Our  Interactive-CRA, CRC, CRI & CCRP training programs 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. Get training in online classes 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