ICH-GCP certifiedClinical Research Associate
CRA training program
An interactive program for clinical research professionals, with or without on-site trial experience, to monitor clinical trials in every country that follows ICH-GCP guidelines.
10training modules
9program objectives
ICH-GCPcertification included
About the program
Monitor clinical trials with confidence
Our interactive CRA training program is designed for people with or without prior on-site clinical trials experience.
It suits those seeking qualifications and / or current practical knowledge to work effectively in the monitoring of clinical trials globally, in all countries that follow the ICH-GCP guidelines for conducting clinical trials.
Prepares you to work as
- Principal Investigator (PI)
- Clinical Research Associate (CRA)
- Clinical Research Coordinator (CRC)
- Clinical Data Coordinator
- Clinical Data Manager (CDM)
Program objectives
What you will be able to do
- 01
Describe the drug development process, the importance of Good Clinical Practice, and the roles and responsibilities of the research team
- 02
Define the regulatory requirements, explain the differences between ICH and FDA guidelines, and describe the elements of a protocol
- 03
Outline required elements of the informed consent
- 04
Identify the investigational product accountability requirements and the impact of the reconciliation process on the study
- 05
Define the safety definitions and comprehend the safety reporting requirements
- 06
Prepare for and complete source document verification
- 07
Perform the steps involved in monitoring the study — pre-visit, during the visit, and post-visit
- 08
Create cohesive, well-written protocol deviations and action items, and accurately complete the monitoring visit report and site follow-up letter
- 09
Define the impact of quality assurance and audits in clinical research
Program outline
10 modules, from drug development to audits
- Module 1
Drug Development Process, Good Clinical Practice (GCP), and Clinical Research Team Roles and Responsibilities
- Module 2
IRB, Clinical Study Protocol Elements and Amendments
- Module 3
Informed Consent
- Module 4
Investigational Product Accountability
- Module 5
Safety Definitions and Reporting Requirements
- Module 6
Source Document Verification
- Module 7
Monitoring the Study
- Module 8–9
Monitoring Visit Reports and Contact Reports
- Module 10
Regulatory Compliance and Quality Assurance: Audits and Inspections
Who can attend
Built for clinical research professionals
Early-career CRAs
Clinical Research Associates with less than two years of experience — in-house or field-based.
Role changers
Those currently working in the industry in a different role and seeking to change roles.
New hires & teams
Ideal for “on-boarding” individual new hires or entire teams (individual registrations required).
Note: This course is for individual registrants only and does not allow for group training.
Become a certified CRA.
Call and enroll over the phone with one of our representatives, or book a free demo class.