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Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 1 QM in Clinical studies Deepening Topics.

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Präsentation zum Thema: "Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 1 QM in Clinical studies Deepening Topics."—  Präsentation transkript:

1 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 1 QM in Clinical studies Deepening Topics

2 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 2 Regulations  EU-Directive, e.g. 2001/20/EC  Drug Law  Medical Device Act  GCP-Regulation Clinical Studies

3 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 3 Standards  ISO 14155:2012 Clinical investigation of medical devices for human subjects - Good clinical practice  „International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)“  Guideline for Good Clinical Practice (GCP)  ISO 9001:2008 Chapter 7.3 Design and Development  EN 15224:2012 Chapter 7.3 Design and Development Clinical Studies

4 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 4 Study management persons Clinical Studies Principal investigator and his Deputy person responsible for study conduct Sponsor Study assistance/ Study nurse Federal agencies

5 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 5 Sponsor  Natural or legal person  Responsibilities for initiation, organisation and financing of the clinical study  Designates principal investigator, also in case of multicenter studies or if more investigators involved  Reporting to Federal agencies and ethical committee:  e.g. undesirable side effects  e.g. individual case reporting on severe side effects Clinical Studies

6 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 6 Principal Investigator  Responsible for study conduct  At least 2 years experience in clincal studies of drugs  Regular exchange and cooperation with study assistance  Designates qualified cooperators of the study group, leads and monitors them  Designates at least one deputy with equal qualifications  Responsible for compliance with GCP  Reports undesirable side effects to sponsor Clinical Studies

7 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 7 Investigator  Designated by principal investigator  Has to prove specific further education in studies Position can be taken also by the principal investigator Study secretariate  Designated persons for the secretariate and defined rooms, in which the documentation of the study conduct and the archiving of the documents is taking place. Compliance with GCP rules  From there the communication with the study conducting cooperators is organised  Must be informed about critical results Clinical Studies

8 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 8 Study assistence (Study nurse)  Qualification  Special professional training, e.g. MTA (medical technical assistance) or a special qualified nurse  Plus special training for study assistance  Contribution in study conduct  Recruites, registers, assists in the patient informed consent Cares for patients and post-treatment care  Organisation, coordination of e.g. diagnostic, laboratory  Elicitation and documentation  Prepares and cooperates in audits and at the inspections of authorities Clinical Studies

9 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 9 Federal authorities  BfArM:  Admission-licence of human drugs  Handling at notifications of severe adverse events  GCP-inspectors: Auditing of rooms, equipment, documentation, informed consent, insurance, QM-system  GLP-Authority in the Federal institute for risk evaluation: Conducts GLP-inspections Ethical-committee is independent Board:  For the Safety and Welfare of the study patients Clinical Studies

10 Dr. Erwig Pinter QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 10 Clinical trail protocol  Describes intentions, planning, methods, statistical considerations and organisation of a trial  Requirements for the protocol in ISO 14155:2012 Publication of results  Favourable as well as negative results have to be published  Reporting of results according to the GCP-requirements Clinical Studies


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