EmpiriStat Boot Camp Series101

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  • 1. SERIES 101: Introductory Courses for the Boot Camp Series in four key areas of statistics, epidemiology, clinical data management and clinical trials. Teaching Methods Knowledge and skills will be gained through:  the use of slides and presentations  small group case study sessions on the topic area  individual work on a problem for resolution  group discussions and exploration  directed question and answer periods  summary quizzes of the main topics for the day Sample Group Activities  Sample size and power case study and discussion: participants are given a hypothesis, and a sample size table, then each small group comes up with a decision of which sample size and power estimate to use.  Hypothesis and objectives: the small groups are given a hypothesis, and then they need to pick from a number of endpoints to create a meaningful comparison to study in order to test a hypothesis.  Database building small groups: each group will be given a small study and CRFs and they will be asked to write the database specifications and variable names (annotate the CRFs, outline the database).  Data analysis files small groups: Part A: each group will be given three small spreadsheets from three sites and asked to write specifications on how to merge the files; Part B: each group will be given three small spreadsheets from three DIFFERENT studies and asked to write specification on how to merge the files Boot Camp Training Series 101  CONSORT: each small group will be given a peer reviewed publication and the CONSORT statement and asked to critique the publication Essentials of Epidemiology – November 29, 2010 (0900-1630) based on the CONSORT statement. Essentials of Clinical Trials – November 30, 2010 (0900-1630)  Epidemiology case studies: each group will be given a case study to interpret point estimates and confidence intervals, RRs, and ORs. Introduction to Clinical Data Management – December 1, 2010 (0900-1630)  Small writing groups: each small group will be given a different case Statistics for Non-Statisticians – December 2, 2010 (0900-1630) and analysis summary of data, and they will create and write the abstract of that data and present to the group. Location: Creekside Suites & Conference Center 13694 Sam Hill Drive Mount Airy, MD 21771 50 Citizens Way, Suite 303 866-935-STAT (7828) Tel 866-276-STAT (7828) Fax Frederick, Maryland 21701 www.empiristat.com Parking is available at the Court Street Parking Deck (2 Court St.), with skywalk access to the conference center
  • 2. Small group activitie 101 ESSENT IAL S O F CL INICAL TRIA LS Reas onab le Pric es In this course, professionals will acquire the knowledge of designing, implementing, and interpreting clinical trials. Session topics include the flexible training solutions One Day Course : principles of clinical trial design, phase I – III trials, defining clinical and  Government $250.00 statistical benefits, biostatistics and common statistical methodology,  Industry $375.00 Clinical Data   FACULTY data management, program management and resourcing, and Student (<25yrs) $175.00 Clinical Trials regulatory requirements for filing clinical data to the United States Food and Drug Administration and the European Union. This course will Management F our Day Serie s: also cover clinical research essential documents, hypothesis Nicole C. Close, PhD  Government $900.00 generation, objectives and endpoints, along with superiority, non-  Industry $1400.00 inferiority and equivalence trials, protocols, informed consent process, Statistics for   Student (<25yrs) $600.00 safety monitoring and plans, clinical monitoring, quality control, Epidemiologic  Non‐ recruitment and retention plan and execution, Good Clinical Practices, Methods ICH Guidances, and a CONSORT introductory workshop. This is a Statisticians fast-paced and fun tour of all of the essentials in Clinical Trials for all study team members and executives. Registra ti on Send an E-Mail to 101 ESSENTIALS OF DATA MANAGEMEN T “You have made us like Statistics” info@empiristat.com or call 240- Collecting data is easy, so what more do you need to know? The data Devin J. Hunt ~Workshop Attendee 744-0000 x704 and ask to register collected during your study is the most valuable asset from the trial, so with the Training Coordinator you need to make sure your data management is done correctly and “Dr. Close did an excellent job efficiently. Without proper data management, there could be major discussing stats as a mere mortal.” ~Workshop Attendee of Statistics for Series 101 Boot Camp Training in Meals and Snacks consequences and setbacks for the clinical trial, costing time, money, Non-Statisticians Provided and integrity. This course is designed to present participants with Four Essential Research Areas Continental Breakfast knowledge about good clinical data management practices, the “Devin was engaging and very Boxed Lunch and Networking development of documents used in clinical data management, knowledgeable, and the data database design considerations, some of the standards used in clinical management course was a good review 101 STATI STICS FOR NON - STATISTICIAN S Afternoon Refreshments for an experienced Data Manager and Who do those biostatisticians think they are anyway? Are you a member data management, and how to remain compliant with FDA and ICH gave some food for thought.” of a team, part of a project, or have just seen these folks lurking around in guidelines and regulations. Your guide will help participants solidify the ~Workshop Attendee Paymen ts knowledge they learn by the use of hands-on workshop examples. the hallways, and want to know exactly what do they do. No slide rules, Check or Credit Card in advance no calculators and no derivations in this series. Your statistical guide will introduce you to concepts including hypotheses, endpoints, sample size, types of study design, power, randomization, significance, common Canc ella ti on Policy 101 ESSENT IAL S O F EPID EMIOL OG Y statistical tests and appropriate data presentation. At the end of the Cancellations accepted up to 30 Epidemiology [Greek word for epi (upon) and demos (population)]. Some can course you will have a new sense of ownership of common clinical trial days in advance; within 30 days of pronounce it, but most don’t know exactly what it means. This is the first course in statistical concepts and will be equipped to talk the talk with a training a $100 processing fee per the series to introduce professionals to the study of factors that determine the biostatistician. course is applied. occurrence and distribution of disease in a population. An understanding of Epidemiology enables the professionals who work in clinical research to understand the way diseases are studied through population-oriented research of the community origins of health and discovering risk factors that might be altered in a population to prevent or delay disease or death. OUR TRAINING MISSION Our training mission is to empower professionals with a better understanding Sample Topics to be covered in lecture and through in class activities: of the concepts and methods and to leave  History of Epidemiology and common terms the training with this empowerment to  Epidemiology Study Designs implement these skills and knowledge in  Measures of Disease Frequency and Association including Relative Risk, their research settings. Odds Ratios, Confidence Intervals, Attributable Risk, and more  Biases  Confounding and Interaction  Calculations and Interpretations of Risk