<!--
INDIVIDUAL CASE SAFETY REPORT
XML DOCUMENT TYPE DEFINITION VERSION 2.0
-->



<!--
==================================================================
Entities
==================================================================
-->

<!--
The lang attribute may be used to indicate the language of an element content via an ISO 639 language Code.
-->
<!ENTITY % lang.att "lang CDATA #IMPLIED">


<!--
Standard Character Entities to escape SGML special characters.    When "<", ">", and "&" occur in text, they should be replaced by "&lt;", "&gt;", and "&amp;" respectfully.
-->
<!-- Less Than "<" -->
<!-- <!ENTITY lt     "&#38;#60;"> -->

<!-- Greater Than ">" -->
<!-- <!ENTITY gt     "&#38;#62;"> -->

<!-- Ampersand "&" -->
<!-- <!ENTITY amp    "&#38;#38;"> -->


<!--
==================================================================
Elements
==================================================================
-->


<!--
Entity ref:
Entity title:	 ICSR MESSAGE
Comment :	The relational model of the Message is described in the following figure:




-->
<!ELEMENT ichicsr
(ichicsrmessageheader,
safetyreport+)>
<!ATTLIST ichicsr
	lang	CDATA	#REQUIRED
>

<!-- ICH ICSR Header Information -->

<!--
Entity ref:	M.1
Entity title:	ICSR Message Header
Entity name:	ichicsrmessageheader
-->
<!ELEMENT ichicsrmessageheader
	(messagetype			,
	messageformatversion		,
	messageformatrelease		,
	messagenumb				,
	messagesenderidentifier		,
	messagereceiveridentifier	,
	messagedateformat			,
	messagedate)>
<!ATTLIST ichicsrmessageheader
	%lang.att;
>

<!--
Block title:	MESSAGE HEADER
-->

<!--
Field ref:	M.1.1
Field title:	Message Type
Field name:	messagetype
Field length:	16AN
Field values:	icsr
-->
<!ELEMENT messagetype		    (#PCDATA) >
<!ATTLIST messagetype
	%lang.att;
>

<!--
Field ref:	M.1.2
Field title:	Message Format Version
Field name:	messageformatversion
Field length:	3AN
Field values:
Comment :	In Step 4 ICSR DTD version 2.0, this field will have value "2".
-->
<!ELEMENT messageformatversion 	    (#PCDATA) >
<!ATTLIST messageformatversion
	%lang.att;
>

<!--
Field ref:	M.1.3
Field title:	Message Format Release
Field name:	messageformatrelease
Field length:	3AN
Comment :	In Step 4 ICSR DTD version 2.0, this field will have value "0".
-->
<!ELEMENT messageformatrelease 	    (#PCDATA) >
<!ATTLIST messageformatrelease
	%lang.att;
>

<!--
Field ref:	M.1.4
Field title:	Message Number
Field name:	messagenumb
Field length:	100AN
Comment :	This field is important for the efficient tracking of Reports. Since the SafetyReportID field is optional, the identification and acknowledgement of safety reports must be done on the basis of the Message Number an the position of each Safety Report in a Message.
Comment :	The Message Number is specific to one transmission between one Sender and one Receiver.
-->
<!ELEMENT messagenumb	 	    (#PCDATA) >
<!ATTLIST messagenumb
	%lang.att;
>

<!--
Field ref:	M.1.5
Field title:	Message Sender Identifier
Field name:	messagesenderidentifier
Field length:	60AN
Comment :	This field is of primary importance for efficient tracking of Safety Reports. It permits a Receiver to define a Thread of Reports related to a Case and to analyse the sequence of follow-ups. It is also required for the acknowledgement of Reports.
Comment :	It should be a coded value agreed between correspondents through an Interchange Agreement. Message not having pre-agreed values in this field should be rejected.
-->
<!ELEMENT messagesenderidentifier     (#PCDATA) >
<!ATTLIST messagesenderidentifier
	%lang.att;
>

<!--
Field ref:	M.1.6
Field title:	Message Receiver Identifier
Field name:	messagereceiveridentifier
Field length:	60AN
-->
<!ELEMENT messagereceiveridentifier     (#PCDATA) >
<!ATTLIST messagereceiveridentifier
	%lang.att;
>

<!--
Field ref:	M.1.7.a
Field title:	Message Date Format
Field name:	messagedateformat
Field length:	3N
Field values:	204=CCYYMMDDHHMMSS
-->
<!ELEMENT messagedateformat	   	(#PCDATA) >
<!ATTLIST messagedateformat
	%lang.att;
>

<!--
Field ref:	M.1.7.b
Field title:	Message Date
Field name:	messagedate
Field length:	14N
-->
<!ELEMENT messagedate	   	(#PCDATA) >
<!ATTLIST messagedate
	%lang.att;
>

<!--
Entity ref:	A.1
Entity title:	SAFETY REPORT
Entity name:	safetyreport
Comment :	The following fields are specific to the Report and should be considered as a Report Header: safetyreportid, safetyreportversion, transmissiondateformat, transmissiondate, receivedateformat, receivedate, sender, receiver. A Sender may change the contents of these fields without altering the contents of the Report associated to a Case. In this case, the Sender acts as a Relay.
Comment :	Any change in the other fields generates a new Report. The Sender acts as an Author.
Comment :	At present, there is no way to identify when the Sender acts as Relay or as Author, the ReceiptDate being insufficient for this purpose. This would require that the Sender would highlight the fields added, deleted or modified from a Report they received. This function was discussed by the ICH M2 EWG and may be introduced in the future as part of the message specification. The Receiver must compare subsequent Reports within one thread and between threads.
Comment :	The relational model of the Safety Report is described in the following figure:



Comment :	One and only one of the following fields should be populated:
A.1.10.1 - National regulatory authority's case report number
A.1.10.2 -  Company's case report number
A.1.10.3 - Other sender's case report number
Comment :	While the Case Number (A.1.10) is used to identify a Case and is fixed by the Case Author, the Report Identifier is used to facilitate the communication between two correspondents: Sender and Receiver. Being the safetyreportid and safetyreportversion optional fields, the Sender may choose among the following identification policies:
a.- not to specify safetyreportid. In this case, the reference to the report is done on the basis of the messagenumber and the position of the Report in the Message (the third report in the message. The acknowledgement will follow this identification policy).
b.- to specify the Report Number (safetyreportid) but not to specify the Report Version (safetyreportversion). The Report Number is the number given by the Sender to the report, as opposed to the Case Number, given by the original Case author. As indicated by the ICH E2B EWG, the ReceiptDate may be used to locate the report in the sequence of follow-ups related to a Case, or more specifically to a Thread.
c.- to specify the Report Number (safetyreportid) and the Report Version (safetyreportversion). This may be done by Case authors not interested in keeping the historic but interested in keeping track of the number of follow-ups transmitted.
Comment :	A possible flow of reports is described in the following picture. The fact that the Case Number (CN) remains the same makes it possible to recognise that the three reports respond to the same Case (MN: message number, RN: report number, LRN: Local Report Number, CN: case number).




-->
<!ELEMENT safetyreport
	(
	safetyreportid?			,
	safetyreportversion?		,
	primarysourcecountry?		,
	occurcountry?			,
	transmissiondateformat?		,
	transmissiondate?			,
	reporttype?				,
	serious?				,
	seriousnessdeath?			,
	seriousnesslifethreatening?	,
	seriousnesshospitalization?	,
	seriousnessdisabling?		,
	seriousnesscongenitalanomali?	,
	seriousnessother?			,
	receivedateformat?		,
	receivedate?			,
	receiptdateformat?		,
	receiptdate?			,
	additionaldocument?		,
	documentlist?			,
	fulfillexpeditecriteria?	,
	authoritynumb?			,
	companynumb?			,
	othernumb?				,
	duplicate?				,
	casenullification?		,
	nullificationreason?		,
	medicallyconfirm?			,
		(reportduplicate*		,
		linkedreport*		,
		primarysource+		,
		sender			,
		receiver			,
		patient))>
<!ATTLIST  safetyreport
	%lang.att;
>

<!--
Entity ref:
Entity title:	REPORT DUPLICATE
Entity name:	reportduplicate
Comment :	This repeatable entity will be present whenever duplicate is set to "yes".
Comment :	A possible scenario for the use of reportduplicate is the following (MN: message number, RN: report number, CN: case number):

-->
<!ELEMENT reportduplicate
	(duplicatesource?			,
	duplicatenumb?)>
<!ATTLIST  reportduplicate
	%lang.att;
>


<!--
Entity ref:
Entity title:	LINKED REPORT
Entity name:	linkedreport
-->
<!ELEMENT linkedreport	   	(linkreportnumb?)>
<!ATTLIST  linkedreport
	%lang.att;
>

<!--
Entity ref:	A.2
Entity title:	PRIMARY SOURCE
Entity name:	primarysource
Comment :	The following fields must be populated:
	A.2.1.1d reporterfamilyname
	A.2.1.2a reporterorganization
	A.2.1.2d reportercity
	A.2.1.3 reportercountry
	A.2.1.4 reporterqualification
-->
<!ELEMENT primarysource
	(reportertitle?                 ,
	reportergivename?               ,
	reportermiddlename?             ,
	reporterfamilyname?             ,
	reporterorganization?           ,
	reporterdepartment?             ,
	reporterstreet?                 ,
	reportercity?                   ,
	reporterstate?                  ,
	reporterpostcode?               ,
	reportercountry?                ,
	qualification?                  ,
	literaturereference?            ,
	studyname?                      ,
	sponsorstudynumb?               ,
	observestudytype?)>
<!ATTLIST  primarysource
	%lang.att;
>

<!--
Entity ref:	A.3.1
Entity title:	SENDER
Entity name:	sender
Comment :	It has been discussed if Sender refers to the first sender or to the last sender.
The reasons in favour of being the first sender include the following:
-the sender is already indicated at the message header level. -the additional administrative information should be available in the data base of addresses of the receiver.
-the sender block does not allow for a coded value: sender id identification required for controlled transmission of safety reports.
-if the sender is the last sender, this require consistency checking for all the reports in one message.
The reasons in favour of being the last sender include the following:
-there may be difference correspondents within the same sender organisation for difference reports.
-spontaneous reporting may be done by non-registered correspondents.
-->
<!ELEMENT sender
	(sendertype?                    ,
	senderorganization?             ,
	senderdepartment?               ,
	sendertitle?                    ,
	sendergivename?                 ,
	sendermiddlename?               ,
	senderfamilyname?               ,
	senderstreetaddress?            ,
	sendercity?                     ,
	senderstate?                    ,
	senderpostcode?                 ,
	sendercountrycode?              ,
	sendertel?                      ,
	sendertelextension?             ,
	sendertelcountrycode?           ,
	senderfax?                      ,
	senderfaxextension?             ,
	senderfaxcountrycode?           ,
	senderemailaddress?)>
<!ATTLIST sender
	%lang.att;
>

<!--
Entity ref:	A.3.2
Entity title:	RECEIVER
Entity name:	receiver
-->
<!ELEMENT receiver
	(receivertype?                  ,
	receiverorganization?           ,
	receiverdepartment?             ,
	receivertitle?                  ,
	receivergivename?               ,
	receivermiddlename?             ,
	receiverfamilyname?             ,
	receiverstreetaddress?          ,
	receivercity?                   ,
	receiverstate?                  ,
	receiverpostcode?               ,
	receivercountrycode?            ,
	receivertel?                    ,
	receivertelextension?           ,
	receivertelcountrycode?         ,
	receiverfax?                    ,
	receiverfaxextension?           ,
	receiverfaxcountrycode?         ,
	receiveremailaddress?)>
<!ATTLIST receiver
	%lang.att;
>

<!--
Entity ref:	B.1
Entity title:	PATIENT
Entity name:	patient
Comment :	There must be one and only one Patient entity in one Safety Report.
Comment :	At least one of the following fields must be populated:
B.1.1 - Patient initials
B.1.1.1a - GP medical record number
B.1.1.1b - Specialist record number
B.1.1.1c - Hospital record number
B.1.1.1d - Patient investigation number
B.1.2.1 - Date of Birth
B.1.2.2a - Age value at time of onset reaction/event
B.1.2.3 - Patient age group
B.1.5 - Sex
-->
<!ELEMENT patient
	(patientinitial?			,
	patientgpmedicalrecordnumb?	,
	patientspecialistrecordnumb?	,
	patienthospitalrecordnumb?	,
	patientinvestigationnumb?	,
patientbirthdateformat?		,
	patientbirthdate?			,
	patientonsetage?			,
      patientonsetageunit?		,
	gestationperiod?			,
gestationperiodunit?		,
	patientagegroup?			,
	patientweight?			,
	patientheight?			,
	patientsex?				,
	(lastmenstrualdateformat|patientlastmenstrualdateformat)?	,
	patientlastmenstrualdate?	,
	patientmedicalhistorytext?	,
	resultstestsprocedures?		,
		(medicalhistoryepisode*	,
		patientpastdrugtherapy*	,
		patientdeath?		,
		parent?			,
		reaction+			,
		test*				,
		drug+				,
		summary?))>
<!ATTLIST patient
	%lang.att;
>

<!--
Entity ref:	B.1.7
Entity title:	RELEVANT MEDICAL HISTORY EPISODE
Entity name:	medicalhistoryepisode
-->
<!ELEMENT medicalhistoryepisode
	(patientmedicalepisodename?	,
	patientmedicalstartdateformat?	,
	patientmedicalstartdate?	,
	patientmedicalcontinue?		,
	patientmedicalenddateformat?	,
	patientmedicalenddate?		,
	patientmedicalcomment?)>
<!ATTLIST  medicalhistoryepisode
	%lang.att;
>

<!--
Entity ref:	B.1.8
Entity title:	RELEVANT PAST DRUG HISTORY
Entity name:	patientpastdrugtherapy
-->
<!ELEMENT patientpastdrugtherapy
	(patientdrugname?               ,
	patientdrugstartdateformat?           ,
	patientdrugstartdate?           ,
	patientdrugenddateformat?             ,
	patientdrugenddate?             ,
	patientdrugindication?          ,
	patientdrugreaction?)>
<!ATTLIST  patientpastdrugtherapy
	%lang.att;
>

<!--
Entity ref:	B.1.9
Entity title:	PATIENT DEATH
Entity name:	patientdeath
Comment :	This entity contains the fields and entities relevant to the case in with death took place.
-->
<!ELEMENT patientdeath
	(patientdeathdateformat?	,
	patientdeathdate?			,
	patientautopsyyesno?		,
		(patientdeathcause*	,
		 patientautopsy*)) >
<!ATTLIST patientdeath
	%lang.att;
>


<!--
Entity ref:
Entity title:	CAUSE OF PATIENT DEATH
Entity name:	patientdeathcause
-->
<!ELEMENT patientdeathcause	   	(patientdeathreport?)>
<!ATTLIST  patientdeathcause
	%lang.att;
>

<!--
Entity ref:
Entity title:	PATIENT AUPTOPSY
Entity name:	patientautopsy
-->
<!ELEMENT patientautopsy	   	(patientdetermineautopsy?)>
<!ATTLIST  patientautopsy
	%lang.att;
>

<!--
Entity ref:	B.1.10
Entity title:	PARENT
Entity name:	parent
Comment :	Information concerning the parent for a parent-child / fetus report.
-->
<!ELEMENT parent
	(parentidentification?        ,
	parentbirthdateformat?		,
	parentbirthdate?              ,
	parentage?                    ,
	parentageunit?                ,
	parentlastmenstrualdateformat?	,
	parentlastmenstrualdate?	,
	parentweight?                 ,
	parentheight?                 ,
	parentsex?                    ,
	parentmedicalrelevanttext?    ,
		(parentmedicalhistoryepisode*		 ,
		 parentpastdrugtherapy*))>
<!ATTLIST parent
	%lang.att;
>

<!--
Entity ref:	B.1.10.7
Entity title:	RELEVANT MEDICAL HISTORY
Entity name:	parentmedicalhistoryepisode
-->
<!ELEMENT parentmedicalhistoryepisode
	(parentmedicalepisodename?              ,
	parentmedicalstartdateformat?                 ,
	parentmedicalstartdate?                 ,
	parentmedicalcontinue?                  ,
	parentmedicalenddateformat?                   ,
	parentmedicalenddate?                   ,
	parentmedicalcomment?)>
<!ATTLIST  parentmedicalhistoryepisode
	%lang.att;
>

<!--
Entity ref:	B.1.10.8
Entity title:	PARENT PAST DRUG THERAPY
Entity name:	parentpastdrugtherapy
Comment :	Relevant past drug history.
-->
<!ELEMENT parentpastdrugtherapy
	(parentdrugname?			,
	parentdrugstartdateformat?	,
	parentdrugstartdate?		,
	parentdrugenddateformat?	,
	parentdrugenddate?		,
	parentdrugindication?		,
	parentdrugreaction?)>
<!ATTLIST  parentpastdrugtherapy
	%lang.att;
>

<!--
Entity ref:	B.2
Entity title:	REACTION
Entity name:	reaction
Comment :	The following field must be populated:
B.2.i.2 - Reaction term
This field should be a valid MedDRA 2.1 or superior LLT
-->
<!ELEMENT reaction
	(primarysourcereaction?		,
	reactionterm?			,
	termhighlighted?			,
	reactionstartdateformat?	,
	reactionstartdate?		,
	reactionenddateformat?		,
	reactionenddate?			,
	reactionduration?			,
	reactiondurationunit?		,
	reactionfirsttime?		,
	reactionfirsttimeunit?		,
	reactionlasttime?			,
	reactionlasttimeunit?		,
	reactionoutcome?)>
<!ATTLIST  reaction
	%lang.att;
>

<!--
Entity ref:	B.3
Entity title:	TEST
Entity name:	test
Comment :	Results of tests and procedures relevant to the investigation of the patient.
-->
<!ELEMENT test
	(testdateformat?			,
testdate?				,
	testname?				,
	testresult?				,
	testunit?				,
	lowtestrange?			,
	hightestrange?			,
	moreinformation?)>
<!ATTLIST  test
	%lang.att;
>

<!--
Entity ref:	B.4
Entity title:	DRUG
Entity name:	drug
Comment :	The following field should be populated:
B.4.k.2.1- Proprietary medicinal product name
-->
<!ELEMENT  drug
	(drugcharacterization?          ,
	medicinalproduct?               ,
	obtaindrugcountry?              ,
	drugbatchnumb?                  ,
	drugauthorizationnumb?          ,
	drugauthorizationcountry?       ,
	drugauthorizationholder?        ,
	drugstructuredosagenumb?        ,
	drugstructuredosageunit?        ,
	drugseparatedosagenumb?         ,
	drugintervaldosageunitnumb?     ,
	drugintervaldosagedefinition?   ,
	drugcumulativedosagenumb?       ,
	drugcumulativedosageunit?       ,
	drugdosagetext?                 ,
	drugdosageform?                 ,
	drugadministrationroute?        ,
	drugparadministration?          ,
	reactiongestationperiod?	,
	reactiongestationperiodunit?	,
	drugindication?			,
	drugstartdateformat?		,
	drugstartdate?			,
	drugstartperiod?			,
	drugstartperiodunit?		,
	druglastperiod?			,
	druglastperiodunit?		,
	drugenddateformat?		,
	drugenddate?			,
	drugtreatmentduration?		,
	drugtreatmentdurationunit?	,
	actiondrug?				,
	drugrecurreadministration?	,
	drugadditional?			,
		(activesubstance*		,
		drugrecurrence*		,
		 drugreactionrelatedness*))>
<!ATTLIST  drug
	%lang.att;
>

<!--
Entity ref:
Entity title:	ACTIVE SUBSTANCE
Entity name:	activesubstance
-->
<!ELEMENT activesubstance         (activesubstancename)>
<!ATTLIST  activesubstance
	%lang.att;
>

<!--
Entity ref:
Entity title:	DRUG RECURRENCE
Entity name:	drugrecurrence
-->
<!ELEMENT drugrecurrence         (drugrecuraction)>
<!ATTLIST  drugrecurrence
	%lang.att;
>

<!--
Entity ref:	B.4.k.18
Entity title:	RELATEDNESS OF DRUG TO REACTION / EVENT
Entity name:	drugreactionrelatedness
-->
<!ELEMENT drugreactionrelatedness
	(drugreactionasses?             ,
	drugassessmentsource?           ,
	drugassessmentmethod?           ,
	drugresult?)>
<!ATTLIST  drugreactionrelatedness
	%lang.att;
>

<!--
Entity ref:	B.5
Entity title:	NARRATIVE CASE SUMMARY
Entity name:	summary
-->
<!ELEMENT summary
	(narrativeincludeclinical?      ,
	reportercomment?                ,
	senderdiagnosis?                ,
	sendercomment?)>
<!ATTLIST summary
	%lang.att;
>

<!--
Block name:
Block ref:	A.1
Block title:	REPORT IDENTIFICATION
-->

<!--
Field ref:
Field title:	Safety report id identifier
Field name:	safetyreportid
Field length:	100AN
Comment :	This field contains the Report Number (report Id identifier) given by a sender to a report. Contrary to the Case Number, that is given by the creator of the Case and remains unchanged all through the life cycle of the Case, and to the Message Number, that is given by the message sender and is specific to one transmission between the Sender and one Receiver, the Report Number is given by the Sender to one Report and is sent to as many correspondents as required. All the receivers of the Report will refer to it by the same number (or alternatively by the Message number and the sequential position of the Report in the message).
Comment :	At present, this field is optional. However, all the Senders should have a consistent numbering system for reports.
Comment :	Senders may choose by generating a new Report Number when data is added or modified in the Report or by keeping the same Report Number and increasing the Report Version.
-->
<!ELEMENT safetyreportid	   	(#PCDATA)>
<!ATTLIST safetyreportid
	%lang.att;
>

<!--
Field ref:
Field title:	Safety report version
Field name:	safetyreportversion
Field length:	2AN
Comment :	This field is optional. Receivers may re-create the version number for a Report in a particular Thread on the basis of the Receipt Date (InfoDate).
-->
<!ELEMENT safetyreportversion	   	(#PCDATA)>
<!ATTLIST safetyreportversion
	%lang.att;
>

<!--
Field ref:	A.1.1
Field title:	Identification of the country of the primary.
Field name:	primarysourcecountry
Field length:	2A
Field values:	ISO3166
-->
<!ELEMENT primarysourcecountry          (#PCDATA)>
<!ATTLIST primarysourcecountry
	%lang.att;
>

<!--
Field ref:	A.1.2
Field title:	Identification of the country where the reaction / event occurred
Field name:	occurcountry
Field length:	2A
Field values:	ISO3166
-->
<!ELEMENT occurcountry                  (#PCDATA)>
<!ATTLIST occurcountry
	%lang.att;
>

<!--
Field ref:	A.1.3a
Field title:	Date format
Field name:	transmissiondateformat
Field length:	3N
Field values:	102:CCYYMMDD
-->
<!ELEMENT transmissiondateformat              (#PCDATA)>
<!ATTLIST transmissiondateformat
	%lang.att;
>

<!--
Field ref:	A.1.3b
Field title:	Date of this transmission
Field name:	transmissiondate
Field length:	8N
Comment :	Must be indicated according to the date format.
-->
<!ELEMENT transmissiondate              (#PCDATA)>
<!ATTLIST transmissiondate
	%lang.att;
>

<!--
Field ref:	A.1.4
Field title:	Type of report
Field name:	reporttype
Field length:	1N
Field values:
1=Spontaneous
2=Report from study
3=Other
4=Not available to sender (unknown)
-->
<!ELEMENT reporttype                    (#PCDATA)>
<!ATTLIST reporttype
	%lang.att;
>

<!--
Field ref:	A.1.5.1
Field title:	Serious
Field name:	serious
Field length:	1N
Field values:
1=Yes
2=No
-->
<!ELEMENT serious                       (#PCDATA)>
<!ATTLIST serious
	%lang.att;
>

<!--
Block ref:	A.1.5.2
Block title:	SERIOUSNESS CRITERIA
Block name:
-->

<!--
Field ref:	A.1.5.2a
Field title:	Results in death
Field name:	seriousnessdeath
Field length:	1N
Field values:
1=Yes
2=No
-->
<!ELEMENT seriousnessdeath              (#PCDATA)>
<!ATTLIST seriousnessdeath
	%lang.att;
>

<!--
Field ref:	A.1.5.2b
Field title:	Life threatening
Field name:	seriousnesslifethreatening
Field length:	1N
Field values:
1=Yes
2=No
-->
<!ELEMENT seriousnesslifethreatening            (#PCDATA)>
<!ATTLIST seriousnesslifethreatening
	%lang.att;
>

<!--
Field ref:	A.1.5.2c
Field title:	Caused/prolonged hospitalization
Field name:	seriousnesshospitalization
Field length:	1N
Field values:
1=Yes
2=No
-->
<!ELEMENT seriousnesshospitalization            (#PCDATA)>
<!ATTLIST seriousnesshospitalization
	%lang.att;
>

<!--
Field ref:	A.1.5.2d
Field title:	Disabling/Incapacitating
Field name:	seriousnessdisabling
Field length:	1N
Field values:
1=Yes
2=No
-->
<!ELEMENT seriousnessdisabling          (#PCDATA)>
<!ATTLIST seriousnessdisabling
	%lang.att;
>

<!--
Field ref:	A.1.5.2e
Field title:	Congenital anomaly/birth defect
Field name:	seriousnesscongenitalanomali
Field length:	1N
Field values:
1=Yes
2=No
-->
<!ELEMENT seriousnesscongenitalanomali          (#PCDATA)>
<!ATTLIST seriousnesscongenitalanomali
	%lang.att;
>

<!--
Field ref:	A.1.5.2f
Field title:	Other medically important condition
Field name:	seriousnessother
Field length:	1N
Field values:
1=Yes
2=No
-->
<!ELEMENT seriousnessother              (#PCDATA)>
<!ATTLIST seriousnessother
	%lang.att;
>

<!--
Field ref:	A.1.6a
Field title:	Date report was first received from source format
Field name:	receivedateformat
Field length:	3N
Field values:	102=CCYYMMDD
-->
<!ELEMENT receivedateformat                   (#PCDATA)>
<!ATTLIST receivedateformat
	%lang.att;
>

<!--
Field ref:	A.1.6b
Field title:	Date report was first received from source
Field name:	receivedate
Field length:	8N
-->
<!ELEMENT receivedate                   (#PCDATA)>
<!ATTLIST receivedate
	%lang.att;
>

<!--
Field ref:	A.1.7a
Field title:	Date of receipt of the most recent information format
Field name:	receiptdateformat
Field length:	3N
Field values:	102=CCYYMMDD
-->
<!ELEMENT receiptdateformat                   (#PCDATA)>
<!ATTLIST receiptdateformat
	%lang.att;
>

<!--
Field ref:	A.1.7b
Field title:	Date of receipt of the most recent information
Field name:	receiptdate
Field length:	8N
Comment :	Mandatory field.
-->
<!ELEMENT receiptdate                   (#PCDATA)>
<!ATTLIST receiptdate
	%lang.att;
>

<!--
Field ref:	A.1.8.1
Field title:	Are additional documents available?
Field name:	additionaldocument
Field length:	1N
Field values:
1=Yes
2=No
-->
<!ELEMENT additionaldocument            (#PCDATA)>
<!ATTLIST additionaldocument
	%lang.att;
>

<!--
Field ref:	A.1.8.2
Field title:	List of documents held by sender
Field name:	documentlist
Field length:	100AN
-->
<!ELEMENT documentlist                  (#PCDATA)>
<!ATTLIST documentlist
	%lang.att;
>

<!--
Field ref:	A.1.9
Field title:	Does this case fulfill the local criteria for an expedited report?
Field name:	fulfillexpeditecriteria
Field length:	1N
Field values:
1=Yes
2=No
-->
<!ELEMENT fulfillexpeditecriteria       (#PCDATA)>
<!ATTLIST fulfillexpeditecriteria
	%lang.att;
>

<!--
Block ref:	A.1.10
Block title:	CASE NUMBER
Block name:
Comment :	The case number is used to identify a Case in a unique way and to relate Reports associated to the same Case. The Case number is described in any of the following three fields: authority number, company number, other number. The case number is populated following the following three criteria:
Only one of these numbers must be populated and it must be populated by the creator of the case. If the creator was a hospital, the other number will be populated. Authority number or company number will not be populated at any later stage. The original other number will remain unchanged through any transaction related to this case. The same applies to the authority number or to the company number if the case creator was an authority or a company.
The value of that field must remain unchanged all through the life cycle of the case.
The required format to populate this field is thought to make the value unique: CountryID-OrganizationID-CaseID.
Comment :	The application developer may decide to create a field casenumber containing the only one number that must and may be populated and use it for identification of duplicates and follow-ups. An additional field: authortype, may be created to reflect the nature of the organisation that assigned the unique number to the case: authority, company, other.
-->

<!--
Field ref:	A.1.10.1
Field title:	National regulatory authority's case report number
Field name:	authoritynumb
Field length:	100AN
-->
<!ELEMENT authoritynumb                 (#PCDATA)>
<!ATTLIST authoritynumb
	%lang.att;
>

<!--
Field ref:	A.1.10.2
Field title:	Company's case report number
Field name:	companynumb
Field length:	100AN
-->
<!ELEMENT companynumb                   (#PCDATA)>
<!ATTLIST companynumb
	%lang.att;
>

<!--
Field ref:	A.1.10.3
Field title:	Other sender's case report number
Field name:	othernumb
Field length:	100AN
-->
<!ELEMENT othernumb                     (#PCDATA)>
<!ATTLIST othernumb
	%lang.att;
>

<!--
Field ref:	A.1.11
Field title:	Suspected duplicate : Are there duplicates?
Field name:	duplicate
Field length:	1N
Field values:
null
1=yes
-->
<!ELEMENT duplicate                     (#PCDATA)>
<!ATTLIST duplicate
	%lang.att;
>

<!--
Field ref:	A.1.11.1
Field title:	Source of the duplicate
Field name:	duplicatesource
Field length:	50AN
-->
<!ELEMENT duplicatesource               (#PCDATA)>
<!ATTLIST duplicatesource
	%lang.att;
>

<!--
Field ref:	A.1.11.2
Field title:	Case report number of the suspected duplicate
Field name:	duplicatenumb
Field length:	100AN
Field values:
-->
<!ELEMENT duplicatenumb                 (#PCDATA)>
<!ATTLIST duplicatenumb
	%lang.att;
>

<!--
Field ref:	A.1.12
Field title:	Identification number of the report which is linked to this report
Field name:	linkreportnumb
Field length:	100AN
Field values:
-->
<!ELEMENT linkreportnumb                (#PCDATA)>
<!ATTLIST linkreportnumb
	%lang.att;
>

<!--
Field ref:	A.1.13
Field title:	Report nullification
Field name:	casenullification
Field length:	1N
Field values:	1=YES
-->
<!ELEMENT casenullification             (#PCDATA)>
<!ATTLIST casenullification
	%lang.att;
>

<!--
Field ref:	A.1.13.1
Field title:	Reason for nullification
Field name:	nullificationreason
Field length:	200AN
Field values:
-->
<!ELEMENT nullificationreason           (#PCDATA)>
<!ATTLIST nullificationreason
	%lang.att;
>

<!--
Field ref:	A.1.14
Field title:	Was the case medically confirmed, if not initially from health professional?
Field name:	medicallyconfirm
Field length:	1N
Field values:
1=Yes
2=No
-->
<!ELEMENT medicallyconfirm              (#PCDATA)>
<!ATTLIST medicallyconfirm
	%lang.att;
>

<!--
Block ref:	A.2
Block title:	PRIMARY SOURCE
Block name:
-->

<!--
Field ref:	A.2.1.1a
Field title:	Reporter's title
Field name:	reportertitle
Field length:	10AN
Field values:
-->
<!ELEMENT reportertitle                 (#PCDATA)>
<!ATTLIST reportertitle
	%lang.att;
>

<!--
Field ref:	A.2.1.1b
Field title:	Reporter's given name
Field name:	reportergivename
Field length:	35AN
-->
<!ELEMENT reportergivename              (#PCDATA)>
<!ATTLIST reportergivename
	%lang.att;
>

<!--
Field ref:	A.2.1.1c
Field title:	Reporter's middle name
Field name:	reportermiddlename
Field length:	15AN
-->
<!ELEMENT reportermiddlename            (#PCDATA)>
<!ATTLIST reportermiddlename
	%lang.att;
>

<!--
Field ref:	A.2.1.1d
Field title:	Reporter's family name
Field name:	reporterfamilyname
Field length:	35AN
Field values:
-->
<!ELEMENT reporterfamilyname            (#PCDATA)>
<!ATTLIST reporterfamilyname
	%lang.att;
>

<!--
Field ref:	A.2.1.2a
Field title:	Reporter's organization
Field name:	reporterorganization
Field length:	60AN
Field values:
-->
<!ELEMENT reporterorganization          (#PCDATA)>
<!ATTLIST reporterorganization
	%lang.att;
>

<!--
Field ref:	A.2.1.2.b
Field title:	Reporter's department
Field name:	reporterdepartment
Field length:	60AN
Field values:
-->
<!ELEMENT reporterdepartment            (#PCDATA)>
<!ATTLIST reporterdepartment
	%lang.att;
>

<!--
Field ref:	A.2.1.2.c
Field title:	Reporter's street
Field name:	reporterstreet
Field length:	60AN
Field values:
-->
<!ELEMENT reporterstreet                (#PCDATA)>
<!ATTLIST reporterstreet
	%lang.att;
>

<!--
Field ref:	A.2.1.2.d
Field title:	Reporter's city
Field name:	reportercity
Field length:	35AN
Field values:
-->
<!ELEMENT reportercity                  (#PCDATA)>
<!ATTLIST reportercity
	%lang.att;
>

<!--
Field ref:	A.2.1.2.e
Field title:	Reporter's state or province
Field name:	reporterstate
Field length:	40AN
Field values:
-->
<!ELEMENT reporterstate                 (#PCDATA)>
<!ATTLIST reporterstate
	%lang.att;
>

<!--
Field ref:	A.2.1.2.f
Field title:	Reporter's post code
Field name:	reporterpostcode
Field length:	15AN
Field values:
-->
<!ELEMENT reporterpostcode              (#PCDATA)>
<!ATTLIST reporterpostcode
	%lang.att;
>

<!--
Field ref:	A.2.1.3
Field title:	Reporter's country
Field name:	reportercountry
Field length:	2A
Field values:	ISO3166
-->
<!ELEMENT reportercountry               (#PCDATA)>
<!ATTLIST reportercountry
	%lang.att;
>

<!--
Field ref:	A.2.1.4
Field title:	Reporter's qualification
Field name:	qualification
Field length:	1N
Field values:
1=Physician7
2=Pharmacist
3=Other Health Professional
4=Lawyer
5=Consumer or other non health professional
-->
<!ELEMENT qualification                 (#PCDATA)>
<!ATTLIST qualification
	%lang.att;
>

<!--
Field ref:	A.2.2
Field title:	Literature reference(s)
Field name:	literaturereference
Field length:	500AN
Field values:
-->
<!ELEMENT literaturereference           (#PCDATA)>
<!ATTLIST literaturereference
	%lang.att;
>

<!--
Field ref:	A.2.3.1
Field title:	Study name
Field name:	studyname
Field length:	100AN
Field values:
-->
<!ELEMENT studyname                     (#PCDATA)>
<!ATTLIST studyname
	%lang.att;
>

<!--
Field ref:	A.2.3.2
Field title:	Sponsor study number
Field name:	sponsorstudynumb
Field length:	35AN
Field values:

-->
<!ELEMENT sponsorstudynumb              (#PCDATA)>
<!ATTLIST sponsorstudynumb
	%lang.att;
>

<!--
Field ref:	A.2.3.3
Field title:	Study type in which the reactions / events were observed
Field name:	observestudytype
Field length:	3N
Field values:
1=Clinical trials
2=Individual patient use
3=Other studies
-->
<!ELEMENT observestudytype              (#PCDATA)>
<!ATTLIST observestudytype
	%lang.att;
>

<!--
Block ref:	A.3.1
Block title:	SENDER
Block name:
-->

<!--
Field ref:	A.3.1.1
Field title:	Sender type
Field name:	sendertype
Field length:	1N
Field values:
1=Pharmaceutical Company
2=Regulatory Authority
3=Health professional
4=Regional Pharmacovigilance Center
5=WHO Collaborating Center for International Drug Monitoring
6=Other
-->
<!ELEMENT sendertype                    (#PCDATA)>
<!ATTLIST sendertype
	%lang.att;
>

<!--
Field ref:	A.3.1.2
Field title:	Sender's organization
Field name:	senderorganization
Field length:	60AN
Field values:
Comment :	Mandatory field. The contents of this field must be previsously agreed and specified in the Interchange Agreement.-->
<!ELEMENT senderorganization            (#PCDATA)>
<!ATTLIST senderorganization
	%lang.att;
>

<!--
Field ref:	A.3.1.3a
Field title:	Sender's department
Field name:	senderdepartment
Field length:	60AN
Field values:
-->
<!ELEMENT senderdepartment              (#PCDATA)>
<!ATTLIST senderdepartment
	%lang.att;
>

<!--
Field ref:	A.3.1.3b
Field title:	Sender's title
Field name:	sendertitle
Field length:	10AN
Field values:
-->
<!ELEMENT sendertitle                   (#PCDATA)>
<!ATTLIST sendertitle
	%lang.att;
>

<!--
Field ref:	A.3.1.3c
Field title:	Sender's given name
Field name:	sendergivename
Field length:	35AN
Field values:
-->
<!ELEMENT sendergivename                (#PCDATA)>
<!ATTLIST sendergivename
	%lang.att;
>

<!--
Field ref:	A.3.1.3d
Field title:	Sender's middle name
Field name:	sendermiddlename
Field length:	15AN
Field values:
-->
<!ELEMENT sendermiddlename              (#PCDATA)>
<!ATTLIST sendermiddlename
	%lang.att;
>

<!--
Field ref:	A.3.1.3e
Field title:	Sender's family name
Field name:	senderfamilyname
Field length:	35AN
Field values:
-->
<!ELEMENT senderfamilyname              (#PCDATA)>
<!ATTLIST senderfamilyname
	%lang.att;
>

<!--
Field ref:	A.3.1.4a
Field title:	Sender's street address
Field name:	senderstreetaddress
Field length:	40AN
Field values:
-->
<!ELEMENT senderstreetaddress           (#PCDATA)>
<!ATTLIST senderstreetaddress
	%lang.att;
>

<!--
Field ref:	A.3.1.4b
Field title:	Sender's city
Field name:	sendercity
Field length:	35AN
Field values:
-->
<!ELEMENT sendercity                    (#PCDATA)>
<!ATTLIST sendercity
	%lang.att;
>

<!--
Field ref:	A.3.1.4c
Field title:	Sender's state or province
Field name:	senderstate
Field length:	40AN
Field values:
-->
<!ELEMENT senderstate                   (#PCDATA)>
<!ATTLIST senderstate
	%lang.att;
>

<!--
Field ref:	A.3.1.4d
Field title:	Sender's post code
Field name:	senderpostcode
Field length:	15AN
Field values:
-->
<!ELEMENT senderpostcode                (#PCDATA)>
<!ATTLIST senderpostcode
	%lang.att;
>

<!--
Field ref:	A.3.1.4e
Field title:	Sender's country code
Field name:	sendercountrycode
Field length:	2A
Field values:	ISO3166
-->
<!ELEMENT sendercountrycode             (#PCDATA)>
<!ATTLIST sendercountrycode
	%lang.att;
>

<!--
Field ref:	A.3.1.4f
Field title:	Sender's telephone
Field name:	sendertel
Field length:	10AN
Field values:
-->
<!ELEMENT sendertel                     (#PCDATA)>
<!ATTLIST sendertel
	%lang.att;
>

<!--
Field ref:	A.3.1.4g
Field title:	Sender's telephone extension
Field name:	sendertelextension
Field length:	5AN
Field values:
-->
<!ELEMENT sendertelextension            (#PCDATA)>
<!ATTLIST sendertelextension
	%lang.att;
>

<!--
Field ref:	A.3.1.4h
Field title:	Sender's telephone country code
Field name:	sendertelcountrycode
Field length:	3AN
Field values:
-->
<!ELEMENT sendertelcountrycode          (#PCDATA)>
<!ATTLIST sendertelcountrycode
	%lang.att;
>

<!--
Field ref:	A.3.1.4i
Field title:	Sender's fax
Field name:	senderfax
Field length:	10AN
Field values:
-->
<!ELEMENT senderfax                     (#PCDATA)>
<!ATTLIST senderfax
	%lang.att;
>

<!--
Field ref:	A.3.1.4j
Field title:	Sender's fax extension
Field name:	senderfaxextension
Field length:	5AN
Field values:
-->
<!ELEMENT senderfaxextension            (#PCDATA)>
<!ATTLIST senderfaxextension
	%lang.att;
>

<!--
Field ref:	A.3.1.4k
Field title:	Sender's fax country code
Field name:	senderfaxcountrycode
Field length:	3AN
Field values:
-->
<!ELEMENT senderfaxcountrycode          (#PCDATA)>
<!ATTLIST senderfaxcountrycode
	%lang.att;
>

<!--
Field ref:	A.3.1.4l
Field title:	Sender's email address
Field name:	senderemailaddress
Field length:	100AN
Field values:
-->
<!ELEMENT senderemailaddress            (#PCDATA)>
<!ATTLIST senderemailaddress
	%lang.att;
>

<!--
Block ref:	A.3.2
Block title:	RECEIVER
Block name:
-->

<!--
Field ref:	A.3.2.1
Field title:	Receiver type
Field name:	receivertype
Field length:	1N
Field values:
1=Pharmaceutical Company
2=Regulatory Authority
4=Regional Pharmacovigilance Center
5=WHO Collaborating Center for International Drug Monitoring
6=Other
-->
<!ELEMENT receivertype                  (#PCDATA)>
<!ATTLIST receivertype
	%lang.att;
>

<!--
Field ref:	A.3.2.2a
Field title:	Receiver's organization
Field name:	receiverorganization
Field length:	60AN
Field values:
-->
<!ELEMENT receiverorganization          (#PCDATA)>
<!ATTLIST receiverorganization
	%lang.att;
>

<!--
Field ref:	A.3.2.2b
Field title:	Receiver's department
Field name:	receiverdepartment
Field length:	60AN
Field values:
-->
<!ELEMENT receiverdepartment            (#PCDATA)>
<!ATTLIST receiverdepartment
	%lang.att;
>

<!--
Field ref:	A.3.2.2c
Field title:	Receiver's title
Field name:	receivertitle
Field length:	10AN
Field values:
-->
<!ELEMENT receivertitle                 (#PCDATA)>
<!ATTLIST receivertitle
	%lang.att;
>

<!--
Field ref:	A.3.2.2d
Field title:	Receiver's given name
Field name:	receivergivename
Field length:	35AN
Field values:
-->
<!ELEMENT receivergivename              (#PCDATA)>
<!ATTLIST receivergivename
	%lang.att;
>

<!--
Field ref:	A.3.2.2e
Field title:	Receiver's middle name
Field name:	receivermiddlename
Field length:	15AN
Field values:
-->
<!ELEMENT receivermiddlename            (#PCDATA)>
<!ATTLIST receivermiddlename
	%lang.att;
>

<!--
Field ref:	A.3.2.2f
Field title:	Receiver's family name
Field name:	receiverfamilyname
Field length:	35AN
Field values:
-->
<!ELEMENT receiverfamilyname            (#PCDATA)>
<!ATTLIST receiverfamilyname
	%lang.att;
>

<!--
Field ref:	A.3.2.3a
Field title:	Receiver's streed address
Field name:	receiverstreetaddress
Field length:	40AN
Field values:
-->
<!ELEMENT receiverstreetaddress         (#PCDATA)>
<!ATTLIST receiverstreetaddress
	%lang.att;
>

<!--
Field ref:	A.3.2.3b
Field title:	Receiver's city
Field name:	receivercity
Field length:	35AN
Field values:
-->
<!ELEMENT receivercity                  (#PCDATA)>
<!ATTLIST receivercity
	%lang.att;
>

<!--
Field ref:	A.3.2.3c
Field title:	Receiver's state or province
Field name:	receiverstate
Field length:	40AN
Field values:
-->
<!ELEMENT receiverstate                 (#PCDATA)>
<!ATTLIST receiverstate
	%lang.att;
>

<!--
Field ref:	A.3.2.3d
Field title:	Receiver's post code
Field name:	receiverpostcode
Field length:	15AN
Field values:
-->
<!ELEMENT receiverpostcode              (#PCDATA)>
<!ATTLIST receiverpostcode
	%lang.att;
>

<!--
Field ref:	A.3.2.3e
Field title:	Receiver's country code
Field name:	receivercountrycode
Field length:	2A
Field values:	ISO3166
-->
<!ELEMENT receivercountrycode           (#PCDATA)>
<!ATTLIST receivercountrycode
	%lang.att;
>

<!--
Field ref:	A.3.2.3f
Field title:	Receiver's telephone
Field name:	receivertel
Field length:	10AN
Field values:
-->
<!ELEMENT receivertel                   (#PCDATA)>
<!ATTLIST receivertel
	%lang.att;
>

<!--
Field ref:	A.3.2.3g
Field title:	Receiver's telephone extension
Field name:	receivertelextension
Field length:	5AN
Field values:
-->
<!ELEMENT receivertelextension          (#PCDATA)>
<!ATTLIST receivertelextension
	%lang.att;
>

<!--
Field ref:	A.3.2.3h
Field title:	Receiver's telephone country code
Field name:	receivertelcountrycode
Field length:	3AN
Field values:
-->
<!ELEMENT receivertelcountrycode        (#PCDATA)>
<!ATTLIST receivertelcountrycode
	%lang.att;
>

<!--
Field ref:	A.3.2.3i
Field title:	Receiver's fax
Field name:	receiverfax
Field length:	10AN
Field values:
-->
<!ELEMENT receiverfax                   (#PCDATA)>
<!ATTLIST receiverfax
	%lang.att;
>

<!--
Field ref:	A.3.2.3j
Field title:	Receiver's fax extension
Field name:	receiverfaxextension
Field length:	5AN
Field values:
-->
<!ELEMENT receiverfaxextension          (#PCDATA)>
<!ATTLIST receiverfaxextension
	%lang.att;
>

<!--
Field ref:	A.3.2.3k
Field title:	Receiver's fax country code
Field name:	receiverfaxcountrycode
Field length:	3AN
Field values:
-->
<!ELEMENT receiverfaxcountrycode        (#PCDATA)>
<!ATTLIST receiverfaxcountrycode
	%lang.att;
>

<!--
Field ref:	A.3.2.3l
Field title:	Receiver's e-mail address
Field name:	receiveremailaddress
Field length:	100AN
Field values:
-->
<!ELEMENT receiveremailaddress          (#PCDATA)>
<!ATTLIST receiveremailaddress
	%lang.att;
>

<!--
Block ref:	B.1.1
Block title:	PATIENT
Block name:
-->

<!--
Field ref:	B.1.1
Field title:	Patient initials
Field name:	patientinitial
Field length:	10AN
Field values:
-->
<!ELEMENT patientinitial                (#PCDATA)>
<!ATTLIST patientinitial
	%lang.att;
>

<!--
Field ref:	B.1.1.1a
Field title:	GP medical record number
Field name:	patientgpmedicalrecordnumb
Field length:	20AN
Field values:
-->
<!ELEMENT patientgpmedicalrecordnumb            (#PCDATA)>
<!ATTLIST patientgpmedicalrecordnumb
	%lang.att;
>

<!--
Field ref:	B.1.1.1b
Field title:	Specialist record number
Field name:	patientspecialistrecordnumb
Field length:	20AN
Field values:
-->
<!ELEMENT patientspecialistrecordnumb           (#PCDATA)>
<!ATTLIST patientspecialistrecordnumb
	%lang.att;
>

<!--
Field ref:	B.1.1.1c
Field title:	Hospital record number
Field name:	patienthospitalrecordnumb
Field length:	20AN
Field values:
-->
<!ELEMENT patienthospitalrecordnumb     (#PCDATA)>
<!ATTLIST patienthospitalrecordnumb
	%lang.att;
>

<!--
Field ref:	B.1.1.1d
Field title:	Investigation number
Field name:	patientinvestigationnumb
Field length:	20AN
Field values:
-->
<!ELEMENT patientinvestigationnumb      (#PCDATA)>
<!ATTLIST patientinvestigationnumb
	%lang.att;
>

<!--
Field ref:	B.1.2.1a
Field title:	Date of birth format
Field name:	patientbirthdateformat
Field length:	3N
Field values:	102=CCYYMMDD
-->
<!ELEMENT patientbirthdateformat              (#PCDATA)>
<!ATTLIST patientbirthdateformat
	%lang.att;
>

<!--
Field ref:	B.1.2.1b
Field title:	Date of birth
Field name:	patientbirthdate
Field length:	8N
Field values:
-->
<!ELEMENT patientbirthdate              (#PCDATA)>
<!ATTLIST patientbirthdate
	%lang.att;
>

<!--
Field ref:	B.1.2.2a
Field title:	Age at time of onset of reaction/event value
Field name:	patientonsetage
Field length:	5N
Field values:
-->
<!ELEMENT patientonsetage               (#PCDATA)>
<!ATTLIST patientonsetage
	%lang.att;
>

<!--
Field ref:	B.1.2.2b
Field title:	Age at time of onset of reaction/event unit
Field name:	patientonsetageunit
Field length:	3N
Field values:
800=Decade
801=Year
802=Month
803=Week
804=Day
805=Hour
-->
<!ELEMENT patientonsetageunit               (#PCDATA)>
<!ATTLIST patientonsetageunit
	%lang.att;
>

<!--
Field ref:	B.1.2.2.1a
Field title:	Gestation period when reaction/event was observed in the fetus
Field name:	gestationperiod
Field length:	3N
Field values:
-->
<!ELEMENT gestationperiod               (#PCDATA)>
<!ATTLIST gestationperiod
	%lang.att;
>

<!--
Field ref:	B.1.2.2.1b
Field title:	Gestation period unit
Field name:	gestationperiodunit
Field length:	3N
Field values:
802=Month
803=Week
804=Day
810=Trimester
-->
<!ELEMENT gestationperiodunit               (#PCDATA)>
<!ATTLIST gestationperiodunit
	%lang.att;
>

<!--
Field ref:	B.1.2.3
Field title:	Patient age group
Field name:	patientagegroup
Field length:	1N
Field values:
1=Neonate
2=Infant
3=Child
4=Adolescent
5=Adult
6=Elderly
-->
<!ELEMENT patientagegroup               (#PCDATA)>
<!ATTLIST patientagegroup
	%lang.att;
>

<!--
Field ref:	B.1.3
Field title:	Weight (kg)
Field name:	patientweight
Field length:	6N
Field values:
-->
<!ELEMENT patientweight                 (#PCDATA)>
<!ATTLIST patientweight
	%lang.att;
>

<!--
Field ref:	B.1.4
Field title:	Height (cm)
Field name:	patientheight
Field length:	3N
Field values:
-->
<!ELEMENT patientheight                 (#PCDATA)>
<!ATTLIST patientheight
	%lang.att;
>

<!--
Field ref:	B.1.5
Field title:	Sex
Field name:	patientsex
Field length:	1N
Field values:	(ISO 5218)
1=Male
2=Female
9=Not specified
0=Unknown
-->
<!ELEMENT patientsex                    (#PCDATA)>
<!ATTLIST patientsex
	%lang.att;
>

<!--
Field ref:	B.1.6a
Field title:	Last menstrual period date format
Field name:	lastmenstrualdateformat
Field length:	3N
Field values:
102=CCYYMMDD
610=CCYYMM
602=CCYY
-->
<!ELEMENT patientlastmenstrualdateformat      (#PCDATA)>
<!ATTLIST patientlastmenstrualdateformat
	%lang.att;
>

<!--
Field ref:	B.1.6a
Field title:	Last menstrual period date format
Field name:	lastmenstrualdateformat
Field length:	3N
Field values:
102=CCYYMMDD
610=CCYYMM
602=CCYY
-->
<!ELEMENT lastmenstrualdateformat      (#PCDATA)>
<!ATTLIST lastmenstrualdateformat
	%lang.att;
>

<!--
Field ref:	B.1.6b
Field title:	Last menstrual period date
Field name:	patientlastmenstrualdate
Field length:	8N
Field values:
-->
<!ELEMENT patientlastmenstrualdate      (#PCDATA)>
<!ATTLIST patientlastmenstrualdate
	%lang.att;
>

<!--
Field ref:	B.1.7.1a
Field title:	Disease/surgical procedure
Field name:	patientmedicalepisodename
Field length:	100AN
Field values:
-->
<!ELEMENT patientmedicalepisodename     (#PCDATA)>
<!ATTLIST patientmedicalepisodename
	%lang.att;
>

<!--
Field ref:	B.1.7.1b
Field title:	Start date format
Field name:	patientmedicalstartdateformat
Field length:	3N
Field values:
102=CCYYMMDD
610=CCYYMM
602=CCYY
-->
<!ELEMENT patientmedicalstartdateformat       (#PCDATA)>
<!ATTLIST patientmedicalstartdateformat
	%lang.att;
>

<!--
Field ref:	B.1.7.1c
Field title:	Start date
Field name:	patientmedicalstartdate
Field length:	8N
Field values:
-->
<!ELEMENT patientmedicalstartdate       (#PCDATA)>
<!ATTLIST patientmedicalstartdate
	%lang.att;
>

<!--
Field ref:	B.1.7.1d
Field title:	Continuing
Field name:	patientmedicalcontinue
Field length:	1N
Field values:
1=Yes
2=No
3=Unknown
-->
<!ELEMENT patientmedicalcontinue        (#PCDATA)>
<!ATTLIST patientmedicalcontinue
	%lang.att;
>

<!--
Field ref:	B.1.7.1e
Field title:	End date format
Field name:	patientmedicalenddateformat
Field length:	3N
Field values:
102=CCYYMMDD
610=CCYYMM
602=CCYY
-->
<!ELEMENT patientmedicalenddateformat         (#PCDATA)>
<!ATTLIST patientmedicalenddateformat
	%lang.att;
>

<!--
Field ref:	B.1.7.1f
Field title:	End date
Field name:	patientmedicalenddate
Field length:	8N
Field values:
-->
<!ELEMENT patientmedicalenddate         (#PCDATA)>
<!ATTLIST patientmedicalenddate
	%lang.att;
>

<!--
Field ref:	B.1.7.1g
Field title:	Comments
Field name:	patientmedicalcomment
Field length:	100AN
Field values:
-->
<!ELEMENT patientmedicalcomment         (#PCDATA)>
<!ATTLIST patientmedicalcomment
	%lang.att;
>

<!--
Field ref:	B.1.7.2
Field title:	Text for relevant medical history and concurrent conditions
Field name:	patientmedicalhistorytext
Field length:	2000AN
Field values:
-->
<!ELEMENT patientmedicalhistorytext     (#PCDATA)>
<!ATTLIST patientmedicalhistorytext
	%lang.att;
>

<!--
Block ref:	B.1.8
Block title:	DRUG HISTORY
Block name:
-->

<!--
Field ref:	B.1.8a
Field title:	Name of drug
Field name:	patientdrugname
Field length:	70AN
Field values:
-->
<!ELEMENT patientdrugname               (#PCDATA)>
<!ATTLIST patientdrugname
	%lang.att;
>

<!--
Field ref:	B.1.8b
Field title:	Start date format
Field name:	patientdrugstartdateformat
Field length:	3N
Field values:
102=CCYYMMDD
610=CCYYMM
602=CCYY

-->
<!ELEMENT patientdrugstartdateformat          (#PCDATA)>
<!ATTLIST patientdrugstartdateformat
	%lang.att;
>

<!--
Field ref:	B.1.8c
Field title:	Start date
Field name:	patientdrugstartdate
Field length:	8N
Field values:
Comment :
-->
<!ELEMENT patientdrugstartdate          (#PCDATA)>
<!ATTLIST patientdrugstartdate
	%lang.att;
>

<!--
Field ref:	B.1.8d
Field title:	End date format
Field name:	patientdrugenddateformat
Field length:	3N
Field values:
102=CCYYMMDD
610=CCYYMM
602CCYY
-->
<!ELEMENT patientdrugenddateformat            (#PCDATA)>
<!ATTLIST patientdrugenddateformat
	%lang.att;
>

<!--
Field ref:	B.1.8e
Field title:	End date
Field name:	patientdrugenddate
Field length:	8N
Field values:
-->
<!ELEMENT patientdrugenddate            (#PCDATA)>
<!ATTLIST patientdrugenddate
	%lang.att;
>

<!--
Field ref:	B.1.8f
Field title:	Indication
Field name:	patientdrugindication
Field length:	100AN
Field values:
-->
<!ELEMENT patientdrugindication         (#PCDATA)>
<!ATTLIST patientdrugindication
	%lang.att;
>

<!--
Field ref:	B.1.8g
Field title:	Reaction
Field name:	patientdrugreaction
Field length:	100AN
Field values:
-->
<!ELEMENT patientdrugreaction           (#PCDATA)>
<!ATTLIST patientdrugreaction
	%lang.att;
>

<!--
Block ref:	B.1.9
Block title:	PATIENT DEATH
Block name:
-->

<!--
Field ref:	B.1.9.1a
Field title:	Date of death format
Field name:	patientdeathdateformat
Field length:	3N
Field values:
102=CCYYMMDD
610=CCYYMM
602=CCYY
-->
<!ELEMENT patientdeathdateformat              (#PCDATA)>
<!ATTLIST patientdeathdateformat
	%lang.att;
>

<!--
Field ref:	B.1.9.1b
Field title:	Date of death
Field name:	patientdeathdate
Field length:	8N
Field values:
-->
<!ELEMENT patientdeathdate              (#PCDATA)>
<!ATTLIST patientdeathdate
	%lang.att;
>

<!--
Field ref:	B.1.9.2
Field title:	Reported cause of death
Field name:	patientdeathreport
Field length:	100AN
Field values:
Comment :	Field controlled by MedDRA LLT 2.1 or superior.
-->
<!ELEMENT patientdeathreport            (#PCDATA)>
<!ATTLIST patientdeathreport
	%lang.att;
>

<!--
Field ref:	B.1.9.3
Field title:	Was autopsy done?
Field name:	patientautopsyyesno
Field length:	1N
Field values:
1=Yes
2=No
3=Unknown
-->
<!ELEMENT patientautopsyyesno           (#PCDATA)>
<!ATTLIST patientautopsyyesno
	%lang.att;
>

<!--
Field ref:	B.1.9.4
Field title:	Autopsy-determined causes(s) of death
Field name:	patientdetermineautopsy
Field length:	100AN
Field values:
Comment :	Field controlled by MedDRA LLT 2.1 or superior.
-->
<!ELEMENT patientdetermineautopsy       (#PCDATA)>
<!ATTLIST patientdetermineautopsy
	%lang.att;
>

<!--
Block ref:	B.1.10
Block title:	PARENT
Block name:
-->

<!--
Field ref:	B.1.10.1
Field title:	Parent identification
Field name:	parentidentification
Field length:	10AN
Field values:
-->
<!ELEMENT parentidentification          (#PCDATA)>
<!ATTLIST parentidentification
	%lang.att;
>

<!--
Field ref:	B.1.10.2.1a
Field title:	Date of birth of parent format
Field name:	parentbirthdateformat
Field length:	3N
Field values:	102=CCYYMMDD
-->
<!ELEMENT parentbirthdateformat               (#PCDATA)>
<!ATTLIST parentbirthdateformat
	%lang.att;
>

<!--
Field ref:	B.1.10.2.1b
Field title:	Date of birth of parent
Field name:	parentbirthdate
Field length:	8N
Field values:
-->
<!ELEMENT parentbirthdate               (#PCDATA)>
<!ATTLIST parentbirthdate
	%lang.att;
>

<!--
Field ref:	B.1.10.2.2a
Field title:	Age of parent value
Field name:	parentage
Field length:	2N
Field values:
-->
<!ELEMENT parentage                     (#PCDATA)>
<!ATTLIST parentage
	%lang.att;
>

<!--
Field ref:	B.1.10.2.2b
Field title:	Age of parent unit
Field name:	parentageunit
Field length:	3N
Field values:	801=Year
-->
<!ELEMENT parentageunit                     (#PCDATA)>
<!ATTLIST parentageunit
	%lang.att;
>

<!--
Field ref:	B.1.10.3a
Field title:	Last menstrual period date format
Field name:	parentlastmenstrualdateformat
Field length:	3N
Field values:	102=CCYYMMDD
-->
<!ELEMENT parentlastmenstrualdateformat       (#PCDATA)>
<!ATTLIST parentlastmenstrualdateformat
	%lang.att;
>

<!--
Field ref:	B.1.10.3b
Field title:	Last menstrual period date
Field name:	parentlastmenstrualdate
Field length:	8N
Field values:
-->
<!ELEMENT parentlastmenstrualdate       (#PCDATA)>
<!ATTLIST parentlastmenstrualdate
	%lang.att;
>

<!--
Field ref:	B.1.10.4
Field title:	Weight (kg) of parent
Field name:	parentweight
Field length:	6N
Field values:
-->
<!ELEMENT parentweight                  (#PCDATA)>
<!ATTLIST parentweight
	%lang.att;
>

<!--
Field ref:	B.1.10.5
Field title:	Height (cm) of parent
Field name:	parentheight
Field length:	3N
Field values:
-->
<!ELEMENT parentheight                  (#PCDATA)>
<!ATTLIST parentheight
	%lang.att;
>

<!--
Field ref:	B.1.10.6
Field title:	Sex of parent
Field name:	parentsex
Field length:	1N
Field values:	(ISO5218)
1=Male
2=Female
9=Not Specified
0=Unknown
-->
<!ELEMENT parentsex                     (#PCDATA)>
<!ATTLIST parentsex
	%lang.att;
>

<!--
Block ref:	B.1.10.7
Block title:	PARENT MEDICAL EPISODE
Block name:
-->

<!--
Field ref:	B.1.10.7.1a
Field title:	Desease / surgical procedure
Field name:	parentmedicalepisodename
Field length:	100AN
Field values:
Comment :	Field controlled by MedDRA LLT 2.1 or superior.
-->
<!ELEMENT parentmedicalepisodename      (#PCDATA)>
<!ATTLIST parentmedicalepisodename
	%lang.att;
>

<!--
Field ref:	B.1.10.7.1b
Field title:	Start date format
Field name:	parentmedicalstartdateformat
Field length:	3N
Field values:
102=CCYYMMDD
610=CCYYMM
602=CCYY
-->
<!ELEMENT parentmedicalstartdateformat        (#PCDATA)>
<!ATTLIST parentmedicalstartdateformat
	%lang.att;
>

<!--
Field ref:	B.1.10.7.1c
Field title:	Start date
Field name:	parentmedicalstartdate
Field length:	8N
Field values:
-->
<!ELEMENT parentmedicalstartdate        (#PCDATA)>
<!ATTLIST parentmedicalstartdate
	%lang.att;
>

<!--
Field ref:	B.1.10.7.1d
Field title:	Continuing
Field name:	parentmedicalcontinue
Field length:	1N
Field values:
1=Yes
2=No
3=Unknown
-->
<!ELEMENT parentmedicalcontinue         (#PCDATA)>
<!ATTLIST parentmedicalcontinue
	%lang.att;
>

<!--
Field ref:	B.1.10.7.1e
Field title:	End date format
Field name:	parentmedicalenddateformat
Field length:	3N
Field values:
102=CCYYMMDD
610=CCYYMM
602=CCYY
-->
<!ELEMENT parentmedicalenddateformat          (#PCDATA)>
<!ATTLIST parentmedicalenddateformat
	%lang.att;
>

<!--
Field ref:	B.1.10.7.1f
Field title:	End date
Field name:	parentmedicalenddate
Field length:	8N
Field values:
-->
<!ELEMENT parentmedicalenddate          (#PCDATA)>
<!ATTLIST parentmedicalenddate
	%lang.att;
>

<!--
Field ref:	B.1.10.7.1g
Field title:	Comments
Field name:	parentmedicalcomment
Field length:	100AN
Field values:
-->
<!ELEMENT parentmedicalcomment          (#PCDATA)>
<!ATTLIST parentmedicalcomment
	%lang.att;
>

<!--
Field ref:	B.1.10.7.2
Field title:	Text for relevant medical history and concurrent conditions (not including reaction / event) of parent
Field name:	parentmedicalrelevanttext
Field length:	500AN
Field values:
-->
<!ELEMENT parentmedicalrelevanttext     (#PCDATA)>
<!ATTLIST parentmedicalrelevanttext
	%lang.att;
>

<!--
Field ref:	B.1.10.8a
Field title:	Name of drug
Field name:	parentdrugname
Field length:	70AN
Field values:
-->
<!ELEMENT parentdrugname                (#PCDATA)>
<!ATTLIST parentdrugname
	%lang.att;
>

<!--
Field ref:	B.1.10.8b
Field title:	Start date format
Field name:	parentdrugstartdateformat
Field length:	3N
Field values:
102=CCYYMMDD
610=CCYYMM
602=CCYY
-->
<!ELEMENT parentdrugstartdateformat           (#PCDATA)>
<!ATTLIST parentdrugstartdateformat
	%lang.att;
>

<!--
Field ref:	B.1.10.8c
Field title:	Start date
Field name:	parentdrugstartdate
Field length:	8N
Field values:
-->
<!ELEMENT parentdrugstartdate           (#PCDATA)>
<!ATTLIST parentdrugstartdate
	%lang.att;
>

<!--
Field ref:	B.1.10.8d
Field title:	End date format
Field name:	parentdrugenddateformat
Field length:	3N
Field values:
102=CCYYMMDD
610=CCYYMM
602=CCYY
-->
<!ELEMENT parentdrugenddateformat             (#PCDATA)>
<!ATTLIST parentdrugenddateformat
	%lang.att;
>

<!--
Field ref:	B.1.10.8e
Field title:	End date
Field name:	parentdrugenddate
Field length:	8N
Field values:
-->
<!ELEMENT parentdrugenddate             (#PCDATA)>
<!ATTLIST parentdrugenddate
	%lang.att;
>

<!--
Field ref:	B.1.10.8f
Field title:	Indication
Field name:	parentdrugindication
Field length:	100AN
Field values:
-->
<!ELEMENT parentdrugindication          (#PCDATA)>
<!ATTLIST parentdrugindication
	%lang.att;
>


<!--
Field ref:	B.1.10.8g
Field title:	Reactions (if any and known)
Field name:	parentdrugreaction
Field length:	100AN
Field values:
-->
<!ELEMENT parentdrugreaction            (#PCDATA)>
<!ATTLIST parentdrugreaction
	%lang.att;
>

<!--
Block ref:	B.2
Block title:	REACTION
Block name:
-->

<!--
Field ref:	B.2.i.1
Field title:	Reaction / event as reported by primary
Field name:	primarysourcereaction
Field length:	100AN
Field values:
-->
<!ELEMENT primarysourcereaction         (#PCDATA)>
<!ATTLIST primarysourcereaction
	%lang.att;
>

<!--
Field ref:	B.2.i.2
Field title:	Reaction / event term
Field name:	reactionterm
Field length:	100AN
Field values:
Comment :	Field controlled by MedDRA LLT 2.1 or superior.
-->
<!ELEMENT reactionterm                  (#PCDATA)>
<!ATTLIST reactionterm
	%lang.att;
>

<!--
Field ref:	B.2.i.3
Field title:	Term highlighted by the reporter
Field name:	termhighlighted
Field length:	1N
Field values:	1=Yes
-->
<!ELEMENT termhighlighted               (#PCDATA)>
<!ATTLIST termhighlighted
	%lang.att;
>

<!--
Field ref:	B.2.i.4a
Field title:	Date of start of reaction/event format
Field name:	reactionstartdateformat
Field length:	3N
Field values:
102=CCYYMMDD
203=CCYYMMDDHHMM
610=CCYYMM
602=CCYY
-->
<!ELEMENT reactionstartdateformat             (#PCDATA)>
<!ATTLIST reactionstartdateformat
	%lang.att;
>

<!--
Field ref:	B.2.i.4b
Field title:	Date of start of reaction/event
Field name:	reactionstartdate
Field length:	12N
Field values:
-->
<!ELEMENT reactionstartdate             (#PCDATA)>
<!ATTLIST reactionstartdate
	%lang.att;
>

<!--
Field ref:	B.2.i.5a
Field title:	Date of end of reaction/event format
Field name:	reactionenddateformat
Field length:	3N
Field values:
102=CCYYMMDD
203=CCYYMMDDHHMM
610=CCYYMM
602=CCYY
-->
<!ELEMENT reactionenddateformat               (#PCDATA)>
<!ATTLIST reactionenddateformat
	%lang.att;
>

<!--
Field ref:	B.2.i.5b
Field title:	Date of end of reaction/event
Field name:	reactionenddate
Field length:	12N
Field values:
-->
<!ELEMENT reactionenddate               (#PCDATA)>
<!ATTLIST reactionenddate
	%lang.att;
>

<!--
Field ref:	B.2.i.6a
Field title:	Duration of reaction/event value
Field name:	reactionduration
Field length:	5N
Field values:
-->
<!ELEMENT reactionduration              (#PCDATA)>
<!ATTLIST reactionduration
	%lang.att;
>

<!--
Field ref:	B.2.i.6b
Field title:	Duration of reaction/event unit
Field name:	reactiondurationunit
Field length:	3N
Field values:
801=Year
802=Month
803=Week
804=Day
805=Hour
806=Minute
807=Second
-->
<!ELEMENT reactiondurationunit              (#PCDATA)>
<!ATTLIST reactiondurationunit
	%lang.att;
>

<!--
Field ref:	B.2.i.7.1a
Field title:	Time interval between beginning of suspect drug administration and start of reaction/event
Field name:	reactionfirsttime
Field length:	5N
Field values:
-->
<!ELEMENT reactionfirsttime             (#PCDATA)>
<!ATTLIST reactionfirsttime
	%lang.att;
>

<!--
Field ref:	B.2.i.7.1b
Field title:	Time interval unit between beginning of suspect drug administration and start of reaction/event
Field name:	reactionfirsttimeunit
Field length:	3N
Field values:
801=Year
802=Month
803=Week
804=Day
805=Hour
806=Minute
807=Second
-->
<!ELEMENT reactionfirsttimeunit             (#PCDATA)>
<!ATTLIST reactionfirsttimeunit
	%lang.att;
>

<!--
Field ref:	B.2.i.7.2a
Field title:	Time interval between last dose and start of reaction/event
Field name:	reactionlasttime
Field length:	5N
Field values:
-->
<!ELEMENT reactionlasttime              (#PCDATA)>
<!ATTLIST reactionlasttime
	%lang.att;
>

<!--
Field ref:	B.2.i.7.2b
Field title:	Time interval between last dose and start of reaction/event unit
Field name:	reactionlasttimeunit
Field length:	3N
Field values:
801=Year
802=Month
803=Week
804=Day
805=Hour
806=Minute
807=Second
-->
<!ELEMENT reactionlasttimeunit              (#PCDATA)>
<!ATTLIST reactionlasttimeunit
	%lang.att;
>

<!--
Field ref:	B.2.i.8
Field title:	Outcome of reaction / event at the time of last observation
Field name:	reactionoutcome
Field length:	1N
Field values:
1=recovered/resolved
2=recovering/resolving
3=not recovered/not resolved
4=recovered/resolved with sequel
5=fatal
6=unknown
-->
<!ELEMENT reactionoutcome               (#PCDATA)>
<!ATTLIST reactionoutcome
	%lang.att;
>

<!--
Block ref:	B.3
Block title:	TEST
Block name:
-->

<!--
Field title:	Date format
Field name:	testdateformat
Field ref:	B.3.1a
Field length:	3N
Field values:	102=CCYYMMDD; 610=CCYYMM; 602=CCYY
-->
<!ELEMENT testdateformat                      (#PCDATA)>
<!ATTLIST testdateformat
	%lang.att;
>

<!--
Field ref:	B.3.1b
Field title:	Test date
Field name:	testdate
Field length:	8N
Field values:
-->
<!ELEMENT testdate                      (#PCDATA)>
<!ATTLIST testdate
	%lang.att;
>

<!--
Field ref:	B.3.1c
Field title:	Test
Field name:	testname
Field length:	70AN
Field values:
-->
<!ELEMENT testname                      (#PCDATA)>
<!ATTLIST testname
	%lang.att;
>

<!--
Field ref:	B.3.1d
Field title:	Result
Field name:	testresult
Field length:	10AN
Field values:
-->
<!ELEMENT testresult                    (#PCDATA)>
<!ATTLIST testresult
	%lang.att;
>

<!--
Field ref:	B.3.1e
Field title:	Test unit
Field name:	testunit
Field length:	35AN
Field values:
-->
<!ELEMENT testunit                      (#PCDATA)>
<!ATTLIST testunit
	%lang.att;
>

<!--
Field ref:	B.3.1.1
Field title:	Normal low range
Field name:	lowtestrange
Field length:	10AN
Field values:
-->
<!ELEMENT lowtestrange                  (#PCDATA)>
<!ATTLIST lowtestrange
	%lang.att;
>

<!--
Field ref:	B.3.1.
Field title:	Normal high range
Field name:	hightestrange
Field length:	10AN
Field values:
-->
<!ELEMENT hightestrange                 (#PCDATA)>
<!ATTLIST hightestrange
	%lang.att;
>

<!--
Field ref:	B.3.1.3
Field title:	More information available (Y/N)
Field name:	moreinformation
Field length:	1N
Field values:
1=Yes
2=No
-->
<!ELEMENT moreinformation               (#PCDATA)>
<!ATTLIST moreinformation
	%lang.att;
>

<!--
Field ref:	B.3.2
Field title:	Results of tests and procedures relevant to the investigation of the patient
Field name:	resultstestsprocedures
Field length:	2000AN
Field values:
-->
<!ELEMENT resultstestsprocedures        (#PCDATA)>
<!ATTLIST resultstestsprocedures
	%lang.att;
>

<!--
Block ref:	B.4
Block title:	DRUG
Block name:
-->

<!--
Field ref:	B.4.k.1
Field title:	Characterization of drug
Field name:	drugcharacterization
Field length:	1N
Field values:
1=Suspect
2=Concomitant
3=Interacting
-->
<!ELEMENT drugcharacterization          (#PCDATA)>
<!ATTLIST drugcharacterization
	%lang.att;
>

<!--
Field ref:	B.4.k.2.1
Field title:	Proprietary medicinal product name
Field name:	medicinalproduct
Field length:	70AN
Field values:
Comment :	Mandatory field. This field should be populated according to the EMP Product Dictionary or the WHO Drug Dictionary.
-->
<!ELEMENT medicinalproduct              (#PCDATA)>
<!ATTLIST medicinalproduct
	%lang.att;
>

<!--
Block ref:	B.4.k.2
Block title:	ACTIVE SUBSTANCE
Block name:
-->

<!--
Field ref:	B.4.k.2.2
Field title:	Active drug substance name
Field name:	activesubstancename
Field length:	70AN
Field values:
-->
<!ELEMENT activesubstancename           (#PCDATA)>
<!ATTLIST activesubstancename
	%lang.att;
>

<!--
Field ref:	B.4.k.2.3
Field title:	Identification of the country where the drug was obtained
Field name:	obtaindrugcountry
Field length:	2A
Field values:	ISO3166
-->
<!ELEMENT obtaindrugcountry             (#PCDATA)>
<!ATTLIST obtaindrugcountry
	%lang.att;
>

<!--
Field ref:	B.4.k.3
Field title:	Batch / lot number
Field name:	drugbatchnumb
Field length:	35AN
Field values:
-->
<!ELEMENT drugbatchnumb                 (#PCDATA)>
<!ATTLIST drugbatchnumb
	%lang.att;
>

<!--
Field ref:	B.4.k.4.1
Field title:	Authorization / application number
Field name:	drugauthorizationnumb
Field length:	35AN
Field values:
-->
<!ELEMENT drugauthorizationnumb         (#PCDATA)>
<!ATTLIST drugauthorizationnumb
	%lang.att;
>

<!--
Field ref:	B.4.k.4.2
Field title:	Country of authorization / application
Field name:	drugauthorizationcountry
Field length:	2A
Field values:	ISO3166
-->
<!ELEMENT drugauthorizationcountry      (#PCDATA)>
<!ATTLIST drugauthorizationcountry
	%lang.att;
>

<!--
Field ref:	B.4.k.4.3
Field title:	Name of drug authorization holder
Field name:	drugauthorizationholder
Field length:	60AN
Field values:
-->
<!ELEMENT drugauthorizationholder       (#PCDATA)>
<!ATTLIST drugauthorizationholder
	%lang.att;
>

<!--
Field ref:	B.4.k.5.1
Field title:	Dose (number)
Field name:	drugstructuredosagenumb
Field length:	8N
Field values:
-->
<!ELEMENT drugstructuredosagenumb       (#PCDATA)>
<!ATTLIST drugstructuredosagenumb
	%lang.att;
>

<!--
Field ref:	B.4.k.5.2
Field title:	Dose (unit)
Field name:	drugstructuredosageunit
Field length:	3N
Field values:
001=kg kilogram(s)
002=G gram(s)
003=Mg milligram(s)
004=µg microgram(s)
005=ng nanogram(s)
006=pg picogram(s)
007=mg/kg milligram(s)/kilogram
008=µg/kg microgram(s)/kilogram
009=mg/m 2 milligram(s)/sq. meter
010=µg/ m 2 microgram(s)/ sq. Meter
011=l litre(s)
012=ml millilitre(s)
013=µl microlitre(s)
014=Bq becquerel(s)
015=GBq gigabecquerel(s)
016=MBq megabecquerel(s)
017=Kbq kilobecquerel(s)
018=Ci curie(s)
019=MCi millicurie(s)
020=µCi microcurie(s)
021=NCi nanocurie(s)
022=Mol mole(s)
023=Mmol millimole(s)
024=µmol micromole(s)
025=Iu international unit(s)
026=Kiu iu(1000s)
027=Miu iu(1,000,000s)
028=iu/kg iu/kilogram
029=Meq milliequivalent(s)
030=% percent
031=Gtt drop(s)
032=DF dosage form
-->
<!ELEMENT drugstructuredosageunit       (#PCDATA)>
<!ATTLIST drugstructuredosageunit
	%lang.att;
>

<!--
Field ref:	B.4.k.5.3
Field title:	Number of separate drug separate dosages
Field name:	drugseparatedosagenumb
Field length:	3N
Field values:
-->
<!ELEMENT drugseparatedosagenumb        (#PCDATA)>
<!ATTLIST drugseparatedosagenumb
	%lang.att;
>

<!--
Field ref:	B.4.k.5.4
Field title:	Number of units in the interval
Field name:	drugintervaldosageunitnumb
Field length:	3N
Field values:
-->
<!ELEMENT drugintervaldosageunitnumb            (#PCDATA)>
<!ATTLIST drugintervaldosageunitnumb
	%lang.att;
>

<!--
Field ref:	B.4.k.5.5
Field title:	Definition of the interval
Field name:	drugintervaldosagedefinition
Field length:	3AN
Field values:
-->
<!ELEMENT drugintervaldosagedefinition          (#PCDATA)>
<!ATTLIST drugintervaldosagedefinition
	%lang.att;
>

<!--
Field ref:	B.4.k.5.6
Field title:	Cumulative dose to first reaction (number)
Field name:	drugcumulativedosagenumb
Field length:	10N
Field values:
-->
<!ELEMENT drugcumulativedosagenumb      (#PCDATA)>
<!ATTLIST drugcumulativedosagenumb
	%lang.att;
>

<!--
Field ref:	B.4.k.5.7
Field title:	Cumulative dose to first reaction (unit)
Field name:	drugcumulativedosageunit
Field length:	3AN
Field values:
-->
<!ELEMENT drugcumulativedosageunit      (#PCDATA)>
<!ATTLIST drugcumulativedosageunit
	%lang.att;
>

<!--
Field ref:	B.4.k.6
Field title:	Dosage text
Field name:	drugdosagetext
Field length:	100AN
Field values:
-->
<!ELEMENT drugdosagetext                (#PCDATA)>
<!ATTLIST drugdosagetext
	%lang.att;
>

<!--
Field ref:	B.4.k.7
Field title:	Pharmaceutical form (Dosage form)
Field name:	drugdosageform
Field length:	50AN
Field values:	Field controlled by the  List of Standard Terms.
-->
<!ELEMENT drugdosageform                (#PCDATA)>
<!ATTLIST drugdosageform
	%lang.att;
>

<!--
Field ref:	B.4.k.8
Field title:	Route of administration
Field name:	drugadministrationroute
Field length:	3N
Field values:
001=Auricular (otic)
002=Buccal
003=Cutaneous
004=Dental
005=Endocervical
006=Endosinusial
007=Endotracheal
008=Epidural
009=Extra-amniotic
010=Hemodialysis
011=Intra corpus cavernosum
012=Intra-amniotic
013=Intra-arterial
014=Intra-articular
015=Intra-uterine
016=Intracardiac
017=Intracavernous
018=Intracerebral
019=Intracervical
020=Intracisternal
021=Intracorneal
022=Intracoronary
023=Intradermal
024=Intradiscal (intraspinal)
025=Intrahepatic
026=Intralesional
027=Intralymphatic
028=Intramedullar (bone marrow)
029=Intrameningeal
030=Intramuscular
031=Intraocular
032=Intrapericardial
033=Intraperitoneal
034=Intrapleural
035=Intrasynovial
036=Intratumor
037=Intrathecal
038=Intrathoracic
039=Intratracheal
040=Intravenous bolus
041=Intravenous drip
042=Intravenous (not otherwise specified)
043=Intravesical
044=Iontophoresis
045=Nasal
046=Occlusive dressing technique
047=Ophthalmic
048=Oral
049=Oropharingeal
050=Other
051=Parenteral
052=Periarticular
053=Perineural
054=Rectal
055=Respiratory (inhalation)
056=Retrobulbar
057=Sunconjunctival
058=Subcutaneous
059=Subdermal
060=Sublingual
061=Topical
062=Transdermal
063=Transmammary
064=Transplacental
065=Unknown
066=Urethral
067=Vaginal
-->
<!ELEMENT drugadministrationroute       (#PCDATA)>
<!ATTLIST drugadministrationroute
	%lang.att;
>

<!--
Field ref:	B.4.k.9
Field title:	Parent route of administration (in case of a parent child / fetus report)
Field name:	drugparadministration
Field length:	3N
Field values:
001=Auricular (otic)
002=Buccal
003=Cutaneous
004=Dental
005=Endocervical
006=Endosinusial
007=Endotracheal
008=Epidural
009=Extra-amniotic
010=Hemodialysis
011=Intra corpus cavernosum
012=Intra-amniotic
013=Intra-arterial
014=Intra-articular
015=Intra-uterine
016=Intracardiac
017=Intracavernous
018=Intracerebral
019=Intracervical
020=Intracisternal
021=Intracorneal
022=Intracoronary
023=Intradermal
024=Intradiscal (intraspinal)
025=Intrahepatic
026=Intralesional
027=Intralymphatic
028=Intramedullar (bone marrow)
029=Intrameningeal
030=Intramuscular
031=Intraocular
032=Intrapericardial
033=Intraperitoneal
034=Intrapleural
035=Intrasynovial
036=Intratumor
037=Intrathecal
038=Intrathoracic
039=Intratracheal
040=Intravenous bolus
041=Intravenous drip
042=Intravenous (not otherwise specified)
043=Intravesical
044=Iontophoresis
045=Nasal
046=Occlusive dressing technique
047=Ophthalmic
048=Oral
049=Oropharingeal
050=Other
051=Parenteral
052=Periarticular
053=Perineural
054=Rectal
055=Respiratory (inhalation)
056=Retrobulbar
057=Sunconjunctival
058=Subcutaneous
059=Subdermal
060=Sublingual
061=Topical
062=Transdermal
063=Transmammary
064=Transplacental
065=Unknown
066=Urethral
067=Vaginal
-->
<!ELEMENT drugparadministration         (#PCDATA)>
<!ATTLIST drugparadministration
	%lang.att;
>

<!--
Field ref:	B.4.k.10a
Field title:	Gestation period at time of exposure
Field name:	reactiongestationperiod
Field length:	3N
Field values:
-->
<!ELEMENT reactiongestationperiod       (#PCDATA)>
<!ATTLIST reactiongestationperiod
	%lang.att;
>

<!--
Field ref:	B.4.k.10b
Field title:	Gestation period unit
Field name:	reactiongestationperiodunit
Field length:	3N
Field values:
802=Month
803=Week
804=Day
810=Trimester
-->
<!ELEMENT reactiongestationperiodunit       (#PCDATA)>
<!ATTLIST reactiongestationperiodunit
	%lang.att;
>

<!--
Field ref:	B.4.k.11
Field title:	Indication for use in the case
Field name:	drugindication
Field length:	100AN
Field values:
Comment :	Field controlled by MedDRA LLT 2.1 or superior.
-->
<!ELEMENT drugindication                (#PCDATA)>
<!ATTLIST drugindication
	%lang.att;
>

<!--
Field ref:	B.4.k.12a
Field title:	Date of start of drug format
Field name:	drugstartdateformat
Field length:	3N
Field values:
102=CCYYMMDD
610=CCYYMM
602=CCYY
-->
<!ELEMENT drugstartdateformat                 (#PCDATA)>
<!ATTLIST drugstartdateformat
	%lang.att;
>

<!--
Field ref:	B.4.k.12b
Field title:	Date of start of drug
Field name:	drugstartdate
Field length:	8N
Field values:
-->
<!ELEMENT drugstartdate                 (#PCDATA)>
<!ATTLIST drugstartdate
	%lang.att;
>

<!--
Field ref:	B.4.k.13.1a
Field title:	Time interval between beginning of drug administration and start of reaction/event
Field name:	drugstartperiod
Field length:	5N
Field values:
-->
<!ELEMENT drugstartperiod	        (#PCDATA)>
<!ATTLIST drugstartperiod
	%lang.att;
>

<!--
Field ref:	B.4.k.13.1b
Field title:	Time interval between beginning of drug administration and start of reaction/event unit
Field name:	drugstartperiodunit
Field length:	3N
Field values:
801=Year
802=Month
803=Week
804=Day
805=Hour
806=Minute
807=Second
-->
<!ELEMENT drugstartperiodunit	        (#PCDATA)>
<!ATTLIST drugstartperiodunit
	%lang.att;
>

<!--
Field ref:	B.4.k.12.2a
Field title:	Time interval between last dose of drug and start of reaction/event
Field name:	druglastperiod
Field length:	5N
Field values:
-->
<!ELEMENT druglastperiod	        (#PCDATA)>
<!ATTLIST druglastperiod
	%lang.att;
>

<!--
Field ref:	B.4.k.13.2b
Field title:	Time interval between last dose of drug and start of reaction/event unit
Field name:	druglastperiodunit
Field length:	3N
Field values:
801=Year
802=Month
803=Week
804=Day
805=Hour
806=Minute
807=Second
-->
<!ELEMENT druglastperiodunit	        (#PCDATA)>
<!ATTLIST druglastperiodunit
	%lang.att;
>

<!--
Field ref:	B.4.k.14a
Field title:	Date of last administration format
Field name:	drugenddateformat
Field length:	3N
Field values:
102=CCYYMMDD
610=CCYYMM
602=CCYY
-->
<!ELEMENT drugenddateformat                   (#PCDATA)>
<!ATTLIST drugenddateformat
	%lang.att;
>

<!--
Field ref:	B.4.k.14b
Field title:	Date of last administration
Field name:	drugenddate
Field length:	8N
Field values:
-->
<!ELEMENT drugenddate                   (#PCDATA)>
<!ATTLIST drugenddate
	%lang.att;
>

<!--
Field ref:	B.4.k.15a
Field title:	Treatment duration
Field name:	drugtreatmentduration
Field length:	5N
Field values:
-->
<!ELEMENT drugtreatmentduration         (#PCDATA)>
<!ATTLIST drugtreatmentduration
	%lang.att;
>

<!--
Field ref:	B.4.k.15b
Field title:	Treatment duration unit
Field name:	drugtreatmentdurationunit
Field length:	3N
Field values:
801=Year
802=Month
803=Week
804=Day
805=Hour
806=Minute
-->
<!ELEMENT drugtreatmentdurationunit         (#PCDATA)>
<!ATTLIST drugtreatmentdurationunit
	%lang.att;
>

<!--
Field ref:	B.4.k.16
Field title:	Action(s) taken with drug
Field name:	actiondrug
Field length:	1N
Field values:
1=Drug withdrawn
2=Dose reduced
3=Dose increased
4=Dose not changed
5=Unknown
6=Not applicable
-->
<!ELEMENT actiondrug                    (#PCDATA)>
<!ATTLIST actiondrug
	%lang.att;
>

<!--
Block ref:	B.4.k.17
Block title:	DRUG RECURRENCE
Block name:
-->

<!--
Field ref:	B.4.k.17.1
Field title:	Did reaction recur on readministration?
Field name:	drugrecurreadministration
Field length:	1N
Field values:
1=Yes
2=No
3=Unknown
-->
<!ELEMENT drugrecurreadministration     (#PCDATA)>
<!ATTLIST drugrecurreadministration
	%lang.att;
>

<!--
Field ref:	B.4.k.17.2
Field title:	If yes, which reaction / event recurred?
Field name:	drugrecuraction
Field length:	100AN
Field values:
Comment :	Field controlled by MedDRA LLT 2.1 or superior.
-->
<!ELEMENT drugrecuraction               (#PCDATA)>
<!ATTLIST drugrecuraction
	%lang.att;
>

<!--
Block ref:	B.4.k.18
Block title:	DRUG/REACTION RELATEDNESS
Block name:
-->

<!--
Field ref:	B.4.k.18.1
Field title:	Reaction assessed
Field name:	drugreactionasses
Field length:	100AN
Field values:
-->
<!ELEMENT drugreactionasses             (#PCDATA)>
<!ATTLIST drugreactionasses
	%lang.att;
>

<!--
Field ref:	B.4.k.18.2
Field title:	Source of assessment
Field name:	drugassessmentsource
Field length:	60AN
Field values:
-->
<!ELEMENT drugassessmentsource          (#PCDATA)>
<!ATTLIST drugassessmentsource
	%lang.att;
>

<!--
Field ref:	B.4.k.18.3
Field title:	Method of assessment
Field name:	drugassessmentmethod
Field length:	35AN
Field values:
-->
<!ELEMENT drugassessmentmethod          (#PCDATA)>
<!ATTLIST drugassessmentmethod
	%lang.att;
>

<!--
Field ref:	B.4.k.18.4
Field title:	Assessment result
Field name:	drugresult
Field length:	35AN
Field values:
-->
<!ELEMENT drugresult                    (#PCDATA)>
<!ATTLIST drugresult
	%lang.att;
>

<!--
Field ref:	B.4.k.19
Field title:	Additional information on drug
Field name:	drugadditional
Field length:	100AN
Field values:
-->
<!ELEMENT drugadditional                (#PCDATA)>
<!ATTLIST drugadditional
	%lang.att;
>

<!--
Block ref:	B.5
Block title:	SUMMARY
Block name:
-->

<!--
Field ref:	B.5.1
Field title:	Case narrative including clinical course, therapeutic measures, outcome and additional relevant information
Field name:	narrativeincludeclinical
Field length:	10000AN
Field values:
-->
<!ELEMENT narrativeincludeclinical      (#PCDATA)>
<!ATTLIST narrativeincludeclinical
	%lang.att;
>

<!--
Field ref:	B.5.2
Field title:	Reporter's comments
Field name:	reportercomment
Field length:	210AN
Field values:
-->
<!ELEMENT reportercomment               (#PCDATA)>
<!ATTLIST reportercomment
	%lang.att;
>

<!--
Field ref:	B.5.3
Field title:	Sender's diagnosis / syndrome and / or reclassification of reaction / event
Field name:	senderdiagnosis
Field length:	210AN
Field values:
Comment :	Field controlled by MedDRA LLT 2.1 or superior.
-->
<!ELEMENT senderdiagnosis               (#PCDATA)>
<!ATTLIST senderdiagnosis
	%lang.att;
>

<!--
Field ref:	B.5.4
Field title:	Sender's comments
Field name:	sendercomment
Field length:	1000AN
Field values:
-->
<!ELEMENT sendercomment                 (#PCDATA)>
<!ATTLIST sendercomment
	%lang.att;
>