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

CRP 3.0 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 (Monitoring)

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 3.0. This program covers the theoretical and practical foundation for the conduct of new drugs and medical devices studies, as well as the obligations of almost all players in a clinical trial, including the Study Coordinator, who does most of the work at the clinical site, and the sponsor’s Monitor, the CRA, who verifies is all the work done in compliance with the protocol and the regulations. As an inspector, the CRA must be familiar with all clinical trial activities and regulations concerning the study.

Additional Information

REFERRAL BONUS 10% bonus for referring a candidate who enrolls some day (unlimited number of bonuses)
PAYMENT MODES Credit Card, eTransfer, PayPal (+3% PayPal charges), bank transfer, certified check, etc.
FINAL EXAM Included in price, Post-Graduate diploma of Certified Clinical Research Professional (CCRP)
E INTERNSHIPS Included in price, to provide the Canadian “hands-on” experience required  by law
JOB SUPPORT Included in price (till hired), with unlimited CV adaptation and interview preparation
MENTORING Included in price (till hired), with 7/7 LIVE Support directly from Level II specialists

 

Office

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Montreal, QC H3N 1M3, Canada

(office closed for quarantine, call)

Contact Us

info@cra-school.com
Support  : +1 (514) 257-3003
Students: +1 (514) 430-9978
Skype: CRA School Montreal

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