Welcome UCI Fellows and Faculty!
As you know, UC San Diego has made available 8 core courses of the CREST certificate and
Master’s degree in Clinical Research curriculum starting summer 2009 through spring 2011
quarters via synchronous, live broadcast – distance learning.
Now, we are offering “Patient Oriented Research I (CLRE-250)-first year” and
“Health Services Research (CLRE-252)- second year” courses as well for summer
2011 enrollment.
These programs were created in response to an increasing demand for well-qualified
professionals able to perform patient-based research in academia, industry, research
institutes, and health and regulatory agencies. For more information on the Master’s degree
program please visit: http://clre.ucsd.edu and on the CREST program:
http://crest.ucsd.edu.
Information on the Courses:
Patient Oriented Research I (POR I), CLRE-250, 2 units: Allen J. McCutchan, MD
Objectives: This course will develop and apply the theory of clinical trial design and analysis, discuss the practical
issues of financing and implementation of clinical trials, and describe issues of monitoring trials and working in
cooperative groups. The scholar will design and present to a group of peers a concept sheet for a phase I/II and
phase II/III clinical trial. Course Content:
Topic
Content
Hypothesis Generation and Formulation
Framework, Types, and Characteristics of Good Research
Questions and formulating a testable hypothesis
Introduction to POR
Definition of POR; Origins & Scientific Basis; Causality;
Validity of Inference; Classification of Clinical Research
Measurement
Objectives, classes, and characteristics of measures in POR
and their validity, accuracy, and precision
Fundamentals of Clinical Trials
Study Objectives, Target Populations, Comparison Groups,
Blinds, Outcomes and Endpoints
Overview of the Process of Drug and Device
Development
Preclinical and clinical development of drugs from an
industrial prospective
Statistical Issues in Clinical Trials
Sample Size/ Power Analysis; Randomization Procedures;
Analytic Strategies - Sequential, Interval and Terminal;
Analysis Plan
Selecting and Measuring Outcomes and Study
Implementation I
Outcomes: Selecting outcomes: who gets counted, clinical
vs. surrogates, and simple vs. compound. Implementation:
Defining, recruiting, consenting, initially assessing, tracking,
and retaining participants; IRB submission.
Complex Trial Design
Multi-centered studies, Crossover and Factorial Designs,
equivalence vs. superiority trials, and testing diagnostics
2006 POR I Course Syllabus is used
Health Services Research (HSR), CLRE-252, 2 units: Theodore Ganiats, MD, Interim Chair of
Family and Preventive Medicine – UCSD – School of Medicine
Objectives: Scholars will evaluate relevant outcomes in patient-oriented research from the patient (quality of life) and
societal (economic) perspectives and locate potential resources for assessing the relevant outcomes in a wide variety
of study designs. They will also be able to describe the relative strengths of different health services research
approaches to a clinical problem. Finally, they will understand the components of clinical practice guidelines,
including patient preferences, and how these guidelines both depend upon as well as inform patient-oriented
research.
Course Content:
Topic
Content
Evidence-based medicine
Fundamentals of EBM; Reading the literature;
Levels of evidence
Survey Research
Types of survey questions, Developing surveys
Measurement principles
Patient Safety
Safety research; JCAHO safety goals
Costs
Types of costs, Costs vs. charges, Data collection
Incremental & marginal costs, Types of analyses
Perspective
Qualitative Research
Principles of qualitative research, How to perform
Quality of Life Measurement
Quality of life instruments, Patient preferences
Measuring QOL
Guidelines and Quality
Level of evidence/ strength of recommendation
Practice guidelines, Patient preferences
Quality Improvement/ Quality Assurance
Cost-effectiveness
Theoretical foundation, Assumptions, Practical overview
Effectiveness Research
Disease reservoir, Practice variation
UC Irvine location for live broadcast *:
Hewitt Research Hall – small conference room #1360
*Location is subject to change!
Time:
POR I – Wednesday evenings, 4-6PM
HSR – Thursday evening, 4-6PM
Enrollment/Payment Procedures
Courses are set up as graduate courses through “Concurrent Enrollment,” which is
administered through the UCSD Extension - Registrar’s Office:
Fee Structure/Categories:
UCSD-- CREST Fellows – $500 ($250 per unit)
UCSD - CREST Faculty – $700 ($350 per unit)
UCI affiliates and MAS candidates - $1400 ($700/unit)
There are two different methods of payment:
Student Self-Payments: Unaffiliated-UCI Students and those whose departments are not
funding their training must complete a Self-Payer application (Form A) complete with credit
card payment information or attach a check.
Department Recharges/Fund transfers: the UNEX Registrar office will enroll and
register UCI fellows/faculty via a quarterly list that the MAS Office will provide with campus
recharge number, fund/org/program information for fund transfers, student contact
information, course sect. ID’s and discount fee category (Form B)
The forms are provided below. The self-paying students submit Form A to UCSD
Extension Student Services – Quang Nguyen via one of the following methods:
Quang Nguyen
Via mail:
UCSD Extension Student Services
9600 N. Torrey Pines Rd.
La Jolla, CA 92037 – 0176H
Mail code: 0176H
Via fax: (858) 534-8527 (Please, attach cover sheet to the attention of Quang Nguyen!)
Phone: (858) 534-3400 (for confirmation and receipts)
Via email: quangn@ucsd.edu
The recharge/fund transfer students submit Form B to Krisztina Hershon via one of
the following methods:
Via mail:
Krisztina Hershon
La Jolla Village Professional Center
8950 Villa La Jolla Dr., Suite A-124
La Jolla, CA 92037
Via fax: (858) 964-1345 (Please, attach cover sheet to the attention of Krisztina Hershon!)
Phone: (858) 964-1313 (for confirmation and receipts)
Via email: khershon@ucsd.edu
NOTE: Enrollment and payment are one process at Extension. Students are not enrolled in a
course unless full payment is received either by recharge or by student’s own payment.
Be advised that according to UCSD refund policy a 100% refund of course fees will be
provided for those who withdraw up till the 2nd week of classes, unless an extenuating
circumstance prevents you from requesting such by the deadline. Administrative fees
(reg.fee) are non refundable! Contact Krisztina Hershon at khershon@ucsd.edu should you
need to drop the course and request a refund.
CREST/MAS in Clinical Research
FORM A
COURSE ENROLLMENT AND FEE PAYMENT FORM
FOR SELF‐PAYMENTS ONLY
QUARTER:
th
Summer 2011 – REGISTRATION/PAYMENT DEADLINE: June 20
, 2011
*The fee covers the costs for all lectures (broadcast/technical) and course materials including text books
and computer software.
Name:
 MS.  MR.  DR.  MISS  MRS.
Email:
Position/Title:
Dept :
Work Phone: (
SS#:
_______
Mail Code:
)
Home/Cell Phone: (
)
Work Address (at UCI):
City
_______________________
State
Zip
City
State
Home Address:
DISCOUNT FEE CATEGORY (check one):
______ UCI FELLOW
_______UCI FACULTY
PAYMENT METHOD (check one):
_______ Personal Check (Made payable to UC Regents)
_______ VISA/MasterCard/Discover Card: #______________________________
Exp Date: _______ / _______ Signature:
_
===========================================================================
* FEES
COURSE TITLE
SECTION ID
(Circle one)
SECTION ID FOR BB
(check one)
(enrollment is automatic)
1) POR I (CLRE‐ 250)
2 units
084406
084407
084408
083801
UCSD Fellow/Staff: $500 _____
UCSD Faculty:
$700 _____
UCI Affiliates:
$1,400______
2) HSR (CLRE‐ 252)
2 units
084409
084410
084411
083805
UCSD Fellow/Staff: $500 _____
UCSD Faculty:
$700 _____
UCI Affiliates:
$1,400______
Total Fees:
Submit completed form with check or completed credit card information to:
Quang Nguyen
Fax: (858) 534‐8527
UCSD Extension Student Services
Phone: (858) 534‐3400
9600 N. Torrey Pines Rd.
quangn@ucsd.edu
La Jolla, CA 92037–0176H
____________
Zip
CREST/MAS in Clinical Research
FORM B
COURSE ENROLLMENT & DEPARTMENT RECHARGE
FOR DEPARTMENT RECHARGES/FUND TRANSFERS ONLY
QUARTER:
Summer 2010 – REGISTRATION /PAYMENT DEADLINE:
June 20th, 2011
*The fee covers the costs for all lectures (broadcast/technical) and course materials including text books
and computer software.
Date: _______________
Student Name: ____________________________
DISCOUNT FEE CATEGORY (check one):
____UCI FACULTY
_____UCI FELLOW
______NON‐UCI AFFILIATE
=================================================================================
*DISCOUNTED FEES
COURSE TITLE
SECTION ID
(Circle one)
SECTION ID FOR BB
(check one)
(enrollment is automatic)
1) POR I (CLRE‐ 250)
2 units
084406
084407
084408
083801
UCSD Fellow/Staff: $500 _____
UCSD Faculty:
$700 _____
UCI Affiliates:
$1,400______
2) HSR (CLRE‐ 252)
2 units
084409
084410
084411
083805
UCSD Fellow/Staff: $500 _____
UCSD Faculty:
$700 _____
UCI Affiliates:
$1,400______
Total Fees:
____________
==================================================================================
DEPARTMENT RECHARGE INFO:
Location: _______ Account: __________ Fund: ________ Sub: ______ Object Code: __________
Department Name: __________________
Department Contact Name: __________________
Email: _____________________________
Telephone/Extension: ___________________
Department Authorization:
Signature
SUBMIT COMPLETED FORM TO:
Krisztina Hershon
UCSan Diego
9500 Gilman Drive, #0170X
La Jolla, CA 92093‐0170
Tel: 858‐534‐9164
Fax: 858‐534‐9168
khershon@ucsd.edu