Field

Description

Title (A.2.1.1a/C.2.r.1.1)

The title of Reporter/Patient/Investigator/Author

Name

Last (A.2.1.1d/C.2.r.1.4)

First (A.2.1.1b/C.2.r.1.2)

MI (A.2.1.1c/C.2.r.1.3)

The name of the Reporter/Patient/Investigator/Author . Click the lookup icon for choosing the name from the Person Lookup window.

1. Click the Lookup icon. The Lookup window appears.

2. Enter the search criteria and click OK.  The search results appear in the list.

3. Choose the required information from the list and click Select. The selected information appears in the Full Data Entry page.

Health care professional

Indicate if the reporter also works as a health professional.

There are Yes and No option to indicate whether the person belongs to health care profession. The application automatically determines or you must manually select Yes or No option.

The application automatically determines and selects the Health care profession option based on the following conditions:

• the ON or OFF status of the validation "Auto Calculation of Health Care professional field" (validation ID "5030") in the Admin > Setup > Validation > Validation Information Maintenance page.

• the profession you select for the person from the Reporter type (A.2.1.4/C.2.r.4) drop-down list.  

The application selects:

• Yes - When the 5030 validation is ON in ADMIN and the Reporter type (A.2.1.4/C.2.r.4) is Physician/Dentist/Nurse or Physician (General Practice)/Other health professional.

• No  - When the 5030 validation is ON in ADMIN and the Reporter type (A.2.1.4/C.2.r.4) you select is other than Physician/Dentist/Nurse or Physician (General Practice)/Other health professional.

Manual – Select this check box to modify the Health care profession option which is automatically determined by application.

Primary reporter

To indicate the reporter as the primary reporter of the incident, select the check box.

Do not report name

To not report the name of the reporter to the authorities, select the check box.

Primary source for regulatory submission

To indicate that the Reporter who provided the significant information is the primary reporter.

When the adverse event is reported from multiple reporter and when the company receives an account of adverse event information from multiple reporters, then to determine the reporter who gave significant information on the event as the primary reporter, select the check box.

Sex

Specify the gender of the reporter. If you do not know the gender, then select Unknown.

Initial reporting method

The medium through which the reporter sent the report.

Reporter type (A.2.1.4/C.2.r.4)

Highest qualification

The highest qualification of the reporter.

Occupation

The area of occupation of the reporter.

Specialization

The area of specialization of the reporter.

Department(A.2.1.2b/ C.2.r.2.2)

The department to which the reporter belongs.

Hospital code

Indicates the Japanese hospital code.

Owner ID

Use the Japan Hospital Lookup for selecting additional information on hospital.

To select additional hospital information from Japan Hospital Lookup:

1. Click the Hospital code lookup icon.

The Japan Hospital Lookup screen appears.

2. Enter the search criteria and then click OK.
   Or
   Click OK.

The search results appear in the list.

3. Select the required information from the list and then click Select.
   For example: Select the record based on the ‘Owner ID’ column.

4. Based on the selection, the respective values are displayed in the respective fields.

5. Click Save.

Records in the ‘Owner ID’ column are displayed from the JPN_HOSPITAL_CODE table. When you click the Save icon, all the records are saved in the AER_PERSON table.

Hospital/Organization name (A.2.1.2a/ C.2.r.2.1)

This represents the hospital or the organization name to which the reporter belongs.

Other Health Care Professional (C.2.r.4.KR.1)

Indicates if the person also works as other health care professional. The options are :

• Other

• Nurse

This specific R3 tags are  mandatory for the MAH’s to submit for ICSR R3 cases. And also, it supports exporting and importing of an R3 ICSR file.

Address 1

Address 2

Address 3 (C.2.r.2.3)

Indicates the address of the reporter.

City (A.2.1.2d/C.2.r.2.4)

Indicates the city in which the reporter resides.

County (FDA.C.2.r.2.5.1/FDA.D.1i)

Indicated the county to which the reporter belongs.

State (A.2.1.2e/ C.2.r.2.5))

The State in which the reporter resides.

Zip code (A.2.1.2f/ C.2.r.2.6)

The Postal code of the place where the reporter resides.

Country (A.2.1.3/C.2.r.3/ D.CN.4)

The country in which the reporter resides.

Click the drop down list box and select the country.

Phone Numbers

Residence (C.2.r.2.7)

Country code

Office (C.2.r.2.7/D.CN.5)

Ext. no.

Fax No.

Ext. no.

Country Code

The residence phone number of the reporter.

The country code of the phone number.

Reporter’s official telephone number.

The reporter’s extension number of the phone number.

Fax number of the reporter.

The extension number of the fax.

The country code of the fax number.

Email address (A.2.1.3.FDA.4/FDA.C.2.r.2.8/ FDA.D.1m)

The E-mail address of the reporter.

Previously reported AE

To indicate to whom the reporter had earlier reported the event, select one of the following check boxes:

• To doctor

• To manufacturer

• To Regulatory Authority

• If the reporter had not reported the event earlier, then select the No check box.

Has this reporter informed MAH?

Indicates if the reporter has informed about the event to the Marketing Authority Holder (MAH) or not.

Reporter informed authority directly?

Indicates if the reporter has informed the authority directly about the adverse event or not.

Spain state

Indicates, if the case is originating from the Country Spain.

Select the State from the drop down list. This includes the nineteen autonomous communities of Spain.

Data Privacy is applied to Spain State also when you select the Data Field State in Admin application. Data Privacy for Spain State is not applicable in Study and Literature pages.

When the country is entered as SPAIN the Spain State is auto-populated to the State field and only English decodes are considered for populating the value. If the country field value is changed, the auto-populated value of state is retained as same.

Italian State

Indicates, if the case is originating from the Country, Italy.

Select the state from the drop-down list. This includes the twenty-two autonomous communities of Italy.

The Italian state field information is auto synchronized with the ‘State’ field. If the Country is selected as “Italy” then Italian State field’s data is auto populated in State field.

Data Privacy is applicable to Italian State and is associated with State field in all the four tabs (Reporter, Patient, Investigator and Author), when the state field of any person type is made as Data privacy, then the Italian State associated to that Person type is also considered as a data privacy field.