Suspected unexpected serious adverse reactions (SUSAR)
The requirements for the reporting of suspected unexpected serious adverse reactions by the sponsor are described in article 42 of the Clinical Trials Regulation.
All suspected unexpected serious adverse events of investigational medicinal products occurring in that clinical trial should be sent to EudraVigilance (EVCTMPROD module) by the sponsor. There is no need to forward them locally.
Organisations can register via this link:
Annual safety reporting (ASR)
The requirements related to the annual reporting by the sponsor are described in article 43 of the Clinical Trials Regulation.
The annual safety reports must be written according to the ICH E2F guidelines and submitted in the Central Information System (CTIS). No additional submission to the Ethics Committee is required in Belgium.
Module 18 of the CTIS training program describes how to prepare and submit an annual safety report and how to respond to related requests for information.
For non-commercial sponsors conducting a single clinical trial on Investigational Medicinal Products (IMPs) with a MAH in any of the EU/EEA member states and where the SmPC is used as reference safety information (RSI) submitting a simplified ASR based on the ICH-E2F may be appropriate. This template gives detailed instructions on what information is expected and what may be omitted in this setting.
- The simplified ASR should always be written in English.
- The reporting period for the first ASR starts with the approval date of the clinical trial.
- The reporting period ends after one full year and cannot be exceeded = Data Lock Point (DLP)
- After the DLP, the sponsor has 60 days to prepare and submit the ASR in CTIS.
- If the study ends during the reporting period, no subsequent ASR is required.
The requested action and the conclusion of the evaluation of the ASR are obtained through the ASR procedure in CTIS. Due to technical issues in CTIS, it is not always possible to provide the conclusion in CTIS, therefore the sponsor will be contacted by e-mail if any action is required. If no feedback is received in CTIS nor via e-mail, no specific action is required from the sponsor.
Fees
In Belgium, the fee for safety assessing member state (saMS) is an annual fee, which is indexed every year. An invoice is sent per timeframe of one year, covering the period from the 1st of July until the 30th of June. An invoice is sent for every active substance for which we were responsible as saMS during that timeframe and if it is part of the test IMP. Our responsibilities as saMS include:
- Screening and assessing SUSARs: saMS is responsible for screening and assessing SUSARs reported during clinical trials. This screening is conducted at regular intervals: every 2 weeks for a non-authorized product and once per month for an authorized product. The screening frequency can be increased accordingly for e.g. weekly if safety profile of the active substance requires more close supervision.
- Assessing ASR: saMS evaluates the ASRs submitted by sponsors to ensure that all safety data is accurately reported, analyzed, and appropriate actions are taken if necessary.
- Supporting the assessment of the RSI: saMS supports the assessment of the RSI during clinical trial and substantial modifications procedures to ensure that it is up-to-date and reflects the current understanding of the safety profile of the IMP.
- Performing coordinated assessment of any other safety-relevant information as lead member state: saMS leads coordinated assessments of any other safety-relevant information as the lead Member State. This includes making general recommendations related to the safety of the active substance to the concerned Member States and reporting Member State.
- Providing assistance with any additional safety matter related to the active substance: saMS provides assistance with any additional safety matters related to the active substance, ensuring comprehensive safety oversight.
We are invoicing based on the timeframe in which we are saMS instead of invoicing upon receipt of an ASR.
Contact
Clinical Trial Safety Entity: ctrsafety@fagg-afmps.be