Fundamentals in the Conduct of Human Research Studies: BUMC Clinical Research Professional Staff Training
Summary: This 2 half-day long training utilizes International Conference on Harmonization Good Clinical Practice (ICH-GCP) as the gold standard for the conduct of clinical research and will cover key topics and concepts to ensure human/clinical research professionals at BUMC/BMC are able to successfully conduct research study activities. The training will include an overview of:
- resources available to researchers and their staff,
- institutional policies influencing the conduct of research, and
- regulatory requirements all researchers and their staff should be aware of.
- 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 BUMC/BMC (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.
Upcoming Training Dates+
Part 1: Wednesday, September 28, 2016, 9:00 AM to 1:00 PM
Part 2: Wednesday, October 5, 2016, 9:00 AM to 1:00 PM
Part 1: Thursday, February 9, 2017, 9:00 AM to 1:00 PM
Part 2: Thursday, February 16, 2017, 9:00 AM to 1:00 PM
Part 1: Friday, May 12, 2017, 9:00 AM to 1:00 PM
Part 2: Friday, May 19, 2017, 9:00 AM to 1:00 PM
Location: Evans Building, Room E-720 +Note that the above dates are subject to change; frequency of offerings will be based on interest.
Online pre-registration is required and there is a $75 registration fee for each workshop participant. Notification of opening of pre-registration will be sent by e-mail to the BUMC/BMC community ~ 3 weeks before each session and be limited to the first 25 enrollees; others will be put on a wait-list to either join the current session if openings become available or for the next available training. Click here to register for the February 9 and 16, 2017, sessions. People on this list will receive priority registration. Each participant’s registration includes:
- A bound reference training materials,
- An FDA/ICH Good Clinical Practice Reference Guide,
- A Certificate of Completion,
- Breakfast and snacks.
Payment can be made by credit card only (Visa, MasterCard, Amex and Discover). There are no refunds for cancellations. The registration fee can be transferred to another participant or to a future training.
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 BU/BMC;
- 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.