Study follow-up procedures

Substantial amendments

For the submission of a substantial amendment to the CNER, see the page "Opinion request for a new study / an amendment".

Annual progress reports (specific Luxembourgish requirement)

For the submission of annual progress reports of the studies to the CNER, download the template (where the information to be provided is listed) in the guidance documents on the "Publications" page.

Final study report

After the closure of a study, a final report addressing the following topics must be sent to the CNER:

study start date;
start and end dates of participant enrolment;
date of the last participant's last visit;
end date of analyses;
total number of participants included;
number of participants leaving the study (due to withdrawal of consent, death or other reasons);
reminder of the objectives and the evaluation criteria;
results;
conclusions: study completed? objectives achieved?
dissemination of results (with accompanying publications where appropriate).

In addition, for interventional studies, the following information must also be provided:

For interventional studies (except those with medical devices):
- number of fatal or life-threatening SAEs* and SUSARs** that occurred during the study;
For studies with medical devices :
- number of serious adverse events that have a causal relationship with the investigational device, the comparator or the investigation procedure or where such causal relationship is reasonably possible;
- number of cases of device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate.

Safety reporting recommendations

Clinical trials with medicinal products:

Here are the documents to be submitted to the National Research Ethics Committee (by e-mail to contact@cner.lu) regarding safety reporting for clinical trials with medicinal products:

New events, and actions taken if any;
Local SUSARs (same protocol and other protocols with the same investigational drug);
- Submission deadlines: SUSARs that resulted or may result in death must be reported within 7 days of the sponsor becoming aware of the adverse event. For other SUSARs, the deadline for reporting to the CNER is extended to 15 days.
Annual safety report;
- In blinded or unblinded format, annual submission
Luxembourg SAE reports.
- Immediate submission of serious adverse events (SAEs) occurring in Luxembourg, limited to death and life-threatening cases

Clinical trials with medical devices:

For clinical trials with medical devices, the sponsor shall report without delay to the CNER, via e-mail:

(a) any serious adverse event that has a causal relationship with the investigational device, the comparator or the investigation procedure or where such causal relationship is reasonably possible;
(b) any device deficiency that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate
(c) any new findings in relation to any event referred to in points (a) and (b).

The reporting deadline shall take the severity of the event into account. To allow for a timely notification, the sponsor may, if appropriate, submit an incomplete first report before submitting a complete one.

* SAE: serious adverse event

** SUSAR: suspected unexpected serious adverse reaction