Medicines and Governance

Question 1

What does Governance mean?

Answer 1

A framework which accounts for all the processes of governing an organisation = Improve the quality of their services and safeguarding high standards of care.

Question 2

What are the 3 main processes of governance?

Answer 2

Strategic Planning
Performance Management
Risk Management

Question 3

Why do we need systems for governance?

Answer 3

Meet health needs of target populations.

Question 4

Why do we need strategic planning for governance?

Answer 4

Creating objectives and setting goals for where company wants to go in the future.

Question 5

Why do we need performance management for governance?

Answer 5

Performing at best results in patient care improving.

Question 6

Why do we need risk management for governance?

Answer 6

Minimising risk to patients.

Question 7

In terms of stakeholders, what are they?

Answer 7

They are investors whose actions determine the outcome of your business decisions.

Question 8

Name some examples of stakeholders.

Answer 8

Patients
Physicians
Employers
Insurance Companies

Question 9

What does the ‘Good Clinical Practice’ regulation outline?

Answer 9

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.

Question 10

Who is the ‘Good Clinical Practice’ regulation produced by?

Answer 10

ICH = International Conference on Harmonisation

Question 11

What does following ‘Good Clinical Practice’ regulation mean for the data produced?

Answer 11

It is credible data.

Question 12

What are the 5 main requirement for an authorisation to conduct a clinical trial?

Answer 12

Ethics Committee 
Licensing Authority (MHRA)
Pharmacovigilance : Drug Safety
IMP handling and labelling 
GCP Adherence

Question 13

What does pharmacovigilance mean?

Answer 13

Practice of monitoring the effects of medical drugs after they have ben licensed for use.

Question 14

Why is IMP handling and labelling so important?

Answer 14

Ensures protection of the participant and traceability = thus enables the identification of the product and the trial.

Question 15

What is the purpose of the MHRA?

Answer 15

Regulates ALL medicines and medical devices in the uk by ensuring they work and are acceptably safe to use.

Question 16

What does the Human Tissue Act in 2004 denote?

Answer 16

Regulates the removal // storage // use of human tissue.

Question 17

What is a protocol?

Answer 17

A comprehensive set of instructions to carry out a scientific experiment.

Question 18

What are the basic elements mentioned in a protocol?

Answer 18

Scientific background and rationale 
Objectives
Design 
Data Collection and Analysis
Organisation of the trial

Question 19

What is a standard operating procedure?

Answer 19

Set of step by step instructions compiled by an organisation to help workers carry out complex routine operations.

Question 20

What is the cycle used which involves the standard operating procedure?

Answer 20

Standard Operating Procedure
Staff Training
Audit
Review and change management

Question 21

What is an Audit?

Answer 21

A systematic approach to reviewing // analysing // evaluating work of an organisation.

Question 22

What is clinical trial monitoring?

Answer 22

The act of overseeing the conduct of a clinical trial.

Question 23

Who normally oversees the clinical trial monitoring?

Answer 23

Done by the principal clinical investigator.

Question 24

What is a RAG rating?

Answer 24

Red // Amber // Green

= Indicates how well a certain project is performing.

Question 25

What is incident reporting?

Answer 25

Unintended // Unexpected incident which could’ve led to harm for one // more patients receiving healthcare : ensures NHS learns from any mistakes.

Question 26

What is a clinical dashboard?

Answer 26

Visual Display which provides clinicians with relevant and timely access to the information they need in order to improve the quality of patient care.