Quality management in clinical trials

Provided by CCRI (Children's Cancer Research Institute)

ZANDR

* Quality Management (support)
The QM always works in close cooperation with all staff members to provide cellular therapeutic agents, tissues, diagnostic services and study results of the highest quality and in compliance with legal requirements, guidelines and standards. This includes – but is not restricted to – support in the following respects:
Document management (writing, approval, distribution, version control, archiving, …)
Process management (recording of process flow diagrams, assignment of responsibilities, monitoring of process indicators, process enhancement, …)
Training and further education (conduct, management and refreshment of training)
Risk assessment and performance of risk analyses
Fault and deviation management (classification, allocation, processing and closing of errors, performance of root cause analyses and implementation of improvements)
Complaint handling
Supplier qualification (obtaining certificates or quality questionnaires, approval or blocking of suppliers, …)
Approval of maintenance, calibration and qualification reports for critical equipment
Method and process validation (defining and writing validation plans, calculating and representing results, writing validation reports, …)
Recording and reporting of side effects (pharmacovigilance, tissue vigilance, medical device vigilance)
Implementation of new standards
Auditing and monitoring including their reporting
Annual reporting (product quality reports, vigilance reports, management reports, and others)

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Quality Management Services

Provided by EUROPEAN RESEARCH INFRASTRUCTURE CONSORTIUM (BBMRI-ERIC)

BBMRI-ERIC

Quality Management Services
– Knowledge Hub (Consulting on international standards relevant for biobanking and biomedical research; Quality management tasks in EU projects)
– Training & Support (In-house and online training, university courses, summer schools, short courses, workshops and consulting services covering various quality management systems relevant for biobanking and biomedical research )
– Auditing (The BBMRI-ERIC Self-Assessment Surveys (SAS) help to determine relevant requirements for work processes defined in international standards for biobanking and biomedical research)
– Audit programmes (Remote/on-site) (Quality check mark in Directory (assessment processes, including a remote or on-site audit, can lead to a Q-mark in the BBMRI-ERIC Directory))
BBMRI-ERIC delivers services to their member states in 3 different areas: IT, Quality Management and ELSI

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