Deepening Topics

Dr. Erwig PinterQKB-Qualität im Krankenhaus Beratungsgesellschaft mbH 1

QM in Clinical studies

Deepening Topics


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

Clinical Studies

Principal investigator and his Deputy

--------------------------person responsible for

study conduct

Sponsor

Study assistance/Study nurse

Federal agencies


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

Clinical Studies

Deepening Topics

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