Entering Causality Information

Causality denotes a necessary relationship between one event (called cause) and the product entered for a case.

To comply with the ICH guidelines, ARISg synchronizes data given by the Reporter or Company in the Causality data entry page.

In this section, you enter the causality information for the following:

• Product Reaction

• AER

• Product

• E2B

To enter the product reaction causality:

1. On the Full Data Entry page, click the Causality tab.
   The data entry page to enter the product reaction information opens.

Note: The application automatically displays the Product information and Reported term, based on the information you enter in the Suspect Product and Event data entry pages.

When you select the Product Reaction Causality from the drop-down list of the Causality Data Entry page or click the icon and enter Additional Causality Details, then information displays in either of these pages.

The application allows to evaluate the AE's of special interest (AESI) while completing the activity. To evaluate the AESI, make sure to select the checkbox Evaluate for AESI from Admin Workflow Designer for the particular activity. For more information on Designer, refer to the WFMASTER guide. The evaluation of AESI is performed only for suspect products and current events.

Medical Evaluators (doctors or medical professionals) evaluates data related to Causality information.

Automatic selection of the AESI checkbox:  If the reported term entered in the Event tab for a product in ARISg client is mentioned as the AE of special interest for that product in ARISg Admin CPD maintenance, then the AESI checkbox in the Product-AE Causality is marked automatically in ARISg client.

In case where the AESI checkbox is selected, the application will verify if the case satisfies the AESI criteria and if not the AESI checkbox is reset as unchecked. In case the AESI checkbox is selected manually, irrespective of AESI criteria being satisfied or not the checkbox will not be reset.  

For Example: Product Crocin in Admin CPD consists four AE's of special interest.

• Fever (LLT), Pyrexia (PT)

• • Select Crocin as product in the AER

  • Enter Fever as Reported Term and code. The result after coding: Fever is LLT and Pyrexia is PT.

  • The application now checks for the product Crocin AE's of special interest as Fever and Pyrexia marked in Admin, the AESI checkbox is marked automatically.

Automatic selection of the Watch List checkbox:  If the reported term entered in the Event tab for a product in ARISg is as same as the product in Admin CPD maintenance, then the Watch list and Action on the Causality screen is selected, providing if the validation in admin is ON and the Manual check box, adjacent to the Action field is unchecked.

Note: MedDRA version and coding type values is not stored for the LLT/PT/SOC terms specified in the Admin AESI screen, but is stored for the SMQ/CMQ. The SMQ/CMQ MedDRA Version captured in CPD will be used to select the appropriate SMQ matching the version but it will not be used to compare the version of the LLT/PT codes available in the case with the SMQ term.

 When you check the Manual checkbox, AESI will not happen for a causality record.

AESI is not applicable for logically deleted products or events.

Auto Calculation of Anticipated Event

Following is a scenario depicting the auto calculation of an Anticipated Event.

1. 1. Create a Study Case.

   2. In the Study tab, select the Protocol no from the lookup and the Project no is auto filled.

   3. Remember to select the same Protocol as added in  the Admin>Library>Protocol Maintenance application.

   4. For the selected Protocol, in the Events Tab, enter the associated anticipated event in the reported term field.
      The anticipated event should be as entered in the Admin>Library>Protocol Maintenance>Product>Anticipated Event Information.

   5. Perform MedDRA coding for the selected term.

   6. Enter Reporter causality and Company causality in the causality section. .

   7. Save the Case.

While saving the case if the products anticipated events associated to the protocol are matched with the event LLT and PT codes, then the Product-Event combination is marked as an Anticipated event in the Causality section.

If the matching causality records are not found, then the application creates a new causality record where the anticipated event is checked by default.

The associated product-event combinations will be marked as anticipated event irrespective of the causality level set in admin.

You can select the manual checkbox to manually calculate the Anticipated Event. Select the reason and enter the Reason text to manually calculate the anticipated event

Note:  Make sure you enter your comments in Reason text. On selecting the Reason as Unknown. This  conditional data entry is enabled by the validation 411650 when is set to ON.

2. To enter information in the Product Reaction Causality section, click the different column cells and select the text from the drop-down list.
   Field Descriptions of Additional Product Reaction Causality

   2. 
      

      Field	Description
      Product And Reaction Information
      Product Flag (B.4.k.1/G.k.1)	The type of product used. This parameter Product based available in Admin>>Parameters>>Installation Parameters>>General>>Security determine whether the product level security entered within an AER (for which users have access) are applicable for the Most suspect product, Any suspect product or, Any product.
      Product Description (B.4.k.2.1/G.k.2.2)	The application displays the selected value in the Product Description field available in the Full Data Entry > Product >Product Information section.
      Reported Term (B.2.i.0)	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.
      Assessment
      Reported term (B.2.i.0)	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.
      Lab test confirmation	The result of the lab test.
      Receipt site causality	The causality assessment at the site.
      Not reportable to PMS	Considers the records that are not reported to PMS.
      Watchlist	1. Create a case with minimum data. 2. Enter Product description, which has watch List event associated to it. 3. Enter the Reported term, which has matching LLT/PT/SOC codes as in Watch List.   4. Save the case 5. In the Causality screen, verify Watch List and Action fields. The Watch List check box is selected and the Action text displays from the CPD when the following combination match in the case. • Product • Corresponding event • Matching watchlist event configured in the Company Product Dictionary of Admin The application indicates the appropriate action for the matching drug –AE combination. Auto calculation of IME, DME, Watchlist and anticipated events are applicable for current reactions and not for Past Reactions.
      Action	The application indicates the appropriate action for the matching drug –AE combination. When agEncoder is used as coding system, the agEncoder application updates the user action text on auto-coding the event and after manual coding of event from agEncoder. Note : The user action text will not be updated if the term is recoded from Impact Analysis. Data from this field is printed in AER data and Detail audit reports with comma separation.
      Manual	Select the check box to override the automatic calculation of the watchlist.
      Not Reportable To CT	Considers the records that are not reported to CT.
      LSO Causality	The Causality provided by LSO(Local Safety Officer).
      Causality as Per (Device)
      Reporter	The causality related to the  Drug/Vaccine or Device as given by the reporter.
      Company	The causality related to the  Drug/Vaccine or Device as given by the company.
      HQ	The causality related to the  Drug/Vaccine or Device as given by the head quarters.
      Date Causality	The date of assessing the causality.
      Temporal association	To indicate if a sequential association exists in the product reaction relationship, select one of the following options: Yes No
      Latency Information
      Latency (B.4.k.13. 1a/G.k.9.i.3.1a)  Manual (Type)	To specify the time period from the start of drug administration to the start of the reaction: Select the Manual check box. Enter the time (number) in the text box. Select the unit from the drop-down list.
      Last dose Latency (B.4.k.13.2a/G.k.i.3.2a) Manual (Type)	To specify the time period from the end of drug administration to the end of the reaction: Select the Manual check box. Enter the time (number) in the text box. Select the unit from the drop-down list.
      Causality As Per (Cosmetic)
      Causality Assessment (Cosmetic)	Select the option from the Causality assessment drop-down, depending on the level of causality assessment used. There are five levels of causality, following are the options: • Excluded • Likely • Not clearly attributable • Unassessable • Unlikely • Very Likely Selection of the Manual check box disables automatic calculation for Cosmetic causality. By default, this checkbox will be un checked.
      Symptomatology	Select the Symptomatology indicating the compatibility of the symptoms with the reaction. Following are the options: Evocative: A symptom which can be reasonably expected and sufficiently specific to suggest causality. Only partially or not evocative: A symptom which is not reasonably expected and not sufficiently specific to suggest causality
      Chronology Cosmetic	From the Chronology Cosmetic drop-down list, select the option according to the sequence between the product use and the occurrence of symptoms. The time sequence may be  as follows: Compatible Incompatible Only partial compatible Unknown
      Additional Examinations	Select the option additional examinations conducted on the cosmetic product. Following are the options: AE1:Positive AE2:Negative AE3: No examinations were performed or the results were ambiguous.
      E2B/Korean/Chinese Causality
      Chinese Causality
      Chinese Source (G.k.9.i.2.r.CN.1)	Select the source of the causality from the drop-down list. The available options are: Initial reporter MAH
      Chinese Result (G.k.9.i.2.r.CN.2)	Select the result of the causality from the drop-down list. The available options are: Sure Very likely Possible May not be relevant Unable to evaluate To be evaluated
      Chinese Assessment Method (G.k.9.i.2.r.2)	Choose your option from the Causality assessment method drop-down, depending on the level of causality assessment used.
      Latency Information
      Latency (B.4.k.13. 1a/G.k.9.i.3.1a) Manual (Type)	To specify the time period from the start of drug administration to the start of the reaction: Select the Manual check box. Enter the time (number) in the text box. Select the unit from the drop-down list.
      Last dose Latency (B.4.k.13.2a/G.k.i.3.2a) Manual (Type)	To specify the time period from the end of drug administration to the end of the reaction: ·         Select the Manual check box. ·         Enter the time (number) in the text box. Select the unit from the drop-down list.
      Rechallenge/Dechallenge
      Action(s) Taken With Drug (B.4.k.16/ G.k.8)	The actions taken with the drug.
      Outcome After Change	The effect of changing the dosage.
      Dechallenge (G.k.9.i.CN.2)	The effect of discontinuing the product.
      Rechallenge (B.4.K.17.1/ G.k.9.i.4)	The effect of introducing the product again.
      Outcome After Re-Intro	To indicate if the introduction of the product again caused an effect, select one of the following options: • Re-appeared • Did not reappear • Not reported • Not applicable • Unknown
      French Imputability
      Chronology	Select from the drop-down list the sequence of the event. This field is considered to print in  the French report.
      Semiology per se	Select from the drop-down list any signs of the event occurring on its own. This field is considered to print in  the French report.
      Imputability	Select the probability of the event occurring. This field is considered to print in  the French report.
      Imputability- Manual (check box)	Selection of this check box restricts auto calculation of imputability score and vice-versa. This check box is unchecked by default. Select the Automatic/ Manual Entry option in Adminà SetupàDefault value maintenance screenà Codelist field to change the default value.    Selection of this check box prints the Manual field information on the AER       data report.
      Bibliographic imputability	Select from the drop-down list the academic study of the event. This field is considered to print in  the French report.
      AESI
      AESI	Select the check box to evaluate AE's of special interest (AESI).
      Manual	On selecting the manual check box the application does  not evaluate AESI. It is imperative that we enter Reason and the Reason text on selecting the Manual check box. The following validation message appears if the fields are empty. “When Manual is selected for AESI ‘Reason text' or ‘Reason' should be entered or selected. In record number 1 of AE Product Association information”. Irrespective of the selection of the Manual checkbox in AESI panel, the Reason and Reason Text are retained, if already available
      Reason	Select the reason from the drop-down for manually evaluating AESI. The values are as follows: Reason1 Reason2 Reason3 Other
      Reason text	Enter the reason for manually evaluating AESI.
      Anticipated Event
      Manual	On selecting the manual check box the application does not evaluate the Anticipated event.
      Anticipated Event	Select the check box to evaluate the Anticipated event.
      Reason	Select the reason from drop-down  for manually evaluating the Anticipated event. The values are as follows : Negative Not Applicable Positive Unknown
      Reason text	Enter the text for manually evaluating the Anticipated event.

    

3. To enter the causality for the entire case, click the AER Causality link. The following window opens.

For information on the Assessment, Rechallenge/Dechallenge, Latency and Imputability fields, refer to the table Full Data Entry - Additional Product Reaction Causality.

4. To enter the causality for a particular product, click the Product Causality link. The following window opens.
   Field Description of General Product Causality

   Field	Description
   General Product Information
   Internal Drug Code	Drug code given within the company.
   Made By(G.K.CN.3)	The product made by the company or marketed by the company.
   End Therapy	The status of the drug administration.
   Total Period(B.4.k.15a/G.k.4.r.6a)	The total time period for which the patient took the drug in the text box and select the unit from the drop-down list.
   Period Type	The total time taken for giving the drug to the patient.
   Total Period Text	Brief description of the total time taken for giving the drug to the patient.
   Prior Use Of Equivalent Drug	One of the options to indicate if the patient received the an equivalent for the drug earlier.
   Prior Use	One of the options to indicate if the patient received the drug earlier.
   Tolerated?	To indicate if the patient tolerated the drug, select one of the following options: Yes No
   Physician Directed	A value to indicate if the physician directed the drug dosage for the patient.
   Interacting Drug(B.4.k.1)	To indicate if the patient received an interacting drug, select one of the following options: Yes No
   Dose No. In Series	The vaccine dosage (number) in the text box and select the unit from the drop-down list.
   Country Obtained(B.4.k.2.3/G.k.2.4)	The country in which the patient purchased the drug.
   Gestation Period(B.4.k.10a/G.k.6a)	Enter the total time period (number) of the patient from conceiving the child to taking the drug in the text box and select the unit from the drop-down list.
   Parent/Patient	To indicate on whom you enter the product information, select one of the following options: Parent Patient
   Patient Exposed To Product	To indicate the exposure of the patient to the product, select one of the following options: Yes No Unknown
   Dosage Comment	When you do not have structured information at the therapy level, then enter your comments on the product dosage in the text box.

    

5. To enter details on the patient’s treatment, click the Therapy tab. The following page displays.

Field Description of Therapy Information

• For information on the Approval No. /Lot No., refer to the table Data Entry - App.No/Lot No.

• For information on the Drug-AE relationship, refer to the table Data Entry - Additional Product Reaction Causality.

• For information on the J.12 - Studies, refer to the table Data Entry - J12 Studies.

6. To export the causality data in XML through E2B gateway, click the E2B Causality link on the Causality data entry page.

Field Description of E2B Causality Information

Deleting Causality record

You have the option to delete a causality record from the list.

To delete a causality record.

1. Select the record which you want to delete from the list.

2. Click the Delete link.

The application displays the message Are you sure you want to delete this record.

3. Click Yes to delete the causality record.

The record is removed from the list.

The Delete option is also available in the Record menu of the AER Causality screen, using which you can delete a causality record.

When the ‘Synchronize causality data automatically’ is set to ‘Product-AE Association to E2B causality’ in Admin, the associated E2B causality record is also deleted along with the respective causality record.

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