30 Questions
What is the benefit of evidence-based decision making?
Increased likelihood of achieving desired outcomes
How can organizations improve performance through managing relationships with stakeholders?
By sharing resources and managing risks related to quality
What is a key part of the ISO 9001:2015 PDCA cycle?
Ensuring adherence to mandatory requirements
What should an SGQ ensure according to the text?
Adherence to mandatory requirements
How can an organization demonstrate the effectiveness of its past decisions?
By managing risks and opportunities effectively
What is one reason why processes of decision-making should be improved?
To achieve better operational effectiveness
What is the purpose of accreditation according to NP EN ISO/IEC 17000:2005?
To certify the competence of entities to carry out specific conformity assessment activities.
Who can provide accreditation according to the text?
Organisms accredited by IPAC.
What is one advantage of ISO certification mentioned in the text?
Access to new global markets.
How does accreditation differ from certification according to the text?
Accreditation certifies competence to carry out specific conformity assessment activities.
What does ISO certification provide regarding the credibility of a company?
Credibility with users/patients and other social and economic-related institutions/entities.
Why is accreditation considered a formal recognition according to the text?
To ensure the reliability of activity results.
What is the main difference between Police and SOP as mentioned in the text?
Police is more formal, while SOPs can vary from study to study.
What do Work Instructions focus on?
Informal guidelines
What is the purpose of Standard Operating Procedures (SOPs)?
To guide how tests or activities should be performed
In what areas can SOPs be found based on the text?
Pharmaceutical industry, CROs, Research Centers
Which of the following is NOT a difference between SOPs and Work Instructions?
Controlled distribution
What should Standard Operating Procedures (SOPs) ensure according to the text?
Proper execution of procedures
What is the main purpose of a Quality Management System (QMS) in a Research Center according to the text?
To support clinical trial activities and consistently apply laws and regulations.
What does the ICH GCP Addendum emphasize regarding quality management in clinical trials?
Designing efficient protocols, ensuring human subject protection, and reliable results.
Why should the methods used to assure and control trial quality be proportionate to the risks involved?
To align with the risks inherent in the trial and the collected information's significance.
What should sponsors avoid when managing quality in a clinical trial according to the text?
Adding unnecessary complexity, procedures, and data collection.
How should a Quality Management System in a Research Center adapt according to the text?
By being tailored to fit the organization's size and nature.
Which aspect should sponsors primarily focus on during a clinical trial according to the ICH GCP Addendum?
Ensuring human subject protection and reliable trial results.
What is a common observation related to personnel training according to the text?
Electronic training modules conducted by individuals not listed in the site's signature log
What is a common issue related to the organization and personnel mentioned in the text?
Discrepancies between the Team Member lists in TMF and CRO Study Team List
What is a common problem observed regarding the auditing of the research center's documents according to the text?
Acceptance of an electronic registration system as a valid source document
What is an issue related to the engagement between the promoter and CRO as per the text?
Proper documentation of delegation specifics to the CRO
What is one of the issues mentioned regarding personnel training in the text?
Documentation completion after a delay following new ICHGCP versions
What is a notable issue identified concerning patient records based on the given information?
'Source' documents not clearly identified and verified properly
Learn about the effectiveness and efficiency of Standard Operating Procedures (SOPs) in a Quality Management System (QMS). Understand the importance of organization, structure, responsibilities, procedures, and resources in ensuring quality within an organization.
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