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 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 Study management persons Federal agencies Sponsor Principal investigator and his Deputy -------------------------- person responsible for study conduct Study assistance/ Study nurse

Clinical Studies 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 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 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 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 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 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