nee nee nee Wordt proefpersoon aan handelingen onderworpen of gedragswijze opgelegd?

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Medischwetenschappelijk onderzoek en deelname proefpersonen? Wordt proefpersoon aan handelingen onderworpen of gedragswijze opgelegd? Worden behandelingen met elkaar via randomisatie vergeleken?

1 Medischwetenschappelijk onderzoek en deelname proefpersonen? Wordt proefpersoon aan handelingen onderworpen of gedragswijze opgelegd? Worden behandelingen met elkaar via randomisatie vergeleken? Vallen de handelingen binnen de kaders van de standaard behandeling? Geen toetsing Toetsing volgens Toetsingskader n-plichtig onderzoek Toetsing volgens Onderzoek met niet-geregistreerd gesmiddel of medisch hulpmiddel? Onderzoek met geregistreerd gesmiddel in andere formuliering, dosis? Bij twijfel Wordt fysieke of psychische integriteit door onderzoekshandel ingen aangetast? Version nr. 1.0 NL version date 19 July 2011

2 EU Directives WGBO WBP KWZ Interventie gesmiddelen onderzoek = GCP plicht = EudraCT Andere interventies: Voedingsmiddelen Chirurgie Psychologie Indringende interviews n: Code goed gedrag Code goed gebruik Privacy reglement Restweefsel reglement Bevolkingsonderzoek Research code WBIG Etc. Medical devices = ISO Embryowet Nieuwe wetgeving

3 1. Onderzoekers, artsen andere afdelingen 2. Stage student, opleiding AIO 3. Monitor, auditor, Leden METC, Inspectie IGZ Derden Dossie r zonder ID geen toestemming vereist Dossie r zonder ID Behandelaar (arts) Behandelteam WGBO WBP nul uren contract Dossier met ID sleutellijst Dossier met ID Uitdrukkelijke toestemming patient (betrokkene)/ Informed consent, tenzij algemeen ondzk en onevenredige 3

Sponsor initiates study Study starts Investigator records all observations in CRF and in source documents Study completed experimentally Study protocol draft Appoint monitor Select investigator(s)

4 Sponsor initiates study Study starts Investigator records all observations in CRF and in source documents Study completed experimentally Study protocol draft Appoint monitor Select investigator(s) Perform feasibility study Manufacture study medication Design and implement SOP s Appoint coordinating clinical investigator Quality and train sponsor personnel Make/update Investigator s Drug Brochure (IB) Design study protocol Discuss and include statistics in protocol Documents Submitted to aec and CA Regulatory and technical green lights obtained All essential documents obtained Perform Monitoring Visits Monitor: Check completeness Check accuracy Check consistency Check procedures Verify filing Check reliability by conducting SDV Verify drug accountability Report Adverse Events Start data entry and validation Investigator: Report Serious Adverse Event immediately Sponsor: Submit reportable events (SUSARs) to the MEB Report SUSARs to aec and other investigators Study data analyzed Data management starts when completed CRF becomes available: Perform data validation (queries) Arrange Data Review Meeting Close database Study documents final Instruct, train and qualify investigators Label and pack materials Make overall project plan (time, resources) Arrange for submission to aec Make cost budget Notify study to CCMO/Minister Design Case Report Form Finalize investigator contracts Prepare study monitoring forms Finalize third party contracts Prepare instruction manuals Randomize study treatment Design patient information and consent Arrange start up meetings Arrange for insurance coverage Design database Design data validation plan Design Statistical Analysis plan Quality Assurance: Independent auditing prior to, during and after study for investigational site and monitoring activities Study report finalized Write statistical report Write integrated study report Send summary of report to investigators, CCMO and aec Study documents: IB, study protocol CV s investigators List centres aec approval CCMO notification Investigator agreement Insurance certificate Patient info, consent CRF Forms AE, ADE Monitor contact info Version nr. 1.0 NL version date 04-Jun-2004 Copyright Profess Sponsor responsibilities: Sign approved study protocol Ensure that all deviations from protocol are reported and accounted for Ensure that all AE s are reported as required Inform all investigators about all SAE s Inform investigator when study is terminated prematurely or suspended Inform investigators on development status drug Review and approve deviations from study protocol Collect, store, keep secured and ensure completion of essential documents Monitor responsibilities: Verify if compliance with protocol is maintained Verify if drug is used according to plan Verify qualification of investigational staff Verify if investigator has access to adequate number of subjects Verify if informed consents are properly signed and dated Verify if AE have been recorded and reported adequately Verify drug accountability and traceability Verify maintenance and calibration equipment Verify recording subject withdrawal, non-compliance Report monitoring visits Investigator responsibilities: Have resources to conduct study Has no conflict of interest Knows the drug and its properties Knows the study protocol Supports the monitor and auditor Communicates deviations from the protocol Ensures compliance with protocol for all staff Protects health and welfare of subjects Communicates with the aec on SAE s, submission amendments Endeavors to ensure adequate recruitment Ensures that informed consent is obtained and documented Reports any deviation due to emergency 4 Ensures drug accountability

5 Per 1 nuari 2010: Ondzk Meldt SAE binnen 24 uur en beoordeelt causaliteit SAE Investigator-initiated studies -Gesmiddelen -Voedingsmiddelen -Medische hulpmiddelen Bepaalt causaliteit: Verdenking of? Bepaalt verwachtheid Gedocumenteerd of? SAE SSAR ToetsingOnline Rapporteert binnen 7 of 15 dagen en naar Ondzks 30 dagen SUSAR Ondzks METC EudraCT 5

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