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Mastering Clinical Research Monitoring: A Complete Guide to Techniques, Compliance, and Innovation
Mastering Clinical Research Monitoring: A Complete Guide to Techniques, Compliance, and Innovation
Curriculum
7 Sections
28 Lessons
10 Weeks
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Module 1: Introduction to Clinical Research Monitoring
5
1.0
Chapter 1: Introduction to Clinical Trials – Gain an understanding of the fundamental concepts of clinical trials, including their purpose, phases, and key stakeholders involved.
1.1
Chapter 2: Ethical Considerations: Informed Consent, Patient Safety, and Respect for Participants Rights – Explore the ethical principles governing clinical research, focusing on informed consent, patient safety, and the protection of participants’ rights.
1.2
Chapter 3: Regulatory Framework: Understanding Key Regulations and Guidelines – Understand the regulatory framework governing clinical research, including key regulations and guidelines such as Good Clinical Practice (GCP).
1.3
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1 Minute
1.4
Your Knowledge, Simplified
Module 2: Roles and Responsibilities in Monitoring
5
2.0
Chapter 1: The Role of the Clinical Research Monitor – Define the role of the clinical research monitor and outline their responsibilities throughout the trial process.
2.1
Chapter 2: Site Management: Strategies for Effective Site Management and Support – Learn site management strategies to optimize site performance and ensure successful trial conduct.
2.2
Chapter 3: Communication Skills: Effective Communication Techniques with Trial Sites and Other Stakeholders – Develop communication skills essential for interaction with trial sites and stakeholders involved in clinical research.
2.3
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2.4
Your Knowledge, Simplified
Module 3: Conducting the Monitoring Visit
5
3.0
Chapter 1: Pre-Visit Planning and Preparation – Guide through the pre-visit planning process, including the development of visit schedules, checklists, and communication with trial sites.
3.1
Chapter 2: On-Site Activities: Conducting the Site Visit, Including Data Verification and Compliance Checks – Focus on practical aspects of conducting on-site monitoring visits, including data verification and compliance checks.
3.2
Chapter 3: Close-Out Visit Follow-Up: Conducting an Effective Close-Out Visit – Learn about the importance of close-out visits in ensuring trial completion and data integrity.
3.3
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3.4
Your Knowledge, Simplified
Module 4: Data Management and Quality Assurance
5
4.0
Chapter 1: Data Collection and Verification: Methods for Ensuring Data Integrity and Accuracy -Explore techniques for collecting and verifying clinical trial data to ensure its integrity and accuracy.
4.1
Chapter 2: Handling of Non-Compliance: Identifying, Reporting, and Managing Non-Compliance Issues – Address the identification, reporting, and management of non-compliance issues in clinical trials.
4.2
Chapter 3: Quality Assurance Practices: Audits, Continuous Improvement, and CAPA (Corrective and Preventive Actions) – Cover quality assurance practices aimed at maintaining high standards throughout the trial process.
4.3
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4.4
Your Knowledge, Simplified
Module 5: Modern Strategies and Technologies in Clinical Research Monitoring
5
5.0
Chapter 1: Diverse Monitoring Approaches – Explore various monitoring approaches, including on-site, remote, centralized, and risk-based monitoring.
5.1
Chapter 2: Innovative Monitoring Technologies – Discover innovative technologies transforming clinical research monitoring, such as electronic data capture (EDC) and remote monitoring tools.
5.2
Chapter 3: Emerging Trends and Future Challenges – Examine emerging trends shaping the future of clinical research monitoring and the challenges and opportunities they present.
5.3
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5.4
Your Knowledge, Simplified
Quiz
1
6.0
Quiz – Mastering Clinical Research Monitoring
15 Questions
Premium Materials Included in Your Course Package:
Why Premium Matters? With these premium materials, you’ll gain hands-on tools and resources that elevate your learning experience, ensuring you’re equipped with practical skills to excel as a CRA.
3
7.1
What is IWRS
7.2
Documentation in Clinical Trials and ALCO+
7.3
eCRF
🎦
https://clinicaltrialsuniversity.com/wp-content/uploads/CRAm1-VEED-1.mp4
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