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CRP 112 Audits > CRP 112 Lecture 1 > Flashcards

CRP 112 Lecture 1 Flashcards

1
Q

critical thinking (4)

A

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

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2
Q

3 characteristics of critical thinking

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

reasoning

A

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

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4
Q

reflection

A

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

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5
Q

practicality

A

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

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6
Q

steps for critical thinking (6)

A

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

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7
Q

knowledge

A

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

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8
Q

comprehend

A

-truely understand what the problem is

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9
Q

application

A

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

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10
Q

Analysis

A

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

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11
Q

synthesis

A

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

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12
Q

Action

A

put decision into action
-plan of action
-several steps

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13
Q

5 steps to improve critical thinking

A
  1. formulate questions
  2. gather information
  3. apply information
  4. consider implications
  5. consider other points of view
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14
Q

Criteria of good argument (4)

A
  1. Relevance
  2. Acceptability
  3. Sufficient grounds
  4. Rebuttal and charity
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15
Q

Relevance

A

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

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16
Q

Acceptability

A

Premise must be acceptable to a rational person

17
Q

Sufficient grounds

A

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

18
Q

Rebuttal and charity

A

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

19
Q

Deductive

A

Based on facts if true

20
Q

Inductive

A

Based on opinions

21
Q

Critical analysis

A

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

22
Q

Quality definition

A

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

23
Q

Quality system definition

A

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

24
Q

Quality assurance definition

A

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

25
Q

Quality control definition

A

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

26
Q

Quality is the…

A

Absence of errors that matter

27
Q

Quality plan

A

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

28
Q

Operational QC

A

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

29
Q

Operation QC consists of (6)

A
  1. Study design phase
  2. Investigator selection
  3. Study monitoring
  4. Source data verification
  5. Query resolution
  6. Regulations compliance
30
Q

Examples of risk entities

A

Protocol, data, science review, SOPs

31
Q

Objectives of quality by design

A

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

32
Q

Plan do check act cycle

A
  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
33
Q

Quality by design plan do check act cycle

A
  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
34
Q

Benefits of quality by design

A

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

35
Q

High quality clinical trials

A

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

36
Q

Impact of errors

A

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

37
Q

Errors that matter

A

Affect patient safety or credibility of study results

CRP 112 Audits (4 decks)

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