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ICH ICSR Implementation Guide 12 April 2013
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C.3 INFORMATION ON SENDER OF CASE SAFETY REPORT
C.3.1 Sender Type
User Guidance This data element captures the type of sender organisation or individual.
In this context, ‘Pharmaceutical company’ includes biotechnology
companies, market authorisation holders and other manufacturers required
to submit ICSRs.
Conformance Required
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.7
Value Allowed 1=Pharmaceutical Company
2=Regulatory Authority
3=Health Professional
4=Regional Pharmacovigilance Centre
5=WHO collaborating centres for international drug monitoring
6=Other (e.g. distributor or other organisation)
7=Patient /Consumer
Business Rule(s)
ICH ICSR Implementation Guide 12 April 2013
-62-
C.3 INFORMATION ON SENDER OF CASE SAFETY REPORT
C.3.1 Sender Type
User Guidance This data element captures the type of sender organisation or individual.
In this context, ‘Pharmaceutical company’ includes biotechnology
companies, market authorisation holders and other manufacturers required
to submit ICSRs.
Conformance Required
Data Type 1N
OID 2.16.840.1.113883.3.989.2.1.1.7
Value Allowed 1=Pharmaceutical Company
2=Regulatory Authority
3=Health Professional
4=Regional Pharmacovigilance Centre
5=WHO collaborating centres for international drug monitoring
6=Other (e.g. distributor or other organisation)
7=Patient /Consumer
Business Rule(s)