Pharmacovigilance for Clinical Trials with Medicinal Products
Changes in safety reporting due to Regulation (EU) 536/2014
All SUSARs should be reported directly to the EudraVigilance database (EVCTM), regardless of whether the trial is conducted under EU Regulation 536/2014 or Directive 2001/20/EC.
If the clinical trial continues to run under Directive 2001/20/EC, the reporting requirements under CT-3 must be met. This also means that a request by the sponsor for exemption from the reporting obligation regarding serious adverse events according to the AMG must be submitted to the BASG in advance.
- Form: SUSAR Waiver (F_I437)| 62 KBRequest for waiver for direct reporting of SUSARs according to §41e AMG as amended.11/12/2019
Reporting requirements during the clinical trial
The sponsor's reporting obligations are divided into those that must be fulfilled immediately and those that must be fulfilled annually.
The immediate notification obligations of the sponsor include:
Notification of any suspected unexpected serious adverse drug reaction (SUSAR) that has occurred within the framework of the same clinical trial in Austria or abroad and that has led to a death or is life-threatening, within 7 days of becoming known (Section 41e (1) AMG as amended),
Notification of any other suspected unexpected serious adverse drug reaction that occurred within the framework of the same clinical trial in Austria or abroad within 15 days of becoming known (Section 41e (2) AMG as amended)
The concept of a suspected unexpected serious adverse reaction (SUSAR) is of central importance for the immediate notification obligations of the sponsor.
The definition results from the combination of the definitions
- serious adverse reaction (adverse reaction leading to death, life-threatening, requiring or prolonging hospitalisation, leading to permanent or serious disability or invalidity, causing congenital anomalies or birth defects); and
- unexpected adverse reaction (an adverse reaction that does not correspond to the nature or severity of the IMPD information available).
Annual Safety Report (ASR)/Development Safety Update Report (DSUR)
In addition to the immediate notification obligations, the sponsor must submit an annual report once a year during the duration of the clinical trial in accordance with Section 41e (3) of the Austrian Medicines Act (AMG) as amended, which is to be prepared in accordance with guideline CT-3 of the European Commission in the format specified in guideline ICH Topic E2F "Development Safety Update Report (DSUR)".
For further details, please refer to Section 8 of the CT-3 Guideline and the BASG FAQ on this subject.