Mapping-ICH_ICSR

Data Element Number	SGML Tag (DTD Descriptor)	Attribute	Prnt Rel'n	Req'd	Description	Data Model Source/Derivation		Buscomp	Buscomp Field	UI (if diff)	Comments
	<ichicsr>			Y	The ICH Message header definition.	Constant: lang="en" Required, non-repeatable.
M.1	<ichicsrmessageheader>				The ICH ICSR message header.
M.1.1		<messagetype>			The Message Type: Type of information being transmitted. 16AN	Constant: ICSR ISSUE: Spec actually lists the string “ichicsr” but “ICSR” was accepted by the EMEA during testing.
M.1.2		<messageformatversion>			The version number of message format (2.0 or 2.1). 3AN	On export, this is derived from the E2B_ EXPORT_RULES.E2B_VERSION for the RECEIVER_ID that matches the run-time parameter AGENCY.
M.1.3		<messageformatrelease>			The release number of the Message Format. 3AN	Constant: 1.0
M.1.4		<messagenumb>			The Message Number. 100AN	The Queue ID of the job that created the E2B file.
M.1.5		<messagesenderidentifier>			The Message sender identifier. 60AN	Derived from the run-time parameter SENDERID unless USE_DRUG_ APPROVALS flag is true for recipient, then SENDERID is taken from DRUG_ APPROVALS.SENDER_ID.					Siebel Life Sciences 7.8.2
M.1.6		<messagereceiveridentifier>			The message receiver identifier. 60AN	On export, this is from the E2B_EXPORT_ RULES.RECEIVER_ID for the RECEIVER_ID that matches the run-time parameter AGENCY unless USE_DRUG_APPROVALS flag is true for recipient, then RECEIVER_ID is taken from DRUG_ APPROVALS.RECEIVER_ID.
M.1.7a		<messagedateformat>			The format of the Message date. Required to be in 204 format. 3N	Constant: 204
M.1.7b		<messagedate>			The message date. Required to be in 204 format (CCYYMMDDHHMMSS) 14N	On export the SYSDATE when the E2B file was generated. On import this value is echoed in the acknowledgment. Because, contrary to the spec, the FDA FOI data contains colons separating the hours, minutes, and seconds, the import strips colons from this field.
A.1	<safetyreport>		1:M
No tag ID		<safetyreportversion>			The report version for the safety report (case). There is no clear guidance on how this field is specifically used. For export, AERS uses the Case Version view to populate this element. Customers can customize this view as needed. Note: This element is formatted 2AN but this view could return values larger than two characters.	On export TH_CASE_VERSION.VERSION On Import see note OTHER CASE REFS
A.1.0.1		<safetyreportid>			This is the sender’s case ID. On import it is used to determine if this report is a new case or an update. 100AN	On export, if the USE_LONG_CASE_ID option is True for the receiver, AERS first checks that the case does not have a global case ID already, if it does not, then it looks for a case ID in the AE_OTH_CASE_REFS table with a Source Type =’E2B’. If none exists, AERS generates a global case ID by concatenating the Country Code of the Primary Reporter, the Sender ID, and the AERS Case ID. If the USE_LONG_CASE_ID is false, AE_CASE.CASE_ID. On Import the mapping depends upon the setting of E2B_IMPORT_RULES.USE_ SENDER_CASEID. See notes on OTHER CASE REFS and Import rules		LS Medical Product Issue	Primary SR Id	SR#
A.1.1		<primarysourcecountry>			An identification of the country where reaction/event was reported Codes defined in ISO 3166. 2A	On import, the field goes in the case comments. If the occurcounty is missing, this value is set AE_CASES.EV_OCC_ COUNTRY_CD On export this is the country from the first report sources record that qualifies as the primary source. (AE_REPORT_ SOURCE.RPT_COUNTRY_CD)
A.1.2		<occurcountry>			An identification of the country where reaction/event occurred. Codes defined in ISO 3166. 2A	AE_CASES.EV_OCC_COUNTRY_CD
A.1.3a		<transmissiondateformat>			The format for the date of the transmission. 3N	Constant: 102
A.1.3b		<transmissiondate>			The date of this transmission. Required to be 102 (CCYYMMDD) 8N	On export the sysdate that the report was run. On Import depending on Import rule, if the USE_SENDER_RECEIVE_DATE is TRUE, then populate the EC_CONTACT_ LOG.RECEIVE_DATE with the data in this element, otherwise use SYSDATE to populate EC_CONTACT_LOG.RECEIVE_DATE.
A.1.4		<reporttype>			ICH Code List: 1=Spontaneous 2=Report from study 3=Other 4=Not Available 1N	AE_CASES.CASE_TYPE		LS Medical Product Issue	Area	Area	Spontaneous = 1, Study = 2, otherwise leave blank
A.1.5.1		<serious>			Serious Yes = 1/No = 2 1N	AE_CASES.SERIOUS_FLAG		LS Medical Product Issue	Sub-Area	Subarea	Serious = 1, Non Serious = 2, otherwise leave blank
A1.5.2a		<seriousnessdeath>			Seriousness Death Yes = 1/No = 2 1N	AE_CASES.DIED_FLAG		LS Medical Product Issue	OE Death Flag
A1.5.2b		<seriousnesslifethreatening>			Seriousness Life Threatening Yes = 1/No = 2 1N	AE_CASES.LF_THREAT_FLAG		LS Medical Product Issue	OE Life Threatening Flag
A1.5.2c		<seriousnesshospitalization>			Seriousness Hospitalization Yes = 1/No = 2 1N	AE_CASES.HOSPITALIZATION_FLAG		LS Medical Product Issue	OE Hospitalization Flag
A1.5.2d		<seriousnessdisabling>			Seriousness Disabling Yes = 1/No = 2 1N	AE_CASES.DISAB_FLAG		LS Medical Product Issue	OE Disability Flag
A1.5.2e		<seriousnesscongenitalanomali>			Seriousness Congenital Anomaly Yes = 1/No = 2 1N	AE_CASES.CONGEN_FLAG		LS Medical Product Issue	OE Congenital Anomaly Flag
A1.5.2f		<seriousnessother>			Seriousness Other Yes = 1/No = 2 1N	AE_CASES.OUTCOME_OTH_FLAG		LS Medical Product Issue	OE Other
A.1.6a		<receivedateformat>			Specified as 102, i.e., CCYYMMDD 3N	Constant: 102		LS Medical Product Issue	PI Received Date	Received
A.1.6b		<receivedate>			The date the report was first received from the primary source. Must be full precision date, i.e., Day Month Year. 8N	On export, AE_CASES.FIRST_RCVD_DT. If this is not a full date and the Suppress Partial Date option is TRUE for receiver, then this element is not included. On import EC_CONTACT_LOG.RECEIVE_ DATE and AE_CASES.FIRST_RCVD_DT. See note on Contact Log Import.		LS Medical Product Issue	PI Received Date	Received
A.1.7a		<receiptdateformat>			The format for the Receipt Date. Specified as 102, i.e., CCYYMMDD 3N	Constant: 102
A.1.7b		<receiptdate>			The date of receipt of most recent information for this report. Must be full precision date, i.e., Day Month Year 8N	On export Max value of EC_CONTACT_ LOG. RECEIVE_DATE where the AE_INFO_ RECEIVED = ‘Y’ On import EC_CONTACT_LOG.RECEIVE_ DATE and AE_CASES.FIRST_RCVD_DT. If the USER_SENDER_RECEIVE_DATE = ’Y’ and the receiptdate is later than the receivedate, the import creates a second EC_ CONTACT_LOG row using this receiptdate. See note on Contact Log Import.
A.1.8.1		<additionaldocument>			Are additional documents available? 1=Yes, 2=No 1N	On export, if any EC_ DOCUMENTS.INCLUDE_IN_E2B_EXPORT = ‘Y’ then 1 otherwise blank. On import case comments.
A.1.8.1		<documentlist>			A list of documents held by sender (e.g., clinical records, hospital records, autopsy reports). 100AN	WWSBR_ALL_ITEMS.DISPLAY_NAME for each EC_DOCUMENTS where INCLUDE_ IN_E2B_EXPORT = ‘Y’ On import Case comments.
A.1.9		<fulfillexpeditecriteria>			Does this case fulfill local criteria for an expedited report? This item is used to provide the sender’s local requirements since the definition of expedited depends on local regulatory requirements. Yes=1, No=2. 1N	AE_CASES.EXPEDITED_IN_ORIGINAL_ COUNTRY
A.1.10.1		<authoritynumb>			The National Regulatory Authority case report number. The world wide unique case ID for the report when the case is originally reported to a regulator. 100AN	AE_OTH_CASE_REFS.OTHER_CASE_ID if the OTHER_SOURCE_TYPE=’AUT’ See note on Other Case Refs.
A.1.10.2		<companynumb>			The company case report number. The world wide unique case ID for the report when the case is originally reported to a pharmaceutical company. 100AN	AE_OTH_CASE_REFS.OTHER_CASE_ID if the OTHER_SOURCE_TYPE=’CO’ See note on Other Case Refs.		LS Medical Product Issue	Product Issue Number	PI#
A.1.10.3		<othernumb>			The other sender’s case report number. Used by senders who are neither a national regulatory authority nor a company. 100AN Not in DTD version 2.1	AE_OTH_CASE_REFS.OTHER_CASE_ID if the OTHER_SOURCE_TYPE=’OTH’ See note on Other Case Refs.
A.1.11		<duplicate>			Suspected Duplicate 1=Yes Only affirmative answer needed. Otherwise, field should be left empty. AERS duplicate checking assumes that duplicates are detected in the data entry process and not reported. 1N	Data corresponds to AE_OTH_CASE_REFS with a Source Type =’DUP’ or as configured in the E2B_RECEIVERS table.
	<reportduplicate>				The block is used to store case IDs in other databases that may hold this same case	Prints element tag if there are any duplicate sources to report.
A.1.11.1		<duplicatesource>			The name of the company or agency that created the following case ID. 50AN	AE_OTH_CASE_REFS.OTHER_SOURCE where the OTHER_SOURCE_TYPE is “DUP” or as configured in the E2B_RECEIVERS Table (See note on Other case refs).
A.1.11.2		<duplicatenumb>			A case ID from another company or agency for this case. 100AN	AE_OTH_CASE_REFS.OTHER_CASE_ID See note on Other case refs.
	<linkedreport>				A header element for linked reports.	Prints if there are any records in the AE_ RELATED_CASES table for the case. Because there can be related cases managed in this table that are not considered "related" according to the E2B specification, an E2B decode on the RELATION_REASON_CD is used to determine which records should be included. Any record with a RELATION_ REASON_CD that decodes to E2B language =’Y’ is included in the export file.
A.1.12		<linkedreportnumb>			Identification number of the report which is linked to this report. Used in a case of mother/child pair where both had reactions/events, siblings with common exposure, several reports for the same patient, or several similar reports from same reporter (cluster). 100AN	AE_RELATED_CASES.RELATED_CASE_ID
A.1.13		<casenullification>			Case nullification. 1=Yes Used to indicate that a previously transmitted report should be considered completely void, e.g., when the case was found to be erroneous. 1N	On export this flag is set to 1 if the NULLIFYREPORT runtime parameter is set to Y. On import if the sender rules allow updates and nullification, this flag sets the case delete flag. No other updates are made to the case. See notes on import exceptions.
A.1.13.1		<nullificationreason>			Reason for nullification. 200AN	Set to the value of the runtime parameter NULLIFICATIONREASON
A.1.14		<medicallyconfirm>			Medically Confirmed? 1 = Yes, 2 = No 1N	AE_CASES.EV_MED_CONF_FLAG
A.2.1	<primarysource>		1:M	Y	This section maps directly to the AERS REPORT_SOURCES table. The reporter identifier section is mandatory. However, in some countries, explicit identification of a reporter may be subject to confidentiality restrictions. In this case the initials of the reporter can be used.	Required, repeatable. If the HIDE_REPORTER_NAME option is True for the receiver, the only data included in this block is the first letter of the first, middle, and last names. All other fields are NULL.
		Special import derivation				AE_REPORT_SOURCES.REPORT_SOURCE_ TYPE On import the report source type is derived. For maximum configuration flexibility, the following values are encoded using the “RPT” language codelist for the REPORT_ SOURCE_TYPE. As with E2B encoding the USER_ENTERABLE_FLAG is used to find the correct code. If there is a sponsor study number the type is ‘C’. If there is a literature reference the type is ‘L’. Otherwise the type is ‘S’.
A.2.1.1a		<reportertitle>			Reporter Title 50AN	AE_REPORT_SOURCES.RPT_TITLE		Contact	M/M	Mr/Ms
A.2.1.1b		<reportergivename>			Reporter first name 30AN	AE_REPORT_SOURCES.RPT_FRST_NAME If the HIDE_REPORTER_NAME option is True for the receiver, then only the first character is written to the file.		Contact	First Name	First Name
A.2.1.1c		<reportermiddlename>			Reporter middle name. 15AN	AE_REPORT_SOURCES.RPT_MID_INITIAL If the HIDE_REPORTER_NAME option is True for the receiver, then only the first character is written to the file.		Contact	Middle Name	Middle
A.2.1.1d		<reporterfamilyname>			Reporter last name 50AN	AE_REPORT_SOURCES.RPT_LST_NAME If the HIDE_REPORTER_NAME option is True for the receiver, then only the first character is written to the file.		Contact	Last Name	Last Name
A.2.1.2a		<reporterorganization>			Reporter organization 60AN	AE_REPORT_SOURCES.RPT_ORG_NAME
A.2.1.2b		<reporterdepartment>			Reporter Department 60AN	AE_REPORT_SOURCES.RPT_ DEPARTMENT
A.2.1.2c		<reporterstreet>			Reporter Street 100AN	AE_REPORT_SOURCES.RPT_ADDR1		Contact	Address
A.2.1.2d		<reportercity>			Reporter city 35AN	AE_REPORT_SOURCES.RPT_CITY_NAME		Contact	City
A.2.1.2e		<reporterstate>			Reporter state or province 40AN	Code list with lang=’ENG’ For AE_REPORT_SOURCES.RPT_STATE_ CD		Contact	State
A.2.1.2f		<reporterpostcode>			Reporter postcode 15AN	AE_REPORT_SOURCES.RPT_ZIP_CD		Contact	Postal Code
A.2.1.3		<reportercountry>			Reporter country code ISO 3166 2A	AE_REPORT_SOURCES.RPT_COUNTRY_ CD		Contact	Country
A.2.1.4		<qualification>			Reporter Qualification E2B code list: 1=Physician 2=Pharmacist 3=Other Health Professional 4=Lawyer 5=Consumer or other nonhealth professional qualification 1N	If the consumer_flag is Y then ‘5’. Otherwise: AE_REPORT_SOURCES.RPT_ OCCUPATION
A.2.2		<literaturereference>			All literature references. Refs should be given in the “Vancouver Style” as specified in the N Engl J Med 1991;324:424-8 500AN	AE_REPORT_SOURCES. LITERATURE_ DESC
A.2.3.1		<studyname>			Study Name 100AN	AE_REPORT_SOURCES.STUDY_DESC		LS Medical Product Issue	Protocol Number	Protocol #
A.2.3.2		<sponsorstudynumb>			Sponsor Study Number 35AN	AE_CASES.STUDY_ID On import take the last study number goes into AE_CASES.STUDY_ID.
A.2.3.3		<observestudytype>			Study type in which RE was seen. 1=Clinical trials 2=Individual patient use 3=Other studies 1N	RPT_SOURCE_TYPE.ICH_STUDY_TYPE
A.3.1	<sender>				The sender of the report. ON import the sender data is used to for the External contacts portion of the EC_ CONTACT_LOG record. On export a select subset sender fields are set by report parameter.	On export the sender information comes from the sender details in Drug Approvals if the USE_DRUG_APPROVALS flag is True for the receiver. If the flag is true but no data exists at the approval level or the Flag is False, then use the sender run-time parameters. On import the sender data is written to the EC_CONTACT_LOG.
A.3.1.1		<sendertype>			Sender Type ICH Codelist: 1=Pharmaceutical Company 2=Regulatory Authority 4=Regional PV Center 5=WHO Collaborating Center 6=Other 1N	Export: Parameter SENDERTYPE/DRUG_ APROVALS.SENDER_TYPE Import: EC_CONTACT_LOG. EXT_ CONTACT_E2B_TYPE
A.3.1.2		<senderorganization>			Sender Organization 60AN	Export: Parameter SENDERORGANIZATION/DRUG_ APROVALS.SENDER_ORGANIZATION Import: EC_CONTACT_LOG. EXT_ CONTACT_ORGANIZATION
A.3.1.3a		<senderdepartment>			Sender Department 60AN	Export: Parameter SENDERDEPARTMENT/DRUG_ APROVALS.SENDER_DEPARTMENT Import: EC_CONTACT_LOG. EXT_ CONTACT_DEPARTMENT
A.3.1.3b		<sendertitle>			Title 10AN	Export: SENDERTITLE/DRUG_ APROVALS.SENDER_TITLE Import: EC_CONTACT_LOG. EXT_ CONTACT_TITLE
A.3.1.3c		<sendergivename>			First name 35AN	Export: Parameter SENDERGIVENNAME/DRUG_ APROVALS.SENDER_GIVEN_NAME Import: EC_CONTACT_LOG. EXT_FRST_ NAME
A. 3.1.3d		<sendermiddlename>			Middle name 15AN	Export: Parameter SENDERMIDDLENAME/DRUG_ APROVALS.SENDER_MIDDLE_NAME Import: EC_CONTACT_LOG. EXT_ CONTACT_MIDDLE_NAME
A. 3.1.3e		<senderfamilyname>			Sender Last name 35AN	Export: Parameter SENDERFAMILYNAME/DRUG_ APROVALS.SENDER_FAMILY_NAME Import: EC_CONTACT_LOG. EXT_ CONTACT_LST_NAME
A. 3.1.4a		<senderstreetaddress>			Sender Street 100AN	Export: Parameter SENDERSTREETADDRESS/DRUG_ APROVALS.SENDER_ADDRESS Import: EC_CONTACT_LOG. EXT_ CONTACT_ADDR1
A. 3.1.4b		<sendercity>			Sender city 35AN	Export: Parameter SENDERCITY/DRUG_ APROVALS.SENDER_CITY Import: EC_CONTACT_LOG. EXT_ CONTACT_CITY
A. 3.1.4c		<senderstate>			Sender state or province 40AN	Export: Parameter SENDERSTATE/DRUG_ APROVALS.SENDER_STATE Import: EC_CONTACT_LOG. EXT_ CONTACT_STATE
A. 3.1.4d		<senderpostcode>			Sender postcode 15AN	Export: Parameter SENDERPOSTCODE/DRUG_ APROVALS.SENDER_POST_CODE Import: EC_CONTACT_LOG. EXT_ CONTACT_ZIP
A. 3.1.4e		<sendercountrycode>			Sender country code (ISO 3166) 2A	Export: Parameter SENDERCOUNTRY/DRUG_ APROVALS.SENDER_COUNTRY Import: EC_CONTACT_LOG. EXT_ CONTACT_COUNTRY
A. 3.1.4f		<sendertel>			Sender Telephone Number 10AN	Export: Parameter SENDERTEL/DRUG_ APROVALS.SENDER_PHONE Import: EC_CONTACT_LOG. EXT_ CONTACT_PHONE
A. 3.1.4g		<sendertelextension>			Sender Telephone extension 5AN	Export: Parameter SENDERTELEXTENSION/DRUG_ APROVALS.SENDER_PHONE_EXT Import: EC_CONTACT_LOG.EXT_ CONTACT_PHONE_EXT
A. 3.1.4h		<sendertelcountrycode>			Telephone country code 3AN	Export: Parameter SENDERTELCOUNTRYCODE/DRUG_ APROVALS.SENDER_PHONE_COUNTRY_ CODE Import: EC_CONTACT_LOG.EXT_ CONTACT_PHONE_COUNTRY_CODE
A. 3.1.4I		<senderfax>			Sender Fax number 10AN	Export: Parameter SENDERFAX/DRUG_ APROVALS.SENDER_FAX Import: EC_CONTACT_LOG.EXT_ CONTACT_FAX
A. 3.1.4j		<senderfaxextension>			Sender Fax Extension 5AN	Export: Parameter SENDERFAXEXTENSION/DRUG_ APROVALS.SENDER_FAX_EXT Import: EC_CONTACT_LOG.EXT_ CONTACT_FAX_EXT
A. 3.1.4k		<senderfaxcountrycode>			Sender Fax country code 3AN	Export: Parameter SENDERFAXCOUNTRYCODE/DRUG_ APROVALS.SENDER_FAX_COUNTRY_ CODE Import: EC_CONTACT_LOG.EXT_ CONTACT_FAX_COUNTRY_CODE
A. 3.1.4l		<senderemailaddress>			Sender e-mail address 100AN	Export: Parameter SENDEREMAIL/DRUG_ APROVALS.SENDER_EMAIL Import: EC_CONTACT_LOG.EXT_ CONTACT_EMAIL
	</sender>
A.3.2	<receiver>				Receiver Identified the party the report is being sent to.	Import: the receiver data goes into the case comments. Export: the receiver data come from the E2B_ RECEIVERS table unless the USE_DRUG_ APPROVALS is true for the Receiver. In this case, the receiver details are written from the DRUG_APPROVALS table. The primary key of the receivers table is AGENCY (supplied at run-time).
A.3.2.1		<receivertype>			Receiver Type ICH Codelist: 1=Pharmaceutical Company 2=Regulatory Authority 4=Regional PV Center 5=WHO Collaborating Center 6=Other 1N	E2B_RECEIVERS. RECEIVER_ TYPE/DRUG_APROVALS.RECEIVER_TYPE
A.3.2.2a		<receiverorganization>			Receiver Organization 60AN	E2B_RECEIVERS. RECEIVER_ID/DRUG_ APROVALS.RECEIVER_ORGANIZATION
A.3.2.2b		<receiverdepartment>			Receiver Dept. 60AN	E2B_RECEIVERS. RECEIVER_ DEPARTMENT/DRUG_ APROVALS.RECEIVER_DEPARTMENT
A.3.2.2c		<receivertitle>			Receiver Title 10AN	E2B_RECEIVERS. RECEIVER_ TITLE/DRUG_APROVALS.RECEIVER_ TITLE
A. 3.2.2d		<receivergivename>			Receiver First name 35AN	E2B_RECEIVERS. RECEIVER_GIVEN_ NAME/DRUG_APROVALS.RECEIVER_ GIVEN_NAME
A. 3.2.2e		<receivermiddlename>			Receiver Middle name 15AN	E2B_RECEIVERS. RECEIVER_MIDDLE_ NAME/DRUG_APROVALS.RECEIVER_ MIDDLE_NAME
A. 3.2.2f		<receiverfamilyname>			Receiver Last name 35AN	E2B_RECEIVERS. RECEIVER_FAMILY_ NAME/DRUG_APROVALS.RECEIVER_ LAST_NAME
A. 3.2.3a		<receiverstreetaddress>			Receiver Street 100AN	E2B_RECEIVERS. RECEIVER_ ADDRESS/DRUG_APROVALS.RECEIVER_ ADDRESS
A. 3.2.3b		<receivercity>			Receiver City 35AN	E2B_RECEIVERS. RECEIVER_CITY/DRUG_ APROVALS.RECEIVER_CITY
A. 3.2.3c		<receiverstate>			Receiver State or province 40AN	E2B_RECEIVERS. RECEIVER_ STATE/DRUG_APROVALS.RECEIVER_ STATE
A. 3.2.3d		<receiverpostcode>			Receiver Postcode 15AN	E2B_RECEIVERS. RECEIVER_ZIP/DRUG_ APROVALS.RECEIVER_POST_CODE
A. 3.2.3e		<receivercountrycode>			Receiver Country code (ISO 3166) 2A	E2B_RECEIVERS. RECEIVER_ COUNTRY/DRUG_APROVALS.RECEIVER_ COUNTRY_CD
A. 3.2.3f		<receivertel>			Receiver Telephone Number 10AN	E2B_RECEIVERS. RECEIVER_ PHONE/DRUG_APROVALS.RECEIVER_ PHONE
A. 3.2.3g		<receivertelextension>			Receiver Telephone extension 5AN	E2B_RECEIVERS. RECEIVER_PHONE_ EXT/DRUG_APROVALS.RECEIVER_ PHONE_EXT
A. 3.2.3h		<receivertelcountrycode>			Receiver Telephone country code 3AN	E2B_RECEIVERS. RECEIVER_PHONE_ COUNTRY_CODE/DRUG_ APROVALS.RECEIVER_PHONE_ COUNTRY_CODE
A. 3.2.3I		<receiverfax>			Receiver Fax 10AN	E2B_RECEIVERS. RECEIVER_FAX/DRUG_ APROVALS.RECEIVER_FAX
A. 3.2.3j		<receiverfaxextension>			Receiver Fax Extension 5AN	E2B_RECEIVERS. RECEIVER_FAX_ EXT/DRUG_APROVALS.RECEIVER_FAX_ EXT
A. 3.2.3k		<receiverfaxcountrycode>			Receiver Fax country code 3AN	E2B_RECEIVERS. RECEIVER_FAX_ COUNRY_CODE/DRUG_ APROVALS.RECEIVER_FAX_COUNTRY_ CODE
A. 3.2.3l		<receiveremailaddress>			Receiver E-mail address 100AN	E2B_RECEIVERS. RECEIVER_ EMAIL/DRUG_APROVALS.RECEIVER_ EMAIL
	</receiver>				Closing tag for the receiver block
B.1	<patient>		1:1	Y	Patient Characteristics	Required, non-repeatable.
B.1.1		<patientinitial>			Patient Initials 10AN	AE_CASES.PT_INITLS
B.1.1.1a		<patientgpmedicalrecordnumb>			MRN from patients primary care physician Repeat this field as many times as necessary. 20AN	AE_OTH_CASE_REFS.CASE_ID where OTHER_SOURCE_TYPE=’GPN’ See Note on Other Case Refs.
B.1.1.1b		<patientspecialistrecordnumb>			MRN from patients specialist physician. 20AN	AE_OTH_CASE_REFS.CASE_ID where OTHER_SOURCE_TYPE=’SPN’ See Note on Other Case Refs.
B.1.1.1c		<patienthospitalrecordnumb>			MRN from patients hospital. 20AN	AE_OTH_CASE_REFS.CASE_ID where OTHER_SOURCE_TYPE=’HPN’ See Note on Other Case Refs.
B.1.1.1d		<patientinvestigationnumb>			Investigation Number. 20AN	AE_CASES.PATIENT_ID		LS Medical Product Issue	Patient Identifier	Patient Identifier
B.1.2.1a		<patientbirthdateformat>			Format of Birth date Date format 3N	Constant: 102		LS Medical Product Issue	Patient Date of Birth
B.1.2.1.b		<patientbirthdate>			Date of Birth CCYYMMDD 8N	AE_CASES. PT_DOB If the SUPPsuppressRESS_PARTIAL_DATES option is TRUE for the receiver, then only complete dates are output.		LS Medical Product Issue	Patient Date of Birth
B.1.2.1a		<patientonsetage>			Age At onset of RE 5N	AE_CASES.PT_AGE_CHR
B.1.2.2b		<patientonsetageunit>			Age at onset of RE 800=Decade 801=Year 802=Month 803=Week 804=Day 805=Hour 3N	AE_CASES.PT_AGE_UNIT
B.1.2.2.1a		<gestationperiod>			Gestation Period when reaction/event was observed in the fetus 3N	AE_CASES. GESTATION_PERIOD
B.1.2.2.1b		<gestationperiodunit>			Gestation period units. 802=Month 803=Week 804=Day 810=Trimester 3N	AE_CASES. GESTATION_PERIOD_UNIT
B.1.2.3		<patientagegroup>			Patient age group E2B code list: 1=Neonate 2=Infant 3=Child 4=Adolescent 5=Adult 6=Elderly 1N	AE_CASES.PT_AGE_GROUP
B.1.3		<patientweight>			Weight 6N	AE_CASES.PT_WEIGHT_KG (999.99)
B.1.4		<patientheight>			Height 3N	AE_CASES.PT_HEIGHT_CM (999)
B.1.5		<patientsex>			Patient Sex ISO5218 code list: 1=Male 2=Female 9 =Not specified 0=Unknown 1N	AE_CASES.PT_SEX_CD		LS Medical Product Issue	Patient Sex
B.1.6a		<lastmenstrualdateformat>			Format for date of Patient Last Menstrual Date -- Always 102 for DTD 2.1 (per EMEA validation rules, DTD spec states partial dates are accepted). 3N	Date_Form(AE_CASES.PT_LST_MP_DT) or constant = 102 for DTD 2.1
B.1.6b		<patientlastmenstrualdate>			Last menstrual period date. 8N	AE_CASES.PT_LST_MP_DT Is suppressed if Partial and suppress_ PARTIAL_DATES is TRUE for Receiver.
B.1.7	<medicalhistoryepisode>				Relevant medical history and concurrent conditions. The following, i.e., B.1.7a through B.1.7g, should be repeated as often as needed. All explanatory material can be included in B.1.7g..	The block maps directly to AE_OTHER_DX.
B.1.7.1a.1		<patientepisodenamemeddraversion>			Version of MedDRA used to encode the Medical History. 8AN	AE_OTHER_DX.DX_DID
B.1.7.1a.2		<patientepisodename>			Disease/Surgical procedure etc. 250AN	AE_OTHER_DX.OTH_DX_VERBTM If SUPPRESS_NON_MEDDRA_TERMS is True for the receiver, only MedDRA coded LLTs is included. If Convert to Free Text option EPISODE_TO_ MEDHIST is true and there is no MedDRA term for the procedure, the data is written to <patientmedicalcomment> (B.1.7.1g).
B.1.7.1b		<patientmedicalstartdateformat>			Date Format for Start Date 102-CCYYMMDD 610-CCYYMM 602-CCYY 3N	Date_Form(AE_OTHER_DX.FROM_DT)
B.1.7.1c		<patientmedicalstartdate>			Medical History Start Date 8N	AE_OTHER_DX.FROM_DT
B.1.7.1d		<patientmedicalcontinue>			Continuing? 1=Yes 2=No 3=Unknown 1N	AE_OTHER_DX.PAST_PRESENT_STS
B.1.7.1e		<patientmedicalenddateformat>			Date Format for End Date 102-CCYYMMDD 610-CCYYMM 602-CCYY 3N	Date_Form(AE_OTHER_DX.TO_DT)
B.1.7.1f		<patientmedicalenddate>			End Date 8N	AE_OTHER_DX.TO_DT
B.1.7.1g		<patientmedicalcomment>			Comments 100AN	AE_OTHER_DX.OTHER_DX_DTLS This field contains the text from Patient Medical History if the Convert to Free Text conditions for <patientepisodename> are met.
	</medicalhistoryepisode>
B.1.7.2		<patientmedicalhistorytext>			Relevant medical history text Specifications say to use only if structured information is not available. AERS always includes this field if it is not null. 10,000 AN	AE_CASES.OTH_RELVNT_HIST_CMNT		LS Medical Product Issue	AE Relevant History	Relevant History
B.1.8	<patientpastdrugtherpay>		1:M		Relevant past drug history This section deals with previously taken drugs, not concomitant ones. Use the words provided by the primary source in completing the drug name. The word “None” can be used as appropriate. Dates can be imprecise. Entire section B.1.8a through B.1.8.g should be repeated as necessary.	This block maps directly to the subset of AE_ MEDICATIONS where AE_MEDICATIONS. MEDICATION TYPE = ‘P’ P is the code for past.
B1.8a		<patientdrugname>			Reported name of drug 100AN	AE_MEDICATIONS.DRUG_NAME
B1.8b		<patientdrugstartdateformat>			Date Format for Start Date 102-CCYYMMDD 610-CCYYMM 602-CCYY 3N	Date_Form(AE_MEDICATIONS.START_DT)
B.1.8c		<patientdrugstartdate>			Medication start date 8N	AE_MEDICATIONS.START_DT
B1.8d		<patientdrugenddateformat>			Date Format for End Date 102-CCYYMMDD 610-CCYYMM 602-CCYY 3N	AE_MEDICATIONS.END_DT
B.1.8e		<patientdrugenddate>			Medication End Date 8N	AE_MEDICATIONS.END_DT
B1.8f.1		<patientindicationmeddraversion>			MedDRA version used to encode Medication Indication. 8AN	AE_MEDICATIONS.DX_DID
B1.8f.2		<patientdrugindication>			Indication for use. 250AN	AE_MEDICATIONS.INDICATION If SUPPRESS_NON_MEDDRA_TERMS is True for the receiver, only MedDRA coded LLTs are included.
B.1.8g.1		<patientdrgreactionmeddraversion>			MedDRA version for adverse reaction to previous medication. 8AN	AE_MEDICATION.ADVERSE_EVENT_DID
B.1.8g.2		<patientdrugreaction>			Adverse reaction to previous medication. 250AN	AE_MEDICATIONS. ADVERSE_EVENT_ VERBATIM If SUPPRESS_NON_MEDDRA_TERMS is True for the receiver, only MedDRA coded LLTs are included.
	</patientpastdrugtherpay>
B.1.9	<patientdeath>				In Case of Death	To avoid an empty block the export checks that at least one of the data values used in this block is non-null.
B1.9.1a		<patientdeathdateformat>			Date Format for Death Date 102-CCYYMMDD 610-CCYYMM 602-CCYY 3N	Date_Form(AE_CASES.DEATH_DT)
B.1.9.1b		<patientdeathdate>			Patient Death Date. 8N	AE_CASES.DEATH_DT
B.1.9.2	<patientdeathcause>					All rows from AE_CAUSE_DEATH
B1.9.2.a		<patientdeathreportmeddraversion>			Version of MedDRA used to encode the Patient Cause of Death. 8AN	AE_CAUSE_DEATH.DX_DID On import one row is created in AE_CAUSE_ DEATH for each distinct value of patientdeathreport and patientdetermineautopsy.
B1.9.2.b		<patientdeathreport>			Cause of Death. 250AN	AE_CAUSE_DEATH.CAUSE_OF_DEATH On import one row is created in AE_CAUSE_ DEATH for each distinct value of patientdeathreport and patientdetermineautopsy. If SUPPRESS_NON_MEDDRA_TERMS is True for the receiver, only MedDRA coded LLTs are included.
	</patientdeathcause>
B1.9.3		<patientautopsyyesno>			1=Yes 2=No 3=Unknown 1N	AE_CASES.AUTOPSY_DONE_FLAG
B.1.9.4	<patientautopsy>				Causes of death found by autopsy.	AE_CAUSE_DEATH rows Where VERIFY_BY_AUTOPSY_FLAG = ‘Y’
B.1.9.4a		<patientdetermautopsmeddraversion>			MedDRA version used to encode the Cause of Death. 8AN	AE_CAUSE_DEATH.DX_DID
B.1.9.4b		<patientdetermineautopsy>			Autopsy-determined cause of death. 250AN	AE_CAUSE_DEATH CAUSE_OF_DEATH If SUPPRESS_NON_MEDDRA_TERMS is True for the receiver, only MedDRA coded LLTs are included.
	</patientautopsy>
	</patientdeath>
B.1.10	<parent>		1:1		Use this section only in the case of a parent-child/fetus report to report relevant information on the parent. It is assumed that the company has appropriately completed the Relations tables in AERS for the conditions outlined in the regulatory guidance (specifically, a case where a child/fetus experienced an adverse event but the parent did not).	Use the AE_RELATION_INF table. Send Parent Info for first relation whose relation type translates to P using in the RPT language. This subsetting is critical because AERS uses the Relations tables to store other details often required for parent/child and sibling reporting (e.g. vaccine reporting to the US FDA). Optional, non-repeatable.
B.1.10.1		<parentidentification>			Parent Initials 10AN	AE_RELATION_INF.REL_INITLS
B.1.10.2.1a		<parentbirthdateformat>			Date format 3N	Constant: 102
B.1.10.2.1b		<parentbirthdate>			Date of Birth CCYYMMDD 8N	AE_RELATION_INF.REL_DOB If the suppress_PARTIAL_DATES option is True for the receiver, this data only prints if a complete date is entered.
B.1.10.2.2a		<parentage>			Age (in years) 2N	AE_RELATION_INF.REL_AGE_YRS
B.1.10.2.2b		<parentageunit>			Age Unit (always years) 3N	801
B.1.10.3a		<parentlastmenstrualdateformat>			Last Menstrual Period Date Format 3N	102
B.1.10.3b		<parentlastmenstrualdate>			Last Menstrual Period Date for Parent. 8N	AE_RELATION_INF.REL_LAST_ MENSTRUAL_PERIOD_DT If the suppress_PARTIAL_DATES option is True for the receiver, this data only prints if a complete date is entered.
B.1.10.4		<parentweight>			Weight of parent in KG. 6N	AE_RELATION_INF.REL_WEIGHT_KG (999.99)
B.1.10.5		<parentheight>			Height of parent in CM. 3N	AE_RELATION_INF REL_HEIGHT_CM (999)
B.1.10.6		<parentsex>			Sex of parent. ISO5218 codes: 1=Male 2=Female 9=Not Specified 0=Unknown 1N	AE_RELATION_INF.REL_SEX_CD
B.1.10.7	<parentmedicalhistoryepisode>					All records for AE_RELATION_DX_HIST for the "parent" relation.
B.1.10.7.1a		<parentmedicalstructure>			Disease/surgical procedure. ISSUE: not in DTD 2.1. Is this specific to 2.0???	AE_ RELATION_DX_HIST.DX_VERBTM
B.1.10.7.1a.1		<parentmdepisodemeddraversion>			MedDRA Term ID for the Disease/surgical procedure. 3N	AE_ RELATION_DX_HIST.DX_DID
B.1.10.7.1a.2		<parentmedicalepisodename>			Disease/surgical procedure. 250AN	AE_ RELATION_DX_HIST.DX_VERBTM If SUPPRESS_NON_MEDDRA_TERMS is True for the receiver, only MedDRA coded LLTs are included. If Convert to Free Text option PARENT_ EPISODE_TO_MEDHIST is true and there is no MedDRA term for the procedure, the data is written to <patientmedicalcomment> (B.1.10.7.1g).
B.1.10.7.1b		<parentmedicalstartdateformat>			Start Date Format. 102-CCYYMMDD 610-CCYYMM 602-CCYY 3N	Date_form(AE_ RELATION_DX_ HIST.FROM_DT)
B.1.10.7.1c		<parentmedicalstartdate>			Start Date. 8N	AE_ RELATION_DX_HIST.FROM_DT
B.1.10.7.1d		<parentmedicalcontinue>			History Item Continuing? E2B Code list 1=Yes, 2=No, 3=Unknown 1N	AE_ RELATION_DX_HIST.ONGOING_ FLAG If ‘Y’ then 1. If ‘N’ then 2. Otherwise 3 (Unknown).
B.1.10.7.1e		<parentmedicalenddateformat>			End Date Format Date Format for Death Date. 102-CCYYMMDD 610-CCYYMM 602-CCYY 3N	Date_form(AE_ RELATION_DX_HIST.TO_ DT)
B.1.10.7.1f		<parentmedicalenddate>			End Date.	AE_ RELATION_DX_HIST.TO_DT
B.1.10.7.1g		<parentmedicalcomment>			Text for medical history comments. 100AN	AE_RELATION_DX.MEDICAL_HISTORY_ COMMENT This field contains the text from Parent Medical History if the Convert to Free Text conditions for <parentmedicalepisodename> are met.
	</parentmedicalepisode>
B.1.10.7.2		<parentmedicalrelevanttext>			Relevant medical history and concurrent conditions of parent. 10,000AN	AE_RELATION_INF. MEDICAL_HISTORY_ COMMENT
B.1.10.8	<parentpastdrugtherapy>				Relevant past drug history of parent.	This block maps to AE_REL_MEDICATIONS for child records of the Parent relation record.
B.1.10.8a		<parentdrugname>			Parent drug name. 100AN	AE_REL_MEDICATIONS.DRUG_NAME
B.1.10.8b		<parentdrugstartdateformat>			Parent Drug Start Date Format. 102-CCYYMMDD 610-CCYYMM 602-CCYY 3N	Date_Form(AE_REL_ MEDICATIONS.START_DATE)
B.1.10.8c		<parentdrugstartdate>			Parent Drug Start Date. 8N	AE_REL_MEDICATIONS.START_DATE
B.1.10.8d		<parentdrugenddateformat>			Parent Drug End Date. 102-CCYYMMDD 610-CCYYMM 602-CCYY 3N	Date_form(AE_REL_MEDICATIONS.END_ DATE)
B.1.10.8e		<parentdrugenddate>			Parent Drug End Date. 8N	AE_REL_MEDICATIONS.END_DATE
B.1.10.8		<parentdrugindicationmeddraversion>			MedDRA version used to encode Parent Drug Indication For Use. 8AN	AE_REL_MEDICATIONS.DX_DID
B.1.10.8		<parentdrugindication>			Parent Drug Indication for Use. 250AN	AE_REL_MEDICATIONS.INDICATION If SUPPRESS_NON_MEDDRA_TERMS is True for the receiver, only MedDRA coded LLTs are included.
B.1.10.8		<parentdrugreactionmedddraversion>			See notes on MedDRA version. 8AN	AE_REL_MEDICATIONS. ADVERSE_ EVENT_DID
B.1.10.8		<parentdrugreaction>			Adverse Event in response to parent drug use. 250AN	AE_REL_MEDICATIONS. ADVERSE_ EVENT_VERBATIM If SUPPRESS_NON_MEDDRA_TERMS is True for the receiver, only MedDRA coded LLTs are included.
	</parentpastdrugtherapy>
	</parent>
B.2	<reaction>		1:M	Y	Repeat as necessary.	Required, repeatable for each record in the AE_EVENTS table. Data are derived from this table through the dictionary views.
B.2.i.1.0		<primarysourcereaction>			RE as reported by primary source. 200AN	DH_EVENTS.RPT_VERBTM
B.2.i.1.a		<reactionmeddraversionllt>			Version of MedDRA used to encode the LLT. 8AN	DH_EVENTS.EVENT_DID
B.2.i.1.b		<reactionmeddrallt>			MedDRA LLT Code for reaction/event. 250AN	DH_EVENTS.EVENT_LLT
B.2.i.2.a		<reactionmeddraversionpt>			Version of MedDRA used to encode the PT. 8AN	DH_EVENTS.EVENT_DID
B.2.i.2.b		<reactionmeddrapt>			MedDRA PT Code for reaction/event. 250AN	DH_EVENTS.PREFERRED_EVENT_TERM
B.2.i.2		<reactionterm> *			DTD 2.0 only.	DH_EVENTS.PREFERRED_EVENT_TERM
B.2.i.3		<termhighlighted>			In 2.1 this field is overloaded to include both the term highlighted by report and event level serious flag. Thus, four different values are allowed. In 2.0 This means the term highlighted by report. 1N	In 2.1 this tag maps to both AE_ EVENTS.TERM_HIGHLIGHTED and AE_ EVENTS.SERIOUS_FLAG. The E2B import and export does not support code lists for this field. Only Y and N are supported. 1=Term highlighted, case NOT serious. 2=Term NOT highlighted, case NOT serious. 3=Term highlighted, case serious. 4=Term NOT highlighted, case serious.
B.2.i.4a		<reactionstartdateformat>			Date format for start date. 102-CCYYMMDD 203-CCYYMMDDHHMM 610-CCYYMM 602-CCYY 3N	Date_Form(NVL(DH_EVENTS.START_DT, AE_CASES.EV_ONSET_DT))
B.2.i.4b		<reactionstartdate>			RE start date. 12N	NVL(DH_EVENTS.START_DT, AE_ CASES.EV_ONSET_DT).
B.2.i.5a		<reactionenddateformat>			Date format for end date. 102-CCYYMMDD 203-CCYYMMDDHHMM 610-CCYYMM 602-CCYY 3N	Date_Form(DH_EVENTS.TO_DT)
B.2.i.5b		<reactionenddate>			RE End Date. 12N	DH_EVENTS.TO_DT
B.2.i.6a		<reactionduration>			Duration of RE. 5N	IF DH_EVENTS.DURATION AND DhEvents.duration_unit are not null, then print DH_EVENTS.DURATION.
B.2.i.6b		<reactiondurationunit>			Duration Units. 801=Year 802=Month 803=Week 804=Day 805=Hour 806=Minute 807=Second 3N	If <REACTIONDURATION> is not null then print Code list for DH_EVENTS.DURATION_ UNIT
B.2.i.7a		<reactionfirsttime>			Time interval between start of suspect drug administration and start of reaction Typically used for very short duration (minutes) and when precise dates are unknown. The E2B report relies on the user’s judgement. If the field in the data is included in the report. 5N	AE_EVENTS.DUR_OF_TRTMT_TO_EV
B.2.i.7.1b		<reactionfirsttimeunit>			Duration of Treatment to Event Units. 801=Year 802=Month 803=Week 804=Day 805=Hour 806=Minute 807=Second 3N	AE_EVENTS.DUR_OF_TRTMT_TO_EV_ UNIT
B.2.i.7.2a		<reactionlasttime>			Time interval between last dose of suspect drug admin and start of RE. 5N	AE_EVENTS. DUR_LAST_DOSE_TO_EV
B.2.i.7.2b		<reactionlasttimeunit>			Duration of Last Dose to Event Units. 801=Year 802=Month 803=Week 804=Day 805=Hour 806=Minute 807=Second 3N	AE_EVENTS.DUR_LAST_DOSE_TO_EV_ UNIT
B.2.i.8		<reactionoutcome>			Latest outcome of RE using the ICH codelist. 1=recovered/resolved 2=recovering/resolving 3=not recovered/not resolved 4=recovered/resolved with sequelae 5=fatal 6=unknown 1N	AE_EVENTS.OUTCOME_CD
	</reaction>
B.3	<test>
B.3.1a		<testdateformat>			Date format for test date. 102-CCYYMMDD 610-CCYYMM 602-CCYY 3N	Date_Form(AE_LAB_TESTS.COLLECTED_ DT)
B.3.1b		<testdate>			Date test collected. 8N	AE_LAB_TESTS.COLLECTED_DT
B.3.1c		<testname>			Test Name. The EMEA wants this field to be MedDRA encoded. In AERS the test name is not a dictionary field but customers can associate an LOV against MedDRA to support this requirement. It is recommended that this list be subset to include only the LLTs in the Investigations SOC. 100AN	AE_LAB_TESTS.TEST_NAME
B.3.1d		<testresult>			Test result. 35AN	AE_LAB_TESTS.RESULT_DESC
B.3.1e		<testunit>			Test Result Unit. 35AN	AE_LAB_TESTS.RESULT_UNIT
B.3.1.1		<lowtestrange>			Low range for test. 50AN	AE_LAB_TESTS.LOW_BOUND
B.3.1.2		<hightestrange>			High range for test. 50AN	AE_LAB_TESTS.UP_BOUND
B.3.1.3		<moreinformation>			Additional information. 100AN	AE_LAB_TESTS.MORE_DATA_AVAILABLE If the Convert to Free Text option LABRESULTS_TO_NARRATIVE is True for the receiver and the data for this tag exceeds the length, the balance of the information is placed in the narrative field <narrativeincludeclinical>.
	</test>
B.3.2		<resultstestsprocedures>		Y	The results of the tests and procedures relevant to the investigation of the patient. 2000 AN	Required, non-repeatable. TH_CONFIRMATORY_TST_ CMNT.CONFIRMATORY_TST_CMNT If Convert to Free Text option LABRESULTS_ TO_NARRATIVE is true and the data for this field exceeds the length of the tag, the data is written to <narrativeincludeclinical> (b.5.1).		LS Medical Product Issue	Summary
B.4	<drug>				For suspect Drugs. Repeatable blocks	DE_SUSPECT DRUGS or AE_ MEDICATIONS depending on the drug characterization On export of suspect drugs this section is the outer join Cartesian product of suspect drugs, indications, doses, and dose lots. The number of created in Suspect drugs and dosages depends upon the “NORMALIZE DRUGS” import rules flag. On import, the drug name is derived using the Derive Drug Names algorithm.
B.4.k.1		<drugcharacterization>			Drug characterization. 1 = Suspect 2 = Concomitant 3 = Interacting 1N	if RPT decode of DH_SUSPECT_ DRUGS.DRUG_INTERACTION_FLAG = ‘Y’, then ‘3’. Otherwise, ‘1’ or DH_ MEDICATIONS.DRUG_TYPE =’C’ then 2.
B.4.k.2.1		<medicinalproduct>			Usually the brand name. 70AN	DH_SUSPECT_DRUGS.DRUG_NAME/DH_ MEDICATIONS.DRUG_NAME		LS Medical PI Product	Product Name	Product	Repeatable for all related products
B.4.k.2.3		<obtaindrugcountry>			Country where drug was obtained (ISO3166). 2A	Code list for lang ‘ISO’DH_SUSPECT_ DRUGS.PURCH_COUNTRY_CD. Not available for Con Meds.
B.4.k.3		<drugbatchnumb>			Batch/lot number. 35AN	DH_SUSPECT_DRUGS.LOT_NBR/DH_ MEDICATIONS.LOT_NBR		LS Medical PI Product	Lot Number	Lot #	Repeatable for all related products
B.4.k.4	?????	Heading			Premarketing authorization or marketing identification holder and number.	On import this section maps to comments.
B.4.k.4.1		<drugauthorizationnumb>			License Number. 35AN	Not supported on export.
B.4.k.4.2		<drugauthorizationcountry>			Country ISO 3166 code. AERS data model does not currently have a column to support this field. 2A	Not supported on export.
B.4.k.4.3		<drugauthorizationholder>			Name of authorization holder. 60AN	Not supported on export.
B.4.k.5	?????	Heading			Structured Dosage Information.	There is no such repeatable entity in the DTD to store multiple AE_DOSAGES records. Entire medication record is repeated for suspect drugs with multiple dose records.
B.4.k.5.1		<drugstructuredosagenumb>			Dose(number) 8N	DH_SUSPECT_DRUGS.Dose_Chr
B.4.k.5.2		<drugstructuredosageunit>			Dose Unit. E2B Code list included with product. 3N	DH_SUSPECT_DRUGS.DOSE_UNIT If Convert to Free Text option DOSEUNIT_ TO_DRUGINFO is true and there is no E2B decode for the Form, the data is written to <drugadditional> (b.4.k.19); if DOSEUNIT_ TO_DOSETEXT is True and there is no E2B decode for the Form, the data is written to <drugdosagetext> (B.4.k.6).
B.4.k.5.3		<drugseparatedosagenumb>			Num. of separate dosages. 3N	The Separated Dosage details are converted from the information stored in the FREQUENCY_CODES table. This table has conversion metrics for each E2B Frequency Code that allows the dosage details to be provided in the atomic detail required in the specification. frequency_codes.DOSES_PER_INTERVAL (where frequency_code = dh_suspect_ Drugs.frequency).
B.4.k.5.4		<drugintervaldosageunitnumb>			Num. of units in the interval. 3N	frequency_codes.INTERVAL_DURATION (where frequency_code = dh_suspect_ Drugs.frequency)
B.4.k.5.5		<drugintervaldosagedefinition>			Definition of interval. 801=Year 802=Month 803=Week 804=Day 805=Hour 806=Minute 3N	frequency_codes.INTERVAL_UNITS (where frequency_code = dh_suspect_ Drugs.frequency)
B.4.k.5.6		<drugcumulativedosagenumb>			Cumulative total dose number 10N	AE_SUSPECT_DRUGS.CUM_DOSE_CHR
B.4.k.5.7		<drugcumulativedosageunit>			Cumulative total dose unit. E2B Code list included with product. 3N	AE_SUSPECT_DRUGS.CUM_DOSE_CHR
B.4.k.6		<drugdosagetext>			Dosage text. Use if structured information like above is not available. 100AN	AE_DOSAGES.DOSAGE_TEXT This field contains Drug Form and/or Dose Unit text if the Convert to Free Text conditions for <drugdosageform> and/or <drugstructuredosageunit> are met.		LS Medical PI Product	Dose Per Unit + Unit of Measure + Frequency		Repeatable for all related products
B.4.k.7		<drugdosageform>			Pharmaceutical form (e.g., tablets, vials, syrup). The EMEA has released a 266 item code list for this field. 50AN	AE_DOSAGES.DRUG_FORM If Convert to Free Text option DRUGFORM_ TO_DRUGINFO is true and there is no E2B decode for the Form, the data is written to <drugadditional> (b.4.k.19); if DRUGFORM_ TO_DOSETEXT is True and there is no E2B decode for the Form, the data is written to <drugdosagetext> (B.4.k.6).
B.4.k.8		<drugadministrationroute>			Route. E2B Codelist included in AERS. 3N	AE_DOSAGES.ROUTE		LS Medical PI Product	Route Used		Repeatable for all related products
B.4.k.9		<drugparadministration>			Route for parent, when the report is for the child. The Full E2B Codelist f or Route is used. 3N	AE_SUSPECT_DRUGS. ROUTE_CHILD_CD
B.4.k.10a		<reactiongestationperiod>			Gestation Period. 3N	AE_DOSAGES.GESTATION_PERIOD_AT_ EXPOSURE
B.4.k.10b		<reactiongestationperiodunit>			Gestation Period Unit. 802=Month 803=Week 804=Day 810=Trimester 3N	AE_DOSAGES.GEST_PERIOD_AT_ EXPOSURE_UNIT
B.4.k.11a		<drugindicationmeddraversion>			MedDRA version used to encode the Indication for use. 8AN	AE_INDICATIONS.DX_DID
B.4.k.11b		<drugindication>			Indication for use. 250AN	AE_INDICATIONS.INDICATION Meddra field handling rules apply. If Convert to Free Text option DRUGINDICATION_TO_DRUGINFO is true the indication is not mapped in MedDRA, the data is written to <drugadditional> (b.4.k.19).		LS Medical PI Product	Indication		Repeatable for all related products
B.4.k.12a		<drugstartdateformat>			Format for start date of drug. 102-CCYYMMDD 610-CCYYMM 602-CCYY 3N	Date_Form(AE_DOSAGES.FROM_DT)		LS Medical PI Product	Therapy From Date		Repeatable for all related products
B.4.k.12b		<drugstartdate>			Start date of drug. 8N	AE_DOSAGES.FROM_DT		LS Medical PI Product	Therapy From Date		Repeatable for all related products
B.4.k.13.1a		<drugstartperiod>			Time interval between start of drug administration and start of earliest RE. 3N	AE_SUSPECT_DRUGS.DUR_OF_TRTMT_ TO_EV
B.4.k.13.1b		<drugstartperiodunits>			Units for Duration of Treatment to Event Onset. 801=Year 802=Month 803=Week 804=Day 805=Hour 806=Minute 807=Second 3N	AE_SUSPECT_DRUGS.DUR_OF_TRTMT_ TO_EV_UNIT
B.4.k.13.2a		<druglastperiod>			Time interval between last dose of drug and start of RE. 5N	AE_SUSPECT_DRUGS.DUR_LAST_DOSE_ TO_EV
B.4.k.13.2b		<druglastperiodunit>			Units for Duration of Last Dose to Event Onset. 801=Year 802=Month 803=Week 804=Day 805=Hour 806=Minute 807=Second 3N	AE_SUSPECT_DRUGS.DUR_LAST_DOSE_ TO_EV_UNIT
B.4.k.14a		<drugenddateformat>			Format for drug end date. 102-CCYYMMDD 610-CCYYMM 602-CCYY 3N	Date_form(AE_DOSAGES.TO_DT)		LS Medical PI Product	Therapy To Date
B.4.k.14b		<drugenddate>			Date of end of drug. 8N	AE_DOSAGES.TO_DT		LS Medical PI Product	Therapy To Date
B.4.k.15a		<drugtreatmentduration>			Duration of treatment. 5N	AE_SUSPECT_DRUG.TOTAL_DUR_OF_ TRTMT
B.4.k.15b		<drugtreatmentdurationunit>			Units for Duration of treatment. 801=Year 802=Month 803=Week 804=Day 805=Hour 806=Minute 3N	AE_SUSPECT_DRUG.TOTAL_DUR_OF_ TRTMT
B.4.k.16		<actiondrug>			Action taken in response to the AE. 1=Drug withdrawn 2=Dose reduced 3=Dose increased 4=Dose not changed 5=Unknown 6=Not applicable 1N	AE_SUSPECT_DRUGS.ACTION_TAKEN
B.4.k.17.1		<drugrecurreadministration>			Did reaction reappear on readministration. There is additional detail on the reappearing reactions in the <drugrecurrence> section. 1N	AE_SUSPECT_DRUGS.REAPPEARED_ FLAG
B.4.k.19		<drugadditional>			Additional info on drug. 100AN	AE_SUSPECT_DRUGS.ADDITIONAL_ INFORMATION This field contains Drug From and/or Dose Unit text if the Convert to Free Text conditions for <drugdosageform>, <drugstructuredosageunit> and/or <drugindication> are met.
	<activesubstance>		1:M		Repeatable for each active substance listed in the drug dictionary.	This section appears out of order compared to the ICH Guideline. It is placed at the end because it repeats within the <drug> block.
B.4.k.2.2		<activesubstancename>			The active substance from the drug dictionary. 100AN	On export, this is derived from V_DRUG_ INGREDIENTS.INGREDIENT for the drug.
	</activesubstance>
	<drugrecurrence>				This section captures the Recurrence at the event-drug level. It drives from the Reappeared Flag at the event-to-drug level.	This section appears out of order compared to the ICH Guideline. It is placed at the end because it repeats within the <drug> block. Repeats for each record in the AE_EVENTS_ TO_DRGS where the REAPPEARED_FLAG =’Y’. Not applicable for con meds.
B.4.k.17.2a		<drugrecuractionmeddraversion>			The MedDRA version used to encode the reaction term for the recurring adverse event. 8AN	AE_EVENTS.DID for the event listed in the AE_EVENTS_TO_DRGS.
B.4.k.17.2b		<drugrecuraction>			The reaction term for the recurring adverse event. 250AN	AE_EVENTS.CO_VERBTM for the event listed in the AE_EVENTS_TO_DRGS Meddra field handling rules apply.
	</drugrecurrence>
B.4.k.18	<drugreactionrelatedness>				Captures additional causality assessments for the drug/event combination.	This section appears out of order compared to the ICH Guideline. It is placed at the end because it repeats within the <drug> block. This section repeats for each drug that has additional causality assessments available. This information is stored in AE_EVENTS_ TO_DRUGS_DETAILS table, which is a child table of AE_EVENTS_TO_DRGS. Because this is a child table, the reaction terms are repeated for each assessment method. Not applicable for con meds.
B.4.k.18.1a		<drugreactionassesmeddraversion>			The MedDRA version used to encode the reaction term for the assessed adverse event. 8AN	AE_EVENTS.DID for the event listed in the AE_EVENTS_TO_DRGS table for the parent record of the assessment.
B.4.k.18.1b		<drugreactionasses>			The reaction term for the assessed adverse event. 250AN	AE_EVENTS.CO_VERBTM for the event listed in the AE_EVENTS_TO_DRGS table for the parent record of the assessment. Meddra field handling rules apply
B.4.k.18.2		<drugassessmentsource>			The source of the additional causality assessment. 60AN	AE_EVENTS_TO_DRUGS_ DETAILS.ASSESSMENT_SOURCE for the event in the AE_EVENTS_TO_DRGS.
B.4.k.18.3		<drugassessmentmethod>			The method of the additional causality assessment. 35AN	AE_EVENTS_TO_DRUGS_ DETAILS.ASSESSMENT_METHOD for the event in the AE_EVENTS_TO_DRGS.
B.4.k.18.4		<drugresult>			The additional causality assessment. 35AN	AE_EVENTS_TO_DRUGS_ DETAILS.ASSESSMENT for the event in the AE_EVENTS_TO_DRGS.
	</drugreactionrelatedness>
	</drug>
	</patient>
B.5	<summary>				Narrative case summary and further information.
B.5.1		<narrativeincludeclinical>			Case narrative, includes clinical course, therapies etc. 20,000AN	If company narrative exists the use it, otherwise use reporter narrative. nvl(TH_COMPANY_ NARRATIVE.COMPANY_NARRATIVE, TH_REPORTER_NARRATIVE.REPORTER_ NARRATIVE) This field contains the text from Lab Test Results if the Convert to Free Text conditions for <resultstestsprocedures> are met.		LS Medical Product Issue	AE Relevant Test	Tests/Data
B.5.2		<reportercomment>			Reporters comments. 500AN	On import, AE_CASE_LG.FIELD_VALUE where FIELD_NAME = ‘REPORTER_ COMMENT’		LS Medical Product Issue	Description	Description
B.5.3.a		<senderdiagnosismeddraversion>			The MedDRA version of the diagnosis.	AE_CASES.COMPANY_DIAGNOSIS_DID
B.5.3.b		<senderdiagnosis>			Senders diagnosis/syndrome and/or reclassification of RE. 250AN	AE_CASES.COMPANY_DIAGNOSIS Meddra field handling rules apply
B.5.4		<sendercomment>			Senders comments Some regulators require that this field contain an evaluation of the significance of this case. ItUsers can recommend specific label changes. *The pv comment in the reportability record overrides the case level PV comment. This feature is added because both the connent and language of the PV comment may vary from regualtor to regulator. 2000AN.	AE_CASE_LG.FIELD_VALUE where FIELD_ NAME = ‘PHARMACOVIGILANCE_ COMMENT’ *If it exists AE_ REPORTABLITY.PHARMACOVIGILANCE_ COMMENT is used instead of the case level PV comment.		LS Medical Product Issue	Evaluation Summary	Evaluation
	</summary>
	</safetyreport>
	</ichicsr>