Local Serious Adverse Events/Coordinating Center
By determination of CONEP (Circular Letter No. 008/2011/CONEP/CNS/GB/MS of 22/06/2011) the communication of Local Serious Adverse Events/Coordinating Center, approved before the use of SISNEP must be carried out in specific form.
In this way, for Serious Adverse Events (EAS) with causality, that occur at (Unicamp) or that Unicamp is the coordinated center, the form must be used with all the fields filled in and with the due justifications (when necessary), otherwise the form will be returned without evaluation.
We remind you that in the Plataforma Brasil system, there is no option for submitting EAS, therefore, all EAS must be delivered to the Research Ethics Committee secretariat.
The referral that does not meet the above items will be returned to the responsible researcher, according to Official Letter CEP 240/2012 of 17/04/2012.
Serious Adverse Events from Other Centers
The EAS of others must be submitted using a standard form with the responsible researcher's opinion/opinion about the EAS. It will not be necessary to send the CIOMs form for evaluation, only the form should be used. If necessary, the Research Ethics Committee will ask the researcher to send the CIOMs forms.
We remind you that in the Plataforma Brasil system, there is no option for submitting EAS, therefore, all EAS must be delivered to the Research Ethics Committee secretariat.