Summary

This article describes the default fields available in the configurable add study form.

Table of Contents

• Access Add Study Form
• Specify Study Workflows
• Default Fields
  • Unique Study ID
  • Protocol Field
  • Product Field
  • Study Roles Field
  • Countries Field
  • Sponsor Field
  • CROs Field
  • Objectives Field
  • Therapeutic Area Field
  • Indications Studied Field
  • Phase Field
  • Regulatory Submission Numbers Field
  • Study Status Field
  • Feasibility Form Field
• Save Actions
  • Save Button
  • Save & New Button
  • Cancel Button
• Duplicate Alert Check
• Importing Study Information

A new study to be managed in CTMS is added through the Study form, one of many Configurable Forms.  It is from this screen that relevant information concerning a Study can be collected. Upon saving of the Add Study form the additional forms for management of the study is created. What is displayed on this form can be configured from CTMS Settings.

The Study form is labeled Add Study for a new record and Edit Study for an existing record.

Access Add Study Form

The Add Study form can be reached by clicking “Add Study” in the Actions Menu on the Studies Manager screen.

The Study form for existing Studies can be accessed by clicking on the Protocol in the Studies Manager and the Edit Studies form will appear.

Specify Study Workflows

Designate the following study workflow preferences here.

 Site Visit Report Approval

The Site Visit Report Approval field is used to identify the approval workflow to be used for the Monitoring Reports Transitions. All configured Site Visit Report Workflows will appear as options. If a Monitoring Report Workflow is not selected, monitoring reports cannot be added to the study.

Site Visit Report Collaboration

The Site Visit Report Collaboration field is used to identify which task workflows will be used on site visit reports.

Deviation Approval

The Deviation Approval field is used to identify the approval workflow to be used for Deviation Transitions. All configured Deviation Workflows will appear as options. If a Deviation Workflow is not selected on this form, deviations cannot be added to the study.

Deviation Collaboration

The Deviation Collaboration field is used to identify which task workflows will be used on deviations.

Additional Study Collaboration Workflows

This field is used to identify if any additional task approval workflows are to be used within the study.

Default Fields

The Study form contains the following fields by default:

Unique Study ID

The Unique Study ID field is a read-only field used to assign a system generated unique number for all studies in the CTMS tool. The Unique Study ID will start at 10001.

Protocol Field

The Protocol field is a text field used to identify the Study within managers and other parts of the system. By default, the Protocol field is a required field. If left blank a black alert will fire, preventing the form from being saved until the protocol is entered. The Protocol field’s Visibility settings cannot be changed.

Product Field

The Product field is a Multi-Select field with all active Products from the Product Manager as answer options. By default, the Product field is a required field. If left blank a black alert will fire, preventing the form from being saved until the Product is entered. The Product field’s Visibility settings cannot be changed.

Study Roles Field

The Study Roles field is a Multi-Dropdown Select field used to identify what roles will be used in the study. These options can be configured via the Role Managed List found in CTMS Settings. By default the Role Managed List options are “Primary Investigator”, “Project Manager”, “CRA”, “CTA”, “Data Manager”, “Statistician”, “Safety”, “Medical Writer”, and “Vendor”. The selected Study Roles will become the available role options on the Study, Vendor and Site Personnel screens.
By default, the Study Roles field is a required field. If left blank a black alert will fire, preventing the form from being saved until the Study Roles are entered. The Study Roles field’s Visibility settings cannot be changed.

If roles are not selected in this field, roles cannot be assigned to personnel working on the study. This will also affect the ability to assign responsibilities in Deviation and Monitoring Report Approval Workflows.

Countries Field

The Countries field is a Multi-Dropdown Select field used to identify Countries in which the study will be run. The field will contain as options all Countries supported by the system.
The selected Countries determine the site addition options. By default, the Countries field is a required field. If left blank a black alert will fire, preventing the form from being saved until the Countries are entered. The Countries field’s Visibility settings cannot be changed.

Sponsor Field

The Sponsor field is a Dropdown Select field used to identify the Sponsor for the Study. It is also used as a parameter for Entity-based permissions. These options can be configured via the Sponsor Managed List found in CTMS Settings. By default the Sponsor Managed List is blank and needs to be populated at the beginning of use of the CTMS. By default, the Sponsor field is a preferred field and a red alert will fire if the data is not provided.

CROs Field

The CROs field is a Multi-Dropdown Select field used to identify the CROs for the Study. It is also used as a parameter for Entity-based permissions. These options can be configured via the CRO Managed List found in CTMS Settings. By default the CRO Managed List is blank and needs to be populated at the beginning of use of the CTMS. By default, the CROs field is a preferred field and a red alert will fire if the CRO data is not provided.

Objectives Field

The Objectives field is a Multiline Text field used to identify the objectives of the study per the protocol. By default, the Objectives field is a preferred field and a red alert will fire if the Objectives data is not provided.

Therapeutic Area Field

The Therapeutic Area field is a Dropdown Select field, and is used to identify the therapeutic area of the study. By default options available are:

These options can be changed via the Therapeutic Areas Managed List found in CTMS Settings. By default, the Therapeutic Area field is a preferred field and a red alert will fire if the Therapeutic Area data is not provided.

Indications Studied Field

The Indication Studied field is a Multi-Dropdown Select field used to identify the indications of the study. These options can be configured via the Indications Managed List found in CTMS Settings. By default the Indications Managed List is blank and needs to be populated at the beginning of use of the CTMS. By default, the Indication Studied field is a preferred field and a red alert will fire if the Indication Studied data is not provided.

Phase Field

The Phase field is a Dropdown Select field used to identify the phase of the study. By default options available are “Phase I”, “Phase II”, “Phase II-B”, “Phase III”, “Phase IV”, and “Proof of Concept”. These options can be changed via the Phase Managed List found in CTMS Settings. By default, the Phase field is a preferred field and a red alert will fire if the Phase data is not provided.

Regulatory Submission Numbers Field

The Regulatory Submission Numbers field is a Multiline Text field used to identify the assigned regulatory numbers for the study. By default, the Regulatory Submission Numbers field is a preferred field and a red alert will fire if the Regulatory Submission Numbers data is not provided.

Study Status Field

The Study Status field is a Dropdown Select field used to identify the status of the current study. By default options available are “Start-Up”, “Screening”, “Ongoing”, “Closed” and “Proof of Concept”. These options can be changed via the Study Status Managed List found in CTMS Settings. By default, the Study Status field is a preferred field and a red alert will fire if the Study Status data is not provided.

Feasibility Form Field

The Feasibility Form field is a Dropdown Select field used to identify the Feasibility Form Template that will appear for each Site added to the study. All Site Feasibility Templates that are marked Active will appear as options. By default, the Feasibility Form field is a preferred field and a red alert will fire if the Feasibility Form data is not provided.

If a Feasibility Form is not selected, users will not be able to add a Feasibility Form to a Study Site Menu.

Save Actions

Save Button

When the Save button is selected the data entered for the questions will be saved.

Save & New Button

When the Save & New button is selected the data entered for the questions will be saved and the user will be directed to a new Add Study form.

Cancel Button

When the Cancel button is selected the data entered for the questions will not be saved.

Duplicate Alert Check

If a study protocol matches an existing protocol in the Study Manager, upon saving of the form a warning will display notifying the user of the existing record. Selecting Save will save the study, selecting Cancel will close the notice and the form will not save.

Importing Study Information

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Note: The Submissions tab on the Studies Template requires a Regulatory Body to be listed. The Regulatory Bodies must be associated with the study for the Submissions import to be successful.

Primary Identifiers & Required Fields

For all Import guidelines click here.

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

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