Clinical Trial Management
About This Course
Course Description:
The Clinical Trial Management course is designed to provide in-depth knowledge and practical skills for managing clinical trials effectively. This course is ideal for aspiring clinical research professionals, project managers, and those looking to excel in the field of clinical trial operations. It covers all aspects of clinical trials, from planning and execution to monitoring and regulatory compliance, ensuring participants gain a comprehensive understanding of the clinical research lifecycle.
Key Highlights:
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Learn the fundamentals of clinical trials, including phases, guidelines, and roles of stakeholders.
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Master the process of designing, planning, and executing clinical trials.
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Understand essential regulatory requirements such as ICH-GCP, FDA, and EMA guidelines.
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Gain insights into monitoring and managing trials, including participant recruitment and adverse event reporting.
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Hands-on exercises and case studies to apply theoretical knowledge to real-world scenarios.
What You’ll Learn:
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Introduction to Clinical Trials:
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Overview of clinical research and its significance.
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Understanding trial phases (Phase I-IV).
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Regulatory frameworks and ethical considerations.
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Designing and Planning Clinical Trials:
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Protocol development and study design.
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Site selection, feasibility assessment, and resource allocation.
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Budgeting and financial planning for trials.
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Conduct and Oversight:
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Participant recruitment, retention, and informed consent processes.
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Monitoring clinical trials on-site and remotely.
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Adverse event management and reporting.
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Data Analysis and Reporting:
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Basics of biostatistics in clinical trials.
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Preparation of clinical study reports (CSRs).
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Understanding regulatory submissions and approvals.
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Practical Sessions and Case Studies:
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Real-life scenarios to design and manage clinical trials.
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Hands-on practice in protocol review and study design.
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Who Should Enroll?
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Clinical Research Professionals
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Project Managers in Healthcare
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Aspiring Clinical Trial Managers
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Students and Graduates in Life Sciences or Healthcare Fields
Course Duration: 18 Hours
Mode of Delivery: Online or In-Person
Certification: Upon successful completion of the course, participants will receive a certificate in Clinical Trial Management.
Learning Objectives
Material Includes
- Comprehensive Course Handbook
- Access to Templates for Protocols, Reports, and CRFs
- Real-Life Case Studies and Examples
- Practice Exercises and Hands-On Labs
- Certificate of Completion
Requirements
- Basic Knowledge: Familiarity with biology, life sciences, or healthcare concepts is recommended.
- Technical Requirements:
- Access to a computer with a stable internet connection.
- Basic proficiency in using online platforms for accessing course materials.
- Commitment to Learning: Dedicate time for live sessions, practical exercises, and self-paced study.
Target Audience
- Clinical Research Professionals
- Aspiring Clinical Trial Managers
- Project Managers in Healthcare
- Students and Graduates in Life Sciences, Biotechnology, or Healthcare Fields
- Professionals transitioning into clinical research roles
- Eligibility:
- B.Pharm, M.Pharm, and Pharm.D✓ B.Sc., M.Sc., and Ph.D. (Biotechnology, Microbiology, Biochemistry, Nursing, etc.)
- B.E., B.Tech., M.Tech. (Biotechnology/Biomedical Engineering)
- BPT, MPT, BDS, BAMS, BHMS, MBBS, etc.
Curriculum
Module 1: Introduction to Clinical Trials (3 Hours)
Overview of Clinical Research and Trials
Phases of Clinical Trials (I-IV)
Regulatory Requirements and Guidelines (ICH-GCP, FDA, EMA)
Roles and Responsibilities of Stakeholders
Quiz 01
Module 2: Designing and Planning Clinical Trials (4 Hours)
Module 3: Conduct and Oversight of Clinical Trials (5 Hours)
Module 4: Data Analysis and Reporting (4 Hours)
Module 5: Practical Sessions and Case Studies (2 Hours)
Final Assessment: Master Course in Clinical Research and Medical Writing
Earn a certificate
Add this certificate to your resume to demonstrate your skills & increase your chances of getting noticed.
₹10,999.00₹12,500.00
Material Includes
- Comprehensive Course Handbook
- Access to Templates for Protocols, Reports, and CRFs
- Real-Life Case Studies and Examples
- Practice Exercises and Hands-On Labs
- Certificate of Completion
Medical Writing
₹9,999.00₹15,000.00
