CRP 112 Lecture 1 Flashcards
critical thinking (4)
decide whether:
-opinions are true or false
-ideas are adequatley defended
-recommendations are practical
-any particular solution is effective
3 characteristics of critical thinking
- Reasoning
- Reflection
- Practicality
-ideas are interconnected, build on each other, and goal orientated
reasoning
-type of thinking
-construct reasons to support beliefs
-evaluate reasons to support beliefs
reflection
-examination and evaluation of ours and others’ thoughts and beliefs
practicality
-thinking based on beliefs we take to be justified = practical and rational
steps for critical thinking (6)
1.knowledge
2. comprehension
3. application
4.analysis
5. synthesis
6. action
knowledge
-identify the topic, issues, thesis and main points.
-identify problem or argument to solve
comprehend
-truely understand what the problem is
application
-applying understanding of the problem to the actual situation
-must understand facts and resources required to solve problem
-contruct link between information and resources
Analysis
-break down what you know
-identify situation, strong and weak points, challenges
-set priorities
-identify causes
-prioritize causes based on their impact
synthesis
-make a decision to solve the problem
-initial routes
-evaluate and prioritize alternate solutions
-SWOT analysis -strengths, weaknesses, oppertunities, threats
Action
put decision into action
-plan of action
-several steps
5 steps to improve critical thinking
- formulate questions
- gather information
- apply information
- consider implications
- consider other points of view
Criteria of good argument (4)
- Relevance
- Acceptability
- Sufficient grounds
- Rebuttal and charity
Relevance
The acceptance of the premise: Provides some reason or belief
Counts in favor of or makes a difference to
Acceptability
Premise must be acceptable to a rational person
Sufficient grounds
Is there enough evidence to support the premise, is the right kind of evidence?
Rebuttal and charity
Effective rebuttal to strongest arguments against your conclusion
Must raise the issue ans refute it
Charity could interpret unclear statements generously
Deductive
Based on facts if true
Inductive
Based on opinions
Critical analysis
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
Quality definition
Total set of characteristics of a product or service that affect its ability to satisfy a customer’s stated or implied needs
Quality system definition
Organizational structure, responsibilities, procedures, processes and resources for implementing quality management
Quality assurance definition
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
Quality control definition
Periodic operational. Checks within each functional department to verify clinical data are generated, collected, handled, analyzed, and reported according to protocol, SOPs, and GCP
Quality is the…
Absence of errors that matter
Quality plan
How QC and QA processes are applied, define quality related tasks and their resources
Operational QC
-sampling plans
-data source
-documented metrics
-acceptable quality levels
-methods to report/distribute results
Operation QC consists of (6)
- Study design phase
- Investigator selection
- Study monitoring
- Source data verification
- Query resolution
- Regulations compliance
Examples of risk entities
Protocol, data, science review, SOPs
Objectives of quality by design
Patient safety and data integrity
-SOP and regulatory compliance
-robust processes
-consistency across processes
-transparency
Plan do check act cycle
- 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)
- Do - implement the study risk management strategies and plan
- Check - study the actual results, compare against goals, look for deviations by monitoring leading indicators in trial, chart data to see trends
- 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
Quality by design plan do check act cycle
- Plan - protcol, assess risks, plan mitigation and evaluation
- Do - operations, do the trial, training, procedures tailored to protocol
- Check - monitoring
- Act - make improvements, re assess risks , change protocol, operations or monitoring
Benefits of quality by design
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
High quality clinical trials
Avoid errors that matter to decision making
Human participant protection
Reliability of results
Consider wider environment (public health etc)
Impact of errors
-random errors add noise reduce statistical power but does not produce bias
-systematic errors add bias and lead towards a particular decision
Errors that matter
Affect patient safety or credibility of study results
