CRA Training Program

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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
  • 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.

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