+1 (514) 840-1234 / 8444 info@cra-school.com

Course Outline

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

Module II

6. Overview of drug regulatory process, 21 CFR
7. ICH GCP, Canada Clinical Trials Regulations
8. Institutional Review Board, IRB/IEC/REB
9. Informed Consent Process, ICD design
10. Safety monitoring and AE/SAE reporting

Module III

11. Study Preparation and Design
12. Fundamentals of clinical trials conduct
13. Design of Clinical Trial Protocols
14. Design of Case Report Forms (CRF)
15. Site management, Recruitment, Retention

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. Preventing Errors, Fraud and Misconduct

Module V

21. Clinical Trial Data Management
22. HIPAA Compliance Requirements
23. Data Safety Monitoring Board
24. Clinical Trial Management Systems
25. Audits and Inspections

Module VI

26. Essential documents in clinical trials
27. Medical devices regulations in US & Canada
28. Pre-market notification, FDA 510(k), PMN
29. Investigational Device Exemption, IDE
30. Medical Devices Pre-market Approval, PMA

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

31. Monitoring Efficiency, Time management for CR Professionals (for CCRP-01 only)
32. CV adaptation for clinical research jobs and professional branding (ongoing)
33. Networking 2.0 – coaching on the use of professional social media (ongoing)
34. Job descriptions analysis and Interview preparation (after Module II, till hire)
35. Unlimited Internship in E-CRO environment (from chapter 1, ongoing till hire)

Course Registration

Course Registration

CCRP (CRA+CRC) Certification Program

CCRP-01 This program covers pratically all the activities of the different players in the clinical trials: the coordinator who does all the work at the clinical site, and the monitor of the sponsor who verifies if the work is done in compliance with the protocol and the regulations as an inspector he must be familiar with everything done in the frame of a clinical study.

More Information 

About The Course

A bursary covering 30% of the total fees applies for candidates with low income.  With that, the tuition fees for the complete program, including the internship and job placement support till hire, are between 779,00 $ and 1.310,00 $ depending on the number of installments (see  Additional information on the right). An EDC/CTMS training and internship were added and will be offered in 2019 with a 50% discount (297,50 $).

The bursary is provided to international students and Canadian candidates with low income, mono-parental families, or newcomers (5 years or less in Canada) within the Accessibility program. Eligibility proofs are required.

To get an official Proforma invoice, email what is your status, family revenue, and a preferred number of installments(1 to 6) to info@crа-sсhооl cоm.

To enroll, upload here the Contract of services with the Confidentiality agreement, fill-in and sign them, and email back together with a copy of some official ID document with picture and signature*.

* Note: Mask sensitive information (numbers and dates) with Post-it before scanning.

Additional Information

Additional Information

ACCESSIBLITY PROGRAM

Not applicable, Applicable (proof of eligibility 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%), 2 installments (-10%), 3 installments (-5%), 6 installments (reg.), 9 installments (promo code)

PAYMENT MODE

Paypal (+3% PayPal charges)

FINAL EXAM

Included in price

E INTERNSHIP

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.

  • © 2019 CRA School - Montreal, All Rights Reserved. 
  • Developed by  Manoj Pemmasani.