+1 (514) 257-3003 info@cra-school.com

CRP 2.0 Course Outline

Module I

1. The pharmaceutical industry, Glossary
2. History of the clinical trials regulations
3. Ethics in research, Medical terminology
4. Phases of clinical trials
5. Role & tasks of Sponsor, PI, CRC, CRA & others

Module II

6. The Protocol
7. Case Report Forms
8. Institutional Review Board, IRB/IEC/REB
9. Recruitment, Retention and Compliance
10. Canadian and International Regulations (GCP)

Module III

11. Ethical Review Boards (IRBs)
12. Informed Consent
13. Adverse Events and Safety Reporting
14. Study Design
15. Essential Documents

Module IV (not included in the CRC/PI course)

16. Site Evaluation and Site Selection Visit
17. Investigator Meeting & Site Initiation Visit
18. Site Monitoring Visit, Risk Based Monitoring
19. Study Termination, Site Close-Out Visit
20. Fraud and Misconduct

Module V

21. Clinical Trial Data Management
22. Data Privacy – HIPAA Compliance Requirements
23. Electronic Data Capture
24. Audits and Inspections
25. The Data and Safety Monitoring Board

Module VI

26. Medical devices regulations in US & Canada (optional module)

 
Module VII (Job insertion Assistance Support, provided in parallel with the regulatory training)

27. Monitoring Efficiency, Time management for CR Professionals (for CRP 2.0 only)
28. CV adaptation for clinical research jobs and professional branding (ongoing)
29. Networking 2.0 – coaching on the use of professional social media (ongoing)
30. Job descriptions analysis and Interview preparation (after Module II, till hire)
31. Unlimited e-Internships in Monitoring activities (GCP), EDC platforms and CR practical activities  (from chapter 1, ongoing till hire)

Course Registration

CRP (CRA+CRC) Certification Program

CRP 2.0. This program covers the theoretical and practical foundation for many different players in the clinical trials field, including the coordinator who does much of the work at the clinical site, and the sponsor’s monitor, who verifies if the work is done in compliance with the protocol and the regulations. As an inspector, the CRA must be familiar with clinical activities and regulations concerning the clinical study.

The Global Accessibility Program

The Global Accessibility Program (GAP) – With the goal of making our training available to everyone, we offer a special discounted tuition to those who are financially disadvantaged, including currently-enrolled full-time students, maternity-leave, recent immigrants (less than 5 years), refugees and low-income families.To qualify for the GAP pricing, we require proof of your current situation.

GAP pricing is automatically extended to certain areas including Africa and Asia. 

 

Additional Information

GAP 25% tuition reduction for eligible applicants (proof required)
LOAN AND BURSARY Very low interest loan and bursary covering 20% of the tuition fees is available for candidates with low income, newcomers and international students planning to move to Canada. Certain conditions apply.
NUMBER OF INSTALLMENTS 1 installment (15% off reg. price), 2 installments (7.5% off), 3 installments (reg.)
PAYMENT MODE PayPal (+3% PayPal charges), Credit Cards, eTransfers
FINAL EXAM Included in price
E INTERNSHIPS Included in price
JOB SUPPORT Included in price (till hire)
MENTORING Included in price (till hire)

Office

405 Avenue Ogilvy #101,

Montreal, QC H3N 1M3, Canada

Contact Us

info@cra-school.com
Office: (514) 840-1235 ext. 8444
Fax: (514) 840-1244
Support: (514) 257-3003

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