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A Simple Method of Tracking Serious Adverse Events Reports Used at the Hospital de Clínicas de Porto Alegre RS - Brazi

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

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A Simple Method of Tracking Serious Adverse Events Reports Used at the Hospital de Clínicas de Porto Alegre RS - Brazi

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  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) • Research Ethics Committee (IRB) • Collaboration between SC + IRB • 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. Serious Adverse Events (SAEs) Monitoring Program IRB/HCPA 2,152Events Recorded at IRB / HCPA Since 2001 September 142Different Protocols ©Raymundo/2004

  5. IRB SAE Flowchart SAE Communication to IRB/HCPA with the Investigator’s opinion IRB’s Opinion IRB SAE Form Send SAE Form to CONEP* with investigator’s and IRB’s opinion IRB SAE Evaluation *CONEP ANVISA ©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 • Investigator’s Brochure or in the Informed Consent Form ©Raymundo/2004

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

  8. Relationship of the events with the protocol 2,152 SAE’s 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 SAE’s 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. Conclusions • Duplicate work: IRB / sponsor GCP and CONEP guidelines • Protocol’s Continued Evaluation Process: New versions of protocols, Investigator’s Brochure and Informed Consent Forms

  13. Perspectives • Online information system linked to ANVISA • Grouped Data gathered by the sponsor • Naranjo’s Algorithm

  14. Perspectives Adequate monitoring CONEP ANVISA IRB Investigator Sponsor

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