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KANSAS CITYUNIVERSITYOFMEDICINEANDBIOSCIENCES
COLLEGE OF OSTEOPATHIC MEDICINE
DEPARTMENT OF CLINICAL RESEARCH
Introduction to Clinical Research
Course Description
Introduction to Clinical Research pharmacy student rotation provides students with an advanced
knowledge and experience in the application of the practical aspects required to achieve
success in conducting human research.
Prerequisites:
Successful completion of student’s respective university’s requirements for
participating in experiential training
Course Background
A foundational knowledge in the practical elements of clinical research is of intangible value to
the health professional student and potential future clinician / scientist. The material being
taught to those matriculating through professional healthcare professional programs is
developed and continuously refined through the conduct of research – of which clinical (or
referred to also as translational) plays a major role. Upon completion of these healthcare
professionals’ training, they enter a work force or post-doctoral/professional training programs
that may have as an expectation of success a level of engagement in a clinical research project.
The purpose of this course is to provide the health professional student a working knowledge of
the practical elements of conducting clinical research projects to enable them to achieve a
working knowledge of clinical research. By reaching this goal, these new professionals will
attain distinctiveness amongst their colleagues that could potentially enhance their marketability.
This course will also serve to introduce the student to the obligations of those serving as
principal investigator.
Course Structure:
Online didactic lectures interspersed amongst experiential exercises
(hand-on practical applications of didactic materials from this
course and pre-requisite knowledge).
To meet the requirements for accreditation, courses offered should reflect in the syllabus
the components for accreditation addressed through delivery of materials.
General Course Objectives
Medical Knowledge: The successful student will demonstrate medical knowledge of clinical
research through the following: passing of course tests, research activities, presentations, and
participation in directed reading programs and/or journal clubs; and/or other evidence based
medical activities. Specifically, the student must:
 Demonstrate comprehension of the essential regulatory requirements to initiate research
in humans by constructing a formal presentation during which the student will illustrate
mastery of at least one essential regulatory requirements
 Conduct an analysis of a publication describing research conductance
 Contrast protocol required procedures to those considered standard of care for the
disease of primary interest
Patient Care: The successful student will demonstrate interpersonal and communication skills
with patients and other health care professionals through the following directly-supervised
activities:
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Observe, collect, interpret and communicate in either written or verbal mechanisms to
center personnel the research participant’s response to study medications
Demonstrate empathy and compassion when interacting with study participants
Appropriately interact with research participants in carrying out study protocol
procedures or in answering questions raised by study participants
Interpersonal and Communication Skills: The successful student will demonstrate knowledge
of professional, ethical, legal, practice management, and public health issues applicable to
clinical research through the following directly-supervised activities:
 Demonstrate understanding of role of research oversight bodies
 Gaining familiarity of the standard of care requirements for obtaining and maintaining
health information from research participants
 Properly obtaining informed consent to participate in a clinical trial
Professionalism: The successful student will demonstrate the ability to effectively provide
medical care that incorporates evidenced-based medicine, patient empathy, awareness of
behavioral issues, the incorporation of preventive medicine and health promotion within the
defined scope of practice.
 Demonstrate empathy and compassion when interacting with study participants
 Gain awareness of how health promotion and preventative medicine is incorporated into
medical research protocols
Practice-based Learning and Improvement: The successful student will demonstrate the
ability to critically evaluate their ability to deliver clinical pharmacotherapy, including integration
of evidence-based medicine into treatment plan as well as show an understanding of research
operations and governing regulations influence upon activities.
 Identify and contrast degree and extent of procedures performed specifically to obtain
information on a disease state beyond that minimally required to manage disease
 Assess the proportion of clinical trial procedures mirroring standard of care
 Evaluate the validity of protocol’s design on likelihood of achieving primary study
objectives
Systems-based Practice: The successful student will demonstrate an understanding of health
care delivery systems as applicable to a research environment, provide effective and
qualitatively verifiable excellent patient care with that system, and at all times exemplify a costeffective awareness.
 Analyze how test article will be incorporated into current standard of care models (if
applicable)
 Propose how test article will be engaged into currently available treatment options
Evaluation
Students will be expected to provide one formal presentation to research personnel critically
evaluating an ongoing clinical trial with special attention paid to test article, comparing
procedures to current standard of care, potential impact on currently accepted standard of care,
likelihood of achieving study primary objectives, degree to which the approved informed consent
accurately reflects current known risks associated with test article or study participation,
describe a first-hand evaluation of study participants’ response to test article, and a summary of
select regulatory documents reflective of this study. In order to receive a satisfactory grade in
this course, the student must successfully communicate these to the research personnel in
attendance at the presentation. Additionally, to receive a satisfactory grade in this course, the
student will be expected to actively participate in a journal club session conducted by the site’s
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education experiential coordinator in which recently published clinical research conductance
manuscripts will be critiqued.
GRADES
The student’s university’s rotation evaluation form will be used as required.
COURSE MATERIALS/EQUIPMENT
A reading list is provided to the student upon arrival. The majority of materials used to deliver
curriculum are available freely from various websites. Approximately 35 hours of didactic
lectures are delivered over the course of the rotation. Due to proprietary and confidential
materials, these lectures cannot be made available outside the center. Any other materials
received by the student are to be considered the property of KCUMB, and as such cannot be
replicated or used in any commercial manner without written approval from KCUMB. To aid the
student in obtaining background information that may not be freely available through the
internet, a number of reading materials are on reserve at KCUMB Library and the CRC has its
own library. Students are required to ‘check out’ these materials at the respective location.
Students need to provide their own laptop computer to use on-site. Wireless internet access is
available at no cost to the student.
LABORATORY ACTIVITIES
The students will be participating in ‘lab’ activities throughout course. (As students will need to
complete CITI training in order to begin these activities, it is beneficial – but not mandatory – if
students are able to complete this prior to beginning. See the website: www.citiprogram.org)
Students may be assigned to shadow an individual research professional for the day, observing
activities and gaining insight into that individual’s role on a study and research center. Over the
course of the rotation, the student is assigned to a variety of personnel, enabling the student to
obtain first-hand observations in the following areas: study procedures, laboratory procedures,
regulatory processing, recruitment/marketing, investigator responsibilities and study
management. Depending on the volume of research participants, number of studies ongoing at
the time, the student’s stated interest and the student’s demonstration of mastery of research
rules, regulations and knowledge; these may be repeated multiple times over the course, the
student may be enabled to perform study related procedures on participants.
REQUIRED INSTRUMENTS
Stethoscope
Name tag
Professional dress
COURSE SCHEDULE
Day 1 –
 Start time: 1 pm
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Orientation (afternoon only)
o Tour of center & campus
o Complete applications for:
 Parking passes
 ID badges
o Meet staff of the research center
o Sign for rotation binder
o Review and complete regulatory documents
o Obtain emergency contact information
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Discuss rotation expectations/outcomes
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Day 2 –
 Start time: 8 am (confirm prior to leaving Day 1)
o This may vary depending on clinic visit schedule.
o It is an expectation you would be present for all patient visits and prepared to take an
active role in the visit.
o Beginning on Day 2 and going forward, it is an expectation you will be on site from 8 am
– 4:30 pm unless arrangements made with preceptor or designee in advance.
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Training/Education
o Self-directed
 CITI training (should be completed by the end of this day)
 Certificate to be provided to preceptor
 See printout of website for information on how to log on and complete
training
 Take rotation baseline knowledge assessment exam
 Begin working on IRB submission packet for assigned study.
 It is expected you will continue working on this and have it completed by
the end of the second week on site.
 Begin working to attain and maintain working knowledge of all active protocols.
You should continue to assure this throughout entire rotation period.
 Minimally, you should be able to answer questions from preceptor, investigator,
coordinator, IRB member or study participant that can be formulated from any of
the following:
 Most currently approved protocol
 Investigational drug brochure
 Consent form
 Telephone screening form
 Marketing materials
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Guided/Lecture
 “Introduction to Clinical Research”
 Various lectures are provided throughout entire training period.
 Specific lecture topic and schedule will be on CRC calendar
 Pre-tests (located in binder) are due to lecturer at onset of lecture
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Experiential activities
o Schedule training for checklist tasks with appropriate research center personnel
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Question of the day: Daily questions begin (and can run daily throughout rotation)
o Student is given one question daily.
o It is expected the student will turn in answer to preceptor/designee within 30 minutes
(this will not be given when patient activities are occurring).
o It is an expectation the student, using their judgement, will provide a more complete &
referenced answer the following day if answer turned in previously is unsatisfactory.
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Day 3 –
 Journal club:
o Present articles to be discussed to preceptor for approval
o Present journal club template form you have chosen to use to preceptor for approval
 Review standardized forms supplied in binder with preceptor/designee
o IVRS form or other randomization worksheet
o SAE form
o Source documents (not an exhaustive list)
 Medical history
 Concomitant medication
 Screening log
 Drug accountability
 Master patient list
Subsequent key dates –
 First Friday on site
o Finalize scholarly product with preceptor
o Decide on therapeutic presentation topic
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Second Friday on site
o Rough draft of scholarly product due to preceptor
o Rough draft of therapeutic presentation due to preceptor
o Task checklist to be reviewed with preceptor/designee
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Third Friday on site
o Task checklist to be reviewed with preceptor/designee
o Draft presentation to be given to preceptor
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Mid-point evaluation will be conducted in accordance with your school’s policies
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Final evaluations will take place the final week on site
POLICIES
In addition to university policies, there are specific policies pertaining to being present in the
clinical areas of the research center and on a university campus. These policies will be reviewed
with the student at the outset of the rotation prior to engaging in any activities.
ACADEMIC DISHONESTY
The University holds its students to the highest standards of intellectual integrity. Therefore, the
attempt of any student to pass any examination by improper means, present work which the
student has not performed or aid and abet a student in any dishonest act may result in
disciplinary action including immediate dismissal. Any student witnessing or observing a
perceived violation of academic dishonesty is required to report it as is professionally expected.
Students failing to report an observed violation may also receive disciplinary action.
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CONDUCT
The University expects all students to be responsible individuals who possess the highest
standards of integrity, honesty and personal conduct. These traits are prerequisites to
independent learning, professional development, the successful performance of academic and
clinical assignments, and the conduct of one’s personal life. Accordingly, students are expected
to adhere to a standard of behavior consistent with their university’s standards at all times –
both off and on campus. Compliance with institutional rules and regulations, in addition to city,
state and federal laws, is expected. If a student is determined to demonstrate unprofessional
behavior or wear unprofessional or inappropriate attire, he/she may be subject to disciplinary
action per their respective or this university’s policy.
REQUIRED REFERENCES
All materials listed deemed essential to completion of student’s assignments will either be
provided or made accessible to the student within the research center. Removal of these
materials from the research center is not permitted.
REQUEST FOR CONSIDERATION OF AN EXCUSED ABSENCE
Students should provide a written request for absence at least 24 hours or 1 business day prior
to the intended absence, and must receive written approval in order to obtain an excused
absence from rotation. The student may be required to make up the time and exercises that are
missed in order to pass the course.
COPYRIGHT POLICY
KCUMB must respect and observe the right and privileges of copyright holders, obey the United
States Copyright Act and preserve the integrity of its internal network systems. All students must
sign the technology and software use policy. A copy of this policy must be signed and on file
with the Information and Technology Department at outset of rotation.
DRESS CODE
All students are expected to maintain the highest standards of professional appearance at all
times. Students may wear either clean, well-maintained and matching scrubs or appropriate
professional dress. This includes, but is not necessarily limited to business slacks with opencollar shirt for men, and business slacks or skirt with professional shirt or sweater for women.
Jeans may be permissible as allowed by KCUMB policies. Sleeveless shirts, tank tops, low-cut
shirts, short skirts, and non-medical headgear are not permitted. KCUMB student identification
badges should be worn by students at all times. ID badges must be presented when requested
by any member of KCUMB administration, staff or faculty.
KCUMB FACULTY CONTACT INFORMATION
Primary point of contact:
Patrick G. Clay, PharmD, FCCP, CCTI
Office: (816) 283-2336
Mobile: (816) 536-0974
Email: pclay@kcumb.edu
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Secondary point of contact:
Charlott L. Williams, RN, CCRC
Office: (816) 283-2345
Mobile: (816) 616-7775
Email: CWilliams@kcumb.edu