Deepening Topics
QM in Clinical studies
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
1
Clinical Studies
Regulations
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EU-Directive, e.g. 2001/20/EC
Drug Law
Medical Device Act
GCP-Regulation
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
2
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
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
3
Clinical Studies
Study management persons
Federal agencies
Sponsor
Principal investigator
and his Deputy
-------------------------person responsible for
study conduct
Study assistance/
Study nurse
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
4
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
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
5
Clinical Studies
Principal Investigator
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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
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
6
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
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From there the communication with the study conducting cooperators
is organised
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Must be informed about critical results
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
7
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
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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
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
8
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
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
9
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
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
10