PPT-Exercise 1 The investigator undertakes a case control study to address the research question,

What are the possible explanations for this inverse association between intake of fruits and vegetables and CHD How could each of these possibilities be altered in the design phase of the study How could they be addressed in the analysis phase. Jan Zolkower, MSHL, CIP, CCRP. January 13, 2012. Review Investigator Responsibilities. Discuss recent FDA Warning letters and OHRP Determination letters. Review of Advanced Notice of Proposed Rulemaking (ANPRM). Shannon Simmons, BA, CIP. March 14, 2014. Process Improvement Team. Vanderbilt Human Research Protections Program. Agenda. Review Investigator Responsibilities. Discuss FDA Warning letters . Q & A. What is a Case Study. A body of information. Answer questions about its subject matter.. Inquiry. Processes . and Systems. Product. Probe . what made an initiative click. Success. What about all that did not work – Failures?. Investigator-Initiated . v. Sponsor-Initiated Clinical Trials – What are the special contract and administration issues to be aware of?  . NCURA Western Regional Conference April 5, 2011 – Denver, CO. Jan Zolkower, MSHL, CIP, CCRP. January 13, 2012. Review Investigator Responsibilities. Discuss recent FDA Warning letters and OHRP Determination letters. Review of Advanced Notice of Proposed Rulemaking (ANPRM).  .  . Duanping Liao, MD, Ph.D. Email: . Dliao@psu.edu. Phone: 531-4149. 2. Learning Objectives. Strategies to select cases and controls and to analyze data in pair-matched case-control studies.. Identify strengths and limitations of case-control studies.. Fundamentals of Study Design. Lauren Duke, MA. Program Coordinator. Meharry-Vanderbilt Alliance. 17 July 2015. Session Outline. Research Question. Type of Study. Observational. Experimental. Quasi-experimental. When Negotiating a Clinical Studies Agreement Living Document As of May 21 , 2010 Version 2 .0 Living Document Page 1 of 13 As of May 21, 2010 Introduction Collaboration of academic institutions w Kathleen O’Malley RN, BSN, CCRP. Manager of Education and Training. Jefferson Clinical Research Institute. Kathleen.omalley@jefferson.edu. Stephen . Klasko. , MD, MBA. President and CEO of TJU AND Jefferson Health System. Research designs. Empirical circle. Research designs: . 4 . elements. Randomization. Comparison. Before . vs. . after. Prospective . vs. . retrospective. Randomized controlled study. Controlled before-after study. Yousef Ahmed . Alomi. , Amal Hassan Al-Najjar, . Maha. Hussein . Almadany. , Fakhar Al-. Ayoubi. , . Ghudair. . Tashan. . Alanazi. , . Abeer. . Hussin. . Almasoudi. ABSTRACT: . Objectives: . This study explores the Research Policy of Case-Control and Cohort Study Design in Pharmacy Practice as a new initiative in Saudi Arabia. . Colorado Integrated Food Safety Center for Excellence - 2017. County Fair Chocolate Scare Case. Denver, Colorado. Summary: . the case study . is based on a foodborne illness outbreak caused by the unintentional ingestion of marijuana-infused foods (edibles) at a county fair in . Presented by the . Research Quality Compliance Network.  . PRESENTERS. Ginger Bair, CCRP – QA/QC Coordinator, Office of Quality Compliance and CTSI. Josh Fessel, MD, PhD . –. . Senior Clinical Advisor, Division of Clinical Innovation, NCATS and NIH. Identify a research article. . Differentiate between a research article and lit review. Know the differences between research categories and data collection methods. Define elements involved in a .