According to procedures defined in Resolution CNS 466/12 of the National Health Council (CNS) of the Ministry of Health (MS), it is up to the researcher to prepare and present partial, final or suspension reports for CEP evaluation. With this, the Research Ethics Committee (CEP) will be able to monitor the development of research projects through the reports provided by the researcher in charge.
As there are research projects involving clinical trials (clinical studies) and projects that were approved before and after the implementation of the Brazil platform system, there was a need to prepare a report model for each research situation.
Forms for submitting reports to the CEP
1. Partial report / follow-up for clinical studies
This partial/follow-up report form is intended for clinical studies or phase I, II, III and IV unicentric or multicentric clinical trials that were approved through the PLATAFORMA BRASIL system. The form must be submitted in Word, allowing the use of the “copy and paste” feature.
Partial/monitoring reports must be submitted semi-annually to the CEP after approval of the research project.
The report must be submitted to the CEP through the Platform Brazil, in the “notification” item.
2. Final report for clinical studies
This form is intended for unicentric or multicentric phase I, II, III and IV clinical studies or clinical trials that were approved through the PLATAFORMA BRASIL system and that Unicamp is the COORDINATING CENTER of the research project. The form must be submitted in Word, allowing the use of the “copy and paste” feature.
If necessary, there are some guidelines to assist in completing the final report form (guidelines for completing the final report).
The report must be submitted to the CEP through the Platform Brazil, in the “notification” item.
3. Final report for clinical studies
This final report form is intended for clinical studies or clinical trials of phase I, II, III and IV unicentric or multicentric that were approved through the PLATFORMA BRASIL system and that Unicamp is NOT the COORDINATOR CENTER of the study. The form must be submitted in Word, allowing the use of the “copy and paste” feature.
The report must be submitted to the CEP through the Platform Brazil , in the “notification” item.
4. Partial / follow-up / final report
This partial or final report form is intended for research projects that do not involve any of phases I, II, III and IV (clinical studies/clinical trials) that were approved through the PLATAFORMA BRASIL system. The form must be submitted in Word, allowing the use of the “copy and paste” feature.
Partial/monitoring reports must be submitted annually to the CEP after approval of the research project.
The report must be submitted to the CEP through the Platform Brazil, in the “notification” item.