contenu du dossier - essai clinique non-interventionnel
Conseils & Comités
Last update: 27/03/2008
Academic or non-commercial
Non-interventional clinical trial
A non-interventional clinical trial should comply with the definition of point 8 of Article 2 of the Act of May 7th 2004
Its academic character exempts the sponsor from remunerating the Ethics Committee for examining the clinical records.
If you are the originator of this experiment, the Erasme Hospital is legally the sponsor of this experiment as specified in point 15° article 2 of the law of May 7th, 2004.
You should consider simultaneously submitting the draft trial to the different committees in question if this trial is multi-centre.
In order to facilitate the processing of your application, we would ask you to group the documents together according to the following 3 items in the order proposed below:
1 : electronic version of the submission documents,
2 : our clinical investigation fact sheet including the exact title of the trial, the name of the investigator and his details and the details of the person of contact.
3 : the person of contact on the leading Ethics Committee (name of the committee, authorisation number, e-mail of contact), in charge of issuing the single opinion, appointed by the sponsor or the list of the local ethics committee in question that we represent in the single opinion (name of the committee, authorisation number , e-mail of contact).
4 : a recent version of your curriculum vitae in electronic format (.doc or .pdf format) if the last version submitted to the Committee was over one year previously.
Documents relating to the clinical investigation protocol
5 : the last institutional version of the the Ethics Committee Application Form signed by the main investigator.
6 : the full trial protocol and any possible amendments, the CRFs (Case Report Form), the patients' logs, the questionnaires, etc.
7 : the investigator's brochure (background to the trial), where applicable.
8 : the informed consent form of the French and Dutch participant :
ideally, pages numbered and version number and date of the submitted version at the bottom of the page,
page break between information sheet to the participant and consent form.
--> Written consent is required in all cases (this document will contain the title of the clinical research, the relevant items for the consent, the name of the main investigator and the place for the signatures of the different parties involved in the consent process.)
Additional copies of the following documents
1 additional copy of the project summary (1rst page of the Ethics Committee Application Form)
1 additional copy of the Ethics Committee Application Form
3 additional copies of the French version of the information for the patient and the informed consent form, where applicable.