|Event Name||Coordinating A Clinical Trial
Thursday, September 27, 2012
Friday, September 28, 2012
|Description||This course is designed to provide a brief overview of clinical research, terminology, and acronyms followed by a comprehensive review of FDA Regulations, FDA Guidance on the Supervisory Role of the Investigator, and ICH GCP (E6) Section 4. It also reviews the fundamental elements involved in coordinating a clinical trial from the investigator’s perspective. It includes, the review of SOPs, strategies on study preparation to prevent non-compliance, subject recruitment / retention, GCP compliant consenting, budget assessments and determining if a protocol is practical for your site. The participant performs the following activities: FDA Form 1572 exercise, source document gap analysis, protocol preparation for subject eligibility, AE drill, ICF documentation exercise, source documentation drill, ad reviewing a mock study budget. MRM provides each participant with a CD-ROM Regulatory Reference.