13694 Sam Hill Drive Mount Airy, MD 21771 866-935-STAT (7828) Tel 866-276-STAT (7828) Fax www.empiristat.com

Boot Camp Training Series 101 Essentials of Epidemiology – November 29, 2010 (0900-1630) Essentials of Clinical Trials – November 30, 2010 (0900-1630) Introduction to Clinical Data Management – December 1, 2010 (0900-1630) Statistics for Non-Statisticians – December 2, 2010 (0900-1630)

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

CONSORT: each small group will be given a peer reviewed publication and the CONSORT statement and asked to critique the publication based on the CONSORT statement.

Epidemiology case studies: each group will be given a case study to interpret point estimates and confidence intervals, RRs, and ORs.

Small writing groups: each small group will be given a different case and analysis summary of data, and they will create and write the abstract of that data and present to the group.

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

Location: Creekside Suites & Conference Center 50 Citizens Way, Suite 303 Frederick, Maryland 21701 Parking is available at the Court Street Parking Deck (2 Court St.), with skywalk access to the conference center

Small group activitie

Series 101 Boot Camp Training in Four Essential Research Areas

flexible training solutions 101 ESSENTIALS OF CLINICAL TRIALS In this course, professionals will acquire the knowledge of designing, implementing, and interpreting clinical trials. Session topics include the principles of clinical trial design, phase I – III trials, defining clinical and statistical benefits, biostatistics and common statistical methodology, data management, program management and resourcing, and regulatory requirements for filing clinical data to the United States Food and Drug Administration and the European Union. This course will also cover clinical research essential documents, hypothesis generation, objectives and endpoints, along with superiority, non-inferiority and equivalence trials, protocols, informed consent process, safety monitoring and plans, clinical monitoring, quality control, recruitment and retention plan and execution, Good Clinical Practices, ICH Guidances, and a CONSORT introductory workshop. This is a fast-paced and fun tour of all of the essentials in Clinical Trials for all study team members and executives. 101 ESSENTIALS OF DATA MANAGEMENT Collecting data is easy, so what more do you need to know? The data collected during your study is the most valuable asset from the trial, so you need to make sure your data management is done correctly and efficiently. Without proper data management, there could be major consequences and setbacks for the clinical trial, costing time, money, and integrity. This course is designed to present participants with knowledge about good clinical data management practices, the development of documents used in clinical data management, database design considerations, some of the standards used in clinical data management, and how to remain compliant with FDA and ICH guidelines and regulations. Your guide will help participants solidify the knowledge they learn by the use of hands-on workshop examples.

101 STATISTICS FOR NON-STATISTICIANS Who do those biostatisticians think they are anyway? Are you a member of a team, part of a project, or have just seen these folks lurking around in the hallways, and want to know exactly what do they do. No slide rules, 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 statistical tests and appropriate data presentation. At the end of the course you will have a new sense of ownership of common clinical trial statistical concepts and will be equipped to talk the talk with a biostatistician.

Reasonable Prices One Day Course: Government $250.00 Industry $375.00 Student (<25yrs) $175.00

Four Day Series: Government $900.00 Industry $1400.00 Student (<25yrs) $600.00

Registrat ion

Send an E-Mail to info@empiristat.com or call 240-

744-0000 x704 and ask to register with the Training Coordinator

Meals and Snacks Provided

Continental BreakfastBoxed Lunch and Networking

Afternoon Refreshments

Clinical Trials Clinical Data Management

Statistics for Non‐

Statisticians

Epidemiologic Methods

101 ESSENTIALS OF EPIDEMIOLOGY Epidemiology [Greek word for epi (upon) and demos (population)]. Some can pronounce it, but most don’t know exactly what it means. This is the first course in the series to introduce professionals to the study of factors that determine the 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. Sample Topics to be covered in lecture and through in class activities:

History of Epidemiology and common terms Epidemiology Study Designs Measures of Disease Frequency and Association including Relative Risk,

Odds Ratios, Confidence Intervals, Attributable Risk, and more Biases Confounding and Interaction Calculations and Interpretations of Risk

OUR TRAINING MISSION Our training mission is to empower

professionals with a better understanding of the concepts and methods and to leave

the training with this empowerment to implement these skills and knowledge in

their research settings.

“You have made us like Statistics”

~Workshop Attendee

“Dr. Close did an excellent job discussing stats as a mere mortal.”

~Workshop Attendee of Statistics for Non-Statisticians

“Devin was engaging and very knowledgeable, and the data

management course was a good review for an experienced Data Manager and

gave some food for thought.” ~Workshop Attendee

Payments

Check or Credit Card in advance

Cancel lat ion Pol icyCancellations accepted up to 30

days in advance; within 30 days of training a $100 processing fee per

course is applied.

FAC

ULTY

Nicole C. Close, PhD

Devin J. Hunt