Interactive lecture and hands-on workshop training methods provide participants with the tools to design and manage clinical studies. Course Level: Beginner
内容纲要
Good clinical practices (GCP)
Regulatory requirements for clinical research
Clinical research methodology and its role in pharmaceutical development
The role of clinical research associates (CRA) in clinical research
Monitoring clinical trials to ensure valid and useful study data
Investigator selection and evaluation
US Food and Drug Administration (FDA) audits
Basic Health Insurance Portability and Accountability Act (HIPAA) requirements
Basic protocol development
谁应该参加？
Clinical research associates and clinical study monitors with less than two years of experience
Administrative support personnel
Study support personnel
学习目标
Participants who complete this training should be able to:
Describe the basic clinical research elements in drug development
Recognize the basic elements of clinical trial methodology in the conduct of clinical studies
Identify roles and responsibilities, and regulatory requirements pertinent to clinical research associates
Apply “hands-on” clinical trial monitoring experience to the conduct of clinical studies
Identify and select qualified clinical investigators
Recognize the requirements for safety surveillance
Apply the principles of auditing in clinical investigations
