CR014 Good Clinical Practices (GCP),
Research Ethics and Clinical Research Regulations

CR014 Good Clinical Practices (GCP), Research Ethics and Clinical Research Regulations

Explore the world of clinical research with our comprehensive course, designed to provide an in-depth understanding of the regulations, guidelines, and ethical principles fundamental to this field. This course delves into the history and development of Good Clinical Practices (GCP) and the regulatory landscape of clinical research, both in North America and globally.

Course Insights:

Ethical Foundations: Learn about the pivotal historical events like the Nuremberg Trials and the Tuskegee Syphilis Study that shaped research ethics, focusing on principles such as respect for persons, beneficence, and justice. Understand the role of Ethics Committees in upholding these standards.

Regulatory Framework: The course covers crucial aspects of clinical trial design, conduct, monitoring, and reporting, including ICH E6 (GCP) guideline. Dive into the intricacies of study protocols, case report forms, and adverse event reporting.

Practical Applications: Through case studies and real-world scenarios, students will engage with the practicalities of clinical research regulations and GCP, enhancing critical thinking and problem-solving skills.

Interactive Learning: Group discussions and assignments are integrated to foster a deeper understanding and application of course materials.

Upon Completion:

Graduates of this course will emerge with a robust understanding of the global and Canadian regulatory frameworks governing clinical research. Equipped with this knowledge, students will be adept at designing and conducting clinical trials, ensuring compliance with regulatory requirements.

Key Learning Points:
  • Navigating Clinical Regulations and ICH Guidelines
  • Mastery of the GxP Environment and Good Practice Guidelines
  • Comparison of Canadian vs. US Regulatory Framework (CTA, IND)
  • Deep Dive into the Principles of GCP
  • Roles and Responsibilities of Ethics Committees (IRB/REB)
  • Understanding Investigator and Sponsor Responsibilities
  • Protocols, Amendments, and Informed Consent Procedures
  • Insight into Investigator’s Brochure and Essential Documents
Join us in this enlightening course to become proficient in the essentials of clinical research, positioning yourself as a knowledgeable and skilled professional in this dynamic field.

Registration Fee: $995+HST (CAD)

CR014 Good Clinical Practices (GCP), Research Ethics and Clinical Research Regulations

Our exclusive
happy student saying.

A Transformative Journey

The instructors are industry-experienced in a supportive learning environment. Field-related internships give students real-world experience. Students also receive ongoing job search assistance and career services from AAPS.
Sedigheh Fadaye Vatan

Sedigheh Fadaye Vatan

Pharmaceutical Quality Assurance and Regulatory Affairs Graduate

Taking the AAPS Cannabis Management, Quality & Laboratory course was the one of the best decisions for my career. They are all extremely knowledgeable in their field, with real life experiences to share.
Orenda Von Gernet

Orenda Von Gernet

Cannabis – Management, Quality and Laboratory Graduate

I enrolled in the QA/QC program and midway through the program I successfully landed a 6-month internship at Teva Pharmaceuticals. Upon completing my program part-time, I got a full-time position with PerkinElmer.
Lukman Nahle

Lukman Nahle

Pharmaceutical Quality Assurance and Quality Control Graduate

I am very happy that I chose AAPS as my next academic endeavor after graduating University. The course was very useful in teaching me the things that I will need to know when entering the Cannabis industry.
Zachary Petkov

Zachary Petkov

Cannabis – Management, Quality and Laboratory Graduate

Coming to AAPS to pursue my PG Diploma in CRDSP has been one of the best career decisions. I’ve received my offer letter to join as Project Management Associate at Axiom real-time metrics solutions, On.
Remya Pushparajan Subha

Remya Pushparajan Subha

Clinical Research Graduate

The food safety and quality program at AAPS provided me with the knowledge required for the Canadian food industry. As a newcomer to Canada, I really appreciated the welcoming vibe the college offered.
Dania Hariri

Dania Hariri

Food, Technology, Safety and Quality Graduate

I was newcomer in Canada from Nepal. I enrolled in PG Diploma in Pharmaceutical QC/QA/RA course which i think was the best. After 3 weeks of hard work into co-op days, I was offered a full-time job.
Yushma Shakya

Yushma Shakya

Pharmaceutical Quality Assurance and Quality Control Graduate

I am excited to share my employment news. I am now working as Quality Assurance Manager and I couldn’t have done it without your help and encouragement. I want to specifically thank all the AAPS instructors.
Abolfazl Darashti

Abolfazl Darashti

Food, Technology, Safety and Quality Graduate

Thank you to everyone at AAPS for helping me in my postgraduate training. I am now really excited to be working at the McKesson Corporation (Fortune Top 500 Company) as a Health Services Case Manager.
Amjad Atrash

Amjad Atrash

Clinical Research Graduate

I am happy to share that I have received a job as a Clinical Research Recruiter at BioPharma Services Inc. It was a hard and persistent job but I couldn’t have done it without the AAPS support.
Saeeda Hasan

Saeeda Hasan

Clinical Research Graduate