SAFETYREPORT

DTD Descriptor(2.1 Version)

Safetyreportid (100 AN)

Title - Description

Safety Report Identifier - Sender’s (Case) Safety Report Unique Identifier

Field in ARISg

AER.E2B_IMP_SAFETYREPORT_ID

AER_INFM_AUTH .E2B_IMP_SAFETYREPORT_ID

E2B Import:

If the authoritynumb OR companynumb of the case being imported is already present in the database, then the case is imported with a new version of an existing case. If authoritynumb OR companynumb is NOT present, then the case is imported as a new AER, the AER Number is generated in E2B_<aer_id_sequence> format. Also the 'Latest receipt date' and the sender of the case (in authority based environment) is considered to create a new version.

E2B Export:

The < Safetyreportid> is formed dynamically as specified in the format below:<primarysourcecountry>hyphen<senderorganization>hyphen<AER_NO>

Multi Reporting Japanese Export:

The < Safetyreportid> is formed dynamically as specified in the format below:

<primarysourcecountry>hyphen

<senderorganization>hyphen<AER_NO>><P/I><RUNNING SEQUENCE>

P- PMS, I-CT and sequence followed is INFM_AUTH_SEQ.

For follow up cases the value present in the AER_INFM_AUTH .E2B_IMP_SAFETYREPORT_ID will be exported.

J-Item Size

NA

ARIS Field Size

NA

DTD Descriptor(2.1 Version)

Safetyreportversion (2 AN)

Title - Description

Safety Report Version Number

Field in ARISg

E2B Import:

AER.EXTERNAL_VERSION_NO

AER. E2B_IMP_SAFETYREPORT_VERSION

E2B Export:

AER.VERSION_NOAER.LOCAL_VERSION_NO

OR

AER. E2B_SAFETY_REPORT_VER_NO

(When the language is Japanese)

E2B Import:

Because the format is not defined clearly, this field will be imported into a new field supported in ARISg (i.e. AER.EXTERNAL_VERSION_NO field).  The case number in ARISg (AER.VERSION_NO) will not be populated with this element during import.   If the AER doesn’t exist in database it is imported as version 0. If the AER already exists in the database, a version higher than this will be created based on the versioning scheme in use.This field is also imported into the new field AER.E2B_IMP_SAFETYREPORT_VERSION

E2B Gateway specific:

When E2B Gateway is importing an ICSR, if an unapproved version of the same AER exists in the database then the import will NOT be successful and appropriate message will be recorded in import log file.

E2B Export:

During export, only international version # will be considered.

J-Item Size

NA

ARIS Field Size

[VERSION_NO, NUMBER (3)] [LOCAL_VERSION_NO,NUMBER (2)] [E2B_SAFETY_REPORT_VER_NO, NUMBER (3)]

DTD Descriptor(2.1 Version)

Seriousnessdeath (1N)

Seriousnesslifethreatening (1N)

Seriousnesshosipitalization (1N)

Seriousnessdisabling (1N)

Seriousnesscongenitalanomali(1N)

Seriousnessother (1N)

Title

Seriousness Death

Seriousness Life Threatening

Seriousness Hosipitalization

Seriousness Disabling

Seriousness Congenitalanomali

Seriousness Other

Description

Seriousness criteria

Field in ARISg

AER_AE_CHAR.DEATH/ AER_INFM_AUTH.DEATH

Refer the Appendix section 1.2 for code list mapping.

Multi reporting Japanese Export logic:

Direct mapping to AER_INFM_AUTH. DEATH

AER_AE_CHAR.LIFE_THREATENING/

AER_INFM_AUTH.LIFE_THREATENING

Refer the Appendix section 1.2 for code list mapping.

Multi reporting Japanese Export logic:  

Direct mapping to AER_INFM_AUTH. LIFE_THREATENING

AER_AE_CHAR.HOSP_REQUIRED/ AER_INFM_AUTH.HOSP_REQUIRED

Refer the Appendix section 1.2 for code list mapping.

Multi reporting Japanese Export logic:

Direct mapping to AER_INFM_AUTH. HOSP_REQUIRED

For Japanese as well as non Japanese export, ’r;Hospitalization prolonged’ shall also be considered along with ’r;Hospitalization required’.

In case ’r;Hospitalization required’ is NULL or set to ’r;No’ then ’r;Hospitalization prolonged’ value gets populated for the tag seriousnesshospitalization. When both ’r;Hospitalization prolonged’ as well as ’r;Hospitalization required’ are NULL then the tag is not populated.

AER_AE_CHAR.DISABILITY/ AER_INFM_AUTH.DISABILITY

Refer the Appendix section 1.2 for code list mapping.

Multi reporting Japanese Export logic:

Direct mapping to AER_INFM_AUTH. DISABILITY

AER_AE_CHAR.CONGENITAL_ANOMALY/ AER_INFM_AUTH.CONGENITAL_ANOMALY

Refer the Appendix section 1.2 for code list mapping.

Multi reporting Japanese Export logic:

Direct mapping to AER_INFM_AUTH. CONGENITAL_ANOMALY

AER_AE_CHAR.OTHER_MEDICALLY_IMP_COND

AER_AE_CHAR. REQ_INTERVENTION

AER_INFM_AUTH. REQ_INTERVENTION

E2B Export:

E2B server export the <seriousnessother> tag based on the data in "other Medically important condition"(113137) and "Require intervention" (113115) data.

Please refer the Appendix section 1.28 for the population logic for export.

Multi reporting Japanese Export logic:

Direct mapping to AER_INFM_AUTH. REQ_INTERVENTION

E2B Import:

During Import the data will be imported to the AER_AE_CHAR.OTHER_MEDICALLY_IMP_COND

Refer the Appendix section 1.2 for code list mapping.

J-Item Size

NA

NA

NA

NA

NA

NA

ARIS Field Size

VARCHAR2 (9), CODE

VARCHAR2 (9), CODE

VARCHAR2 (9), CODE

VARCHAR2 (9), CODE

VARCHAR2 (9), CODE

VARCHAR2 (9), CODE

DTD Descriptor(2.1 Version)

Authoritynumb (100AN)

Title - Description

Authority Number - National regulatory authority's case report number

Field in ARISg

AER.AUTHORITY_NUMB

E2B Import:

If the authoritynumb of the case being imported is already present in the database, then the case is imported with a new version of an existing case. If authoritynumb is NOT present, then the case is imported as a new AER, the AER Number is generated in E2B_<aer_id_sequence> format.

E2B Export:

The Authoritynumb tag will not be populated when the initial sender is the pharmaceutical company. It is populated only when the initial sender is authority.

While building the ICSR, E2B Gateway will check for the value in AER.AUTHORITY_NUMB filed, if this field is NOT NULL, then <authoritynumb> tag will be populated with this value.

If the AER.AUTHORITY_NUMB fleld is NULL, then the <authoritynumb> tag will not be populated.

For JapaneseLogic:

<primarysourcecountry>hyphen<senderinterchangeid>hyphen<AER Number>

For Non Japanese Logic:

<primarysourcecountry>hyphen<senderorganization>hyphen<AER Number>

The AER.AUTHORITY_NUMB field will be updated with the formed Autority number value, for further references

J-Item Size

NA

ARIS Field Size

VARCHAR2 (100)

DTD Descriptor(2.1 Version)

Primarysourcecountry (2A)

Title - Description

Primary Source Country - Identification of the country of the primary Source

Field in ARISg

AER.AER_COUNTRY

E2B Import:

The E2B/M2 defined country codes are converted to ARISg country codes

E2B Export:

Countries present in ARISg but not present in E2B/M2 will not be exported. (For example: USSR)

Refer the Appendix section 1.1 for code list mapping.

J-Item Size

NA

ARIS Field Size

VARCHAR2 (9), CODE

DTD Descriptor(2.1 Version)

Receivedateformat (3N)

Receivedate (8N)

Title

Date format

Received Date

Description

Date report was first received from source format

Date report was first received from source

Field in ARISg

E2B Export:

AER.AER_INIT_RECV_DATE_PRECISION

AER.AER_INIT_RECV_DATE

E2B Import:

Refer A.1.3a and A.1.3b data element section for correlated fields mapping during import.

Note: When a follow up case is imported,

AER.AER_INIT_RECV_DATE will be populated with the AER_INIT_RECV_DATE value from initial version of the AER.

Japanese Import:

When initial version of the case is imported, AER.AER_INIT_RECV_DATE and AER.AER_INIT_RECV_DATE_PRECISION would be populated with the the receivedate and receivedateformat tag data. Whereas when a follow up case is imported, AER.AER_INIT_RECV_DATE will be populated with the AER_INIT_RECV_DATE value from initial version of the AER as well as AER.JAP_INIT_RECD_DATE will be populated with the JAP_INIT_RECD_DATE value from the initial version of the AER.

J-Item Size

NA

NA

ARIS Field Size

VARCHAR2 (1)

DATE

DTD Descriptor(2.1 Version)

Companynumb (100AN)

Title - Description

Company Number - Company's case report number

Field in ARISg

AER.COMPANY_NUMB

E2B Import:

If the companynumb of the case being imported is already present in the database, then the case is imported with a new version of an existing case. If companynumb is NOT present, then the case is imported as a new AER, the AER Number is generated as per the sequence specified in E2B.

E2B Export:

While building the ICSR, E2B Gateway will check for the value in AER.COMPANY_NUMB filed, if this field is NOT NULL, then <companynumb> tag will be populated with this value.If the AER.COMPANY_NUMB filed is NULL, then the < companynumb > tag will be formed as specified below: The <companynumb> is formed using three fields, as specified in the format below:<primarysourcecountry>hyphen<senderorganization>hyphen<AER Number>/(for Japanese transmission)<primarysourcecountry>hyphen<senderinterchangeid>hyphen<AER Number>The AER.COMPANY_NUMB field will be updated with the formed company number value, for further references. ed)

J-Item Size

NA

ARIS Field Size

VARCHAR2 (100)

DTD Descriptor(2.1 Version)

Occurcountry (2A)

Title - Description

Occur Country - Identification of the country where the reaction/event occurred

Field in ARISg

AER.COUNTRY_OF_DETECTION

E2B Import:

The E2B/M2 defined country codes are converted to ARISg country codes

E2B Export:

Countries present in ARISg but not present in E2B/M2 will not be exported. (For example. USSR)Refer the Appendix section 1.1 for code list mapping.

J-Item Size

NA

ARIS Field Size

VARCHAR2  (9), CODE

DTD Descriptor(2.1 Version)

Receiptdateformat (3N)

Receiptdate (8N)

Title

Date format

Receipt Date

Description

Date format of receipt of the most recent information for this report

Date of receipt of the most recent information for this report

Field in ARISg

AER.AER_RECV_DATE _PRECISION

AER.AER_RECV_DATE

Japanese Export:

AER. JAP_RECD_DATE

Receipt date tag is populated from AER.JAP_RECD_DATE

Japanese Import:

AER.JAP_RECD_DATE

AER.JAP_RECD_DATE is populated from Receipt date tag

J-Item Size

NA

NA

ARIS Field Size

VARCHAR2 (1)

DATE

DTD Descriptor(2.1 Version)

Casenullification (1N)

Title - Description

Case Nullification - Report nullification

Field in ARISg

AER_INFM_AUTH.NULLIFIEDAER.NULLIFIED

E2B Import:

If the sender of the case is health authority, the nullification information is populated in AER_INFM_AUTH table. If the sender of the case is non-authority, this information will be populated to AER record.

E2B Export:

If the receiver of the case is non-authority, then the tag will be populated from the field AER.NULLIFIEDIf the receiver of the case is health authority the information pertaining to the latest authority record corresponding to the Authority selected from User Interface (AER_INFM_AUTH.NULLIFIED) is considered.

E2B Gateway specific:

The information pertaining to the latest authority record corresponding to the Authority in the E2B_MESSAGE_QUEUE.RECEIVER_INSTITUTION is considered.

Japanese logic:

Refer to the above Authority Fields Mapping Logic (Export) for details.

J-Item Size

NA

ARIS Field Size

VARCHAR2 (9)

DTD Descriptor(2.1 Version)

Transmissiondateformat  (3N)

Transmissiondate (8N)

Title

Date format

Date

Description

Date of this transmission

Field in ARISg

E2B Import:

AER.AER_INIT_RECV_DATE_PRECISION AER.AER_INIT_RECV_DATE

E2B Export:

Date of transmission tag will be taken from the user interface.At the Second level export when the case is exported from the Export Review Section, this tag data will be populated with the Recipients Local Time (JST) if the COMPANY_UNIT.Message_TRANSMISSION_Date = 1(Recipient Local Time) and the Distribution contact country is "Japan" else Oracle Server date will be populated.

E2B Gateway specific:

The date and time of Oracle server when the file is placed under the outbound file directory will be populated. The <messagedate> tag value will also be the same.

J-Item Size

NA

NA

ARIS Field Size

DATE

DTD Descriptor(2.1 Version)

Additionaldocument (1N)

Title - Description

Additional Document - Are additional documents available?

Field in ARISg

AER.ADDITIONAL_DOCS/ AER_INFM_AUTH. FL_ADDITIONAL_DOCS

Refer the Appendix section 1.3 for code list mapping.

Multi reporting Japanese Export logic:

Direct mapping to AER_INFM_AUTH. FL_ADDITIONAL_DOCS

J-Item Size

NA

ARIS Field Size

VARCHAR2 (9), CODE

DTD Descriptor(2.1 Version)

Nullificationreason (200AN (400J))

Title - Description

Nullification Reason - Reason for nullification

Field in ARISg

AER_INFM_AUTH.REASON_FOR_NULLIFICATION

AER.REASON_FOR_NULLIFICATION

E2B Import:

If the sender of the case is non-authority, this information is populated to AER.REASON_FOR_NULLIFICATION.If the sender of the case is authority, this information is populated in AER_INFM_AUTH table.In case of importing a case with nullificationreason and casenullification tags user has to select authority while importing otherwise nullification details will not be populated to AER_INFM_AUTH table.

E2B Export:

If the receiver of the case is non-authority, data from AER.REASON_FOR_NULLIFICATION exported in this tag.If the receiver of the case is authority the information pertaining to the latest authority record corresponding to the Authority selected from User Interface (AER_INFM_AUTH.REASON_FOR_NULLIFICATION) is considered.

Refer to the above Authority Fields Mapping Logic (Export) for more details.

Japanese logic:

Refer to the above Authority Fields Mapping Logic (Export) for details.

J-Item Size

NA

ARIS Field Size

VARCHAR2 (400)

DTD Descriptor(2.1 Version)

Reporttype (1N)

Title - Description

Report Type - Type of report

Field in ARISg

AER.FLAG_SRC_SPONTANEOUS, AER.FLAG_SRC_CLINICAL_STUDY, AER.FLAG_SRC_OTHER, AER.FLAG_SRC_UNKAER_SOURCE. SOURCE

E2B Import:

Based on the type of report (value in <reporttype>), source flags in AER table are set as shown below

<reporttype> value

1. AER.FLAG_SRC_SPONTANEOUS will be set to "1"

2. AER.FLAG_SRC_CLINICAL_STUDY will be set to"1"

3. AER.FLAG_SRC_OTHER will be set to "1"

4. AER.FLAG_SRC_UNK will be set to "1"

If <reporttype> tag is empty or not present in the file, then FLAG_SRC_UNK will be set to "1".All other flags will be set to NULL

A record in AER_SOURCE table is created. PRIMARY_SOURCE_FLAG is set to 1(Yes) AER_SOURCE.SOURCE is set as given below

J-Item Size

NA

ARIS Field Size

VARCHAR2 (1)

DTD Descriptor(2.1 Version)

Documentlist 100AN (200J)

Title - Description

Document List - List of documents held by sender

Field in ARISg

AER.ADDITIONAL_DOCS

AER_INFM_AUTH. ADDITIONAL_DOCS

Field ID: 101508 (AER_TEXT)

E2B Export:

If size exceeds that allowed by E2B/M2, then data is truncated.

Multi reporting Japanese Export logic:

Direct mapping to AER_INFM_AUTH. ADDITIONAL_DOCS

J-Item Size

NA

ARIS Field Size

TEXT (20000)

DTD Descriptor(2.1 Version)

Medicallyconfirm (1N)

Title

Medically Confirm

Description

Was the case medically confirmed, if not initially from health professional?

Field in ARISg

AER.MEDICALLY_CONFIRMED

Refer the Appendix section 1.3 for code list mapping.

J-Item Size

NA

ARIS Field Size

VARCHAR2 (1)

DTD Descriptor(2.1 Version)

Serious (1N)

Title - Description

Serious

Field in ARISg

AER_AE_CHAR.SERIOUSNESS

AER. D_MI_SERIOUSNESS

AER_INFM_AUTH. SERIOUSNESS

E2B Import:

Primary fields are set in AER_AE_CHAR table. (Similar fields in AER table (e.g. CASE_SERIOUS) will be set.  

E2B Export:

During export the data will be exported from AER_AE_CHAR.SERIOUSNESS (seriousness as per reporter) field.

Multi Reporting Japanese Export logic:

Direct mapping to AER_INFM_AUTH. SERIOUSNESS

For Japanese as well as non Japanese export serious data would be populated based on the ARISg admin parameter 'AER is marked as serious based on assessment by' under Installation parameters ->AER data maintenance.

If this parameter is set to 'As per Company' serious is exported based on company’s assessment. Whereas if this parameter is set to 'As per reporter' then serious is exported based on reporters assessment.

When the parameter is set to 'Both' (i.e other than 'As per Company' or 'As per Reporter' ); the serious tag shall be exported based on the table in Appendix section 1.32

J-Item Size

NA

ARIS Field Size

VARCHAR2 (9)

DTD Descriptor(2.1 Version)

Fulfillexpeditecriteria (1N)

Title - Description

Fulfill Expedite Criteria - Does this case fulfill the local criteria for an expedited report?

Field in ARISg

AER.LOCAL_EXPEDITED

AER_INFM_AUTH. LOCAL_EXPEDITED

Refer the Appendix section 1.3 for code list mapping.

Multi reporting Japanese Export logic:

Direct mapping to AER_INFM_AUTH. LOCAL_EXPEDITED

J-Item Size

NA

ARIS Field Size

VARCHAR2 (1)