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Event NameCoordinating A Clinical Trial
Event Date(s) Thursday, September 27, 2012  to Friday, September 28, 2012
Event Location
Coral Springs, Florida
U.S.A.
Costn/a
DescriptionThis 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.
SponsorN/A
Host CompanyN/A
Contact Information Phone: 877-633-3322
Fax:   800-763-4103 
Email: info@cra-training.com
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