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

Fundamentals Training Overview and Registration

Fundamentals will take place on a quarterly schedule (March, June, September, and December) and is open to all BU and BMC human/Clinical Research Professionals.  The Fundamentals training consists of four 2.5-hour sessions, in consecutive weeks throughout the month. This will give the opportunity for learners to digest the information in between sessions more effectively. See below for the upcoming Fundamentals course schedule:

December 2021

Tuesday, November 30, 2021 8:30-11:00 am
Tuesday, December 7, 2021 8:30-11:00 am
Tuesday, December 14, 2021 8:30-11:00 am
Tuesday, December 21, 2021 8:30-11:00 am

December’s training will take place via Zoom-only to limit COVID risk. Note that attendees must have video and audio (speaker + microphone) capabilities.  Also, videos must be ON during the training.

Note that there is much overlap between the Fundamentals training and the PI training.  See here for a comparison.  Typically it does not make sense to sign up for both trainings.

If you have questions about this training please contact Mary-Tara Roth (mtroth@bu.edu).

REGISTER for the December Fundamentals training.

Summary:

The Fundamentals training utilizes International Conference on Harmonization Good Clinical Practice (ICH-GCP) and the Joint Task Force for Clinical Trial Competency as the structure for the training topics and competencies. The training covers key topics and concepts to ensure human/clinical research professionals at BMC and BU Medical Campus are able to successfully conduct research study activities.

Successful completion of this in-person training fulfills the BMC/BUMC HRPP GCP training requirement for 3 years.  Successful completion means attendance of 80% of sessions and score of 75% or more on the post-quiz.

This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.

Target Audience:

  • BU Medical Campus and BMC Clinical Research Professionals (clinical research coordinators, research nurses, research project managers, and research assistants, etc.) with <1 – 2 years of experience,
  • Recent hires to BMC and BU Medical Campus (regardless of duration of experience), and
  • Experienced clinical research support staff interested in a review of fundamental concepts related to the conduct of human research studies.

Except for special circumstances, we typically do not accept registrations from individuals from institutions other than BU and BMC (unless there is a working affiliation with a BU or BMC PI).  One of the reasons is that some of the content is specific to policies and procedures of BU Medical Campus and BMC.  If you are from an outside institution and have interest please contact Mary-Tara Roth (mtroth@bu.edu) to discuss before registering.

Educational Objectives:

At the end of the workshop, participants should be able to:

  • Describe and explain Clinical Research Professional responsibilities from study start-up to study completion;
  • Discuss the regulations governing human subjects research and identify which apply to your research studies;
  • Identify steps to obtain the necessary approvals to conduct clinical research at BMC and BU Medical Campus;
  • Apply the elements of the ICH Good Clinical Practice guidelines to your research studies;
  • Identify best practices in the recruitment, screening, and informed consent of research subjects;
  • Identify strategies to manage study documentation and ensure it fulfills regulatory requirements and supports the quality of your study, including the development of source documents, case report forms, and other applicable regulatory documents for your research studies;
  • Describe appropriate monitoring for adverse events, including identification, documentation, reporting as well as create a study-specific DSMP;
  • Institute a plan of self- assessments to support audit-readiness and validity and integrity of study data.