Offering online Good Clinical Practice (GCP) tutorials to clients

At PMI we know that an investment in study team training can positively impact timelines and budgets. Therefore, we offer a service exclusively for our clients: Online Good Clinical Practice (GCP) tutorials for research coordinators and investigators, which provides in depth guidance on the GCP application in industry-sponsored U.S. clinical research studies.

Our GCP seminars cover the following topics:

• Good Clinical Practices (GCP)
• FDA regulations for clinical trials
• Clinical research team members’ roles and responsibilities
• IRB/Ethics committee review/approval
• Study initiation activities
• Data collection and reporting
• Study documentation requirements
• Adverse event reporting
• Study subject recruitment
• Product accountability
• FDA audits & inspections
• Study close-out requirements