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Manage study information

In IWRS, you can view basic information on any selected study and manage various study settings, including randomization approval preferences, shipment configuration, and more. A portion of study information fields is pulled from the CTMS application so you cannot update these details.

To manage study information

  1. In the IWRS application header, select the TREATMENT DESIGN tab.

  2. On the page that opens, in the left pane, select the Study Information subtab.

    Accessing study configurations
    Figure 1. Accessing study configurations

  3. On the Study Information page that opens, view the available study information and manage various study settings as explained in the following table.

    Managing study configurations

    Important

    The study-level configuration has tips for a few options. These tips guide the effect of the option and represent a prompt about how to use it. To view the tip, bring the cursor close to the info symbol info_icon_light_gray.png next to the option of your interest.

    Figure 2. Managing study configurations

    Element

    Details

    Study Name

    Represents the name of the study.

    Study Type

    Represents the study type that can be, for example, Observational, Interventional, or Feasibility.

    Purpose

    Represents the purpose of the study, for example, to find ways to more effectively prevent, diagnose, or treat disease.

    Phase

    Represents the current phase of the study.

    Randomized

    Indicates whether the study is randomized (Yes) or not (No).

    Blinding Status

    Represents the blinding status of the study, for example, Open-Label, Blinded, or Double-Blinded.

    Randomization Approval Required

    Turn this toggle on for the system to request approval of the assigned user role before performing subject randomization.

    This option can be disabled if the randomization functionality is not activated for your study or the randomization is handled via EDC according to ADMIN settings.

    Set Disable Randomization Approved Condition

    Select gear.jpg to open the page where you can enter a condition for canceling approved randomization for subjects.

    Use the Active toggle to control whether the condition is currently active and implemented for randomization cancellation (if turned on) or inactive and not applied to the randomization cancellation logic (if turned off).

    Entering condition
    Figure 3. Entering condition

    For example, you have configured a condition to cancel approved randomization for subjects over 75 years old. So if randomization for some subjects has been previously approved, and then the data has been entered in EDC indicating that the age of those subjects is over 75, approved randomization will be canceled for such subjects.

    You can only enter and save the condition if according to the ADMIN settings randomization is handled via IWRS and not via EDC.

    Enable dispensing items from multiple lots

    • Turn this toggle on to enable dispensing items from multiple lots to a subject at a dispensation.

    • Turn this toggle off to disable dispensing items from multiple lots to a subject at a dispensation. Disabling this option results in a single dispensing of all drugs from the same lot, which risks dispensing failure.

      For example, the site has four units of aspirin to be dispensed, but two of them are from Lot 001 and another two are from Lot 002. If dispensing items from multiple lots is disabled, and the site needs to dispense four units of aspirin to the subject, the system would consider that the inventory is insufficient for this dispensation.

    Hide cohort in subject information

    Turn this toggle on or off to hide or show the cohort name on the Subject Information page of IWRS.

    Unblind Approval Required

    Turn this toggle on to enable the approval process on unblinding subjects in IWRS.

    Release randomization number bypass quarantine

    Turn this toggle on for the system to bypass the customized quarantine period employed for additional review. This functionality can be beneficial in time-sensitive situations where immediate activation is critical for the progress of the study.

    Shipment Configuration

    Shipment Type

    Represents all types of shipments available in IWRS. They are listed in the table so you can apply custom configurations to each of them depending on the shipment requirements of your study.

    Skip In-Transit

    Select checkboxes in this column next to the shipment types for which you want to skip the In Transit status.

    For example, you have selected to skip the In Transit status for the Return For Destruction shipment type. So every time you return items for destruction to some depot, the system skips this status after the shipment dispatch has been confirmed.

    Enable Draft Shipment

    Select checkboxes in this column next to the shipment types for which you want to allow having shipments created with the Draft status, thus introducing more flexibility to the shipment generation process.

    Must enter Service and Tracking ID

    Select checkboxes in this column next to the shipment types for which you want to make the Service and Tracking ID fields mandatory when creating shipments.

    Approval of Return

    Select checkboxes in this column next to the shipment types for which you want to enable the approval process on returning items in IWRS.

    Enable Custom Shipment Number

    Turn this toggle on or off to enable or disable the option to customize the supply and return shipment identification numbers by composing their numbering convention via Supply Shipment Number Elements and Return Shipment Number Elements fields.

    Supply Shipment Number Elements

    Configure the naming convention for supply shipments with the necessary name components by selecting plus_icon_dotted.png and then moving the components with the select and drag action.

    This setting is only available if the Enable Custom Shipment Number toggle is turned on.

    Return Shipment Number Elements

    Configure the naming convention for return shipments with the necessary name components by selecting plus_icon_dotted.png and then moving the components with the select and drag action.

    This setting is only available if the Enable Custom Shipment Number toggle is turned on.

    Enable Temperature Monitor

    Turn this toggle on or off to enable or disable the depot's and site's functionality to manage shipment temperature regimens. If enabled, the personnel receiving the shipment—once the temperature regimen breach is established—can reflect it in the system and upload a respective document to support their decision.

    Must Upload Attachment

    Turn this toggle on or off to make the upload of the file supporting shipment compliance mandatory or optional upon receiving shipments.

    This setting is only available if the Enable Temperature Monitor toggle is turned on.

    Capture Temperature Logs

    Turn this toggle on or off to enable or disable the upload of the protocol for temperature regimen compliance. If turned on, from the dropdown menu that appears, select Optional or Mandatory to establish the condition of temperature log handling for sites.

    This setting is only available if the Enable Temperature Monitor toggle is turned on.

    Enable Destruction Batch

    Turn this toggle on or off to enable or disable the functionality to create item batches for destruction at depots and at sites.

    Enable Lot Release Approval

    Turn this toggle on or off to enable or disable the functionality to request approval of the dedicated user when releasing items from packaging lot to depots and sites.

    If there is an active item release request when the functionality to request approval becomes disabled, the request remains and has to be processed by the sponsor.

    SAVE

    Select save_button_red_white.png to implement the changes.

    Lock

    Select lock_button.png to prevent any modifications to the study data in IWRS. Learn more in the Lock/Unlock study data section.

    This operation is applied as performed and does not require saving.

    Help Document

    Upload Help Document

    Select upload_icon.png and follow the prompts to upload a file that you find useful for your study. This can be the study protocol version or any other document you need.

    This file will be available for preview and download to all the system users who have access to Study Information page.

    This operation is applied as performed and does not require saving.

    [File name]

    Select the file name link to preview the document contents in the new tab of your browser.

    This operation is applied as performed and does not require saving.

    Download Help Document

    Select download_icon.png and follow the prompts to download the file to your computer.

    This operation is applied as performed and does not require saving.

    Delete Help Document

    Select trash_can_icon.png to delete the file from the system.

    This operation is applied as performed and does not require saving.

Once configured and saved, your study settings are applied, and now the system operates accordingly.

In this section:

An eClinical application that is mainly used to manage and control the personnel, communication, budget, progress, expenses, documents, and declaration involved in the entire clinical trial. It provides study and site management, study quality control, study progress tracking, project management, risk management, reports, and a visualized dashboard.

Get to know all the possibilities of the app with the comprehensive CTMS User Guide.

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.

A batch of items (drugs) that are produced at one time and have common characteristics, such as, for instance, expiration date. In IWRS, there are two types of item lots—packaging lot and manufacturing lot.

In eClinical, a process of providing a subject with medication at a visit to a site during their treatment in the course of a clinical trial.

A group of subjects who share a set of specific factors (characteristics) that is first defined and composed, then studied or tracked over a given time period. In a clinical trial, outlining the study cohort begins with clearly defined, study-specific inclusion criteria.