Download Argus Drug Safety Notes Ch 3 and more Slides Computer science in PDF only on Docsity!
Configuring Clinical Studies
It is important to configure clinical studies in the Argus Console because
it helps the system categorize the source of information for the cases that
have been registered.
Study screen helps in capturing Study information (study specifics,
products involved in the study licensed countries associated with the
study and the clinical references used in the expedited reports.
Study Information is required if a case has been reported while
conducting a study and the participating product(s) belong to the
company.
Configuration of the product is done using the Business Administration-
>Studies section.
To add a study
In the Business Configuration section, select Studies.
In the left panel, select a filtering criterion.
Select a Study and click to view the study details in the right panel.
The details of the study appear in the right panel.
Tip:
■ Before adding study, configure Project ID in codelist
■ You can click Add Study to create a new study(select Project ID,
then add study).
■ Use Copy to make an editable copy of an existing study.
■ Use Copy with Products to make an editable copy of an existing
study, along with all associated products.
Enter the Study ID and Study Name associated with the Study.
Select the Project ID for the Study
Select the Study Type associated with the Study, from the drop-down
list.
Enter the Other ID. This will be an alternative id for the Study.
Select Template to associate a template with the Study.
Click Select placed next to Investigator Alert to select or create an
Advanced Condition for this Study. When this condition is satisfied, the
system automatically sends an e-mail to the investigator group
associated with this study.
Select Study is eligible for Unblinding to enable the study to be
unblinded. If the Study Type selected is Not Blinded", this field is
disabled.
Select Enable Study Specific Encoding to enable the study specific
Auto Encoding. The Auto Encoding features helps you to configure
your own dictionary of encoded data.
Select Inherit Reporting Rules From the drop-down list to configure
study-based reporting requirements.
Adding WHO Drug Details (for adding a non-company product)
The system enables you to add WHO Drug detail information.
To add WHO Drug information
Select Add WHO Drug in the Products section to add the WHO Drug
details associated with the Study.
The system opens the WHO Drug browser window.
Select the Trade Name or the Ingredient radio-button, to search for the
WHO Drug term associated with either the Trade Name or the main
Ingredient of the drug.
Click Search to execute the search. The data is displayed as follows.
Select the required component/row (this can be the key Trade Name or
Ingredient).
The row now appears highlighted and the Drug Details section displays
the associated information.
Click Select to add this drug information in the Product Name section of
the Studies Configuration window.
The WHO Drug browser window closes and the drug appears in the
Study Reporting
Study Reporting is provided in the Study Configuration section to
configure study-based reporting requirements.
Usually the study-specific reporting is configured to handle reporting
requirements for non-company products, e.g. Placebo or a comparator
The reporting rules are not directly defined in the study, but rather
identify which reporting rules to check from the already configured
expedited reporting rules.
The identification is based on specifying what set of reporting rules to
evaluate, as per the criteria of:
■ Country
■ License Type
■ Reporting Destination
To configure study-based reporting
Click Add in the Inherit Reporting Rules From section. The Study
Reporting dialog opens.
Select Always Report as required. Checking this checkbox will force
Argus to check for qualifying expedited reporting rules based on the
country, license type and reporting destination specified even if no non-
company products are identified as study drugs.
Select the Country from the drop-down list. This field specifies which
country's reporting rules should be included. The drop-down list
includes countries for which the expedited reporting rules exist.
Select the License Type from the drop-down list. This field specifies
the license type to be considered for the specified country.
Select the Reporting Destination from the drop-down list. This field is
optional.
Specifying any value in this list limits the reporting rules to be
evaluated to the selected country, license type and reporting destination.
Using Organized by
The filtering browser displays in the top-left corner of the left panel. The
studies section can be filtered based on of any of the three combinations
shown in the following illustration.
The generated output is visible in a tree-format, in the left panel, based
on the entire categorization of Projects, Studies, Products.
If you enable the Organized by Study/Products, only the Study and
Product views will be available in the tree view in the left panel.
The Argus Console helps you to filter information further for the
Business Configuration section.
Once you have selected the Organized by, you can specify whether your
search should contain or start with specific alphabets.
Configuring Expedited Report Rules
This section describes the configuration of Expedited Reports using pre-
defined rules. These reports are required by Regulatory Authorities.
The Administrator is responsible for entering information about
Regulatory Authorities to which regulatory reports will be submitted.
The Reporting Rules configuration feature enables you to define the
reporting rules or criteria for the cases to be qualified for expedited
reporting.
Configuration of the expedited report rules is done using the Business
Administration -> Expedited Report Rules section
Protect Reporter and Patient Confidentiality Enables the user to
configure Protect Reporter and Patient Confidentiality. If this option
checked and a report is generated or draft is viewed, the Patient and
Reporter information will be hidden.
Select Origin of events to include-Domestic to include domestic cases
based on the country of incidence OR Select Origin of events to include-
Foreign to include foreign cases based on the country of incidence
Select Report on Study Drug not Administered. This option ensures that
all study drugs that are not administered are reported.
Select Active Moiety if you want to enable this option. When this option
is enabled the system will disable and ignore the county when evaluating
the domestic/foreign causality sections.
Timeframe field specifies the report's scheduled due-date based on the
number of days, after the initial receipt or significant follow-up date.
Select the required Form from the drop-down list of expedited report
forms.
Select the Local Comment Type from the drop-down list. This field is
used to extract local evaluator comments from case data.
Select the Clinical Reference Type from the drop-down list. This field
is used to obtain information from study configured for a case.
Select the Language and Message Type from the drop-down list.
Select the Listedness from the drop-down list. This ensures that the
license being evaluated for reporting is listed.
Select the Seriousness- Fatal/Life Threatening option from the drop-
down list. This field ensures that cases that contain Death or Life
Threatening seriousness criteria for an event are evaluated.
Select the Seriousness- Serious (Event) option from the drop-down
list. Enable this field to check if the event level seriousness assessment
is Serious
Select the Seriousness- Serious (Case) option from the drop-down
list. Enable this field to check if the case level seriousness assessment is
Serious
Select the Seriousness- Serious (Severity) option from the drop-down
list. This enables you to define the Severity as Mild, Moderate, Severe
and Unknown.
Select or create the Advanced Condition to restrict cases to the
advanced conditions defined here.
If any of these three causalities are confirmed, then the case will be
considered as reportable.
Select the Responsible Group from the drop-down list. This is the
group to which the reports scheduled by this reporting rule will be
assigned.
Select the Cover Letter from the drop-down list. Use this field to select
cover letters that have been configured for reporting template use.
Enter any regulatory report comments under the Comments text box.
Click Save to save the changes made to this section.
Using Organized by
The filtering browser is displayed in the top-left corner of the left panel.
The Expedited Report Rules section can be filtered on the basis of any of
the five combinations shown in the following illustration.
Consider the following examples:
■ If you enable Organized by Country/License Type/Reporting Rule,
then the output generated will be visible in a tree-format, in the left
panel, based on the entire categorization of Country, License Type and
Reporting Rule.
■ If you enable the Organized by Responsible Group/Reporting Rule,
then only the Responsible Group and Reporting Rule views will be
available in the tree view in the left panel.
