INSTRUCTIONAL DESIGN AND ASSESSMENT
Core Competencies for Research Training in the ClinicalPharmaceutical Sciences
Samuel M. Poloyac, PharmD, PhD, Kerry M. Empey, PharmD, PhD, Lisa C. Rohan, PhD,Susan J. Skledar, MPH, BPharm, Philip E. Empey, PharmD, PhD, Thomas D. Nolin, PharmD, PhD,Robert R. Bies, PharmD, PhD, Robert B. Gibbs, PhD, Maggie Folan, BSN, PhD,and Patricia D. Kroboth, PhD
University of Pittsburgh, School of Pharmacy
Submitted October 15, 2010; accepted November 29, 2010; published March 10, 2011.
Objective. To identify and apply core competencies for training students enrolled in the clinicalpharmaceutical scientist PhD training program at the University of Pittsburgh School of Pharmacy.Design. Faculty members reached consensus on the required core competencies for the program andmapped them to curricular and experiential requirements.Assessment. A rubric was created based on core competencies spanning 8 major categories of pro-ficiency, and competencies of clinical versus traditional PhD training were delineated. A retrospectiveevaluation of the written comprehensive examinations of 12 former students was conducted using therubric. Students scored above satisfactory in 11 out of 14 comprehensive examination metrics, witha mean score greater than 3.8 on a 5-point scale.Conclusions. The core competencies identified will provide an essential foundation for informeddecision-making and assessment of PhD training in the clinical pharmaceutical sciences.
Keywords: graduate education, competencies, clinical research, pharmaceutical sciences, doctor of philosophydegree
INTRODUCTIONClinical pharmaceutical research is essential for the
progression of novel preclinical discoveries into mean-ingful changes in patient care. Scientists with the uniqueskills to integrate basic pharmacology and the clinicalpathogenesis of disease are highly sought in academia andthe pharmaceutical industry. Clinical pharmacologists’ abil-ity to integrate preclinical and clinical evidence as it relatesto drug response is a key factor necessary to reduce both thetime of drug development and the likelihood of late-phasedrug failures.1 As with the pharmaceutical industry, trans-lation of preclinical research discoveries into meaningfultherapeutic interventions has been a major initiative withinacademic settings. The creation of an infrastructure for clin-ical research within academic institutions by the NationalInstitutes of Health (NIH) Clinical and Translational Sci-ence Awards (CTSA) has fueled the need for highly skilledresearchers in the clinical pharmaceutical sciences.
Despite the demand by academia and the pharma-ceutical industry, colleges and schools of pharmacy and
medicine graduate too few researchers with skills in clin-ical pharmaceutical sciences and clinical pharmacology.Pharmaceutical scientists with skills in pharmacoge-netics, pharmacometric modeling and simulation, clinicalpharmacotherapeutics, and pharmaceutics are in shortsupply.1-3 In response to this demand, the number of col-leges and schools of pharmacy offering fellowship training,master’s degrees, and PhD degrees in the clinical pharma-ceutical sciences has grown significantly. In 2006, morethan 40% of colleges or schools either offered or wereplanning to offer PharmD/PhD training programs in thepharmaceutical sciences.4 Fellowship training programsalso have attempted to address the need for more clinicalresearchers. The ideal method to train individuals withthe skills to conduct clinical and translational researchwithin the pharmaceutical sciences has been discussedextensively.5-7 Nevertheless, the relatively small num-ber of trainees produced by all training programs is notmeeting the needs of the research community.
In 2006, the American Association of Colleges ofPharmacy (AACP) appointed an Educating Clinical Sci-entists Task Force to explore how academic pharmacy canincrease the capacity and impact of pharmacy researchersin clinical and translational research. This task force de-veloped several essential policy statements focused on the
Corresponding Author: Samuel M. Poloyac, 807 Salk Hall,School of Pharmacy, University of Pittsburgh, Pittsburgh, PA15261. Tel: 412-624-4595. Fax: 412-383-7436. E-mail:[email protected]
American Journal of Pharmaceutical Education 2011; 75 (2) Article 27.
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education and training of future clinical pharmaceuticalscientists.8 In 2009, a follow-up summit was held with thegoal of reaching a consensus on the common and/or bestpractices among institutions offering clinical pharmaceu-tical scientist PhD training. General agreement wasreached that training individuals to conduct clinical andtranslational research is distinctly different from trainingindividuals with a PharmD degree to conduct traditionalPhD research in the pharmaceutical sciences. In otherwords, the addition of a basic science PhD to a prior PharmDdegree will not result in a scientist with the research skillsnecessary to rapidly initiate a career in clinically-orientedresearch. The summit participants universally agreed thatclinical pharmaceutical scientist training programs needto differentiate and specify the training requirements thatprepare graduates in the distinct discipline of clinical re-search in the pharmaceutical sciences. Furthermore, delin-eation of the specific core competencies for these studentswas deemed necessary to provide guidance for new pro-gram development and to identify the specific skillsattained by individuals completing a PhD in the clinicalpharmaceutical sciences.
Concurrent with the summit meetings, faculty mem-bers at the University of Pittsburgh School of Pharmacyidentified the core competencies for the Clinical Pharma-ceutical Scientist PhD Program. This effort was based onthe need to: (1) identify the specific training requirementsfor PharmD and non-PharmD students entering such pro-grams; (2) determine which courses from the Universityof Pittsburgh’s CTSA educational offerings should be in-cluded as curricular requirements for the program; and (3)increase the clarity of the differences in research trainingoffered by the clinical pharmaceutical sciences versustraditional graduate training. In March 2010, the Univer-sity of Pittsburgh School of Pharmacy finalized the corecompetencies and completed a mapping of these compe-tencies to the specific curricular and experiential offer-ings during training. Presented in this paper are the corecompetencies, the mapping of the competencies to thecurrent curriculum, and a retrospective evaluation of writ-ten comprehensive examinations to assess the utility ofthese competencies in evaluating student outcomes. Theexperiential components of our training program and theiruse in the assessment of programmatic outcomes also arediscussed.
DESIGNThe rationale for developing core competencies was
based on a programmatic need for informed decision-making on several issues, including core course require-ments, admission of non-PharmD students, and experientialrequirements for clinical pharmaceutical scientist students.
Since inception of the Clinical Pharmaceutical ScientistPhD Program at the University of Pittsburgh in the 1980s,34 students have completed PhD degrees and 1 student hascompleted a master’s degree. Of these graduates, 15 enteredthe program with a PharmD degree, 1 entered with a bach-elor of science in nursing (BSN) degree, and 19 entered witha master or bachelor of science degree in pharmacy or an-other science-related discipline. The program had severalinformal requirements for training BS versus PharmD stu-dents; however, consensus on the specific training require-ments for students based on their entry degree could not bereached. An informed group decision could not be madeunless a consensus was reached on the key competenciesexpected of all students within the graduate program regard-less of their training background. Therefore, our goal wasto develop a set of core competencies to guide decision-making processes with respect to curricular and experientialrequirements for the Clinical Pharmaceutical Scientist PhDProgram.
Core competencies were developed using a 3-stepprocess. First, the core competency task force was chargedwith identifying the key competencies necessary forcompletion of the Clinical Pharmaceutical Scientist PhDProgram. The group was asked to develop these compe-tencies without considering the content of currently of-fered courses. Once consensus on the core competencieswas achieved, the group refined and mapped the com-petencies to the current required and elective curricularofferings in the Clinical Pharmaceutical Scientist PhDProgram. The final step was to align the mapped corecompetencies to our previously developed assessmentmatrix of learning outcomes for the entire graduate pro-gram in pharmaceutical sciences.
The final core competencies then were opened forreview and recommendations from all faculty membersprior to implementation and dissemination. Feedback alsowas solicited from several students who had completed theprogram and had taken many of the classes being consideredas requirements for the curriculum. The learning objectivesfor our traditional PhD program and the core competenciesof our Clinical and Translational Science Institute were usedas guides in the development of the core competenciesdescribed.
Eight major categories of core competencies wereidentified (Table 1). Under each category, specific com-petencies were listed. An excerpt of the full core compe-tency document is provided in Figure 1. (The completedocument is available at www.pharmacy.pitt.edu/cps). Thehighest levels of Bloom’s Taxonomy were used to createthese individual competencies at the appropriate level forgraduate training outcomes. Each competency was thenmapped to the curricular and experiential offerings to
American Journal of Pharmaceutical Education 2011; 75 (2) Article 27.
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which it corresponded in the Clinical Pharmaceutical Sci-entist PhD Program.
A significant issue addressed by the core competencydocument was the identification of the elements unique toclinical pharmaceutical scientist PhD training versus tra-ditional PhD training in the pharmaceutical sciences. Theclinical pharmaceutical scientist competencies detail theskills necessary to conduct independent, hypothesis-driven,ethically sound research in humans. This skill set is the keydifferentiator between training in the clinical versus tradi-tional pharmaceutical sciences. Examples of these specificskills include demonstration of the student’s ability to rec-ognize and explain the clinical and public health implica-tions of a given research hypothesis, and the ability toidentify important outcome measures to incorporate intoa patient-oriented clinical trial design. Fifteen clinical phar-maceutical scientist-specific competencies were identified(Table 2).
Within the program, several curricular and experien-tial components are aimed at meeting specific clinicalresearch core competencies. The curricular componentsspecific to the clinical pharmaceutical scientist traininginclude Introduction to Translational Research in theHealth Sciences and Clinical Research Methods. Intro-duction to Translational Research in the Health Sciencesis an interprofessional, graduate level course in whichstudents develop and justify a line of research that canhave a major impact on human health in the next 10 years.This project is completed as an interprofessional groupassignment. The course provides the intellectual frame-work for a career in clinical and translational research.The Clinical Research Methods course, a curricular offer-ing from the educational initiatives of the CTSA awardat the University of Pittsburgh, is aimed at providingstudents with the skills to design, implement, and interpretclinical research. For experiential requirements, studentsin the Clinical Pharmaceutical Scientist PhD Programmust include a human study in at least 1 aim of their writ-ten comprehensive examination. This examination requires
the student to submit a written NIH R01 formatted proposal,followed by an oral defense of that proposal in front of theirgraduate committee. Students also are required to serve asan investigator on an Institutional Review Board submis-sion during graduate studies. Finally, the student’s disser-tation research must include at least 1 chapter that involveshuman research as defined by the National Institutes ofHealth.9 Collectively, these experiential and curricular el-ements provide the foundation to achieve the identifiedcompetencies of the Clinical Pharmaceutical Scientist PhDProgram. As we move forward with these identified corecompetencies, our intent is to assess the entire curriculumand experiences to ensure the desired outcomes.
EVALUATION AND ASSESSMENTTo use the core competencies for assessment pur-
poses, we developed a rubric for the comprehensive ex-amination (Appendix 1). Fourteen core competencieswere associated with the comprehensive examination,6 of which were specific to the clinical pharmaceuticalscientist PhD. The goal of this assessment was to identifyhow many of these 14 core competencies were met by pastwritten examinations, and to identify areas of strengthsand weaknesses in our past written proposals. To accom-plish this goal, we obtained the written comprehensiveexaminations of 12 previous clinical pharmaceutical sci-ence graduate students. These 12 proposals were selectedbased on the availability of the written documents fromthe students who had most recently successfully completedthe Clinical Pharmaceutical Scientist PhD Program. Twofaculty members graded each of the 12 comprehensiveexaminations, which yielded 24 assessments. All of theexaminations were de-identified prior to grading. The ex-aminations were graded on a scale of 5 (excellent) to 1(unsatisfactory) for each of the competencies. The averagescores for each competency were determined and the per-centage of examinations receiving an average score of lessthan 3 (satisfactory) also was determined. The results areprovided in Table 3.
The majority of the core competencies for the writtencomprehensive examination were achieved (Table 3).Eleven of the 14 competencies were met by the majorityof students and had mean scores greater than 3.8 on a5-point scale. Three areas in which students were notconsistently meeting the new competencies were identi-fied. Two of these were related to human rights protectionand subject recruiting: (1) develop appropriate methodsto recruit and retain study participants for the selectedresearch design, and (2) demonstrate knowledge of thestandards of professional and ethical conduct establishedto guide researchers in protecting the rights, well-being,and dignity in the recruitment and retention of human
Table 1. Eight Major Categories of Core Competencies
Literature Review and EvaluationHypothesis GenerationResearch Methods and Study DesignStatistical Methods and Data EvaluationGrantsmanshipPresentation and Delivery of Oral and Written Scientific
InformationScientific Leadership, Management, and Cross-Disciplinary
TeamworkEthical Conduct of Research
American Journal of Pharmaceutical Education 2011; 75 (2) Article 27.
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Figure 1. Example of the University of Pittsburgh Clinical Pharmaceutical Scientist Core Competency Grid with curricular andexperiential mapping. The asterisks indicate clinical pharmaceutical scientist PhD-specific competencies. Competencies notmarked with asterisks represent general skills to be acquired by all pharmaceutical sciences graduate students. (www.pharmacy.pitt.edu/cps.)
American Journal of Pharmaceutical Education 2011; 75 (2) Article 27.
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subjects in clinical research. Although these competen-cies were being addressed in other portions of the curric-ulum, we thought that these competencies should beaddressed by the capstone comprehensive examination.Therefore, the guidelines for comprehensive proposalsnow emphasize that the human rights protections sectionis included (as described by NIH guidelines).10 Emphasisof this section ensures that this competency will beassessed as part of our comprehensive examination pro-cess in the future.
The third competency that was not being met fullywas the evaluation of possible problems in design andexecution of a study in the pharmaceutical sciences. Al-though this competency was being addressed in the oraldefense of the written proposal, the evaluation revealedthat several proposals failed to include a specific sectiondetailing the potential limitations of the proposed work.Therefore, the guidelines for the comprehensive exami-nation now specify that the written proposals include asubsection covering potential limitations after discussingthe anticipated results to ensure that this competency isbeing addressed. The comprehensive examination rubricnow is made available to graduate students to provide ad-ditional, previously undisclosed, guidance as they prepare
for this capstone assessment. We intend to use a similaron-going assessment approach to evaluate all curricularand experiential requirements and adjust content asneeded to ensure achievement of these competencies.
DISCUSSIONIn this manuscript we describe the core competencies
for clinical pharmaceutical scientist training developedat the University of Pittsburgh. It is our intent that thesecompetencies can be used to guide faculty members andothers to ensure that the quality, consistency, and expec-tations of training are being met through curricular andexperiential requirements. Specifically, the core compe-tencies will be used to develop methods to assess bothcurricular and experiential components of our ClinicalPharmaceutical Scientist PhD Program. Externally, thecompetency document will help clarify previously unre-solved questions about clinical pharmaceutical scientisttraining. For example, the 2009 Summit on Clinical Phar-maceutical Scientists Training Programs concluded thattraining a PharmD to do traditional PhD research in thepharmaceutical sciences differs from specific training inthe clinical pharmaceutical sciences. While the positiongenerally was agreed upon, a description of specific clinical
Table 2. Specific Competencies for Clinical Pharmaceutical Scientists
Literature Review and EvaluationDescribe the current state of knowledge about a biomedical, clinical, or public health problem.
Hypothesis GenerationDefend the clinical and public health implications of a given research hypothesis.
Research Design and MethodsDevelop appropriate methods to recruit and retain study participants for a selected research design.Identify important outcome measures for incorporation into patient-oriented clinical trial design.Generate a plan for data security/management.Identify barriers in translating research discoveries into meaningful changes in human health.Develop an approach to overcome barriers in translating research to humans.Design appropriate, ethically sound, and hypothesis-driven clinical studies.
Statistical Methods and Data EvaluationSelect the appropriate statistical approach for the interpretation of preclinical and clinical datasets.Define bias in clinical and translational research.
GrantsmanshipIdentify federal and non-federal agencies and programmatic initiatives aimed at translating research to clinical care of patients.Defend a written research proposal that describes specific research aims, significance, innovation, and approach for a human
clinical trial.Preparation and Delivery of Oral and Written Scientific Information
Assess the clinical implications of scientific information.Scientific Leadership, Management, and Cross-Disciplinary Teamwork
Develop a therapeutic protocol/guideline for medication-related issues or management.Ethical Conduct of Research
Demonstrate knowledge of the standards of professional and ethical conduct established to guide researchers in protecting therights, well-being, and dignity in the recruitment and retainment of human subjects in clinical research.
Give examples of the informed consent process including an understanding of the risk/benefit criteria and its impact onthe patient/volunteer.
American Journal of Pharmaceutical Education 2011; 75 (2) Article 27.
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pharmaceutical science core competencies had not beenpreviously delineated. As a result, the lines have becomeblurred regarding what constitutes clinical pharmaceuti-cal scientist training. It is our intent to use these core com-petencies as a guide to define which specific courses andexperiences clearly differentiate clinical pharmaceuticalscientist training. Such information will be useful for otherschools of pharmacy as a guide for the development of com-petencies associated with new training programs at theirinstitutions. This information also may prove valuable torefine educational initiatives associated with CTSA andother clinical research educational initiatives.
Another issue raised at the 2009 Summit was the needto train both pharmacists and nonpharmacists in the clin-ical pharmaceutical sciences. In order to have a significantimpact on clinical research and secure support for suchprograms, colleges and schools of pharmacy need to trainboth PharmD and nonPharmD students in the clinicalpharmaceutical sciences. Although there is general con-sensus on this issue, the specific curricular and experien-tial requirements for a student entering our program withor without a PharmD degree were not clearly detailed.Because the developed core competencies apply to allstudents in the clinical pharmaceutical sciences, the com-
petencies will provide a framework for informed decision-making about the curricular and experiential requirementsnecessary to train all students entering the program regard-less of the entry-level degree earned.
SUMMARYCore competencies were developed for graduate
training in the Clinical Pharmaceutical Scientist PhD Pro-gram at the University of Pittsburgh School of Pharmacy.We describe the use of these competencies for rubric de-velopment and assessment of our capstone written compre-hensive examination. Through this process, we identifiedareas for improvement in our comprehensive examinationprocess, thereby developing additional guidelines to ensurethat all competencies are addressed. In addition, develop-ment of these competencies has allowed the specific skillsthat differentiate training in the clinical pharmaceuticalsciences from traditional pharmaceutical science PhDtraining to be defined.
ACKNOWLEDGMENTSThe project described was supported by Award Num-
ber KL2 RR024154 (KME, PEE) from the National Center
Table 3. Outcomes of the Written Comprehensive Examination Assessment Using the Core Competency Rubric
CompetencyMean Score(1 to 5 Scale)
ExaminationsAchieving
Score . 3, %
Extract literature from appropriate bibliographic sources. 4.6 100Critique clinical and scientific evidence derived from literature. 4.5 100Generate a relevant biomedical, clinical, public health, or translational
research hypothesis.4.3 100
Defend the clinical and public health implications of a given research hypothesis. 4.0 92Design appropriate experiments to address generated research questions in the
pharmaceutical sciences.4.3 100
Evaluate possible problems in the design and execution of a study in thepharmaceutical sciences.
3.0 50
Develop appropriate methods to recruit and retain study participants for aselected research design.
2.9 67
Identify important outcome measures for incorporation into patient-orientedclinical trial design.
3.8 92
Design appropriate, ethically sound, and hypothesis-driven clinical studies. 4.3 100Apply fundamental principles of statistical analysis, such as power analysis,
correlation, causation, regression, and summary statistics.4.3 92
Select the appropriate statistical approach for the interpretation of preclinicaland clinical datasets.
4.2 92
Develop appropriate conclusions based on results from research data. 4.0 92Assess the clinical implications of scientific information. 4.2 100Demonstrate knowledge of the standards of professional and ethical conduct
established to guide researchers in protecting the rights, well-being, anddignity in the recruitment and retention of human subjects in clinical research.
3.1 64
American Journal of Pharmaceutical Education 2011; 75 (2) Article 27.
6
for Research Resources. The content is solely the respon-sibility of the authors and does not necessarily representthe official views of the National Center for ResearchResources or the National Institutes of Health.
REFERENCES1. Honig P, Lalonde R. The economics of drug development: a grimreality and a role for clinical pharmacology. Clin Pharmacol Ther.2010;87(3):247-251.2. Fitzgerald GA. Opinion: anticipating change in drug development:the emerging era of translational medicine and therapeutics. Nat RevDrug Discov. 2005;4(10):815-818.3. Aronson JK, Barnett DB, Breckenridge AM, et al. The UK’s NHSand pharma: need for more clinical pharmacologists. Lancet.2009;373(9671):1251-1252.4. Gourley DR, Rowell C, Wingate L, et al. Status of PharmD/PhDprograms in colleges of pharmacy: the University of Tennessee dualPharmD/PhD program. Am J Pharm Educ. 2006;70(2):Article 44.
5. Dowling TC, Murphy JE, Kalus JS, et al. Recommended educationfor pharmacists as competitive clinical scientists. Pharmacotherapy.2009;29(2):236-244.6. Blouin RA, Pollack GM. Training clinical pharmaceuticalscientists in today’s highly competitive times: it’s time to commit tochange. Pharmacotherapy. 2009;29(2);6-7.7. Bauman JL, Evans WE. PharmD-only investigators are critical to theprofession: let’s preserve the fellowship as an equally important wayto prepare future clinical pharmaceutical scientists: or the case againstthe ‘‘all-PhD.’’ Pharmacotherapy. 2009;29(2):129-133.8. Blouin RA, Bergstrom RF, Ellingrod VL, et al. Report of the AACPeducating clinical scientists task force. Am J Pharm Educ. 2007;71(4):S05.9. Translational Research. National Institutes of Health. Division ofProgram Coordination, Planning, and Strategic Initiatives. http://nihroadmap.nih.gov/clinicalresearch/overview-translational.aspAccessed March 8, 2011.10. Research Involving Human Subjects. Office of ExtramuralResearch, National Institutes of Health. http://grants.nih.gov/grants/policy/hs/ Accessed March 8, 2011.
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clin
ical
stu
die
s.T
he
pro
po
sed
rese
arch
iset
hic
ally
sou
nd
and
app
rop
riat
eT
he
eth
ics
of
the
rese
arch
wer
eco
nsi
der
edb
ut
no
tfu
lly
just
ified
Th
eet
hic
so
fth
ep
rop
ose
dre
sear
chw
ere
no
tad
equ
atel
yco
nsi
der
ed
Sco
re(5
-1)/
Co
mm
ents
:
Ap
ply
fun
dam
enta
lp
rin
cip
les
of
stat
isti
cal
anal
ysi
s,su
chas
po
wer
anal
ysi
s,co
rrel
atio
n,
cau
sati
on
,re
gre
ssio
n,
and
sum
mar
yst
atis
tics
.
An
app
rop
riat
est
atis
tica
lp
ow
eran
aly
sis
and
app
roac
hw
asd
evel
op
edan
dju
stifi
ed
Sta
tist
ical
po
wer
and
app
roac
hto
anal
ysi
sw
asp
rese
nte
dw
ith
som
efl
aws
inu
nd
erst
and
ing
Th
est
atis
tica
lp
ow
eran
dap
pro
ach
wer
eei
ther
no
tp
rese
nte
do
rw
ere
ver
yp
oo
rly
just
ified
Sco
re(5
-1)/
Co
mm
ents
:
Sel
ect
the
app
rop
riat
est
atis
tica
lap
pro
ach
for
the
inte
rpre
tati
on
of
pre
clin
ical
and
clin
ical
dat
aset
s.
Stu
den
tse
lect
edan
dap
pro
pri
atel
yju
stifi
edth
ese
lect
edst
atis
tica
lap
pro
ach
So
me
bu
tn
ot
all
of
the
pro
po
sed
stat
isti
csw
ere
app
rop
riat
ely
sele
cted
and
/or
just
ified
Sig
nifi
can
tfl
aws
inth
ese
lect
edst
atis
tics
wit
ha
po
or
just
ifica
tio
nan
du
nd
erst
and
ing
of
rati
on
ale
for
sele
ctio
n
Sco
re(5
-1)/
Co
mm
ents
:
Dev
elo
pap
pro
pri
ate
con
clu
sio
ns
bas
edo
nre
sult
sfr
om
rese
arch
dat
a.T
he
anti
cip
ated
resu
lts
wer
eap
pro
pri
ate
and
wel
ld
evel
op
edT
he
anti
cip
ated
resu
lts
wer
eg
ener
ally
accu
rate
wit
hso
me
flaw
sin
just
ifica
tio
n
Th
ean
tici
pat
edre
sult
sw
ere
eith
ern
ot
pre
sen
ted
or
wer
ep
oo
rly
just
ified
Sco
re(5
-1)/
Co
mm
ents
:
Ass
ess
the
clin
ical
imp
lica
tio
ns
of
scie
nti
fic
info
rmat
ion
.T
he
stu
den
tw
rote
and
clea
rly
def
end
edth
eim
po
rtan
ceo
fth
ere
sear
chq
ues
tio
nas
itre
late
sto
the
curr
ent
stat
eo
fcl
inic
alp
ract
ice
Th
est
ud
ent
stat
edth
eim
po
rtan
ceo
fth
eq
ues
tio
nw
ith
resp
ect
tocl
inic
alp
ract
ice,
bu
td
idn
ot
clea
rly
stat
e/d
efen
dth
ed
irec
tre
lev
ance
Th
est
ud
ent
did
no
tcl
earl
yst
ate
or
def
end
the
imp
ort
ance
of
the
pro
po
sed
aim
sto
clin
ical
pra
ctic
e
Sco
re(5
-1)/
Co
mm
ents
:
Dem
on
stra
tek
no
wle
dg
eo
fth
est
and
ard
so
fp
rofe
ssio
nal
and
eth
ical
con
du
ctes
tab
lish
edto
gu
ide
rese
arch
ers
inp
rote
ctin
gth
eri
gh
ts,
wel
l-b
ein
g,
and
dig
nit
yin
the
recr
uit
men
tan
dre
ten
tio
no
fh
um
ansu
bje
cts
incl
inic
alre
sear
ch.
Stu
den
tin
clu
ded
ath
oro
ug
h,
wel
l-d
escr
ibed
hu
man
pro
tect
ion
sse
ctio
n
Stu
den
tin
clu
ded
ah
um
anp
rote
ctio
nse
ctio
nth
atw
asn
ot
full
yd
evel
op
ed
Th
est
ud
ent
did
no
tin
clu
de
ah
um
anp
rote
ctio
ns
sect
ion
Sco
re(5
-1)/
Co
mm
ents
:
American Journal of Pharmaceutical Education 2011; 75 (2) Article 27.
9