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.