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Basic study configurations

Using basic configurations, you can efficiently manage the study and its data. These configurations are available on the Study Data List page, which opens upon selecting the STUDY MANAGEMENT tab from the application toolbar. This page's contents depend on the view selected by the user—card grid view or table grid view.

Basic study configurations
Figure 1. Basic study configurations

The basic configurations you can perform to the study are explained in the following sections.

Switch study list between table and card grid view

The card grid view of all the sponsor's studies currently maintained in CTMS helps you make a quick overview of all the basic study details and aspects, providing easy access to various CTMS modules where the depicted study details can be amended or maintained. This view gives you more function and accessibility than the Study Data List table, so you might prefer utilizing it for study management purposes.

To switch the study list between the table and card grid view

  1. In the CTMS application header, select the STUDY MANAGEMENT tab.

  2. On the page that opens, switch to the desired study list view as follows.

You have switched to the desired view—table or card grid—and learned the significance of the available elements. The selected view is now defaulted for you under the STUDY MANAGEMENT tab until switched otherwise.

View study overview chart

The Study Overview chart represents the overall status statistics of the studies maintained in the CTMS application.

To view the study overview chart

  1. In the CTMS application header, select the STUDY MANAGEMENT tab.

  2. On the Study Data List page that opens, from the workspace toolbar, select Study Overview chart_icon_red.png.

    Accessing study overview
    Figure 1. Accessing study overview

  3. In the Study Overview dialog that opens, explore the status statistics of the studies maintained in the CTMS application. The status details can be found in the following table.

    Study overview chart
    Figure 2. Study overview chart

    Status

    Details

    Preparing

    The study is being set up and respective preparations are being held.

    Started

    The study is live and respective sites and institutions start operating in specific countries.

    Subject Enrollment

    The subjects are actively registered and enrolled in a study.

    End of Enrollment

    The subject enrollment process of the study is completed.

    Closed

    The study is closed, although the data analysis and manuscript preparation can still occur.

    Terminated

    The study is aborted before the planned end date for some reason, for instance, due to the observed efficacy of the treatment or, on the contrary, because of the serious adverse effect of the investigated product.

    Suspended

    The study research activities are temporarily halted and pending future actions, for instance, collecting more data on adverse effects occurred.

  4. Select OK_button_red.png to close the chart dialog and return to the Study Data List page.

You have examined the current status statistics of the studies maintained in the CTMS application. You can also change the study status.

Change study status

In CTMS, you can change the study status manually. The study status represents the current stage of the study, which can be in preparation, already started to admit subjects, or else.

To change the study status

  1. In the CTMS application header, select the STUDY MANAGEMENT tab.

    Accessing study management
    Figure 1. Accessing study management

  2. On the Study Data List page that opens, in the table, go to the study whose status you want to change.

  3. In the Status column, select the status you want to set for the study. The statuses are explained in the following table.

    Changing study status
    Figure 2. Changing study status

    Status

    Details

    Preparing

    The study is being set up and respective preparations are being held.

    Started

    The study is live and respective sites and institutions start operating in specific countries.

    Subject Enrollment

    The subjects are actively registered and enrolled in a study.

    End of Enrollment

    The subject enrollment process of the study is completed.

    Closed

    The study is closed, although the data analysis and manuscript preparation can still occur. If this status is assigned to the study, you must confirm the action.

    Note that you can close the study only after all countries/regions associated with it have been closed and all study-related protocol deviation records have been completed.

    Terminated

    The study is aborted before the planned end date for some reason, for instance, due to the observed efficacy of the treatment or, on the contrary, because of the serious adverse effect of the investigated product. If this status is assigned to the study, you must confirm the action.

    Suspended

    The study research activities are temporarily halted and pending future actions, for instance, collecting more data on adverse effects occurred. If this status is assigned to the study, you must confirm the action.

  4. If you update the study status to Closed, Terminated, or Suspended, in the Confirm dialog that appears, provide the details as explained in the following table.

    Important

    The details you need to provide for action confirmation depend on the authentication method configured for you in the system—via SSO or via providing your login and password.

    Confirming study status update
    Figure 3. Confirming study status update

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Reason*

    Enter the reason for terminating or suspending the study. You do not need to provide a reason for closing the study.

    Closed Date* / Terminated Date* / Suspended Date*

    Select date_picker_calendar_gray_small.jpg to indicate the date when the study has been closed, terminated, or suspended.

    Username or Email*

    Enter your CTMS username or email address.

    Send Code

    Select send_code_button.png to send the temporary PIN code to your email for which the SSO method is configured.

    The button is only available if you use the authorization method via SSO.

    Code*

    Enter the temporary PIN code that you received via email.

    The field is only available if you use the authorization method via SSO.

    Password*

    Enter the password you use to log in to the eClinical system.

    The field is only available if you use the authorization method by providing your login and password.

    Title

    View the job title associated with your username.

    SAVE

    Select save_button.png to confirm the study status change.

    CANCEL

    Select cancel_button_white_blue.png to stop the study status change.

Once selected and confirmed, the study status is changed.

View study operation history

In CTMS, with the Operate History option, you can track all the actions performed with a study, find out when and by whom the action has been applied, and if there are any comments on the operation.

To view the study operation history

  1. In the CTMS application header, select the STUDY MANAGEMENT tab.

    Accessing study management
    Figure 1. Accessing study management

  2. On the Study Data List page that opens, in the table, go to the study for which you want to explore the operation history.

  3. In the Actions column, next to the study of your interest, select More > Operation History history_icon.png.

    Accessing study operation history
    Figure 2. Accessing study operation history

  4. In the Operate History dialog that opens, explore the table with all the actions performed with the study.

    Viewing study operation history
    Figure 3. Viewing study operation history

  5. Select close_icon_red.png to close the dialog and return to the Study Data List page.

You have explored the study operation history.

Export study list data

In CTMS, you can export the list of the currently maintained studies, and their planned start and end dates as an XLSX file and use it offline, for instance, to share it with someone without access to the system.

To export study list data

  1. In the CTMS application header, select the STUDY MANAGEMENT tab.

    Accessing study management
    Figure 1. Accessing study management

  2. On the Study Data List page that opens, do one of the following:

    • Export all the studies by selecting Export icon_export.png from the workspace toolbar.

      Exporting study data list
      Figure 2. Exporting study data list

    • Export a specific study by first locating the required study and then next to it, from the Action(s) column, select Export export_icon.png.

      Exporting study
      Figure 3. Exporting study

  3. In the widget that appears, track the export completion. Select the widget to access downloadable files.

    Study data list export progress
    Figure 4. Study data list export progress

  4. In the My Downloads dialog that opens, once the exported file appears under the Download is Ready tab, select download_icon.png next to it to initiate its downloading to your computer.

    Downloading exported study data list
    Figure 5. Downloading exported study data list

Once downloaded and saved, the study list data is available in XLSX format on your computer.

Initiate study decommissioning

Study decommissioning is the final stage of managing a clinical trial in an eClinical system, marking its formal conclusion when the trial is completed, suspended, or terminated. Before starting decommissioning, ensure all collected data is managed per protocol and regulatory guidelines. During this process, trial data across systems is securely finalized and hardlocked, and CTMS archives essential reports in the ADMIN application so sponsors can easily access and download them later.

Tip

The essential reports that are archived by CTMS in the ADMIN application are specified by the system administrators in the ADMIN application.

The decommissioning procedure is usually performed by the project management (PM) team, who typically oversee the planning, execution, and completion of the clinical trial.

Important

The study decommissioning functionality is only available in the PROD environment (lifecycle) as it is the final operation that cannot be performed in DEV or UAT.

Study decommissioning in CTMS is one of the finalization steps taken once the following preconditions are met in other systems:

  • Data collection, review, and management are over and the study is hardlocked in EDC.

  • Files are properly reviewed and organized and the study is locked in eTMF.

  • All subject and drug-related procedures are completed and the study is locked in IWRS.

  • The study status in CTMS is Closed, Terminated, or Suspended.

  • The ticket for study decommissioning is created via the OKTA system and you have its identification number.

To initiate study decommissioning

  1. In the CTMS application toolbar, expand the Lifecycle menu and select PROD.

    Switching to PROD lifecycle
    Figure 1. Switching to PROD lifecycle

  2. In the application header, select the STUDY MANAGEMENT tab.

  3. In the Study Data List table, locate the study of your interest and select More more_icon.png > Decommissioning Ready decommissioning_ready_icon.png.

    Accessing study decommissioning
    Figure 2. Accessing study decommissioning

  4. In the Decommissioning Ready dialog, complete the fields as explained in the following table.

    Important

    Some fields of the dialog differ depending on your authorization method—via username and password or SSO.

    Initiating study decommissioning
    Figure 3. Initiating study decommissioning

    Tip

    In the following table, mandatory elements are marked with an asterisk (*).

    Element

    Details

    Ticket #*

    Enter the ticket identifier number with which the study decommissioning task can be tracked in the OKTA system. The ticket must be created beforehand by the person responsible for decommissioning, usually, the project manager (PM), and the ticket ID must be provided for this purpose.

    LAUNCH

    Select launch_button.png to initiate study decommissioning.

    If you close the Decommissioning Ready dialog upon launch without confirmation, the system does not discard the initiated process and the study remains decommissioning.

    Username or Email*

    Enter the username or email address you use to log in to the CTMS system.

    Title

    Represents the title of the user performing the action. This is autopopulated with the title configured for you via the ADMIN application, you cannot enter the title manually.

    Password*

    Enter the password you use to log in to the CTMS system.

    This field is only available if your authentication method is via username and password. Otherwise, enter a confirmation code.

    Send Code

    Select send_code_button.png to send the temporary PIN code to your email for which the SSO method is configured.

    This button is only available if your authentication method is via SSO.

    Code*

    Enter the temporary PIN code that you received via email.

    The PIN code is valid for 5 minutes before it expires. Select send_code_button.png again to send another email and regenerate the PIN if required.

    This field is only available if your authentication method is via SSO. Otherwise, enter your password.

    Successfully passed the system check, the Study Decommissioning Request has been sent to Admin. Please go to Admin/Report to double confirm

    Select the checkbox to acknowledge your agreement with the stated.

    CONFIRM

    Select conform_button_red_white.png to proceed with decommissioning initiation.

    CANCEL

    • If you select cancel_button_white_blue.png before launching the decommissioning, the dialog closes and your action is discarded with no effect on the study.

    • If you select cancel_button_white_blue.png after launching the decommissioning, the dialog closes but the system does not discard the initiated process and the study remains decommissioning.

Once confirmed, the study decommissioning is initiated in CTMS and requires further confirmation via the ADMIN application otherwise the decommissioning request is not finalized and cannot be completed.

Important

The study decommissioning request can be revoked until confirmed via ADMIN. Once confirmed via ADMIN, the action is final and irreversible.

Revoke study decommissioning

Study decommissioning is the final stage of study management in the eClinical system as it refers to formally ending your trial once it is completed, suspended, or terminated.

Initiating study decommissioning in CTMS is one of the final steps taken after all preconditions are met in other systems. Nevertheless, once you have initiated decommissioning in CTMS but have not yet confirmed it in ADMIN, you can still revoke the operation. This might be helpful if some last-minute modifications must be done before finalizing your study.

To revoke study decommissioning

  1. In the CTMS application toolbar, expand the Lifecycle menu and select PROD.

    Switching to PROD lifecycle
    Figure 1. Switching to PROD lifecycle

  2. In the application header, select the STUDY MANAGEMENT tab.

  3. In the Study Data List table, locate the study for which decommissioning is initiated and next to it, select More more_icon.png > Revoke revoke_icon.png.

    Revoking study decommissioning
    Figure 2. Revoking study decommissioning

  4. In the Reason dialog, enter the reason for revoking the decommissioning request and select save_button.png.

    Initiating study decommissioning
    Figure 3. Initiating study decommissioning

Once saved, the study decommissioning is revoked, the decommissioning icon disappears from the study name in CTMS, and the study becomes available again in the eClinical systems—EDC, eTMF, IWRS, and others.

In this section:

An overarching clinical trial protocol designed to achieve clinical trial objectives under a unified framework. This approach simplifies clinical development by introducing multiple substudies to operate under the same regulatory and operational entity.

An individual component of a master study protocol with its specific objectives, such as evaluating a product, dose, or subject category. Substudy inherits the core structure and governance from the master one but has its own endpoints.

A feature designed to prevent the occurrence of conscious or unconscious bias in the conduct of clinical trials (performance bias) and interpretation of outcomes (ascertainment bias) by concealing the specific study intervention used.

Blinding is a procedure in which one or more parties in a clinical study are kept unaware of which treatment is received by a particular subject or what are the results of that treatment.

In a clinical trial, a location where the subject treatment and drug dispensation occur. It can be a hospital, a private laboratory, or other institutions.

An eClinical application that represents an administrative system used to manage users, authorities, and sponsors at the company level. It provides studies, sites, and sponsors with high-granularity role-based access management across all eClinical applications.