REQUEST FOR OPINION FOR A NEW STUDY Minimize

In the case of a request for an opinion for a new study, the CNER formulates its opinion by considering the following:

a) the pertinence of the clinical trial and its design,

b) the study protocol,

c) the suitability of the investigator and his collaborators,

d) the investigator's brochure,

e) the quality of the installations,

f) the suitability and the exhaustivity of the written information provided, as well as the procedure used to obtain the patients’ informed consent,

g) the provisions set out in order to provide reparations or compensation in the event of damage or death attributable to the clinical trial,

h) any insurance policies or compensation amounts covering the liability of the investigator and the sponsor,

i) the amounts and terms for any reward or compensation for investigators and participants in the clinical trial, and the relevant details of any contract foreseen between the sponsor and the study site(s),

j) the patient recruitment procedures.



Documents to be submitted to the CNER:

 

The documents submitted to the CNER for review have to be sent to the secretariat in 9 copies, at the latest three weeks before the date of the next CNER meeting, and should include the following elements:

  • the filled out descriptive synthetic sheet, downloadable here,
  • the study protocol and all amendments with their respective dates,
  • a written informed consent form and the patient’s information sheets in French and German (and the English templates from which they were translated, if it exists. In any case it has to be indicated which version is the original linguistic version); if the study has a genetic component, the informed consent should be divided in two parts, so that the participants can sign once to mark their agreement to participate in the non-genetic part, and a second time to mark their participation in the genetic part of the study. If personal data of participants are kept, the storage period should be indicated in the information sheet. 
     The documents available for download below explain which elements should be included in the participant information sheet.

 

      Participant information sheet and informed consent form - recommendations (in French, English, and German) - DOWNLOAD    

  • the subject’s recruitment procedures,
  • the investigator’s brochure and all the relevant information concerning the safety and pharmaceutical quality of the drug,
  • information regarding the financial aspects of the study, as well as the financial contract signed between the sponsor and the principal investigator (or institution if applicable),
  • a copy of the insurance policy covering the study,
  • a recent curriculum vitae of the investigator,
  • questionnaires for participants, if applicable,
  • if necessary, documents that are specifically requested by the CNER for a given study,
  • the electronic version of the documents on CD-Rom or USB key.
After the requested documents have been received at the CNER secretariat, the principal investigator is invited to orally present his study to the CNER at its next meeting. If the study is a medical study, it is imperative that one of the responsible physicians be present. Please note that the presentation should be short (not exceeding 5 minutes), that it should address the main aspects relevant to the CNER's review* and be done without powerpoint support.

* i.e. it should include the following : description of the project, its aims and scope, recruitment procedure, intervention(s), risks and potential benefits to the participants, insurance, possible investigator / participant remuneration details, data protection. 

Fees:

See details here.



Deadline for reply:

The National Research Ethics Committee replies to requests within a period of 60 days following the receipt date of the request in due form. A copy of the CNER opinion is also sent to the Health Minister.

 


 




 






 

 

 



 


  
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