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Deepening Topics

Deepening Topics. QM in Clinical studies. Clinical Studies. Regulations EU- Directive , e.g. 2001/20/EC Drug Law Medical Device Act GCP-Regulation. Clinical Studies. Standards ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice

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Deepening Topics

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  1. Deepening Topics QM in Clinical studies

  2. Clinical Studies Regulations • EU-Directive, e.g. 2001/20/EC • Drug Law • Medical Device Act • GCP-Regulation

  3. Clinical Studies Standards • ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice • „International Conference on Harmonisationof Technical Requirementsfor Registration of Pharmaceuticals for Human Use (ICH)“ • Guideline forGood Clinical Practice (GCP) • ISO 9001:2008 Chapter 7.3 Design and Development • EN 15224:2012 Chapter 7.3 Design and Development

  4. Clinical Studies Study managementpersons Sponsor Federal agencies Principalinvestigator andhisDeputy--------------------------personresponsibleforstudyconduct Study assistance/Study nurse

  5. Clinical Studies Sponsor • Natural or legal person • Responsibilitiesforinitiation, organisation and financingof the clinicalstudy • Designates principalinvestigator, also in caseofmulticenterstudiesorifmoreinvestigatorsinvolved • Reporting to Federal agencies and ethicalcommittee: • e.g. undesirablesideeffects • e.g. individual casereporting on severesideeffects

  6. Clinical Studies PrincipalInvestigator • Responsibleforstudyconduct • At least 2 yearsexperience in clincalstudiesofdrugs • Regular exchange and cooperationwithstudyassistance • Designates qualifiedcooperatorsof the studygroup, leads and monitorsthem • Designates at least onedeputywithequalqualifications • Responsibleforcompliancewith GCP • Reports undesirablesideeffectstosponsor

  7. Clinical Studies Investigator • Designatedbyprincipalinvestigator • Hastoprovespecificfurthereducation in studies Position canbetaken also bytheprincipalinvestigatorStudy secretariate • Designatedpersonsfor the secretariate and definedrooms, in which the documentationofthestudyconductandthearchivingof the documentsistakingplace. Compliance with GCP rules • Fromthere the communicationwith the studyconductingcooperatorsisorganised • Must beinformedaboutcriticalresults

  8. Clinical Studies Study assistence (Study nurse) • Qualification • Special professional training, e.g. MTA (medicaltechnicalassistance) or a specialqualifiednurse • Plus specialtrainingforstudyassistance • Contribution in studyconduct • Recruites, registers, assistsin thepatientinformedconsentCaresforpatients and post-treatment care • Organisation, coordinationof e.g. diagnostic, laboratory • Elicitation and documentation • Preparesandcooperatesin audits and at the inspectionsofauthorities

  9. Clinical Studies Federal authorities • BfArM: • Admission-licenceof human drugs • Handling atnotificationsofsevereadverseevents • GCP-inspectors: Auditing ofrooms, equipment, documentation, informedconsent, insurance, QM-system • GLP-Authority in the Federal instituteforriskevaluation: Conducts GLP-inspections Ethical-committeeisindependent Board: • For the Safety and Welfareof the studypatients

  10. Clinical Studies Clinical trailprotocol • Describesintentions, planning, methods, statisticalconsiderations and organisationof a trial • Requirementsfor the protocol in ISO 14155:2012 Publicationofresults • Favourableaswellas negative resultshavetobepublished • Reporting ofresultsaccordingto the GCP-requirements

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