Fundamentals in the Conduct of Clinical Research: BMC and BU Medical Campus Research Professional Staff Training
The Fundamentals training is designed for research staff and covers current regulations and best practices as well as providing tools and resources for successful study implementation. The training is case-based and interactive, covering core principles of International Conference for Harmonisation standards on Good Clinical Practice (ICH-GCP R3) the regulatory framework governing clinical research (including FDA and OHRP/HHS requirements), and the Joint Task Force for Clinical Trial Competency, as the structure for topics and competencies discussed.
Register for the Fundamentals Training
- Save the dates on your calendar and register for these future Fundamentals training dates (Registration closes 48 hours prior to training start)
Who Should Take This Training
- BU Medical Campus, BMC, BMC Brighton, BMC South and Boston HealthNet Community Health Centers staff faculty and 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
- Please use your BU or BMC email address to register. If you do not have one, please reach out to crro@bu.edu to let us know.
What You Need to Know
- All sessions are scheduled for 8:30-11am
- Training sessions of 2.5 hours each week for a total of 12.5 hours
- 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.
- Sessions are offered over Zoom and intended to provide direct interaction and learning. As this is an interactive training, cameras should be on. Video recordings will not be made available for those who cannot attend one or more sessions. No exceptions will be made.
- Successful completion towards GCP Certification is fulfilled by the following requirements.
- Attendance of 80% of each session
- Post-training quiz score of at least 70%
- Includes Pre and Post Training Quizzes to assess learning and provide appropriate Good Clinical Practice certification
- Successful completion of this training fulfills the BMC/BU Medical Campus HRPP GCP training requirement for 3 years.
Educational Objectives
- Describe the regulations that guide your research
- Explain best practices for IRB submissions
- Identify the regulations and guidance that inform and guide the conduct of your study
- Describe and explain Clinical Research Professional (CRP) responsibilities from study start-up to study completion
- Describe the responsibilities and oversight of the Principal Investigator (PI), Sponsor and study team
- Apply the elements of the ICH Good Clinical Practice guidelines to your research studies
- List requirements and best practices for informed consent
- Describe the steps for conducting a study: initiation, activities, closure
- Identify best practices in the recruitment and screening of research subjects
- Explain why and how to best document your study
- Describe the monitoring, evaluation and reporting of adverse events and unanticipated problems
- Institute a plan of self- assessments to support audit-readiness and validity and integrity of study data
Please email snwarth@bu.edu with any questions regarding Fundamentals.
Questions about which training to take? Review a comparison between Fundamentals and PI Training.
Questions about any of the above information? Contact us!