Making Informed Decisions: Key Statistical Principles to Clinical Trial Desi gn Program

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The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI collaborate to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge. Program Overview: This 5-course program, features industry and academic experts discussing the integral role of statistics in medical product development, specifically in clinical trial design. This program provides a foundational understanding of statistical topics related to clinical research in an interactive forum. Statistical principles such as power, multiplicity, and P-values remain critical in designing successful clinical trials. Statistical techniques determine the number of patients needed for a study to meet a pre-set clinical endpoint and to generate meaningful results. While analyses can reveal mathematically significant, this does not always equate to clinical or medical value. Program Outcome: The learner will increase their understanding of basic statistical principles and their application to different clinical trial designs and populations, as well as how results are used to elucidate meaningful findings from raw clinical trial data. Program Topics: Course 1: Basic Statistical Principles: Validity and Sample Size Course 2: Designing Medical Devices Course 3: Pediatric Trials Course 4: CTSI Clinical Study Design Types Course 5: Gender, Race, and Ethnicity in Clinical Trials Learner Level: Intermediate Audience: This symposium is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals, or junior faculty with three or more years of experience seeking to further develop clinical research skills and principles. Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring and complex issues involving site management, study management, and sponsor / CRO challenges. Learner Disclosures: Accreditation Status: Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation. Financial Relationships: ENPDC has evaluated everyone who has the ability to control content of this activity (planning committee members, subject matter experts, presenters) and found that no relevant financial relationships exist. Awarding Contact Hours: To obtain contact hours participants must Review the entire activity Pass the quiz with 100% of questions answered correctly Complete the evaluation at the end Certificates will be distributed at the end of the evaluation. Enduring Materials Dates: Start Date: 09/30/2022 Expiration Date: 09/29/2025 Need Help with Registration? Please contact us at [email protected] or 404-727-9208. Sign up for this program

Intermediate