CR019 Organization of Clinical Trials and Clinical Monitoring Plan Development

CR019 Organization of Clinical Trials and Clinical Monitoring Plan Development

Clinical trials are critical in the development of new drugs, biologics, and medical devices. This course provides an introduction to the organization of clinical trials and the development of clinical monitoring plans. Students will gain an understanding of the essential components of clinical trials, the regulatory framework for clinical trials, and the principles of clinical monitoring plan development.

The course covers topics such as clinical trial design and protocol development, the regulatory framework for clinical trials, data collection and management in clinical trials, adverse event reporting and management, ethical considerations, regulatory compliance, and audits.

Upon completion of this course, students will be able to apply their knowledge to design and conduct clinical trials, understand the role of sponsor and investigator as well as steps involved in site training and site initiation. This course is ideal for individuals who are interested in pursuing a career in clinical research, regulatory affairs, or clinical trial management.

Key Learning Points:
  • Organization of clinical trials and clinical monitoring plan development
  • Introduction to the clinical trial process and safety monitoring
  • Review of the sponsor’s role in the implementation of the study
  • Review of the investigative site and investigator’s role
  • Overview of the clinical study protocol, IRB and DSMB committees
  • The informed consent process, development, documentation, and audit
  • Study preparation and different phases of study documents’ collection
  • Site training and site initiation visit
  • Patient recruitment strategies
  • Safety monitoring and site management
  • Study termination
  • Audits

Registration Fee: $995+HST (CAD)

CR019 Organization of Clinical Trials and Clinical Monitoring Plan Development

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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.
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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

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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