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