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.

These tutorials provide study coordinators and investigators with guidance on the application of GCP in industry-sponsored U.S. clinical research studies. In addition, anyone interested in keeping current or documenting training on GCP can benefit from these programs.

For more information, please follow these links:

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

 

 

 
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