Training Services

All studies require complete, thorough, and detailed training of all clinical trial teams (principal investigators, site staff, monitoring teams, project managers, vendors, etc.). In addition, clear documentation of that training must also be in evidence in the study files. Regulatory auditors continue to cite investigators and sponsors for the poor quality of their training documentation, making this a critical area to oversee.

EndPointe understands the unique requirements of training clinical teams not only to ensure protocol understanding and compliance but also to ensure ongoing training is offered during study implementation as staff members change and the protocol is amended.

To support this important area: EndPointe offers the following training services to our clients:

• Sponsor Teams
  • Study Team Integration: to ensure all trial components are covered, and study teams understand their roles and how they interface with other team members.
  • Protocol and Study Operations
  • Medical Indication
  • Good Clinical Practice (focusing on sponsor responsibilities)
  • Standard Operating Procedures (customized to sponsor documentation)
  • Clinical Monitoring (customized to protocol requirements or as general training for a monitoring team)

• Clinical Study Sites
  • Site Initiation Visit: Protocol and Study Operations
  • Study Coordination: customized to a particular study, or to train new study coordinators in effective and efficient study documentation practices
  • Good Clinical Practice for Clinical Investigators
  • Audit preparation
  • Protocol amendment training

Training can be organized as in-person training or via webinar and conference calls. Documentation will be provided for all training conducted, and training records will be maintained for future access.