Online Certification in Clinical Research Management and ICH-GCP
Event Information
About this Event
Welcome to Crown Medical Research and Pharmaceutical Sciences College of Canada, a United Nations' training vendor (UNGM#548271) registered with 27 UN agencies and operating under the authority of the Crown College of Canada corporation.
Get your fast track Online Crown College Certificate with an affordable fee.
This course is equivalent to 39-hour online or hybrid certification course.
Please note: Once registered here, you will receive the link to online course materials within 24 hours.
If you have opted for the On-line plan: Once you have covered the online course materials at your own pace, please contact us at info@crowncollege.ca for grading and receiving your certification.
If you have opted for the Hybrid plan: Once you have covered the online course materials at your own pace, please contact us at info@crowncollege.ca for scheduling your online class. Your certificate will be sent to you upon the completion of your online exam.
After the successful completion of your on-line evaluation process, participants will be sent by regular mail an official printed certificate.
Program outline:
1. Legislations and Ethics for Clinical Research
This topic is designed to provide a framework for understanding the standards and regulations related to the clinical research functions. The course will start with a historical overview of such documents as the Nuremberg Code, the Belmont Report and the Declaration of Helsinki. Emphasis will be on the International Conference on Harmonization (ICH) guidelines, and GCP. Additionally, safety related topics as the Canadian Tri-Council Policy Statement, the Food and Drugs Act, SAP program and privacy legislation.
2. Fundamentals of Drug Development Process and Pharmaceutical Clinical Research
This topic is designed to orient students to the Drug Development Process, the clinical research, functions within the corporate and regulatory context from Canadian and international perspectives. Development of drugs is used as a model.
3. Pharmaceutical Good Clinical Practice ICH-GCP
This topic covers the ICH-E6 regarding the Canadian and international guidelines for conducting clinical research
4. Clinical Data Acquisition, Data Management and Bio-statistics
This topic will provide an introduction to clinical research and drug safety data entry, computer systems, ICH guidelines for electronic data management, methods required in the development of clinical research data analysis.
After the completion of a program, you can register in online internship courses related to each program. The registration fee for monthly online internship courses is $339 and includes 39 hours of online internship tasks where you will be given tasks to complete at your home office and to give on line report/discuss for 1 hour per week (for a total of 4 hours per month) with your supervisor. You can register in online internship classes after obtaining each related certificate.
The list of our on line internship courses is at http://www.crowncollege.ca/course/index.php?categoryid=12
You can contact us at info@crowncollege.ca or visit http://www.crowncollege.ca for more information
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