Comprehensive Overview of Clinical Studies Regulations and Good Clinical Practice Guidelines
This document explores essential regulations and standards guiding clinical studies, including the EU Directive 2001/20/EC, Drug Law, Medical Device Act, and Good Clinical Practice (GCP) regulations. It covers ISO standards, such as ISO 14155:2012 for clinical investigations and the International Conference on Harmonisation (ICH) Guidelines. Key roles such as sponsors, principal investigators, and study assistance personnel are defined, alongside their responsibilities in ensuring compliance and reporting to federal agencies. The necessity for ethical oversight and the publication of clinical trial results is also emphasized.
Comprehensive Overview of Clinical Studies Regulations and Good Clinical Practice Guidelines
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Presentation Transcript
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 • „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
Clinical Studies Study managementpersons Sponsor Federal agencies Principalinvestigator andhisDeputy--------------------------personresponsibleforstudyconduct Study assistance/Study nurse
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
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
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
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
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
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
