This document discusses quality assurance and quality control in clinical research. It defines quality assurance as planned actions to ensure a trial complies with good clinical practice and regulations. Quality control refers to operational techniques that verify quality requirements are fulfilled. Ensuring accurate, reliable data is an ongoing challenge managed through monitoring data collection and management at all study levels. Sponsors are responsible for quality systems with standard operating procedures and allowing monitoring, auditing and inspections. Quality assurance and quality control help ensure successful project completion and credible, compliant research.
TSDP tells about the essential documents that are required for the #conduct of a clinical trial. For #regulatory medical writing training, contact hello@turacoz.in.
This presentation is a brief overview of ICH-GCP guidelines. Although ICH-GCP is a very vast topic, still this presentation will cover almost all the points. The reader will be able to discuss about the roles and responsibilities of various personnel in clinical trials.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
TSDP tells about the essential documents that are required for the #conduct of a clinical trial. For #regulatory medical writing training, contact hello@turacoz.in.
This presentation is a brief overview of ICH-GCP guidelines. Although ICH-GCP is a very vast topic, still this presentation will cover almost all the points. The reader will be able to discuss about the roles and responsibilities of various personnel in clinical trials.
In any work or process documents that are needed before initiation, Between or generally the end of the process just like in a clinical trial those “Documents which permit evaluation of the conduct of a trial and the quality of the data produced. It is given in the 8th section of the ICH-GCP.
Clinical Data Management Plan_Katalyst HLSKatalyst HLS
Introduction to Data Management Plan in Clinical Data Management in Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Electronic Data Capture & Remote Data CaptureCRB Tech
CRB Tech is one of the best leading Software Development Company in Pune. We are offering Software Development Services as well as IT Training including Java, Dot Net, SEO and Clinical Research training in pune.
Investigator: A person responsible for the conduct of the study at the trial site.
Investigator is a person responsible for the rights, health and welfare of the study subjects.
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
An overview of archiving of clinical studies and data. By RISHI MAHESHWARI , JSS COLLEGE OF PHARMACY , OOTY
For students in V PharmD this topic has been prepared.
Clinical Data Management Plan_Katalyst HLSKatalyst HLS
Introduction to Data Management Plan in Clinical Data Management in Clinical Trials of Pharmaceuticals, Bio-Pharmaceuticals, Medical Devices, Cosmeceuticals and Foods.
Electronic Data Capture & Remote Data CaptureCRB Tech
CRB Tech is one of the best leading Software Development Company in Pune. We are offering Software Development Services as well as IT Training including Java, Dot Net, SEO and Clinical Research training in pune.
Investigator: A person responsible for the conduct of the study at the trial site.
Investigator is a person responsible for the rights, health and welfare of the study subjects.
Table of contents
-Definition of CRF
-What is CRF
-Types & Methods of filling of CRF
-CRF Input team
-CRF Approval team
-Review team
-Facts about CRF
-Purpose of CRF
-CRF Development process & Guidelines
-Elements of CRF
-CRF Design
-CRF completion checklist
-CRF Design tools
-CRF use
-GCP connection
An overview of archiving of clinical studies and data. By RISHI MAHESHWARI , JSS COLLEGE OF PHARMACY , OOTY
For students in V PharmD this topic has been prepared.
The pharmaceutical Quality by Design is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Quality by Design is emerging to enhance the assurance of safe, effective drug supply to the consumer, and also offers promise to significantly improve manufacturing quality performance
Clinical Data Quality Control and Assurance: Ensuring Reliable ResultsClinosolIndia
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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
5/22/2021 CLINICAL RESEARCH PROGRAMS 1
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
5/22/2021 CLINICAL RESEARCH PROGRAMS 3
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
5/22/2021 CLINICAL RESEARCH PROGRAMS 4
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.
5/22/2021 CLINICAL RESEARCH PROGRAMS 5
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
5/22/2021 CLINICAL RESEARCH PROGRAMS 7
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
5/22/2021 CLINICAL RESEARCH PROGRAMS 8
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.
5/22/2021 CLINICAL RESEARCH PROGRAMS 9
10. COMPONENTS OF QUALITY CONTROL
Monitoring
Facilities
Audits
Analysis of
data
Data collection
Validation
Records
Quality
control
5/22/2021 CLINICAL RESEARCH PROGRAMS 10
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).
5/22/2021 CLINICAL RESEARCH PROGRAMS 11
12. RESPONSIBILITIES OF SPONSOR
SPONSOR
• Sponsor is an individual, company,
institution or organization which takes
responsibility for the initiations,
management & financing of clinical
trials.
5/22/2021 CLINICAL RESEARCH PROGRAMS 12
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.
5/22/2021 CLINICAL RESEARCH PROGRAMS 13
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
5/22/2021 CLINICAL RESEARCH PROGRAMS 16
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
5/22/2021 CLINICAL RESEARCH PROGRAMS 18
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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