • Study and Country Level Personnel
  • Site Level Personnel

The Study Personnel form allows the ability to define the personnel who will be working on the study, the role the personnel will have and the start and stop date the personnel participates in the study. Site Personnel and Vendor Personnel are added through their section.

Access Study Personnel Form

The Study Personnel form for existing studies can be accessed by clicking Study Personnel under the Clinical Plans sub-menu for the study.

Add Study Personnel

On the Study Personnel form select the Action “Add Personnel to Study”.

The Add Personnel to Study dialog will appear with all personnel from the Personnel Manager. From this screen, you can select existing personnel or click to add new personnel

• Using the filter and search features for each column find the user to add to the study.
• Select the checkbox for each personnel to be added to the study.
• If a new personnel record is needed, select Add New Personnel to proceed to Step 2. Otherwise, select Next to proceed to Step 3.

If you select Add New Personnel, the Step 2, Add new personnel screen will appear.

• Complete the First Name, Last Name, and Email Address fields for the new record.
• Select Add at the right. The added record will appear in the table below.
• If needed, repeat to create additional records.
• Select Next to continue.

The Step 3 Define Role screen will appear and list personnel selected on Step 1 and/or created in Step 2.

Records will be added to the Personnel Manager for any personnel added to the study via the Add New Personnel functionality. If the personnel already exists in the Personnel Manager (email address must match), but was not visible due to permission restrictions, a duplicate record will not be created. Additionally, any roles selected for Study Personnel will be added to the Personnel Manager record.

Role Field

The Role field is a multi-dropdown field used to identify the role the user will have for the study. Only roles that are defined on the Edit Study form will appear in the role option.

Level Field

The Level field is a dropdown field used to identify the level of the role the user will have for the study.

• Study – select study if the personnel’s role is at the study level.
• Country – select country if the personnel’s role is country-specific.
• Site – select site if the personnel’s role is site-specific.

Country Field

The Country field is a multi-dropdown field used to identify the country the user will be responsible for when the user has country-specific responsibilities. The country field will become active when Country is selected from the Level field. The field will contain as options all countries defined on the Edit Study form for the study.

Site Field

The Site field is a multi-dropdown field used to identify the sites the user will be responsible for when the user has site-specific responsibilities. The site field will become active when Site is selected from the Level field. The field will contain as options all sites that have been added to the study.

Using the Site Filed to assign CRAs to site assignments will allow reporting by CRA on the Monitoring Status Report.

Start Date Field

The Start Date field is a date field used to identify the date the user started the role for the study.

Save Actions

Clear All

Select Clear All to remove all populated roles.

Back

Select Back on Step 2 to go back to Step 1 screen.

Save Button

Select Save to add the personnel to the study.

Cancel Button

When the Cancel button is selected the Add Personnel to Study dialog will close and the data will not be saved.

Personnel Form

On the Study Personnel screen personnel information can be updated.

Roles

Roles can be updated by adding or removing roles for the personnel.

Country

Country can be updated by adding or removing countries for the personnel.

Sites

Sites can be updated by adding or removing sites for the personnel.

Start Date

The Start Date collected in the Add Personnel to Study Dialog will display for each personnel. The Start Date can be changed if needed.

Stop Date

When personnel are no longer on the study the Stop Date can be collected by selecting the date in the Date field.

Delete

If a personnel has been added by mistake and needs to be removed from the listing select the Delete icon.

A confirmation dialog will appear requiring confirmation of deletion request. Select OK to complete the action. Select Cancel to abort the request.

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 back to the 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 form with the saved data displayed.

Importing Study Personnel

<! — DO NOT CHANGE HEADERS. DIRECT URL IN IMPORT TEMPLATE –>

Study and Country Level Personnel

This information can be imported as part of the Study import. Click here for more information.

Site Level Personnel

Imports study personnel (such as Monitors) who have individual site level responsibility.
This information can be imported as part of the Study Vendor Import. Click here for more information.

Need more help?

Please visit the Fountayn Contact Information page.