ICH E2B (R3) - jpma.or.jp

1 ICH E2B (R3) ICH 2010. 2. 17E2B (R3) E2B (R3) SDO Feasibility Testing R3 M2 E2B (R2): M2: 2000 11 ICH Step 42003 10 E2B (R3): M2: SGML XML R3 2003 11 ICH EWG 2004 5 E2B R3 EWG 2005 5 E2B R3 Guideline Step2 2005 7 9 E2B R3 Guideline 2006 6 11 ICH SDO 2007 2 E2B R3 Guideline ver. Step4 2007 3 ICH ISO New Work Item Proposal (NWIP)SDO ICHE2B R3 ver. ICH 2007 10 ICH ISO ICH E2B R3 Guideline ver. HL7 ICSR R2 R3 2008 11 ICH ICH E2B R3 Guideline ver. 2009 4 9 ISO Draft International Standard (DIS) ISO ICH ISOICSR DIS Alfa test 2009 6 ICH Feasibility Testing (Step 2 for Testing) ICH Feasibility Testing ICH ICH 2009 8 ISOICSR DIS ISO 2009 10 ICH E2B R3 E2B(R3) E2B(R2) E2B(R3) E2B(R2) (Safety report version number) ICSR (Identification of the country of the primary source) ( ) criteria held by sender (Regulatory authority s case report number) (Other sender s case report number)

2 Unique case identification number sender of this case s telephone E2B(R3) E2B(R2) E2B(R3) E2B(R2) source for regulatory purposes reference registration number registrationcountry name number type in which the reaction/eventwere occurred (Receiver) history therapies E2B(R3) E2B(R2) E2B(R3) E2B(R2) confirmation by health professional / of the country where the reaction/event occurred / (Reaction/event MedDRA term PT) / LLT PT interval between beginning of suspect drug administration and start of reaction/event / Drug/event matrix interval between last dose and start of reaction/event medication status E2B(R3) E2B(R2) E2B(R3) E2B(R2) (Number of separate dosages)

3 HL7 dose form termID of administration termID indication as reported by the primary source (Effect of rechallenge, for suspect drug only) matrix / E2B(R3) E2B(R2) E2B(R3) E2B(R2) information on drug summary and reporter s comments text EU summary and reporter s comments SDO FDA HL7 ICSR HL7 EMA CEN ISO/CEN ISO CEN ICSR ISO MHLW ICH 14 ICH SDO M2 15 SDO SDO Standard Development Organization ISO HL7 CEN SDO ICH ICH SDO ISO HL7 E2B(R3)

4 M5 2 SDO M2 eCTD SDO Joint Initiative Joint Initiative SDO SDO ISO/TC215 CEN/TC251 HL7 CDISC IEEE DICOM IHTSDO Joint Initiative Council (JIC) Joint Initiative Project Joint Initiative JIC Joint Initiative Project ICSR ISO CEN HL7 CDISC ISO HL7 ICH ISO ISO HL7 18 ICSR SDO E2B(R3)/M2 GuidelineJoint Initiative ICH E2B ICH ISO ICSR ICHISOHL7 HL7 ISO ICSR International Standard(incl. message specification)ICSR message HL7 ICH 19HL7 ICSR / ISO ICSR ICH E2B(R3)/M2 / HL7 20 HL7 ICSR R-MIM ISO ICSR R-MIM XML <xs:include schemaLocation=".

5 / "/> <xs:include schemaLocation=" "/> <xs:include schemaLocation=" "/> <xs:complexType name=" "> <xs:sequence> <xs:group ref="InfrastructureRootElements"/> <xs:element name="representedOrganization" type=" "nillable="true"minOccurs="1"maxOccurs="1"/> </xs:sequence> <xs:attributeGroup ref="InfrastructureRootAttributes"/> <xs:attribute name="nullFlavor" type="NullFlavor" use="optional"/> <xs:attribute name="classCode" type="RoleClassAgent" use="required"/> </xs:complexType> <controlActProcess moodCode="EVN" classCode="CACT"> <effectiveTime value="20090101"/> <! --> <subject typeCode="SUBJ"> <investigationEvent> <id extension=" " root="sendersReportNamespaceOid"/> <id extension=" " root="worldWideCaseIdOid"/> <code/> <text mediaType="text/plain"> </text> <statusCode/> <activityTime> <low value="20090101"/> <!

6 --> </activityTime> <availabilityTime value="20090101"/> <! --> <subject> <investigativeSubject> <subjectPerson determinerCode="INSTANCE"> <name> </name> <administrativeGenderCode code=" "/> <birthTime value="20090101"/> <! --> <deceasedTime value="20090101"/> <! --> <asResearchSubject> ICH 21 M Acknowledgement XML E2B(R3) E2B(R3) ISO XML 22IS /IS 1 FDIS /FDIS 2 DIS /DIS 5 CD /CD 3 NWIP /NWIP 3 NWIP: New Work Item Proposal NWIP CD: Committee Draft CD DIS: Draft International StandardCD DIS FDIS.

7 Final Draft International StandardDIS IS: International StandardFDIS 23 Informative/Normative 1 DSTU 1 International StandardDSTU: Draft Standard for Trial Use DSTU Normative/Informative Informative Normative E2B/M2 24 DISRe-DISFDISIS Feasibility Testing Feasibility Testing ISOICHHL7 Step 225 Feasibility Testing Testing ICH Step2 ICH ICH E2B (R3) M2 ISO HL7 ICH E2B (R2) Step 2 Testing E2B/M2 ICH PMDA HP Testing 5 DIS Feasibility Testing 1 6 6 ICH 6 ISO Feasibility Testing