Clinical Studies
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Transcript Clinical Studies
Deepening Topics
QM in Clinical studies
Dr. Erwig Pinter
QKB-Qualität im Krankenhaus Beratungsgesellschaft mbH
1
Clinical Studies
Regulations
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
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
From there the communication with the study conducting cooperators
is organised
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
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