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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