Other Code List Items

The following table lists and describes additional code list items that you should be aware of.

Code List Item	Description
Accidental Exposure	Enables you to capture Accidental Exposure information. Accidental Exposure is in the Dosage regimen section of the Products tab as a drop-down list.
Action Taken	Enables you to capture Action Taken information. Action Taken information is required to capture information about steps taken when an adverse drug event occurs. The values that you enter in this field are read-only, and appear in the Dosage Regimen section on the Action Taken drop-down in Case Form > Products tab.
Action Type	Enables you to capture Action Type information that describes the action type required for the case. Values entered in this field are read-only, and appear in the Code/Description list of the Activities tab. Go to Code List Maintenance > Code List > Argus and click Action Type in the browser tree.
Age Group	Enables you to capture Age Group information. An Age Group is the range of lower and upper age limits. Patients are categorized in different age groups. This data appears in Expedited and Periodic regulatory reports. The values that you enter in this field appear on the Patient Information Screen, and in the Age Group drop-down list. The Range values that you specify for new age groups must not contain numbering gaps or overlapping values.
Age Unit	Enables you to capture Age Unit information. An Age Unit displays time in periods such as Year, Month, Day, Hours, and so on. This data appears in the Expedited and Periodic regulatory reports. It also appears in the Age Unit drop-down, Gestation Period unit, and Device Age unit fields on the Patient Information screen, as per the settings made to the Age unit, Gestation Period unit, and Device Age unit flags in the Age unit codelist.
Always Serious Term List	Enables you to select the report types you would like the always serious to run against. You can select specific Product Families to have the always serious terms run against.
Anatomical Location	Enables you to capture information about the location where vaccinations are given. This data appears in the expedited and periodic regulatory reports. The values that you enter in these fields appear on the Anatomical Location drop-down list on the Vaccine screen.
Attachment Classifications	Enables you to capture the attachment classification that is used to describe attachment types. The values that you enter in these fields appear in the Attachment Classification section on the Additional Information screen. Attachment Classification that are marked as E2B Additional Doc can be configured to be sent as attachments while transmitting E2B(R2) and E2B(R3) reports.
Attachment Keywords	Enables you to capture information about the attachment keywords that are used to define an attachment type. The values appear in the Attachment Keywords section on the Additional Information screen.
Birth Type	Enables you to capture birth type information when capturing pregnancy information. This data appears in multiple regulatory reports and in the Birth Type drop-down list on the Pregnancy information screen.
Case Classifications	Enables you to capture Case Classification to help categorize cases. This information does not impact any report or screen, but is used during case searches to narrow the results set.
Causality Category	Enables you to capture information about the causality type. This data appears in expedited and periodic regulatory reports and on the Event Causality drop-down list in the Event Assessment section on the Event screen.
Causality Method	Enables you to capture Causality Method information. It appears on the Case Form Event Assessment tab.The E2B report uses this information to determine the drug assessment method.
Causality Source	Enables you to capture Causality Source information. It appears on the Case Form Event Assessment tab.The E2B report uses this information to determine the drug assessment source.
Clinical Reference Type	Enables you to capture information about the clinical reference type. The Clinical Reference Type appears as a drop-down list in Study Configuration.
Condition Type	Enables you to capture information about the condition of the patient such as historical condition, current condition, historical drug, illness at the time of vaccination etc,. This data appears in expedited and periodic regulatory reports and in the Condition Type drop-down list on the Other Relevant History screen.
Contact Type	Enables you to capture information about the type of contact (such as Follow-up, Investigator). The values appear in the Contact Type drop-down list in the Contact Log section of the Activity Tab.
Countries	Enables you to capture information about the country where the adverse event occurred. If you enter A2, A3, or the numeric country code, the system automatically populates the Country field with the name of the country. The 'Countries Grouping' field enables you to create a group of countries. For example, to group all European Union member countries, you first create a country called 'EUROPEAN UNION'. You then select a European Union member country in the countries table, type 'EUROPEAN UNION' in its Countries Grouping field, and then click Save. Repeat the process for all European Union member countries. On screens where you need to enter a list of all European Union members, you can type European Union, and all countries in this group will be entered automatically. The 'Group 2 Country' checkbox enables you to add a Group 2 Country. This is required when the Due Date for expedited reports differs from country to country, as per their regulations. For Group 1 countries, the Due Date is based on the Aware Date received globally for the case. For Group 2 countries, the Due Date is based on the aware date when the affiliate or a company representative of that country received information about the case.
Date Ranges	Enables you to capture date range information as follows: Description - Enables you to enter a description of the date range. Duration - Enables you to specify the exact duration as opposed to a range of dates. Must be used in conjunction with Amount and Units. When you select "Duration," the system disables the Range radio button. Amount—The numeric value that specifies the length of the time period when combined with a value selected from the Units drop-down list (such as days, weeks, months, years, etc.) Units—The unit of the duration (such as days, months, years). Range—Enables you to select a specific range of dates. Must be used in conjunction with the Start and End fields. When you select Range, the system disables the Duration radio button. Start—The initial date of the date range. End—The last date of the date range.
Delivery Types	Enables you to capture information about the type of delivery that occurred during pregnancy. This data appears in expedited and periodic regulatory reports and on the Delivery Types drop-down list on the Pregnancy Information screen.
Device Preliminary Comments	Enables you to capture comments about medical devices. Device Preliminary Comments appear on the Product screen when the user selects the Device option.
Device Subcomponents	Enables you to capture information about subcomponents that are part of a medical device. This information appears on the Product screen when the user selects the Device option.
Device Type	Enables you to capture information about patient device types. This data appears in expedited and periodic regulatory reports.
Dosage Frequency	Enables you to capture information about how often medication is given (such as daily, bid, weekly, etc.) This information appears on the frequency drop-down list on the Products screen. Frequency—Enables the user to specify how often the dose is given. Number of doses per day—Enables the user to specify the number of doses administered each day. Number of separate dosage—Enables the user to define the dosage verbatim. Number of units in the interval—Enables the user to define the dosage verbatim. Definition of Interval—The length of time between doses such as year, month, day, week (default), hour, minute.
Dosage Unit	Enables you to capture dosage units information. This information is required when capturing the quantity of drug on sale and also appears in expedited and periodic reports. Unit Name—The name of the dosage unit. E2B Code—The E2B code associated with the Dosage Unit. Dosage Unit—When checked, it indicates that the current item is the dosage unit. Lab Test Unit—When checked, it indicates that this is a lab test unit. Display—When checked, it indicates that the Unit Name is displayed in the application. A new Strength Unit column has been introduced. Check the Strength Unit checkbox to capture strength unit information about the Dosage unit. For more information on the Factory data for Dosage Units codelist, see the Argus_Safety_CaseForm_Console_Updates_Summary.xls.
Ethnicity	Enables you to capture Race information of the patients. This information appears in periodic regulatory reports and eVAERS reports.
Evaluation Reason	Enables you to capture information about why the product is being evaluated. This information appears in the Evaluation Reason list on the Case Form > Products tab.
Event Frequency	Enables you to capture information about the frequency of the event. It includes categories such as intermittent, continuous, and single episode. The values entered in this field appear in the Event Frequency drop-down list on the Event Information screen.
Event Intensity	Enables you to capture information about the intensity of the adverse event and includes categories such as mild, moderate, and severe. The values that you enter on this screen appear on the Event Intensity drop-down list on the Event Information screen.
Event Outcome	Enables you to capture event outcome information such as Fatal, Abortion due to AE/Infection, and Recovered. This data appears in expedited and periodic regulatory reports and on the Event Outcome drop-down list on the Event Information screen.
Fetal Outcome	Enables you to capture information about fetal outcome and includes information such as abnormal development or pre-natal complications. This data appears in expedited and periodic regulatory reports. The values entered here appear on the Fetal Outcomes drop-down list on the Pregnancy Information screen.
Formulation	Enables you to capture information about the formulations (cream, drop, capsule, etc.) available for a product. The values that you enter here, appear on the Formulation drop-down list on the Product screen.
Gender	Enables you to capture gender information. This information appears in expedited and periodic regulatory reports.
Ingredients	Enables you to capture information about the ingredients in the product. This includes the ingredient, the concentration, and the units of ingredients used to make the product. This information appears in expedited and periodic regulatory reports.
Intermediary	Enables you to capture information about intermediaries such as sales representative, licensee, regulatory authority or local affiliate. The values that you enter here, appear on the Intermediary drop-down list on the Reporters screen.
Interval Units	This codelist is used to maintain the interval units that are used as units for Age, Duration, etc.
Justifications	Enables you to capture justification information. You can enter reasons for overriding system determinations in the Justifications dialog box. The values that you enter here, appear in the Action Justification dialog.
Lab Assessment Terms	Enables you to capture the lab result assessment terms that define the terms that describe the patient's results on various lab tests (such as elevated, depressed, etc). This data is reflected in expedited and periodic regulatory reports. The values that you enter here, appear on the Lab Result Assessment Terms drop-down list on the Laboratory Data screen.
Lab Test Type	Enables you to capture the lab test type. This defines test type and whether it has normal, high, or low values. It can be coded as defined in the MedDRA dictionary. The values that you enter here, appear on the Lab Test drop-down on the Patient screen.
Lab Test Units	This codelist is used to maintain the units of measures used in Lab test.
Languages	This codelist is used to maintain the ISO codes of the languages in which text data entry can be made.
Literary Citations	Enables you to enter information about literary citations.
Local Evaluation Comment Type	Enables you to capture the category of a local comment such as French, German, English, etc. The values that you enter here, appear in the Analysis, Local Comment type.
Location	This codelist is used to maintain the Anatomical locations in which Vaccines are administered.
Manufacturer	Enables you to capture information about the product manufacturer. Manufacturer is required while capturing, adding, or modifying information on manufacturer sites. This data appears in expedited and periodic regulatory reports and on the Manufacturer drop-down list on the Product Configuration screen.
Medical Status	Enables you to capture medical information about patient status. This data appears in both the expedited and periodic regulatory reports. The values that you enter here appear on the Medical Status drop-down list.
Message Type	Enables you to enter information about each E2B message type. The system uses the defined message types when it creates an E2B file.
Nature of Event	Enables you to capture information about the type of adverse event that occurred.
Occupations	Enables you to capture information about patient and reporter occupations such as physician, regulatory agent, and journalist. This data appears in both expedited and periodic regulatory reports. The values that you enter here, are marked as ICH Occupation, and appear in the Reporter's Occupation drop-down list on the General Screen.
Package Units	Enables you to capture information about product packaging. The package units define the number of units in a package.
Product Group	Enables you to capture information about a specific Product Group. Users can use the Product group field to categorize Product Families based on therapeutic area. The values that you enter here appear in the drop-down list associated with the Project Group field of the Product Family.
Project ID	Enables you to capture project ID information used to group similar studies under a single project. The values that you enter in this field appear on the Project ID field drop-down on the Study Configuration.
Purchased With	This code list is used to maintain the Funds from which Vaccine was purchased.
Reference Types	Enables you to capture reference type information and defines a list a reference types such as Parent-Child Link, Patient ID, etc. The values that you enter here, appear in the Type drop-down in the References section on the Additional Information tab.
Relation	This codelist is used to maintain the Reporter relation to the Patient.
Report Media	Enables you to capture Report Media information. The values that you enter appear on a drop-down field in the Reporter Information section.
Report Types	Enables you to capture information about report types. The report type describes the type of report and the abbreviation associated with the specific type. This data appears in expedited and periodic regulatory reports. The values that you enter here, appear on the Report Type drop-down list on the General Screen. The Considered cases for report type drop-down list determines whether a case is considered marketed or investigational for a given reporting destination. When creating a new case report type, the selected value is Marketed by default.
Reporter Information	Enables you to capture reporter information such as First Name, Last Name, Occupation, and so on.
Reporter Type	Enables you to capture information about the person reporting the adverse event and includes categories such as lawyer, nurse, doctor, etc. The values that you enter here, appear on the Reporter Type drop-down list on the Product screen.
Reporting Destination Type	Enables you to capture information about the reporting destination. The values that you enter here, appear on the Reporting Destination configuration.
Routes of Administration	Enables you to capture information about how a drug is administered to a patient such as auricular, cutaneous, dental, and so on.
Study Center	Enables you to capture information about the study centers. Values entered here appear on a drop-down in the Clinical Studies Information dialog and on the Centers tab in List Maintenances. You can also add investigators for each center. You can create a study center with the same center ID but with a different name and address.
Vaccinated At	This code list is used to maintain the Vaccination Facility Type information.