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

Format and Registration

Fundamentals will take place on a quarterly schedule in 2021 (March, June, September, and December).  The Fundamentals training consists of four 2.5-hour afternoon 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:

March 2021

Thursday, March 4, 2021 2:00-4:30pm
Thursday, March 11, 2021 2:00-4:30pm
Thursday, March 18, 2021 2:00-4:30pm
Thursday, March 25, 2021 2:00-4:30pm

(Fundamentals will be offered March, June, September, and December in 2021.)

REGISTER for the March 2021 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.

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

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:

  • Clinical Research Professionals (clinical research coordinators, research nurses, research project managers, and research assistants, etc.) with less than one year 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.

Online pre-registration is required.  Registration is limited to the first 25 enrollees and training sessions fill up quickly so register early.

Click here to register Closer to the training you will be sent Zoom links for each week’s training session.

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.