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Site Staff Training SOP Considerations

All key personnel participating in the research trial, as identified by the site, will complete the necessary education modules as per the site’s policy, prior to participating in a research trial. All key personnel, and other clinical staff as necessary, will be trained on the research protocol, and will include but will not be limited to:

  • History and overview of clinical research
  • Glossary of terms and definitions
  • Standard Operating Procedures (SOPs) for the site
  • Roles and responsibilities of the staff
  • Study recruitment
  • Informed consent process
  • Monitoring/audit visits
  • Investigator File Maintenance
  • Core Competencies (ECG use, phlebotomy, etc.—where applicable

Training will be documented on the “Training Documentation Form” and kept in the training files of each staff member, and in the study regulatory binders. The initial training that must be documented is the Good Clinical Practice (GCP) and local regulations and guidelines training for the staff involved in clinical trials.