ECSafetyReporting object
Adverse Device Effect (ADE): any undesirable clinical event occurring under and related to the normal conditions of use of a medical device, i.e., a device-related adverse event (Art 2(17) MPG)
SAE/SADE: an adverse event or an adverse device effect in accordance with § 2 (17) is to be considered serious if it is fatal or life-threatening, causes permanent damage, or requires or prolongs hospitalization. Any adverse event or adverse device effect causing fetal damage, fetal death, or a congenital anomaly as well as any occurrence of a malignant tumour shall, without exception, be classified as serious (Art 3(16) MPG).
SAE (Serious Adverse Event)
ADE (Adverse Device Effect)
SADE (Serious Adverse Device Effect)
Relevant EC(s)
Sponsor
No specific deadline indicated
Principal Investigator
Investigator
"Meldungsformular" (provided on website of Forum Österreichischer Ethikkommissionen in section "Meldungen": Form to be used for notification of amendments, AEs, and other nofitications to Austrian ECs, available only in German)
Guideline - Safety Reports to Austrian ECs (en)/ Leitlinien für Sicherheitsmeldungen (de) (Link: http://www.ethikkommissionen.at)
1. SUSARs only have to be reported if IMP involved 2. Reporting format depends on concerned EC (Email, Fax, Mail/post, Online portal, Delivery service)
2. Guidance on AE reporting, submission of annual safety report and the standard reporting form is available on the website of the Forum Österreichischer Ethikkommissionen in section: Meldungen
