159
ICH ICSR Implementation Guide 12 April 2013
-160-
19941105131530Z (UTC or ‘Zulu’ time)
To further illustrate date and time: June 1, 2009, at 3:31:15:05:5 pm Pacific Time Zone:
to the millisecond: 20090601231105.5Zor 200906011531105.5-0800
to the second: 20090601231105Z
to the minute: 200906012331Z
to the hour: 2009060123Z
to the day: 20090601
to the month: 200906
to the year: 2009
APPENDIX III -ABBREVIATIONS AND GLOSSARY OF TERMS
Appendix III (A) ABBREVIATIONS
Abbreviations Definition
A Alpha
ADR Adverse Drug Reaction
AE Adverse Event
AN Alphanumeric
APEC Asia-Pacific Economic Cooperation
CDISC Clinical Data Interchange Standards Consortium
CE Coded with Equivalents*
CEN Comité Européen de Normalisation (European Committee for Standardisation ,a
federation of 28 national standards bodies that are also ISO member bodies)
CIOMS Council for International Organisations of Medical Sciences
CMET Common Message Element Type
CS Coded Simple Value
DSTU Draft Standard for Trial Use
DTD Document Type Definition
ECG Electrocardiogram
ED Encapsulated Data*
EDI Electronic Data Interchange
EDIFACT Electronic Data Interchange for Administration, Commerce and Transport
EEA European Economic Area
EMA European Medicines Agency
EFPIA European Federation of Pharmaceutical Industries and Associations
EFTA European Free Trade Association
ESTRI Electronic Standards for the Transmission of Regulatory Information
EU European Union
FDA United States Food and Drug Administration
GCC Gulf Cooperation Countries
GCG Global Cooperation Group
HL7 Health Level 7
HMD Hierarchical Message Description
ICH ICSR Implementation Guide 12 April 2013
-160-
19941105131530Z (UTC or ‘Zulu’ time)
To further illustrate date and time: June 1, 2009, at 3:31:15:05:5 pm Pacific Time Zone:
to the millisecond: 20090601231105.5Zor 200906011531105.5-0800
to the second: 20090601231105Z
to the minute: 200906012331Z
to the hour: 2009060123Z
to the day: 20090601
to the month: 200906
to the year: 2009
APPENDIX III -ABBREVIATIONS AND GLOSSARY OF TERMS
Appendix III (A) ABBREVIATIONS
Abbreviations Definition
A Alpha
ADR Adverse Drug Reaction
AE Adverse Event
AN Alphanumeric
APEC Asia-Pacific Economic Cooperation
CDISC Clinical Data Interchange Standards Consortium
CE Coded with Equivalents*
CEN Comité Européen de Normalisation (European Committee for Standardisation ,a
federation of 28 national standards bodies that are also ISO member bodies)
CIOMS Council for International Organisations of Medical Sciences
CMET Common Message Element Type
CS Coded Simple Value
DSTU Draft Standard for Trial Use
DTD Document Type Definition
ECG Electrocardiogram
ED Encapsulated Data*
EDI Electronic Data Interchange
EDIFACT Electronic Data Interchange for Administration, Commerce and Transport
EEA European Economic Area
EMA European Medicines Agency
EFPIA European Federation of Pharmaceutical Industries and Associations
EFTA European Free Trade Association
ESTRI Electronic Standards for the Transmission of Regulatory Information
EU European Union
FDA United States Food and Drug Administration
GCC Gulf Cooperation Countries
GCG Global Cooperation Group
HL7 Health Level 7
HMD Hierarchical Message Description