Medicines and Governance Flashcards
What does Governance mean?
A framework which accounts for all the processes of governing an organisation = Improve the quality of their services and safeguarding high standards of care.
What are the 3 main processes of governance?
Strategic Planning
Performance Management
Risk Management
Why do we need systems for governance?
Meet health needs of target populations.
Why do we need strategic planning for governance?
Creating objectives and setting goals for where company wants to go in the future.
Why do we need performance management for governance?
Performing at best results in patient care improving.
Why do we need risk management for governance?
Minimising risk to patients.
In terms of stakeholders, what are they?
They are investors whose actions determine the outcome of your business decisions.
Name some examples of stakeholders.
Patients
Physicians
Employers
Insurance Companies
What does the ‘Good Clinical Practice’ regulation outline?
A set of recognised ethical and scientific quality requirements which must be observed for designing // conducting // recording and reporting clinical trials which involve participation of human subjects.
Who is the ‘Good Clinical Practice’ regulation produced by?
ICH = International Conference on Harmonisation
What does following ‘Good Clinical Practice’ regulation mean for the data produced?
It is credible data.
What are the 5 main requirement for an authorisation to conduct a clinical trial?
Ethics Committee Licensing Authority (MHRA) Pharmacovigilance : Drug Safety IMP handling and labelling GCP Adherence
What does pharmacovigilance mean?
Practice of monitoring the effects of medical drugs after they have ben licensed for use.
Why is IMP handling and labelling so important?
Ensures protection of the participant and traceability = thus enables the identification of the product and the trial.
What is the purpose of the MHRA?
Regulates ALL medicines and medical devices in the uk by ensuring they work and are acceptably safe to use.
What does the Human Tissue Act in 2004 denote?
Regulates the removal // storage // use of human tissue.
What is a protocol?
A comprehensive set of instructions to carry out a scientific experiment.
What are the basic elements mentioned in a protocol?
Scientific background and rationale Objectives Design Data Collection and Analysis Organisation of the trial
What is a standard operating procedure?
Set of step by step instructions compiled by an organisation to help workers carry out complex routine operations.
What is the cycle used which involves the standard operating procedure?
Standard Operating Procedure
Staff Training
Audit
Review and change management
What is an Audit?
A systematic approach to reviewing // analysing // evaluating work of an organisation.
What is clinical trial monitoring?
The act of overseeing the conduct of a clinical trial.
Who normally oversees the clinical trial monitoring?
Done by the principal clinical investigator.
What is a RAG rating?
Red // Amber // Green
= Indicates how well a certain project is performing.
What is incident reporting?
Unintended // Unexpected incident which could’ve led to harm for one // more patients receiving healthcare : ensures NHS learns from any mistakes.
What is a clinical dashboard?
Visual Display which provides clinicians with relevant and timely access to the information they need in order to improve the quality of patient care.
