Clinical Trials Training
Investigators and study personnel “who are responsible for study coordination, data collection and data management,” are required to complete training in Good Clinical Practice (GCP). To fulfill the training requirements, Purdue utilizes the CITI Program.
The GCP training courses differ from those required for other training (i.e Human Subjects Research, Responsible Conduct of Research). The NIH requires that Clinical Trials staff refresh training at least every three years.
The IRB may request evidence of prior training or certification when biomedical procedures will be conducted as part of a research protocol (e.g., placement of IVs or drawing of blood) or a plan for training, supervision, and monitoring for required skills.
Principal Investigators are ultimately responsible for leading the research teams and affirming proper training and valid credentials or experience.