Study follow-up procedures Minimize
  • SUBSTANTIAL AMENDMENTS:

For the submission of a substantial amendment to the CNER, see the section “Submission a substantial amendment

 

  • ANNUAL STUDY REPORTS (Luxembourg national REC - specific requirement):

Regarding the submission of annual study reports for studies submitted to the CNER, please download the template here.


  • SAFETY REPORTING REQUIREMENTS:

Note:

Instead of requiring all SUSARs (local, foreign and cross-reports  from other protocols with same IMP), we now require only:

-    Local SUSAR reports (same protocol & other protocols with same IMP)

Concerning the other safety documents to be submitted, our reporting requirements remain unchanged, i.e. we require :

-    6-monthly SUSARs line listing
-    DSUR
-    Luxemburgish SAE reports (only if they have led to death)


Regarding the registration of adverse events and serious and unexpected adverse effects, the CNER refers itself to the dispositions of the 30th May 2005 Grand Ducal Regulation on clinical trials of drugs for human use:

 Art. 16. – Notification of adverse events

(1) The investigator shall report all serious adverse events immediately to the sponsor except for those that the protocol or investigator's brochure identifies as not requiring immediate reporting. The immediate report shall be followed by detailed, written reports. The immediate and follow-up reports shall identify subjects by unique code numbers assigned to the latter.

(2) Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations shall be reported to the sponsor according to the reporting requirements and within the time periods specified in the protocol.

(3) For reported deaths of a subject, the investigator shall supply the sponsor and the Ethics Committee with any additional information requested.

(4) The sponsor shall keep detailed records of all adverse events which are reported to him by the investigator or investigators. These records shall be submitted to the Minister in whose territory the clinical trial is being conducted, if they so request.

Art. 17. – Notification of serious adverse reactions (SUSARs)

(1)  a) The sponsor shall ensure that all relevant information about suspected serious unexpected adverse reactions that are fatal or life-threatening is recorded and reported as soon as possible to the competent authorities in all the Member States concerned, and to the Ethics Committee, and in any case no later than seven days after knowledge by the sponsor of such a case, and that relevant follow-up information is subsequently communicated within an additional eight days

     b) All other suspected serious unexpected adverse reactions shall be reported to the competent authorities concerned and to the Ethics Committee concerned as soon as possible but within a maximum of fifteen days of first knowledge by the sponsor.

     c) The Minister shall ensure that all suspected unexpected serious adverse reactions to an investigational medicinal product which are brought to its attention are recorded.

      d) The sponsor shall also inform all investigators.

(2) Once a year throughout the clinical trial, the sponsor shall provide the Minister in whose territory the clinical trial is being conducted and the Ethics Committee with a listing of all suspected serious adverse reactions which have occurred over this period and a report of the subjects' safety.

(3) (a) The Minister shall see to it that all suspected unexpected serious adverse reactions to an investigational medicinal product which are brought to its attention are immediately entered in a European database to which, in accordance with Article 11(1), only the competent authorities of the Member States, the Agency and the Commission shall have access.

      (b) The Agency shall make the information notified by the sponsor available to the competent authorities of the Member States.

 

  
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