Field

Description

All Reactions

Reported Term (B.2.i.0/E.i.1)

The adverse event term reported by the reporter.  The original reporter's words and/or short phrases used to describe the reaction/event is provided.

If the application finds an exact match in the dictionary, then the application automatically displays the MedDRA and ART codes associated with the reported term.

Configure the parameter Protocol based coding to use the MedDRA version mentioned in the Protocol Library or in Installation Parameter.

When the coding details are edited for the cases for which the Reported Term is already present, a confirmation message “Existing term already coded. Do you want to recode?” is displayed along with options

• Yes -  to recode the Reported Term with new entry

• No - to retain the previously coded information and store the new     reported term details entered.

In a country, people converse in diverse languages that are unique to the geographical location, native and ethnicity. Apart from main stream languages, an AER may be reported in any of these native specific languages, which must be captured as it is in the application.

Reported Term in Native Language (E.i.1.1a)

Type the literals of the term as received by the reporter in the native language.

Native Language (E.i.1.1b)

Select the name of the native language literals in which the reported term is received.

Reporter  Highlight (B.2.i.3/E.i.3.1)

A highlighted term is a reaction/event that the primary source indicated was a major concern or reason for reporting the case. If the information is not explicitly provided by the initial reporter the term is not be considered a highlighted term.

select one of the following options:

• Yes

• No

• Unknown

Reported For

To indicate the event reported, select one of the following options:

• Patient

• Parent

• Brother

• Sister

Time Flag

To indicate when the reaction occurred, select one of the following options:

• Past reaction

• Current reaction

Not relevant?

To print the reaction on the reports, select the Not relevant check box.

Co-manifestation?

This check box appears selected only when the AE of the case is mapped to a co-manifestation symptom or reaction. The mapping is done in the Co-manifestation Assignment screen.

The check box cannot be manually selected.

Not reportable in Japan

Considers the records that are not reported in Japan

DME

The Designated Medical Events (DME) is specific events that are commonly experienced by a patient related to a specific drug. These events are collectively observed and identified by the respective Authority and labelled as DME in terms of LLTs, PTs and SMQ/CMQs.

In ARISg Admin, you have a library of all the DMEs related to various drug that your company is manufacturing.  When the event of a case related to a specific drug consist of LLTs, PT, or SMQ/CMQ terms that belong to a DME defined in the admin, the application automatically classify the event a DME and select the DME flag check box.

This field is auto calculated for the case disposed from IRT or when the case is batch auto coded.

Manual

If the LLTs, PT or SMQ/CMQ qualifies as DME as per the authority but these may not have defined in the Library, and in this scenario you can manually select the DME flag check box and then select the adjacent Manual check box to indicate that the LLT and PT terms recorded for this event are manually identified as DME.

Event Type

To indicate the type of adverse event that occurred, select one of the following options:

• Adverse Event/Reaction: Reaction is an unintended or noxious response to a drug that is used in normal doses.

• Incident:Incident are often referred to any deviation from usual medical care that causes an injury to the patient.

• Both:When a patient was being administered an injection with a syringe loaded with medicine, then if there is a burst of the syringe then this is an incident and accidentally the medicine in it caused some adverse reaction as it came in contact with the patient.

Date Of Outcome

If the reaction resulted in death, then you specify the date on which the patient died.

If the reaction resulted in recovery, then you specify the date on which the patient recovered.

Date Of Assessment

The date on which the medical reviewer assessed the case.

Onset Date Text

The period during which the adverse event occurred.

If you do not know the exact date, then enter text in this field.

For example: first week of June 1998.

AE Cessation Date Text

The period during which the adverse event stopped.

If you do not know the exact date, then enter text in this field.

For example: fortnight of June 1998.

No. Of Days Hospitalized

The number of days the patient was hospitalized.

Caused By Drug Interaction?

Indicates is the reaction caused by interaction of two or more drugs ?

• Yes - to it indicates that the reaction was caused due to the interaction of two or more drugs.

• No - to indicate that the reaction was not caused due to the interaction of two or more drugs.

Country (E.i.9)

The country in which the event occurred.

Onset date (B.2.i.4b)

The date on which the adverse event started according to the information given by the reporter or company.

Medically Confirmed (Event) (E.i.8)

Indicates the case as medically confirmed when the case had not originated from a health professional.

MedDRA codes

*Refer to the table Full Data Entry - General Case Details for details on MedDRA codes.*

Seriousness Criteria

Death? (A.1.5.2a)                  

To indicate if the reaction resulted in death, select one of the following options:

• Yes

• No

• No Information

Life Threatening?(A.1.5.2b)                             

Indicates if the patient was at risk of death at the time of the adverse event or continued use of the device might have resulted in the death of the patient.

Select one of the following options:

• Yes

• No

• No Information

Hospitalization New?(A.1.5.2c)                         

Indicates if the patient required hospitalization on experiencing the AE.

Select one of the following options:

• Yes

• No

• No Information

Hospitalization Prolonged? (A.1.5.2c)

Indicates if the admission to the hospital or prolongation of hospitalization was a result of the adverse event. select one of the following options:

• Yes

• No

• No Information

Disability Or Permanent Damage? (A.1.5.2d)      

Indicates if the adverse event resulted in a substantial disruption of a person’s ability to conduct normal life functions.

Select one of the following options:

• Yes

• No

• No Information

Congenital Anomaly/Birth Defect? (A.1.5.2e)                         

Indicates, if the adverse event is  a congenital anomaly/birth defect. If the patient is exposed to a medical product prior to conception or during pregnancy and may have resulted in an adverse outcome in the new born.

You may select one of the following options or alternately, the option selected in the ARISg > Forms > Assessment > Reaction Assessment tab gets displayed here.

• Yes

• No

• No Information

Require Intervention (Devices)?(A.1.5.2f)                        

To indicate if the reaction requires medical or surgical intervention from the doctor. Example: Allergic brochospasm requires emergency treatment.

Select one of the following options:

• Yes

• No

Unusual Failure of Efficacy

Indicates the failure in efficacy of a new drug in accordance for new drugs marketed in Canada, domestic reports of unusual failure in efficacy must be reported within 15 calendar days of the receipt of information by the MAH.

Select one of the following options:

• Yes

• No

Malfunction

Indicate if the outcome of the reaction is a case of malfunction.

Roll up is executed when the user selects the data in Malfunction field as ‘Yes/No’. On saving the case, malfunction data is rolled up from Event level to Case level seriousness criteria.

Note: Malfunction roll up works only when validations 5020 is set to ON.

Temporary or permanent functional incapacity

Indicates if the adverse event has resulted in permanent or temporary disability.

This criteria is available in Event and Case level. The value from Event level gets displayed  to  Case level.

Select one of the following options.

• Yes

• No

Other Serious (Important Medical Events) (A.1.5.2f)      

Indicates if patient experienced any other important medical events that may not be immediately life-threatening or result in death hospitalization but may jeopardise the patient or may require intervention prevent one of the other outcomes. These should also usually be considered serious.

Examples of such events are intensive treatment in an emergency room or home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalisation; or development of drug dependency or drug abuse.

select one of the following options:

• Yes

• No

Other Medically Serious Info.?

Indicates the medically serious information associated with the adverse reaction.

Any additional information concerning to the adverse reaction that is medically proven as serious.

Assessment

Reporter and Company Assessment

Seriousness (B.2.i.3)

The seriousness of the event as described by the reporter, company or Both.

The parameter ‘AER is marked as serious based on assessment by’ in Installation parameter-->AER Data maintenance screen, determines which assessment (reporter/company/Both) should be considered in the AER lists.  

Accordingly, the Seriousness or Non seriousness icons are displayed in both workflow and QBE window.

Manual

Select the check box to override the seriousness calculation for the event. This checkbox is also available in ISP > Event screen.

IME

Indicates that the Event is part of IME list. This display checkbox is also available in ISP > Event screen.

When a Case is Promoted from IRT to ARISg, or case is coming directly from ESM import

1) Application will check if the event is part of IME list and update the Reporter/Company Seriousness as per the IME configuration in Admin.

2) Marks the ‘Other Serious (Important Medical Events)’ to Yes.

Note: IME is not calculated for the cases containing the first product record as Suspect and the type as Medical Device.

Also, on save, the IME for all event records is recalculated if the cases contain most suspect product of medical device type.

Reason Text

Enter the reason for overriding the seriousness calculation for the event. This text field is also available in ISP > Event screen.

Reason

Select the Reason from the list for overriding the seriousness calculation for the event, it is mandatory to enter the Reason if Manual checkbox is selected for the event. This codelist is also available in ISP > Event screen.

IME MeDRA Version

Set the Coding System to agEncoder.

Create a Serious MedDRA Term Record in Library>Maintenance>Serious MedDRA term Maintenance tab.

In the Event screen, select the reported term as provided in the Admin, Library>Maintenance>Serious MedDRA term Maintenance tab, then the MedDRA Version for the respective term gets populated in IME MedDRA version field. This field gets auto populated only if the term is associated with IME MedDRA. This is a read only text field.

Seriousness (B.2.i.3)

The seriousness of the event as described by the reporter or company.

The parameter AER is marked as serious based on assessment by determines which assessment (reporter/company) should be considered in the AER lists.

Severity

The severity of the reaction evaluated by the reporter or company.

Outcome (B.2.i.8/E.i.7)

The outcome of the reaction as reported by the reporter or company.

Cause of AE

The cause of the adverse event as identified by the reporter or company.

Onset date (B.2.i.4b/E.i.4)

Date on which the adverse event started according to the reporter or company.

Cessation date (B.2.i.5b/E.i.5)

Date on which the adverse event stopped according to the reporter or company.

Text

Additional information about the cause of the adverse event as given by the reporter or company.

Grid

Reported term (B.2.i.0)

The Reported term (B.2.i.0) entered in the All Reaction section is displayed in the grid or the application allows you to enter the reported term. The same is displayed in the All Reaction section and the corresponding MedDRA codes are displayed in the MedDRA Codes section.

Onset Date (B.2.i.4b/E.1.4)

The date on which the adverse event started according to the information given by the reporter or company.

The Onset Date entered in the Assessment section is displayed in this field or the application allows you to enter the date and the same is displayed in the Reporter Assessment section.

End Date (B.2.i.5b/E.i.5)

Date on which the adverse event stopped according to the reporter.

Reporter Seriousness (B.2.i.3)

Indicates the seriousness of the reaction as described by the reporter.

The seriousness selected in the Reporter Assessment section is displayed in this field or the application allows you to select the seriousness which is displayed in the Reporter Assessment section.

Company Seriousness

(A.1.5.1/E.i.3.1)

Indicates the seriousness of the reaction as evaluated by the company.

The seriousness selected in the Company Assessment section is displayed in this field or the application allows you to select the seriousness which is displayed in the Company Assessment section.

Duration (B.2.i.6a/ E.1.6a)

Duration for which the patient experienced the adverse event.

Duration Unit (B.2.i.6b/ E.i.6b)

Unit in which the duration of adverse event is specified. The duration unit may be specified in Hours, Days ,etc. Select the correct unit from the drop down list box.

Manual

Is the duration of the adverse event manually entered by the user or automatically entered by the system. The system calculates the duration as the difference between the date on which the AE occurred and the date on which the AE ended.

Field

Description

Other AE Characteristics

Cancer?

Indicate if the outcome of the reaction was attributed to 'cancer'.

RX Therapy Required?

Indicate if the patient required any treatment therapy on experiencing the adverse event.

Overdose?

Indicate if the adverse event was a case of overdose.

Lack Of Effect?

Indicate if the outcome of the reaction was a case due to lack of effect with a medicinal product.

Dependence?

Indicate if the outcome of the reaction was a case of dependence.

Drug Interaction?

Indicate if the outcome of the reaction was a case of drug interaction.

Req. Therapeutic Measures?

Indicate if the patient required therapeutic measures on experiencing the AE.

Serious Injury?

Indicate if the outcome of the reaction was a serious injury.

Malfunction?

Indicate if the outcome of the reaction was a case of malfunction.

Positive Gram?

Indicate if the outcome of the reaction was a positive gram.

Extending Past Nearest Joints?

Indicate if the adverse event extended past nearest joints.

Purulent Discharge?

Indicate if there was any evidence of a purulent discharge.

Hospitalization Required? - Historic

Indicate if the patient required hospitalization earlier.

Drainage Of Lymph Nodes?

Indicate if the result of the reaction resulted in the drainage of lymph nodes or not.  Normally used for vaccine related cases.  

Unanticipated  Serious  
Health Deteriora

Indicates whether the case is Unanticipated serious health deterioration.

Serious Public Health Threat?

Indicates whether the case is Serious public health threat.

Near Incident?

Indicates whether the case is a Near Incident.

Medication Errors?

Indicate if the outcome of the reaction was any medication errors.

Off-Label

The cases where the product was taken by the patient not according to the current label are considered as Off-Label. This field is set manually.

Death Caused By

The reason or cause of death.

Possible disability?

Indicates if the outcome of the reaction was disability.

Required medical treatment more than30 days?

Indicates if the patient requires medical treatment for more than 30 days.

Sequelae Description

Description about the pathological condition resulting from a disease, injury, or other trauma.

Emergency Room (Vaccines)

Indicates whether vaccines was administered on the patient in the emergency ward when the patient admitted to the hospital.

Infection?

Indicates whether the patient has developed any disease or caused adverse reaction due to usage of a medical device during treatment.

• Yes - Select if any infection details is mentioned in the event reported.

• No - Select if there is no infection observed in the event reported.

Physician Room (Vaccines)

Indicates whether the vaccines was administered by a physician as a part of general consultation at the hospital.

Field

Description

Hospital Information

Hospital name

Name of the Hospital to where the event is observed.

Address (Address 1, Address 2, And Address 3)

The complete address of the Hospital.

City

Name of the city where the Hospital is located.

State

Name of the state where the Hospital is located.

Zip Code

A unique numeric postal code specific to the City and State.

Country

Name of the Country where the Hospital is located.

Phone Numbers

Office

The contact number of the Hospital office or reception.

Extension

The direct extension number of the authorized personal in the Hospital office.

Country Code (Phone)

The standard country code number to be prefixed along with the phone number.

Fax No.

The contact number of the Hospital office or reception.

Extension

The direct fax extension number of the Hospital office.

Country Code (Fax)

The standard country code number to be prefixed along with the fax number.

Email address

The email address of the hospital.