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A Simple Method of Tracking Serious Adverse Events Reports Used at the Hospital de Clínicas de Porto Alegre RS - Brazil Biol. Marcia Mocellin Raymundo,

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Presentation on theme: "A Simple Method of Tracking Serious Adverse Events Reports Used at the Hospital de Clínicas de Porto Alegre RS - Brazil Biol. Marcia Mocellin Raymundo,"— Presentation transcript:

1 A Simple Method of Tracking Serious Adverse Events Reports Used at the Hospital de Clínicas de Porto Alegre RS - Brazil Biol. Marcia Mocellin Raymundo, MSc Post-Graduation and Research Group Hospital de Clínicas de Porto Alegre Porto Alegre – RS – Brazil Presentation at DIA Meeting - Washington-USA/2004

2 Research Ethics in HCPA 1974 Scientific Committee (SC) 1989 Research Ethics Committee (IRB) 1993 Collaboration between SC + IRB 1996 Research Ethics Committee (IRB) CONEP – National Committee of Research Ethics 2001 Institutional Review Board (OHRP – USA – IRB 921) ©Raymundo/2004

3 Serious Adverse Events (SAEs) Monitoring Program IRB/HCPA Begin: September 2001 Goal: Protection of research subjects 2 Biologists 1 Pharmacist 2 Students of Medicine 1 Student of Biology ©Raymundo/2004

4 2,152 Events Recorded at IRB / HCPA Since 2001 September 142 Different Protocols Serious Adverse Events (SAEs) Monitoring Program IRB/HCPA ©Raymundo/2004

5 SAE Communication to IRB/HCPA with the Investigators opinion IRB SAE Form IRB SAE Evaluation IRBs Opinion Send SAE Form to CONEP* with investigators and IRBs opinion *CONEPANVISA IRB SAE Flowchart ©Raymundo/2004

6 SERIOUS ADVERSE EVENT EVALUATION 1 Verifying to which protocol and drugs the event is related to 2 Verifying the severity of the event, the temporal relationship, the concomitant drug history and outcomes of the event 3 Checking if the SAE is mentioned in the protocol, in the Investigators Brochure or in the Informed Consent Form ©Raymundo/2004

7 4Risk estimation based on the data presented in the protocol, in the Investigators Brochure or in the Informed Consent Form 5 Evaluation of local investigators opinion about risks to other subjects and needs about protocol and Informed Consent modifications 6 IRB opinion sent to CONEP with local investigators opinion SERIOUS ADVERSE EVENT EVALUATION ©Raymundo/2004

8 Relationship of the events with the protocol 2,152 SAEs communications 215 ©Raymundo/2004

9 SAEs Prevision Only 173 of 2,152 forms with this item filled out ©Raymundo/2004

10 SAEs Outcome 2,152 SAEs communications ©Raymundo/2004

11 Conclusions Role of IRB: risk monitoring Goal: active protection of research subjects Cost of monitoring Not included in the protocol budget Increase number of participants and research centers involved world wide Consequence: loss of local event relevance ©Raymundo/2004

12 Duplicate work: IRB / sponsor GCP and CONEP guidelines Protocols Continued Evaluation Process: New versions of protocols, Investigators Brochure and Informed Consent Forms Conclusions

13 Online information system linked to ANVISA Grouped Data gathered by the sponsor Naranjos Algorithm Perspectives

14 Perspectives Adequate monitoring IRB SponsorInvestigator CONEP ANVISA


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