discussed general responsibilities of Sponsor and Clinical Research Associate in the field of clinical studies and clinical trials. Along with their Duties and importance in the Clinical studies, the Ethical conduction and regulatory guideline compliance in research work of novel medication.

1. Responsibilities of
sponsor and CRA in
clinical research
Guided by:- Dr. Nerkar Sir
DR. Patil sir
Presented by:-Madhusudan Shinde
Ro Roll no:-MRA12
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2. Introduction
Clinical Research
Clinical Research
Sponsor in Clinical Research
Clinical Research Associate
Responsibilities
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3. Clinical Research
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4. Goals
Importance
Overview
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5. SPONSOR
In clinical research
Sponsor`s Team:-
Project manager
CRA {Associate} Monitor
CRO { Contract Research org.}
Data Manager
Bio-Statesian
Medical writer
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6. RESPONSIBILITIES OF
SPONSOR
Financial Support
Protocol Development
Regulatory Submissions
Study Oversight
Safety Monitoring
Risk Management
Quality Assurance
Data Management
Reporting & Documentation
Trial termination
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7. CRA [Clinical Research Associate]
Professional in the field of clinical research.
Vital role in the planning, execution, monitoring, and
management.
Ensures “Trials” conducted in compliance with applicable
regulatory and ethical guidelines.
Maintain data accuracy, protect the rights and safety of study
participants.
Act as intermediaries between the sponsor and the clinical
research site.
CRAs are critical to maintaining the
standards of Good Clinical Practice
(GCP) in clinical research
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8. CRA Responsibilities
Regulatory Compliance
Monitoring
Patient Recruitment
Site Communication
Data Collection
Site Training
Protocol Compliance
Adverse Event Reporting
Site Selection
Quality Control
Data Verification
Drug Accountability
Site Initiation
Ethical Considerations
Source Document Verification
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9. Collaboration between
Sponsor and CRA
Effective collaboration between clinical research
sponsors and Clinical Research Associates (CRAs)
is a cornerstone of successful clinical trials
Patient Safety
Regulatory
Compliance
Issue Resolution
Ethical Conduct
Quality Research
Efficiency
Data Quality
Benefits of
collaboration
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10. Ensuring Regulatory
Compliance
Ensuring regulatory compliance
is a shared responsibility
between sponsors and CRAs
Adherence to Protocol.
Regulatory Liaison
Quality Control
Documentation
Site Audits
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11. Monitoring in Clinical
Research
Monitoring is a vital component of
quality assurance. It involves the
oversight and evaluation of various
aspects of the trial.
On-Site Visits
Data Verification
Issue Identification Communication
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12. Quality Assurance in
Clinical Research
Quality assurance measures are
essential to maintain the highest
standards in clinical research
Standard Operating
Procedures (SOPs)
Training and
Education
Audits and
Inspections
Data Management Compliance Checks
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13. Ensuring Ethical
Conduct
Ensuring ethical conduct is a shared responsibility among
sponsors, researchers, and Clinical Research Associates (CRAs).
Patient Safety Measures
Informed Consent
Conflict of Interest
Ethical conduct Ethical Decision-Making
Ethical Training
Privacy Protection
Transparency
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14. Reporting and Documentation
Data Accuracy: Accurate and reliable documentation is crucial for
maintaining the integrity and credibility of the research. This includes
recording all relevant information about the study, participants, and
procedures.
Regulatory Submissions: Sponsors, CRAs, and research sites collaborate to
prepare and submit necessary documents to regulatory authorities for
study approval and oversight. This includes the clinical trial protocol,
investigator's brochure, and informed consent forms.
Patient Records: Accurate and organized patient records are maintained
to track individual participation in the trial, document medical history,
and record any health-related events that occur during the study.
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15. Reporting and Documentation
Safety Reporting: Adverse events and safety issues must be promptly
reported to regulatory authorities as required by regulatory standards.
Accurate and thorough documentation of safety data is critical to
protecting study participants.
Trial Progress: Regular documentation of the study's progress, including
recruitment statistics, data quality, and any deviations from the protocol,
helps sponsors and CRAs track and evaluate the trial's performance.
Publication of Results: Ethical and transparent reporting of study results,
whether positive or negative, contributes to the dissemination of
scientific knowledge. Researchers should ensure that results are
published in a timely and unbiased manner.
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16. - Sponsor Responsibilities
- CRA Responsibilities
- Collaboration
-Regulatory Compliance
-Monitoring and Quality Assurance
-Ethical Considerations
- Reporting and Documentation
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17. Current Trends in Clinical
Research
Virtual Trials
Emerging Technologies
Global Collaboration
Real-World Evidence
Artificial Intelligence
Regulatory Innovations
Patient Engagement
Decentralized Trials
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