Fundamentals in the Conduct of Clinical Research: BMC and BU Medical Campus Research Professional Staff Training

Offered quarterly, this training is designed for general study staff and covers current regulations and best practices as well as providing tools and resources for successful study implementation. The training utilizes International Conference for Harmonisation standards on Good Clinical Practice (ICH-GCP) and the Joint Task Force for Clinical Trial Competency as the structure for topics and competencies discussed.

Quarterly Offerings – All sessions are scheduled for 8:30-11am

  • Generally the course is offered in March, June, September, and November
  • Training is a series of sessions of 2.5 hours each week for a total of 10 hours over four weeks
  • Registration closes 48 hours prior to training start
  • Includes Pre and Post Training Quizzes to assess learning and provide appropriate Good Clinical Practice certification
  • Session 1 must be attended in full to be able to continue with the rest of the sessions. If Session 1 is missed, your registration will be canceled. No exceptions will be made as Session 1 is the foundation for all further sessions. It is your responsibility to plan appropriately to attend these sessions. 
  • Sessions are currently offered over Zoom and intended to provide direct interaction and learning. Video recordings will not be made available for those who cannot attend one or more sessions. No exceptions will be made. 
Good Clinical Practice Certification Overview
  • Successful completion of this training fulfills the BMC/BU Medical Campus HRPP GCP training requirement for 3 years.
  • Successful completion towards GCP Certification is fulfilled by the following requirements. No exceptions will be made to these requirements.
    • Attendance of 80% of each session
    • Post-training quiz score of at least 70%

Target Audience

  • BU Medical Campus and BMC staff only. Individuals from external organizations or institutions are unable to attend.
  • Study team members including coordinators, research assistants, research nurses, or project managers
    • New to research
    • New to BMC or BU Medical Campus
    • Experienced clinical research support staff interested in a refresher

Educational Objectives

  • Discuss the regulations governing human subjects research and applicability to different studies
  • Apply the elements of the ICH Good Clinical Practice guidelines
  • Describe and explain Clinical Research Professional responsibilities from study start-up to study completion
  • Identify steps to obtain the necessary approvals to conduct clinical research at BMC and BU Medical Campus
  • Identify best practices in the recruitment, screening, and informed consent of research subjects
  • Identify strategies for managing and developing study documentation that fulfill regulatory requirements and support high quality research
  •  Describe appropriate monitoring for adverse events, including identification, documentation, and reporting

Questions about which training to take? Review a comparison between Fundamentals and PI Training.
Questions about any of the above information? Contact us!