CRP 112 Lecture 1

Question 1

critical thinking (4)

Answer 1

decide whether:
-opinions are true or false
-ideas are adequatley defended
-recommendations are practical
-any particular solution is effective

Question 2

3 characteristics of critical thinking

Answer 2

1. Reasoning
2. Reflection
3. Practicality
   -ideas are interconnected, build on each other, and goal orientated

Question 3

reasoning

Answer 3

-type of thinking
-construct reasons to support beliefs
-evaluate reasons to support beliefs

Question 4

reflection

Answer 4

-examination and evaluation of ours and others’ thoughts and beliefs

Question 5

practicality

Answer 5

-thinking based on beliefs we take to be justified = practical and rational

Question 6

steps for critical thinking (6)

Answer 6

1.knowledge
2. comprehension
3. application
4.analysis
5. synthesis
6. action

Question 7

knowledge

Answer 7

-identify the topic, issues, thesis and main points.
-identify problem or argument to solve

Question 8

comprehend

Answer 8

-truely understand what the problem is

Question 9

application

Answer 9

-applying understanding of the problem to the actual situation
-must understand facts and resources required to solve problem
-contruct link between information and resources

Question 10

Analysis

Answer 10

-break down what you know
-identify situation, strong and weak points, challenges
-set priorities
-identify causes
-prioritize causes based on their impact

Question 11

synthesis

Answer 11

-make a decision to solve the problem
-initial routes
-evaluate and prioritize alternate solutions
-SWOT analysis -strengths, weaknesses, oppertunities, threats

Question 12

Action

Answer 12

put decision into action
-plan of action
-several steps

Question 13

5 steps to improve critical thinking

Answer 13

1. formulate questions
2. gather information
3. apply information
4. consider implications
5. consider other points of view

Question 14

Criteria of good argument (4)

Answer 14

1. Relevance
2. Acceptability
3. Sufficient grounds
4. Rebuttal and charity

Question 15

Relevance

Answer 15

The acceptance of the premise: Provides some reason or belief
Counts in favor of or makes a difference to

Question 16

Acceptability

Answer 16

Premise must be acceptable to a rational person

Question 17

Sufficient grounds

Answer 17

Is there enough evidence to support the premise, is the right kind of evidence?

Question 18

Rebuttal and charity

Answer 18

Effective rebuttal to strongest arguments against your conclusion
Must raise the issue ans refute it
Charity could interpret unclear statements generously

Question 19

Deductive

Answer 19

Based on facts if true

Question 20

Inductive

Answer 20

Based on opinions

Question 21

Critical analysis

Answer 21

Identifies significance
Evaluate,uates strengths and weaknesses
Makes reasoned judgements
Indicates if something is appropriate
Evaluates relative significance of details
Shows relevance of links between info
Draws conclusions

Question 22

Quality definition

Answer 22

Total set of characteristics of a product or service that affect its ability to satisfy a customer’s stated or implied needs

Question 23

Quality system definition

Answer 23

Organizational structure, responsibilities, procedures, processes and resources for implementing quality management

Question 24

Quality assurance definition

Answer 24

Systematic and independent examination of all trial related activities. Audits determine whether activities were appropriately conducted and data were generated, recorded, analyzed and accurately reported according to protcol, SOPs, and GCP

Question 25

Quality control definition

Answer 25

Periodic operational. Checks within each functional department to verify clinical data are generated, collected, handled, analyzed, and reported according to protocol, SOPs, and GCP

Question 26

Quality is the...

Answer 26

Absence of errors that matter

Question 27

Quality plan

Answer 27

How QC and QA processes are applied, define quality related tasks and their resources

Question 28

Operational QC

Answer 28

-sampling plans -data source -documented metrics -acceptable quality levels -methods to report/distribute results

Question 29

Operation QC consists of (6)

Answer 29

1. Study design phase 2. Investigator selection 3. Study monitoring 4. Source data verification 5. Query resolution 6. Regulations compliance

Question 30

Examples of risk entities

Answer 30

Protocol, data, science review, SOPs

Question 31

Objectives of quality by design

Answer 31

Patient safety and data integrity -SOP and regulatory compliance -robust processes -consistency across processes -transparency

Question 32

Plan do check act cycle

Answer 32

1. Plan - establish objectives and processes to deliver quality results for goals (design quality into trial, focus on what matters most: recruitment and eligibility, IP, patient perspective) 2. Do - implement the study risk management strategies and plan 3. Check - study the actual results, compare against goals, look for deviations by monitoring leading indicators in trial, chart data to see trends 4. Act - request corrective actions on anything that varies significantly from plan, determine root causes, determine where to apply changes to improve process. Drive remediation and learning. Adjust = course correction

Question 33

Quality by design plan do check act cycle

Answer 33

1. Plan - protcol, assess risks, plan mitigation and evaluation 2. Do - operations, do the trial, training, procedures tailored to protocol 3. Check - monitoring 4. Act - make improvements, re assess risks , change protocol, operations or monitoring

Question 34

Benefits of quality by design

Answer 34

Early detection: faster corrections, avoided costs, protected image Big picture: comprehensive issue detection, quantifiable risks and prioritization, focused allocation of resources Deeper insights: detection of systematic issues, ID of trends, process improvements

Question 35

High quality clinical trials

Answer 35

Avoid errors that matter to decision making Human participant protection Reliability of results Consider wider environment (public health etc)

Question 36

Impact of errors

Answer 36

-random errors add noise reduce statistical power but does not produce bias -systematic errors add bias and lead towards a particular decision

Question 37

Errors that matter

Answer 37

Affect patient safety or credibility of study results