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Configure study

In PV, basic details about the study, like its name, timeframe, and such, are pulled automatically from the basic study information block of CTMS or from the ADMIN app, depending on which system is available for the client.

However, you need to configure some additional details manually via the Study Setting feature. Here, you can configure your study arms, specify study products pertaining to each arm, and add study references, such as the registration details and more. These study configurations are then used when completing respective ICSR forms, mainly—the Study form.

To configure a study

  1. In the PV application header, select the CONFIGURATION tab.

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

    Accessing study setting
    Figure 1. Accessing study setting

  3. On the Study Setting page that opens, in the table, you can find the list of studies to which you have access. Select the name of the study for which you want to configure details.

    Important

    The list of studies available here depends on the study access permissions granted to your user group via the ADMIN application.

    Selecting study
    Figure 2. Selecting study

  4. In the form that appears, manage the study details as explained in the following table.

    Configuring study details
    Figure 3. Configuring study details

    Tip

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

    Element

    Details

    Study Name

    Represents the name of the study that is uneditable and automatically pulled from CTMS or ADMIN, depending on which system is available for data pull.

    Language

    Select the primary language of the study.

    WHODrug Synonym List

    Select the list of WHODrug synonyms preconfigured for your study via the CODING application.

    Using synonym lists enhances case processing by applying autocoding for all verbatim terms of product names within the cases in your study based on the previous manual coding applied to a similar product verbatim term. This eliminates user interaction to manually code the drug names individually for each submitted case of the study.

    WHODrug Synonym Detail

    Select arrow_circled_right.png to open and preview the list of verbatim terms and their WHODrug coding results configured for your study.

    Checking WHODrug synonym list details
    Figure 4. Checking WHODrug synonym list details

    This feature cannot be used to edit the synonym list but only view the details. To update the synonym list, go to CODING > SYNONYM.

    Study Description

    Represents the description of the study that is automatically pulled from CTMS. If the value is empty, it is not provided on the CTMS side or the CTMS data pull is unavailable, and you can enter the study description manually.

    The synchronization of the study description with CTMS occurs only once, and if this value is missing, you have to provide it manually in PV, even if it is later entered in CTMS.

    Translation

    Select bilingual_view_icon_gray.png and in the Translation dialog that opens, select the translation language of the study description. Then you can enter the translation text manually or select translate_button.png to perform the AI translation. Save the changes to implement the translation.

    Translating study description
    Figure 5. Translating study description

    Study Number

    Enter the identification number of your study. If unavailable, select null_flavour_icon.png next to the field for the system to insert the null flavor value.

    Study Type

    Select the type of your study, such as Clinical Trial, Individual Patient Use, or else.

    Study Phase

    Represents the current phase of the study. The value is automatically pulled from CTMS but can be selected manually if the CTMS data pull is unavailable.

    Start Date

    Represents the actual start date of the study. The value is uneditable and automatically pulled from CTMS.

    End Date

    Represents the actual end date of the study. The value is uneditable and automatically pulled from CTMS.

    Study Status

    Represents the status of the study, for instance, Subject enrollment. The value is uneditable and automatically pulled from CTMS.

    Study Arms

    Arm Name*

    Enter the name of the study arm.

    Blind Type*

    Select the blinding type (Open Label, Single Blind, Double Blind, or Triple Blind).

    Primary License

    Select the primary license from the list of available ones. You can use search to locate your license in the list faster.

    The primary license can only be selected after the study arm products are added.

    If the study arm is blinded (Single Blind, Double Blind, and Triple Blind) and also contains an unblinded product, you can only select a blinded product license as the primary license.

    Study Arm Products

    Configure your study arm products here and then perform the following actions if needed:

    New

    Select plus_icon_gray.png to configure another arm for the study.

    Study References

    Type

    Represents the type of the study reference, such as study registration, CDER IND, or else.

    Country

    Represents the country that is assigned the study reference.

    Number

    Represents the number that is assigned to the study reference as per the reporting region, such as the number of the study registration, the number of the application, or else.

    New

    Select add_new_icon.png to configure a study reference by type.

    SAVE

    Select diskette_icon.png to save changes implemented to any of the study setting form fields.

    Tip

    You can switch between different studies directly from the configuration page with no need to return to the Study Setting table. Simply expand the menu from the toolbar and select the study of your interest.

    Switching between study configurations
    Figure 6. Switching between study configurations

Upon saving, the updates to the study details are implemented.

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 group of subjects formed as a result of randomization for blinding purposes that has its own schedule of visits and treatment plan according to a study protocol.

A coding service that is used for the unified coding of drugs throughout the pharmaceutical industry. In order to achieve this, the service provides the WHODrug dictionary which is an international classification of medicines created by the WHO Program for International Drug Monitoring. The dictionary is managed by the Uppsala Monitoring Centre and contains drug code numbers, along with related information such as trade names, active ingredients, and additional information, such as marketing authorization, pharmaceutical forms, and strengths of the drugs.

For example, the WHODrug drug code for the substance Ibuprofen is 001092 01 001.

An eClinical application that is intended for medical coding and managing elements of data collected during clinical trials to organize large amounts of information in a standardized way—according to WHODrug and MedDRA dictionaries. The application facilitates data analysis and ensures accuracy and consistency in reporting.

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

As part of the U.S. Food and Drug Administration (FDA), ensures that safe and effective drugs are available for people's health improvement. Learn more on the CDER official website.