Good Clinical Practice (GCP) Training Course

Link to Course Info: https://www.nobleprog.com/cc/goodclinicalpractice

Disclaimer: This is a pre-registration for the paid training. The cost is $1500 per person. This course will be conducted if minimum five registrations are received 28 days before the start date. We will reach out to confirm your participation and share payment arrangement. If enough registrations are not received for your desired date, you will be automatically considered for the next available date the training is scheduled in the same geography, and you will be contacted to confirm your registration for this new date. If you are a group of five or more, please reach out to us at . We also offer remote training. If you are interested in a remote format ( Virtual / Remote Training over zoom ) then please send us an email to bmVhbCAhIHNoYWggfCBub2JsZXByb2cgISBjb20= and we would be happy to consider running a virtual event provided the course meets minimum participation requirements.

What to Expect: Our instructor-led training (available online or onsite) offers interactive, hands-on sessions designed to give you both the theoretical understanding and practical tools needed to conduct compliant clinical research following Good Clinical Practice standards in real-world research scenarios.

• Certificate: Course Completion Certificate
• Language: English
• Duration: 14 Hours (7 hours each day from 9am-5pm)
• Credits: 14
• Course Delivery: Classroom or Online

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Course Overview: This training course is designed for clinical research professionals, investigators, and study coordinators who want to master Good Clinical Practice fundamentals — how to conduct ethical clinical trials, ensure regulatory compliance, and maintain research integrity. You'll learn core GCP principles, explore regulatory requirements, and walk away with hands-on experience implementing compliant clinical research protocols. By the end of the course, you'll be able to:

• Understand GCP guidelines for different types of clinical research including ICH E6 and FDA regulations
• Implement ethical research practices with proper informed consent and participant protection
• Conduct compliant clinical trials with proper documentation, safety monitoring, and quality assurance

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Course Contents: This training combines engaging lectures, group discussions, and live practice sessions to make sure you leave with real-world Good Clinical Practice knowledge you can apply immediately. Topics Include:

• GCP Foundation – Overview of clinical research types, ICH E6 guidelines, and FDA regulatory requirements
• Ethics & Oversight – Institutional Review Boards (IRBs), ethics principles, and regulatory compliance frameworks
• Roles & Responsibilities – Investigator duties, sponsor obligations, and IND application requirements
• Participant Protection – Informed consent processes, privacy policies, safety monitoring, and adverse event reporting
• Research Quality – Data integrity, protocol compliance, documentation standards, and record-keeping practices
• Compliance Management – Audit preparation, inspection processes, misconduct prevention, and clinical trial agreements

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Course Features: By the end of this training, you will be able to:

• Navigate different GCP requirements for drugs, devices, biologics, and behavioral research studies
• Implement comprehensive informed consent processes and ensure participant safety throughout trials
• Maintain data quality and integrity while following proper documentation and record-keeping standards
• Prepare for regulatory audits and inspections while avoiding research misconduct

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Certification: Upon completion of the training, participants will receive an official Course Completion Certificate.

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Who Can Attend? This course is ideal for:

• Clinical Research Coordinators and Investigators
• Study Monitors and Clinical Research Associates
• Regulatory Affairs Professionals
• Anyone with a college degree seeking expertise in Good Clinical Practice and clinical trial management

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About Us We are NobleProg, the world's training provider :)! We offer international training and consultancy group, delivering high quality courses to every sector, covering: Artificial Intelligence, IT, Management, Applied Statistics. Over the last 18 years, we have trained more than 50000 people from over 6000 companies and organizations. If you are interested in another course, we're positive we have what you want - go to nobleprog.com and search.

Info: Overview of clinical research types and GCP focus areas

ICH E6 GCP guidelines for drugs, biologics, and medical devices

Understanding differences between ICH GCP E6 and U.S. FDA regulations

Ethics principles and Institutional Review Board (IRB) roles in clinical trials

Info: Investigator and sponsor responsibilities in clinical trials

IND application requirements and industry sponsor obligations

Informed consent requirements and documentation processes

Privacy policies, confidentiality, and participant safety assurance

Info: Adverse event detection, evaluation, and reporting procedures

Data quality assurance and integrity maintenance strategies

Clinical trial protocol design and protocol compliance importance

Clear documentation practices and comprehensive record-keeping standards

Info: Audit and inspection preparation and management processes

Research misconduct prevention and ethical compliance strategies

Participant recruitment and retention best practices

Clinical trial agreement crafting, negotiation, and management

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