basic information on QA & QC in clinical research

1. Quality Assurance
&
Quality Control
In Clinical Research
MSc Clinical Research 2020-2022(Sem-2)
Presented by;
Devarshi Nayak : Roll no - 9
Avani Pansuria : Roll no - 10
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3. WHAT IS QUALITY?
• A measure of excellence or a state of being free from defects, deficiencies and
significant reactions
• Meeting customers expectations
• Exceeding the customers expectation
• Superiority to competitors
Analyze
Plane &
prioritize
Control
& report
Monitor
Identify
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4. IMPACTS OF IGNORANCE OF QUALITY
Lack of therapeutic
effect prolonged
illness , death
Toxic and adverse
reaction
Waste of limited
financial resources
Loss of credibility
Manufacturing process
Packaging
Transportation
Storage condition
MEDICINE
QUALITY
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5. QUALITY ASSURANCE
 QA (ICH sec 1.46 ) –
• All those planned and systemic actions that are established to ensure that the trial is
performed and data are generated , documented (recorded) and reported in
compliance with GCP (good clinical practice) and applicable regulatory
requirements.
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6. QUALITY ASSURANCE ACTIVITIES
Quality
Assurance
Activities
Reporting
Activities
Planning
Data
collection
Quality
control
Docume-
tation
Evaluation
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7. Applying
corrective and
preventive actions to
close the gaps
Keep
monitoring
and auditing
the current
practices
Improve objectives and
Improvement in
plans
Establishing
and
Implementing
best practices
OBJECTIVES OF QUALITY ASSURANCE
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8. COMPONENTS OF QUALITY ASSURANCE
• Strategic level
 Long term decision
 Quality policy
• Tactical level
 Medium term decision
 Training , facilities ,operation of QA
• Operational level
 Day to day operation
 SOP’s worksheet
Strategic level
Long term decision
Tactical Level
Medium term decision
Operational level
Day to day operation
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9. QUALITY CONTROL
 ICH (sec 1.47 )
 The operational techniques and activities undertaken within the quality assurance
system to verify that the requirements for quality of the trial related activities have
been fulfilled.
 As per ISO 9000
 Quality control is defined as a part of quality management focused on fulfilling
quality requirements.
 WHO
 The sum of all procedures undertaken to ensure the identity and purity of particular
pharmaceutical.
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10. COMPONENTS OF QUALITY CONTROL
Monitoring
Facilities
Audits
Analysis of
data
Data collection
Validation
Records
Quality
control
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11. CHALLENGE IN MANAGING THE QUALITY
 The ongoing challenge in managing the quality of clinical data is to
continually monitor data collection procedures and data management practices
at every level of the study.
 This includes:-
• Ensuring that data generated during the study reflect what is specified in the
protocol (CRF (Case Report Form) vs. protocol)
• Comparing data in the CRF and data collected in source documents for
accuracy (CRF vs. source documents)
• Ensuring that the data analyzed are the data recorded in the CRF (database vs.
CRF).
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12. RESPONSIBILITIES OF SPONSOR
SPONSOR
• Sponsor is an individual, company,
institution or organization which takes
responsibility for the initiations,
management & financing of clinical
trials.
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13. • 5.1.1- The sponsor is responsible for implementing and maintaining quality
assurance and quality control system with written SOPs to ensure that trials are
conducted and data are generated, documented (recorded) and reported in compliance
with the protocol, GCP, and the applicable regulatory requirements.
• 5.1.2- The sponsor is responsible for securing agreement from all involved parties to
ensure direct access to all trial-related sites, source data/documents, and reports for
the purpose of monitoring and auditing by the sponsor, and inspection by domestic
and foreign regulatory authorities.
• 5.1.3- Quality control should be applied to each stage of data handling to ensure that
all that data are reliable and have been processed correctly.
• 5.1.4- Agreements, made by the sponsor with the investigator/institution and any
other parties involved with the clinical trial, should be in writing, as a part of the
protocol or in a separate agreement.
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14. Sponsors
Project manager
CRA/Monitor
CRO ( Contract Research Organization)
Data manager
Biostatical
Medical writer
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15. DIFFERENCE
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16. QC QA
Focus Product quality at a given moment Project process
Character Reactive ( defects the issues when
there're already in )
Preventive (blocks the issues by
detecting vulnerabilities)
Starting point Require Presentment gathering stage
in each iteration
Project planning stage
(most efficient)
Any point in the SDLC when the
project is in trouble
Tools and measures Various types of testing
Testing metrics
Test reports
Quality metrics
Reviews
audits
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17. Quality
assurance
& quality
control
Policy,
Objectives,
Procedures,
standards
Continuous
improvements
Customer
satisfaction
Corporate image
Customer
service
Project
success
Corporate
performance
Staff moral,
retention &
satisfaction
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IMPORTANCE OF QA & QC

18. WHY QA & QC IS NEEDED?
• Ensures that the trial is in compliance with protocols,
Standard Operating Procedures (SOPs) and Good Clinical
Practices (GCP)
• Resolves systemic problems before the end of the trial
• Helps minimize data queries
• Come up with ways to minimize cycle times for various
processes
• Assure the credibility and reliability of the data
• Make sure that the data entered at all stages of the trial is
consistent and accurate
• Play an important role in dealing with cases of
nonconformity during the trial
Quality
Quality
assurance
Quality
control
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19. REFERENCES
• A text book of Pharmaceutical quality assurance by anusuya r.kashi, bindu
sukumaran,veena p
• Good clinical practice by josef kolman,paul meng
• Clinical studies management by simon cook
• https://www.scnsoftomlog/qa-vs-qc-fighting-the-fog
• ICH GCP E6(R2) good clinical practice: integrated addendum to ICH E6 (R1)
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