CRA Training Program

CRA Training Program

Our Interactive-CRA training program for Clinical Research Professional are designed for persons with or without prior on-site clinical trials experience, seeking qualifications and/or current practical knowledge to effectively work as a Principal Investigator (PI), Clinical Research Associate (CRA), Clinical Research Coordinator (CRC), Clinical Data Coordinator or Clinical Data Manager (CDM) in the monitoring of clinical trials globally in all countries that follow the ICH-GCP guidelines for conducting clinical trials. All courses include ICH-GCP certification.

Prior to the start of the course, participants will receive comprehensive course material. Come to class prepared to interact – you will be able to ask questions, provide feedback and participate in discussions and group work. Upon course completion, participants will be provided training certificates.

Program Objective:

Describe the drug development process, the importance of Good Clinical Practice, and the roles and responsibilities of the research team

Define the regulatory requirements, explain the differences between ICH and FDA guidelines, and describe the elements of a protocol

Quick Enquiry

Outline required elements of the informed consent

Identify the investigational product accountability requirements and impact of the reconciliation process on the study

Define the safety definitions and comprehend the safety reporting requirements

Prepare for and complete source document verification

Perform the steps involved in monitoring the study pre-visit, during the visit, and post-visit

Create cohesive, well-written protocol deviations and action items, and accurately complete the monitor visit report and site follow-up letter

Define the impact of quality assurance and audits in clinical research

Program outline:

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 and Module 9: Monitoring Visit Reports and Contact Reports

Module 10: Regulatory Compliance and Quality Assurance: Audits and Inspections

Who can attend :

Clinical Research Associates with less than two years of experience – in-house or field-based

Those currently working in the industry in a different role and seeking to change roles

The course is also ideal for “on-boarding” of individual new hires or entire teams (individual registrations required)

NOTE: This course is for individual registrants only and does not allow for group training.