Fundamentals in the Conduct of Clinical Research: BMC and BU Medical Campus Research Professional Staff Training
Summary: training takes place over two half-days on consecutive weeks. This 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 BMC and BU medical Campus are able to successfully conduct research study activities. The completion of both sessions of this in-person training fulfills the GCP training requirement for 3 years.
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.
- 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.
Part 1: Tuesday, February 27, 2018, 9:00 AM to 1:00 PM, location E-720
Part 2: Tuesday, March 6, 2018, 9:00 AM to 1:00 PM, location E-720
Part 1: Thursday, May 17, 2018, 9:00 AM to 1:00 PM, location E-720
Part 2: Thursday, May 24, 2018, 9:00 AM to 1:00 PM, location E-720
+Note that training 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. Registration is 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. Each participant’s registration includes:
- Training slide presentations and materials,
- FDA/ICH Good Clinical Practice Reference Guide,
- 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.
Click here to register for the Fundamentals in the Conduct of Clinical Research program on February 27 and March 6 2018.
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.