Entering the Authority and Other Contact Details

For a case, if the Contact type is Authority and the Authority details are available in the Distribution list then the corresponding information is reflected in the Authority tab.

The contact details are reflected in the Submission details section and the format details are reflected in the report details section of the Authority tab.

If the Contact Type is Authority and the Authority details are not available in the distribution list then the list details are not saved.

The address, city and phone details of the reporting sponsor are displayed in the reporting sponsor tab.

You may add a new authority record without contact only through Forms-> Distribution List.

The application allows the record owners to edit authority information irrespective of the version of the case.

Field Name	Description
Submission Details
Suspect Product	Name of the suspect product that caused the adverse reaction. The application displays the name of the suspect product as entered in the Product page.
Approval Type (J.8)	Determines the approval type for a selected suspect product available in the case.
Clinical Drug Code (J.11)	Indicates to select a Clinical drug code (CDC) associated with the Suspect Product from the lookup. When you select a Suspect Product available in a case, the application displays the Clinical drug code associated with the ingredient present in the Suspect Product. When you find various ingredients associated, then the application displays the Combined Clinical drug code in the text box. Use the Lookup and select a CDC, when a Suspect Product does not contain a Combined Clinical drug code. The application displays the code in the text box.
Approval Country (B.4.k.4.2)	Indicates the code of the Approval Country, to export the cases to ESM.
Version no	The version number of the AER.
Local version no	When the local reporting status is updated and there is no relevance to the other units, then the local version number is created depending on the option configured in the installation parameter settings.
Report	The type of report.
Date Informed	The data and time on which the authority was informed.
Report format	The format of the report in which the case is distributed.
Report Medium	The route for distributing the case. The available options are: Fax Paper mail Phone Electronic transfer - Structured data Electronic transfer - PDF file
Authority ID	The identification number given to the AER by the Authority.
Authority Responded	Indicates, if the Authority responded to the communication.
Respond Date	The date on which the Authority responded. When a company with list of holidays and the business hours, the Respond date depends on the ACK received date along with the Working hours (Time) as mapped in the ESM. For Example: Consider the Business hours for a company to be 9:30 AM to 17:30 PM and assume company does not work on Saturday and Sunday. If company sends ICSR on August 7th 2011 17:00, and ACK is returned on same day 17:05 ICSR Transmit date and time: 7th Aug 11 17:00 ACK receive date and time: 7th Aug 11 17:05 Here, the Respond date in the Distribution list displays 7th Aug 2011. If company sends ICSR on August 7th 2011 17:20, and ACK is returned on same day 17:55 ICSR Transmit date and time: 7th Aug 11 17:20 ACK receive date andtime: 7th Aug 11 17:55 Here, the Respond date in the Distribution list displays 8th Aug 2011. If company sends ICSR on August 7th 2011 17:48, and ACK is returned on same day 17:55 ICSR Transmit date and time: 7th Aug 11 17:48 ACK receive date and time: 7th Aug 11 17:55 Here, the Respond date in the Distribution list displays 8th Aug 2011. If company sends ICSR on August 7th 2011 09:00 AM, and ACK is returned on same day at 09:05 (before start of business hrs) ICSR Transmit date and time: 7th Aug 11 09:00 ACK receive date and time: 7th Aug 11 09:05 Here, the Respond date in the Distribution list displays 7th Aug 2011. If company sends ICSR on August 11th 2011 (Fri) at 17:55 and ACK is returned on same day at 18:00 ICSR Transmit date & time: 11th Aug 11 17:55 ACK receive date & time: 11th Aug 11 18:00 (assuming the company is not working on Sat (12th) and Sunday (13th) Here, the Respond date in the Distribution list displays 14th Aug 2011. This is applicable even on holidays (Holidays declared by the company for the calender year). Remember: Time component used by ESM server and IA update triggers to map with the calendar maintenance for updating the respond date. But, only the respond date appears instead of time in the Distribution list.
E2B Authority ID	The local report number assigned by authorities during the first acknowledgement.
E2 Message Type (M.1.1)	The E2B message type is displayed. The following are the options: BACKLOG BACKLOGCT ICHICSR ICHICSRAK PSUR CTASR CTICSR EVPRM
Reporting Status	The reporting status for the case. The available options are: Authority informed the company Informed Need not be informed Not yet decided To be informed Falied E2B submission
Safety report version number	Indicates the safety report version number.
Safety Report ID (J.1)	Displays the Safety Report ID of J1 validation. Indicates the source ID generated for exchanging case information between the company and the authorities. The Safety Report ID (J.1) is a combination of primary sources like Country-Interchage ID-AER ID of a case. Note: The application generates new "Safety Report ID” only when the case is distributed for the first time. For the distributing the next version of the case, the Safety Product ID of the previous version of the case is considered. For distributing the Unblinded cases, the application copies the "Safety Report ID” of the corresponding Blinded case instead of generating a new Safety Report ID. If any case is submitted for re-distribution, then the application considers the Safety Report ID of the previous version of the case.
Resubmission	This checkbox auto populate follow up information for J.2 (M.2) calculations. The automatic population of report times for MHLW validation is imported from agXchange. The application calculates J2(Safety id) and J5(Follow up no.) based on product sequence and product name in the informed authority record. Create a new IA record with Authority type as MHLW. If authority type and report type matches in any of the previous IA record with the new IA record, ARISg copies the J.5 value (follow up number) and the acknowledgment receipt status (E2B_Transmission_status field is stored in the database) from the previous informed authority record. In order to identify the ”previous” informed authority record, the agXchange application uses the internal sequence number for the Authority and report type. J4.b and J.5 is copied with or without selecting the resubmission option. The follow-up number, E2B Identification Number and E2B_TRANSMISSION_STATUS are copied when updating the existing or the latest authority record if the Authority and report type are matching. Follow up Number, E2B identification Number is not updated. When a New version of the case is created the J.2 Value is copied by Default and if a new IA record for MHLW authority is created, ARISg reads the previous matching IA record. If the authority type is MHLW and report type of the new IA record does not match with the previous (any previous IA record with authority as MHLW), on saving the case J.2 value is not copied/cleared to the new version of the case. The J.2 field is copied to the new version if the report type matches.
Authority no. (A.1.10.1)	Indicates the authority number.
Company no. (A.1.10.2)	Indicates the registration number of the company.
Lateness Reason	Indicates the reason for delay in submission activity of the case to the Authority. For example: The case submission is delayed due to delay during medical review activity phase, the “Medical Review” should be selected as the reason from this drop-down list. By default the application considers lateness reason remains blank.
FSCA NCA Reference Number	Indicates the FSCA NCA reference number.
Cancellation Report	The Follow-up case has to be submitted to authority, before submitting the case make sure to update the causality, the seriousness and the labeling information in the latest approved version. If the IA record is eligible for cancellation, check the Cancellation checkbox and make sure to enter the reason for cancellation in the Other comments (J.10).
Acknowledgement received	The type of Acknowledgement received after submitting the case to the authority. On receiving the acknowledgement, ESM updates the field with Null, Positive Ack or Negative Ack values.
MDN Received	When an ICSR file is transmitted successfully through the ESTRI Gateway, a Message Disposition Notification (MDN) is generated to indicate that the case is sent to the recipient (exported case) or received from the sender (import case). Depending on the MDN received by the ESM, ARISg application selects the checkbox in the submission details page.
Date informed to distributor	The date and time on which the distributor is informed about the reporting status of the case.
Link Report No. (A.1.12)	Indicates the link report number.
Cancellation Report	The Follow-up case has to be submitted to authority, before submitting the case make sure to update the causality, the seriousness and the labeling information in the latest approved version. If the IA record is eligible for cancellation, check the Cancellation checkbox and make sure to enter the reason for cancellation in the Other comments (J.10).
Status Flag (J.6)	Indicates the Status of the Next Report. The following values are: Incomplete Complete
Locally Expedited (A.1.9)	An expedited case issued or dispatched locally.
Comments for Incomplete (J.7/J2.7.2)	Brief information specifying the reason for case status to be incomplete.
Authority no. (A.1.10.1)	Indicates the authority number.
Company no. (A.1.10.2)	Indicates the registration number of the company.
Language	Indicates the language used to enter the comments. When you select a language in the AER text and use the same language to enter the comments in Event description and company remarks, then the application stores and communicates the same language to Outbound Submission Tracking (OST) application used to enter the comments. If you do not select the language in the AER text and enter the comments in the Event description and company remarks, then the language configured in the user preferences is stored and communicated to OST.
Company Remarks	The comments about the adverse event reported in the case.
Language	When you select a language in the AER text and use the same language to enter the comments in Event description and company remarks then the application stores and communicates the same language to Outbound Submission Tracking (OST) application used to enter the comments. If you do not select the language in the AER text and enter the comments in the Event description and company remarks, then the language configured in the user preferences gets stored and communicated to the OST.
Event Description	Details of the reported untoward medical occurrence in a patient.
AER text	When you select a language in the AER text and use the same language to enter the comments in Event description and company remarks then the application stores and communicates the same language to Outbound Submission Tracking (OST) application used to enter the comments. If you do not select the language in the AER text and enter the comments in the Event description and company remarks, then the language configured in the user preferences gets stored and communicated to the OST.
Reason for Next Report (J.7)	Indicates the reason for Next Report.
Case Summary and Reporter's Comments Text	Enter the case summary information about Product, Drug administered, and outcome, etc., in addition to the information provided by the reporter.
Native Language	You can enter the case summary and reporter’s comments text in your native language by selecting the native language from the drop down list.

Field	Description
Report Details
AER review flag	Indicates the review flag. The available options are: Not yet ready for physician’s review Ready for physician’s review Review completed by physician
Reviewed by	Indicates the person who reviewed it.
Decision date	The date on which the decision was taken to inform the authority.
Last date to report	The last date on which the case should be reported to the authority.
Reporter informed authority directly	Indicating, if the reporter has informed the authority directly. The possible options are: Yes No Unknown
Date of report	The date when the report was submitted to the Authority. The date must be entered in precise format while time can be entered in imprecise format. The time component is not printed in the report. When manually generating the MHLW E2B(R2 and R3) Report the date entered in this field is considered as an input date for the Batch Transmission field by the ESM application to generate MHLW E2B (R3) data and XML file.
Incident reported to	Indicates, to whom the incident was reported to. The possible options are: Distributor Importer Manufacturer User Facility
Follow-up no	Follow-up number of the AER, which was submitted to the Authority or is to be submitted. Generation of Follow up number depends on the Authority and Format type. When System Logic is selected, the next number to the existing follow-up no is taken as the maximum number and + 1 is added to this maximum number. This is followed, if any existing number is present in the record. When Follow-Up number is not assigned to the existing records (all previous versions), then the Follow-Up number will be 0 for the new record. For the newly created IA record the reporting status is always set as "To be informed’. User Logic: Enter the function/procedure name in the enabled text area. This creates the follow-Up number based on the logic defined by you in the function/procedure. None: When none option is selected, the follow up number is not generated and is empty.
Final	Select the "Final” checkbox to indicate that the generated report is a final report or a combination of initial and final reports.
Follow-up Type	Captures the information about the AER whose follow-up information is sent to authority. The possible values are: Correction - Indicates, if the follow-up information being sent to the authority is due to corrections to be made in an AER. Additional Information - Indicates, if the case is being followed up to an authority on account of additional information available for an AER. Response to authority request - Indicates, if the follow-up information being sent to the authority is in response to a query from the Authority itself. Device evaluation - Indicates if the follow-up information being sent to the authority is of a medical device.
No. of attached pages	The number of additional pages on FDA 3500A report.
Informing Unit	The Company unit, which informed the authority about the adverse event.
Printing Unit	Company unit address printed in the regulatory report.
Registration no	The Registration number given by the Authority to each company, at the time of registration of the company with the Authorities.
Registration date	The date of registration.
Report sent to mfr, Date	Indicating, if the UF/Distributor report is sent to the manufacturer of the Product.
Date UF/Distri. Report sent to mfr.	The date on which the UF/Distributor report was sent to the Manufacturer.
Report sent to FDA	The UF/Distributor report has been sent to FDA.
Date UF/Distri. Report sent to FDA.	The date on which the UF/Distributor report was sent to the FDA.
Report for Nullification / Amendment (A.1.13)	Report sent to the authorities about nullified or amended case(s). Nullification - The application cancels the details which is entered only at the case level and not at an authority level. Amendment - The changes made to the case is reported again to the authority.
Reason for Nullification / Amendment (A.1.13.1)	The reason for nullification. OR The reason for Amendment.
Comments	Comments for the particular record
Laboratory report	Indicates the laboratory report required or not required. The options are: Required Not Required

When you enter the details of a case in the Informed Authority page and distribute it through OST, the details for the following fields are updated in OST:

Field	Description
Japanese counter measurement (J.9)	Displays the counter measurement description if the contact is for multi-reporting.
Other comments (J.10)	Displays the other comments entered by the company.
Sender comments (B.5.4)	Displays the comments entered by the sender for the case.
List of Document owned by Sender (A.1.8.2)	Displays the list of documents owned by the sender.
Company Remarks (Sender's Comments) (B.5.4/H.4)	Enter your comments about the adverse event reported in the case
Event description (B.5.1)	The case narrative at the Informed Authority level. The narrative includes clinical course, therapeutic measures, outcome and additional relevant information.
AER text	When you select a language in the AER text and use the same language to enter the comments in Event description and company remarks then the application stores and communicates the same language to Outbound Submission Tracking (OST) application used to enter the comments. If you do not select the language in the AER text and enter the comments in the Event description and company remarks then the language set in user preference gets stored and communicated to the OST.
Seriousness (reporter)	To specify the seriousness of the reaction as described by the reporter or company, select one of the following options: Yes No The application calculates the seriousness of the reaction of the Informed authority product, depending on the selection of the manual check box. The application considers this calculation only for MHLW authority.
Death?	To indicate if the reaction resulted in death, select one of the following options: Yes No
Life threatening?	To indicate if the reaction resulted in threat to life, select one of the following options: Yes No
Hospitalization?	To indicate if the patient requires hospitalization on experiencing the adverse event, select one of the following options: Yes No
Disability?	To indicate if the reaction resulted in disability, select one of the following options: Yes No
Congenital anomaly?	To indicate if the reaction resulted in birth defect, select one of the following options: Yes No
Require intervention?	To indicate if the reaction requires intervention from the doctor, select one of the following options: Yes No
Additional documents	When you indicate the availability of any additional documents at the authority level, then the application reflects this by selecting the option Yes.
Other Serious (Important Medical Events)	To indicate if patient experienced any other medically important condition, select one of the following options: Yes No

ARISg supports multi-reporting for cases containing different target suspect products. Using this feature, you can send separate ICSR reports of different suspect products that are in the clinical trials and Post-Marketing Surveillance, to the Ministry of Health and Labour Welfare (MHLW). These reports are routed from the ARISj database through agXchange or ESM in the form of ICSR files.

The results of the study for P1 are reported in an ICSR file, ICSR1, and sent to the authority. The results of the study for P2 are also reported in an ICSR file, ICSR2, though both products within the same case, and sent to the authority. The numbers suffixing the name of ICSR file indicate that the files are related to the same case. The authority, in turn, sends an MDN for each ICSR through agXchange or ESM, confirming the receipt of the files. Later, the authority also sends an acknowledgement after studying the details of the ICSR files. When the acknowledgement is received, the Informed Authority records are updated in the 'Informed Authority’ table. The updates are based on Messagenumber, safetyreportid, and the type of the report.

When the study is followed up, a follow-up report is created for the each report.

Field	Description
Reporting Sponsor	Specifies the details of the sponsor, who takes responsibility for and initiates a clinical investigation. (This is often a pharmaceutical, biotechnology, or medical device company). Enter the address, city and the phone details.
Reason for Next Report	The Last name, First name and Middle name of the Reporting sponsor.

For a case, if a contact type is Partner and the contact details are available in the Distribution list, then the corresponding information is reflected in the Partners tab. If the Contact Type is Partner and the Authority details are not available in the distribution list then the corresponding information is displayed in the Partners tab without the Authority details.

The name of the organization is displayed in the Partners field (in the grid) of Partners tab in the Distribution List, when the contact type is Partner.

You can enter Hospital/Organization name in the New Person to Distribute AER window, when you add a new contact from the Partners tab.

For a selected case, if a contact type is "Other” then the corresponding contact details are displayed in the in the Others tab.

If the Contact Type is Others and the Authority details are not available in the Distribution list, then the corresponding information is displayed in the Others tab.

Field Name	Description
Other Details
Report format	The format of the report in which the case is distributed.
Date submitted	The date on which the authority was informed.
Report medium	The route for distributing the case. The available options are: Fax Paper mail Phone Electronic transfer - Structured data Electronic transfer - PDF file
Reporting Status	The reporting status for the case. The available options are: Authority informed the company Informed Need not be informed Not yet decided To be informed Fiels E2B Submission
Informing unit	The Company unit, which informed the authority about the adverse event.
Printing unit	Company unit address printed in the regulatory report.
Received acknowledgement	Indicates, if the acknowledgement is received for the submitted report.
Acknowledgement date	The date on which you received the Acknowledgement of the report.
Safety report version number (J.2)	Indicates the safety report version number.
Date informed to distributor	The date and time on which the distributor is informed about the reporting status of the case.
Authority no. (A.1.10.1)	Indicates the authority number.
Company no. (A.1.10.2)	Indicates the registration number of the company.
Comments	Description for the record.
Language	Indicates the language used to enter the comments. When you select a language in the AER text and use the same language to enter the comments in Event description and company remarks, then the application stores and communicates the same language to Outbound Submission Tracking (OST) application used to enter the comments. If you do not select the language in the AERtext and enter the comments in the Event description and company remarks, then the language configured in the user preferences is stored and communicated to OST.
Company remarks (Sender's Comments) (B.5.4/H.4)	The comments about the adverse event reported in the case.
Language	When you select a language in the AER text and use the same language to enter the comments in Event description and company remarks then the application stores and communicates the same language to Outbound Submission Tracking (OST) application used to enter the comments. If you do not select the language in the AER text and enter the comments in the Event description and company remarks, then the language configured in the user preferences gets stored and communicated to the OST.
Event description (B.5.1)	Details of the reported untoward medical occurrence in a patient.
Case Summary and Reporter's Comments Text	Enter the case summary information about Product, Drug administered, and outcome, etc., in addition to the information provided by the reporter.
Native Language	You can enter the case summary and reporter’s comments text in your native language by selecting the native language from the drop down list.

Field	Description
Remarks1(J.13.1)(J.13.4)	Displays the MHLW remarks entered at the Informed Authority level.