DIN EN ISO 27953-1:2012-09
Current
The latest, up-to-date edition.
HEALTH INFORMATICS - INDIVIDUAL CASE SAFETY REPORTS (ICSRS) IN PHARMACOVIGILANCE - PART 1: FRAMEWORK FOR ADVERSE EVENT REPORTING (ISO 27953-1:2011)
Hardcopy , PDF
German
01-01-2012
Important note : Users cannot be edited or removed once added to your Multi user PDF.
Vorwort
Einleitung
1 Anwendungsbereich
2 Normative Verweisungen
3 Begriffe
4 Abkürzungen
5 Einzelfallbericht
5.1 Storyboards
5.1.1 Einzelfallberichte (Individual Case Safety
Reporting, PORRST040001UV)
5.2 Anwendungsrollen
5.2.1 Empfänger der ICSR-Mitteilung
(ICSR Notification Receiver, PORRAR040002UV)
5.2.2 Sender der ICSR-Mitteilung (ICSR Notification
Sender, PORRAR040001UV)
5.3 Auslösende Ereignisse
5.3.1 Mitteilung über Erzeugung eines
Einzelfallberichts (ICSR Create Notification,
PORRTE049006UV)
5.3.2 Mitteilung über Zurückziehung eines
Einzelfallberichts (ICSR Withdraw Notification,
PORRTE049008UV)
5.3.3 Mitteilung über Überarbeitung eines
Einzelfallberichts (ICSR Revise Notification,
PORRTE049007UV)
5.4 RMIMs - Verfeinerte Modelle
5.4.1 ICSR Refined Message Information Model
(PORRRM049006UV)
5.4.2 ICSR RProduct (PORRRM049011UV)
5.4.3 ICSR AProductReportingRelevantInformation
(PORRRM049013UV)
5.5 Hierarchische Nachrichtenbeschreibungen
5.5.1 ICSR HMD (PORRHD049006UV)
5.5.2 ICSR AProductReportingRelevantInformation
HMD (PORRHD049013UV)
5.5.3 ICSR RProduct HMD (PORRHD049011UV)
5.6 Interaktionen
5.6.1 Individual Case Safety Report Create
(PORRIN049006UV)
5.6.2 Individual Case Safety Report Retraction
(PORRIN049008UV)
5.6.3 Individual Case Safety Report Revision
(PORRIN049007UV)
| DevelopmentNote |
Available only on CD-ROM. (09/2012)
|
| DocumentType |
Standard
|
| Pages |
33
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Current
|
| Standards | Relationship |
| EN ISO 27953-1:2011 | Identical |
| DIN EN ISO 11238:2013-03 | HEALTH INFORMATICS - IDENTIFICATION OF MEDICINAL PRODUCTS - DATA ELEMENTS AND STRUCTURES FOR THE UNIQUE IDENTIFICATION AND EXCHANGE OF REGULATED INFORMATION ON SUBSTANCES (ISO 11238:2012) |
| DIN EN ISO 11240:2013-03 | Health informatics - Identification of medicinal products - Data elements and structures for the unique identification and exchange of units of measurement (ISO 11240:2012) |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.