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CRP 112 Lecture 4 Flashcards

1
Q

TransCelerate

A

-Non-profit
-Goal to improve health of people around the world by simplifying & accelerating R&D of innovative new therapies
-identify, prioritize, design
implementation of solutions for efficient, effective and high-quality delivery of new medicines worldwide
Has own cQMS (clinical quality management system) initiatives
 Shared investigator platform
 Clinical Research Awareness and Access
 Comparator network

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2
Q

QMS

A

In pharma manufacturing
 Standardized
 ICH Q10: Pharmaceutical Quality System
 ICH Q9: Quality Risk Management
 In clinical
 Fragmented
 No industry wide conceptual framework for
clinical QM

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3
Q

ICH Q10: Pharmaceutical Quality System objectives

A
  1. Achieve product realisation
     Product is delivered to meet patient needs
  2. Establish & Maintain a State of Control
     Continued suitability & capability of processes – risk mgt
  3. Facilitate Continual Improvement
     Use quality risk management
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4
Q

ICH Q10

A

-For systems supporting development & manufacture of
- Pharmaceutical drug substance (API)
- Drug products, including biotechnology & biological products
-Applies throughout product lifecycle (development, tech transfer between development and manufacturing, commercial manufacturing, product discontinuation)

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5
Q

ICH Q10 Management
Responsibility

A

 Management commitment
 Quality policy & quality planning
 Resource management
 Internal communication
 Management review
 Management of outsourced activities & purchased materials
 Management of change in product ownership
 CAPA
 Change Management System
 Management review of process
performance & product quality

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6
Q

ICH Q10 Product Quality
Monitoring

A

 Monitoring system to ensure state of control is
maintained
 Process performance & QMS
 Use quality risk management (ICH Q9)
 Provide tools to measure & analyze
 Analyze parameters & attributes
 Provide feedback on product quality

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7
Q

ICH Integration: Q8, Q9, Q10

A

 Q8 Pharmaceutical Development
 Q9 Quality Risk Management
 Q10 Pharmaceutical Quality Systems
 Together they encompass:
 Quality by Design, Risk Management & Product Quality System

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8
Q

ICH Q9: Quality Risk Management principles

A

2 primary principles
 Base risk evaluation on scientific knowledge & link
to patient protection
 Effort, formality & documentation is based on level of risk

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9
Q

ICH Q9(R1): Risk Assessment

A

 Hazard ID
 Risk Analysis (likelihood and severity of consequences)
 Risk Evaluation

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10
Q

ICH Q9(R1): Risk Control

A

 Reduce or accept risks
 Effort to reduce risk must be proportional to significance of risk

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11
Q

ICH Q9(R1): Risk Communication

A

 Sharing information about risk & risk
management
 Occurs at any stage of process
 Output/result of quality risk management
process should be communicated AND
documented

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12
Q

ICH Q9(R1): Risk Review

A

 Review output/results to take into account new knowledge and experience
 Once initiated, continue for events that might impact original quality risk
management decision
 Planned or unplanned events

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13
Q

cQMS Definition

A
  • Currently no cQMS guidance
     Integrated approach for an organization to systematically:
     Define quality objectives taking into account both strategic objectives & regulatory requirements
     Develop & Implement infrastructure
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14
Q

Advantages of a cQMS

A

 Sites:
 By focusing on “errors that matter”, it decreases burden and streamlines the processes
 Sponsors:
 Fewer delays due to reduced remediation associated with quality issues
 Better ability to solve repetitive quality issues
 Regulators:
 Gives them consistent quality framework to evaluate, especially during inspections
 Participants:
 Increased participant safety
 Focus on “errors that matter” to well being & safety of participants

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15
Q

Foundational aspects of a cQMS (4)

A

-Understanding the Context
-Leadership Commitment to Quality
-Organizational Commitment to Quality
-Continuous Improvement of clinical QMS

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16
Q

cQMS Understanding the Context

A
  • Evaluate external & internal environments
  • Political, economic, social, regulations,
    market structures, trial designs etc.
  • Internal governance, organizational
    structure, roles, policies, culture,
    corporate knowledge etc.
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17
Q

cQMS Leadership Commitment to Quality

A

 Sr. management is accountable & responsible for defining expectations for quality AND communicating the importance of quality
 Each employee should understand how quality applies to them & other stakeholders

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18
Q

cQMS Organizational Commitment to Quality

A

 Sr management needs to cultivate an
environment where everyone takes ownership of quality and holds themselves and others accountable for quality
 Organization should empower individuals to
address quality concerns without fear of reprisal

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19
Q

cQMS Continuous Improvement of clinical QM

A

 Organization monitors internal/external context for changes that might necessitate modification of the QMS
 Leverage outputs from knowledge management activities
 Conduct internal audits
 Ensure appropriate change management is used

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20
Q

Elements of a cQMS (7)

A

-Processes
-Resources, Roles, Responsibilities
-Partnering
-Risk Management
-Issue Management
-Knowledge Management (KM)
-Documentation

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21
Q

cQMS Processes

A

 Well defined and characterized
 Develop clear/concise documents (e.g. SOPs)
-Instill Knowledge Management Activities (identify changes that mean re-evaluation of
processes & associated documents)
 Consider burden of implementation
 Determine which processes/documents mandatory, which are best practices
 Training

22
Q

cQMS Resources, Roles, Responsibilities

A

 Prospectively evaluate required resources & skill-
sets to achieve clinical strategy
 Ensure appropriate resources are available
 Ensure clarity in roles, responsibilities &accountability
 All staff to be qualified (education, training, experience)

23
Q

cQMS Partnering

A

 Co-development and outsourcing (i.e. Sponsor and CRO agreement)
 Prospectively consider for all parties:
 Needs
 Expectations
 Limitations
 Risks
 Ownership must be taken by each party
 Prospectively document agreement on:
 Expectations for how activities are conducted
 Communications (including escalations)
 Performance measurement

24
Q

cQMS Risk Management

A

Types of Risk
 Strategic (Licensing opportunities, partnership benefits)
 Operational (IP productions)
 Quality (Endpoint criteria, data credibility)
 Compliance (Regulatory requirements for registrations)

25
“Plan Do Check Act” (PDCA) cycle
referred to in ISO 31000 – Risk Management -policy and government -program design -implementation -monitoring and review -continual improvement
26
ISO 31000 – Risk Management
 Helps account for unexpected when managing risk  Will identify & analyze risks in organizational context -Active communication, process eval, oversight
27
Clinical trial context Significant risks
 Participant safety  Data integrity  Regulatory compliance  Trust in organization
28
Risk Management Process
1. Understanding the context -Identify changes (Internal and External) that might create risks 2. Risk Assessment -ID, analyze (level), evaluate (likelihood, impact, effectiveness of existing mititgations) 3. Risk Mitigation -ID actions to address the risk (accept, avoid, transfer or reduce) 4. Risk Monitoring and Review -Did actions achieve desired outcome? -Periodically assess changes in internal or external context 5. Communication and Consultation -Include all stakeholders -Include regulatory authorities when applicable -Occurs at all stages of process
29
cQMS Issue Management
 Issues that Matter  Supports effective CAPA process  Issue documentation & investigation  Trending and Analytics
30
cQMS Knowledge Management (KM)
 Getting right information to right people at the right time  Ensure key prior knowledge is accessible to entire team Types of knowledge: Explicit  Visible – easily recognized, shared, documented & assessed Tacit  Experience of team members  Goal is to collaborate and communicate – exchange and maintain knowledge
31
cQMS Documentation
 Level of documentation Commensurate with risk level, significance of activity and meeting stakeholder requirements -Supports the achievement of Quality
32
ACRO QMS
-building on TransCelerate -Sourcing models: Fully Outsourced, Internalized Model (Sponsor has direct visibility into activities), or Hybrid Approach (Shared environment aka Functional Service Provider (FSP) Relationship)  Greater visibility into risk management process & observations  Removal of emotional decisions  Data driven decisions instead!  Pro-active, collaborative oversight model
33
ACRO QMS Components
Knowledge Management Risk Management ID & mitigate risks that impact the 2 things+1!  Participant safety  Data quality & integrity  Plus regulatory compliance Issue Management, Focus on Issues that Matter Roles & Responsibilities Technology Quality Metrics (Key Risk Indicators (KRIs), Quality Tolerant Limits (QTLs), Key Performance Indicators (KPIs)) Policies/Procedures for CRO
34
Building Quality into Clinical Trials
 Quality cannot be monitored, audited, or inspected retrospectively  At the trial level, the protocol – or investigational plan - is the blueprint for quality
35
ICH
International Council for Harmonisation
36
ICH E6(R3)
Designing quality in clinical trials Stakeholder engagement Trial design Proportionate trial management Focus on factors critical to quality of trials -new study designs, conduct, technologies and data sources ICH E8(R1) - designing quality into clinical studies
37
ICH E6(R3) Step 3 Stages
Stage I - Regional regulatory consultation Stage II - Discussion of regional consultation comments Stage III - Finalisation of Step 3 Experts Draft Guideline
38
ICH E6(R3) Principles
Guideline is intended to be media neutral to enable use of different technologies - encourages thoughtful consideration & planning to address aspects of CTs to ensure trial quality -Digital health technologies -variety of relevant data sources -Keep clinical trial conduct in line with advancing science & technological developments -Adapt use of technology to fit participant characteristics & particular trial design -Quality should be built into scientific & operational design/conduct of CTs Prospectively manage risks to Critical to Quality -Computerised systems must be Fit for Purpose addressing factors Critical to Quality -Transparency by registration & public posting of results.
39
ICH E6 (R2) – Quality Risk Management
Quality management includes:  efficient design of clinical trial protocols  data collection & processing tools & procedures  collection of information essential to decision making  Quality management system should use a risk-based approach
40
Sponsor: Quality Management
Sponsor should implement a system to manage quality throughout all stages of the trial process, focus on participant protection and reliability of trial results Quality management includes:  efficient design of clinical trial protocols  data collection & processing tools & procedures  collection of information essential to decision making -all aspects of trial are operationally feasible -Protocols, CRFs, & other operational documents should be clear, concise & consistent -Quality management system should use a risk-based approach
41
Risk based approach (7)
-ID critcal processes and data -ID risks -risk eval -risk control -risk communication -risk review -risk reporting
42
Critical process and data identification
During protocol development, sponsor should identify those processes & data that are:  critical to assure human participant protection & reliability of study results
43
Risk identification
Risks should be considered at both:  system level (e.g. standard operating procedures, computerized systems, personnel) &  clinical trial level (e.g. trial design, data collection & informed consent process)
44
Risk evaluation
Identified risks should be evaluated vs. existing risk controls by considering:  Likelihood of errors occurring  Extent to which such errors would be detect  Impact of errors on human participant protection & reliability of trial results
45
Risk control
Sponsor should decide which risks to:  Reduce and/or accept  Approach used to reduce risk to an acceptable level should be proportionate to significance of risk  Predefined quality tolerance limits should be established  Detection of deviations from predefined quality tolerance limits should trigger an evaluation to determine if action is needed
46
Risk communication
QM activities should be documented & communicated to those involved or affected facilitate:  risk review & continual improvement during clinical trial execution
47
Risk review
Sponsor should periodically review risk control measures to ascertain whether implemented quality management activities remain effective and relevant  Take into account emerging knowledge & experience
48
Risk reporting
Sponsor should -describe quality management approach implemented in trial - summarize important deviations from predefined quality tolerance limits and remedial actions taken
49
TransCelerate Risk Assessment and Categorization Tool (RACT)
Provides categories of risk, questions for discussion & considerations specific to risk categories (i.e phase, complexity, population, tech, CRF source, endpoints, IP etc)
50
RACT considerations
Impact (1-3)  Data integrity, participant safety, GCP compliance Probability of occurring (1-3)  High, medium or low probability Detectability (3-1)  Higher detectability is lower risk (easy to detect =1)

CRP 112 Audits (9 decks)

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