Dr. Mohammed Shabber. MD

The Course instructor has more than 20 years of industry experience. This course is focused on a range of topics of critical importance to the clinical research Associate professional. It is designed to be used in preparation for various clinical research associate certification exams. The format will be lecture based, but will be designed to encourage case based discussion and active participation. In addition, students will be assigned a drug development topic, which they will research and present during the last session of the course. ***Please note that there may be additional fees, not associated with this program associated with registering for many certification exams.

 

 

At the end of this course, you will be proficient in the following areas:

  • Investigational Product Management
  • Investigator’s Brochure
  • Product (drug) Development
  • Protocols
  • In-house and Regional CRA
  • Research Study Phases
  • Study Designs
  • IRB/EC
  • Safety
  • GCP, SOP, FDA, ICH
  • Patient Recruitment
  • Informed Consent
  • Source Data/Documentation
  • Clinical Monitoring
  • Clinical Trial Management
  • Research Site Requirements & Activities
  • Trial Oversight
  • Site qualification initiation and closeout visits

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