Global Certificate in Trial Operations Performance
-- viewing nowThe Global Certificate in Trial Operations Performance (GTOP) course is a comprehensive program designed to enhance the skills of clinical trial professionals. This course focuses on the importance of effective trial operations, which are critical in ensuring the success of clinical trials.
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Course Details
• Trial Operations Fundamentals: Understanding the basics of clinical trial operations, including study design, site selection, and project management.
• Regulatory Compliance: Ensuring adherence to global regulations and guidelines, including ICH-GCP, FDA, and EMA.
• Site Management: Managing relationships with investigator sites, including site initiation, training, and monitoring.
• Data Management: Collecting, cleaning, and managing clinical trial data, including eCRF design and implementation.
• Pharmacovigilance: Managing safety reporting and adverse event monitoring throughout the trial.
• Quality Management: Implementing and maintaining quality systems, including SOP development and CAPA management.
• Budgeting and Financial Management: Developing and managing study budgets, including sponsor and site financial agreements.
• Vendor Management: Selecting, managing, and monitoring vendors, including CROs and other service providers.
Career Path
Entry Requirements
- Basic understanding of the subject matter
- Proficiency in English language
- Computer and internet access
- Basic computer skills
- Dedication to complete the course
No prior formal qualifications required. Course designed for accessibility.
Course Status
This course provides practical knowledge and skills for professional development. It is:
- Not accredited by a recognized body
- Not regulated by an authorized institution
- Complementary to formal qualifications
You'll receive a certificate of completion upon successfully finishing the course.
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