Clinical Research Training Program Course Descriptions
Clinical Research Training Program Class Schedule
(Taken for Credit)
The clinical research methods courses are designed primarily for clinical research project managers, residents, fellows, and faculty interested in careers as clinical research collaborators.Non-Degree, Non-Credit Clinical Research Training Program Course Descriptions
Clinical Research Training Program Class Schedule
These clinical research methods courses are designed for and may be taken by residents and fellows with appointments in UPHS-affiliated hospitals who are interested in careers as clinical research collaborators.
To register for the courses listed below, please go to the Certificate Program Registration page and fill out the registration form.
Enrollment limits have been established for these courses. First priority for enrollment will be granted to School of Medicine residents, fellows, postdoctoral students, and faculty, then to trainees and faculty from other health schools as long as a registration request has been received at least two weeks in advance of registration from those individuals. All others will be enrolled on a first-come, first-served basis.
For questions/problems about course registration and/or additional information about the courses listed below, please contact Anna Nagy (215-898-7946, nagya@mail.med.upenn.edu). Please also contact Ms. Nagy if you are interested in other clinical research training opportunities.
CLINICAL RESEARCH TRAINING PROGRAM COURSE DESCRIPTIONS (Taken for Credit)
Fundamentals of Epidemiologic Study Designs (EP 801)
Fall Semester
Wednesdays, 3:00 p.m. to 5:00p.m.
0.5 course units
Course Director: Gregory Bisson, MD, MSCE
This course is a series of lectures designed to teach basic principles of epidemiologic research design. Lectures include the following topics: definitions of epidemiology; measures of disease frequency; measures of effect and association; epidemiologic study designs, both experimental and non-experimental; and an overview of analysis of epidemiologic studies.
This course satisfies the research methods requirement for the Certificate Program.
Fundamentals of Biostatistics in Practice (EP 802)
Spring Semester
Thursdays, 4:00 p.m. to 6:00 p.m.
0.5 course units
Course Director: Jason Roy, PhD
This course is designed for collaborative researchers and will provide an overview of the fundamental concepts of biostatistics. Topics covered include descriptive statistics, confidence intervals, and parametric and nonparametric hypothesis testing. Emphasis is placed on the proper selection and application of statistical methods appropriate to clinical data.
This course satisfies the biostatistics requirement for the Certificate Program.
Biostatistics in Practice (EP 803)
Spring Semester
Thursdays, 4:00 p.m. to 7:00 p.m.
1 course unit
Course Director: Jason Roy, PhD
This course is designed for collaborative researchers and will provide an overview of the fundamental concepts of biostatistics. Topics covered include descriptive statistics, confidence intervals, and parametric and nonparametric hypothesis testing.
The course includes an optional laboratory session demonstrating the use of statistical analysis software to carry out tests discussed in the lecture. Emphasis in this course is placed on understanding data properties and test selection appropriate to clinical research.
This course satisfies the biostatistics requirement for the Certificate Program.
Practical Applications in Clinical Research Methods (EP 805)
Fall Semester
Thursdays, 5:15 p.m. to 8:15 p.m.
1 course unit
Course Director: John Holmes, PhD
This course, designed especially for those interested in collaborative research, is a series of lectures and seminars designed to introduce students to concepts and issues in data collection and database management, protocol development, regulatory affairs, and research ethics.
This course satisfies the practical applications requirement as well as the scientific and ethical conduct requirement for the Certificate Program.
Critical Appraisal of the Medical Literature (EP 806)
Spring Semester
Mondays, 3:00 p.m. to 4:30 p.m.
0.5 course units
Course Director: Craig A. Umscheid, MD, MSCE
This seminar focuses on techniques for critical appraisal of the medical literature. Each student will be responsible for at least one critical appraisal session covering different epidemiologic topics (including the evaluation of RCTs, observational studies, diagnostic tests, qualitative research, meta-analyses, guidelines, and economic analyses). For his/her session, each student will critically appraise a journal article and lead the discussion concerning that article.
Introduction to Epidemiologic Research Methods (EP 811)
Summer Session I (July 16 through July 27, 2012)
Time: Daily, 1:00 p.m. to 3:00 p.m. (intensive short course)
0.5 course units
Course Director: John Holmes, PhD
This course is a series of lectures introducing basic principles of epidemiologic research design. Lectures include the following topics: definitions of epidemiology; measures of disease frequency; measures of effect and association; epidemiologic study designs, both experimental and non-experimental; data collection methods; and an overview of analysis of epidemiologic studies.
This course satisfies the research methods requirement for the Certificate Program.
Fundamentals of Biostatistics (EP 812)
Summer Session II (July 30 through August 10, 2012)
Time: Daily, 8:00 a.m. to 10:00 a.m.; T, Th, 1:00 p.m. to 2:30 p.m. (intensive short course)
0.5 course units
Course Director: TBA
This course is designed for collaborative researchers and will provide an overview of the fundamental concepts of biostatistics for those unfamiliar with statistical analysis. Topics covered include descriptive statistics, confidence intervals, and parametric and nonparametric hypothesis testing. Emphasis is placed on the proper selection and application of statistical methods appropriate to clinical data and will include exercises using STATA to organize and analyze data.
This course satisfies the biostatistics requirement for the Certificate Program.
Database Management (EP 814)
Summer Session I (July 16 through July 27, 2012)
Time: Daily, 9:00 a.m. to 11:00 a.m. (intensive short course)
0.5 course units
Course Director: John Holmes, PhD
This course focuses on the practical issues of database management and provides students with an introduction to the techniques of data collection and database management as they apply to clinical research. Students learn how to design and implement computerized databases, perform basic query and reporting operations, migrate data between various file formats, prepare databases for statistical analysis, and perform quality assurance procedures. Two to three hours of work outside of class are required each day.
This course satisfies the practical applications requirement for the Certificate Program.
Clinical Trials and Translational Research (EP 815)
Summer Session II (July 30 through August 10, 2012)
Time: Daily, 10:15 a.m. to 12:15 p.m. (intensive short course)
0.5 course units
Course Director: Angela DeMichele, MD, MSCE
This course will cover methods in the design, conduct, and reporting of clinical trials. Topics to be covered include: study design and biostatistical considerations specific to drug development (with particular emphasis on cancer research); research ethics; regulatory and monitoring issues; data management; and methods for the incorporation of biological endpoints into clinical trial design/implementation. A primer on publishing results is also provided.
This course satisfies the practical applications requirement as well as the scientific and ethical conduct requirement for the Certificate Program.
Economic Evaluation of Medical Therapies (EP 816)
Not offered in 2011
0.5 course units
Course Director: Henry Glick, PhD
This course introduces students to cost-effectiveness analysis by use of decision trees and Markov models. Skills development will focus on the ability to: 1) construct a basic decision tree and Markov model; 2) populate these models with probabilities, costs, and QALYs; and 3) analyze these models. Students should expect 1-2 hours of readings/homework per day.
Fundamentals of Pharmacoepidemiology (EP 817)
Not offered in 2011
0.5 course units
Course Directors: Brian L. Strom, MD, MPH and Sean Hennessy, PharmD, PhD
This course is a series of lectures and workshops, designed to teach basic principles of pharmacoepidemiologic research design. Lectures include the following topics: definitions of pharmacoepidemiology; drug exposure; adverse drug events; case reports; sources of pharmacoepidemiology data; and sources of bias and confounding in pharmacoepidemiology.
Survey of Additional Topics in Biostatistics (EP 822)
Not offered in 2011
0.5 course units
Course Director: Seema Sonnad, PhD
This course serves as an introduction to statistical topics and methods important to clinical research that are not covered or are covered only briefly in EPID 802/803 and EPID 812. Students are exposed to an overview of: ANOVA and repeated measures designs, logistic regression, survival analysis, the log rank test and Cox proportional hazards regression, Bayesian methods, meta-analysis, ROC curves, and measurement of association. This course does not include a lab, so participants are not expected to learn how to perform the analyses covered in this class. Rather, the focus is on understanding the presentation of these materials in the literature and recognizing when these methods are applicable. Prerequisite: an introductory course covering fundamental concepts in biostatistics.
Fundamentals of Medical Research I: Epidemiologic Study Designs
Fall Semester
Wednesdays, 3:00p.m. to 5:00 p.m.
0.5 course units
Course Director: Gregory Bisson, MD, MSCE
This course is a series of lectures introducing basic principles of epidemiologic research design. Lectures include the following topics: definitions of epidemiology; measures of disease frequency; measures of effect and association; epidemiologic study designs, both experimental and non-experimental; and an overview of analysis of epidemiologic studies.
This course satisfies the research methods requirement for the Certificate Program.
Fundamentals of Biostatistics in Practice
Spring Semester
Thursdays, 4:00 to 6:00 p.m.
0.5 course units
Course Director: Jason Roy, PhD
This course is designed for collaborative researchers and will provide an overview of the fundamental concepts of biostatistics for those unfamiliar with statistical analysis. Topics covered include descriptive statistics, confidence intervals, and parametric and nonparametric hypothesis testing. Emphasis is placed on the proper selection and application of statistical methods appropriate to clinical data.
This course satisfies the biostatistics requirement for the Certificate Program.
Fundamentals of Medical Research II: Biostatistics in Practice
Spring Semester
Thursdays, 4:00 to 7:00 p.m.
1 course unit
Course Director: Jason Roy, PhD
This course is designed for collaborative researchers and will provide an overview of the fundamental concepts of biostatistics. Topics covered include descriptive statistics, confidence intervals, and parametric and nonparametric hypothesis testing.
The course includes an optional laboratory session demonstrating the use of statistical analysis software to carry out tests discussed in the lecture. Emphasis in this course is placed on understanding data properties and test selection appropriate to clinical research.
This course satisfies the biostatistics requirement for the Certificate Program.
Practical Applications in Clinical Research Methods
Fall Semester
Thursdays, 5:15 to 8:15 p.m.
1 course unit
Course Director: John Holmes, PhD
This course, designed especially for those interested in collaborative research, is a series of lectures and seminars designed to introduce students to concepts and issues in data collection and database management, protocol development, regulatory affairs, and research ethics.
This course satisfies the practical applications requirement as well as the scientific and ethical conduct requirement for the Certificate Program.
Fundamentals of Medical Research III: Critical Appraisal of the Medical Literature
Spring Semester
Mondays, 4:00 to 5:30 p.m.
0.5 course units
Course Director: Richard Aplenc, MD, MSCE
This seminar focuses on techniques for critical appraisal of the medical literature. Each student will be responsible for at least one critical appraisal session covering different epidemiologic topics (including the evaluation of diagnostic tests, clinical course and prognosis of disease, disease etiology, therapy, quality of clinical care, economic evaluation, and meta-analysis). For his/her session, each student will critically appraise a journal article and lead the discussion concerning that article.
Introduction to Epidemiologic Research Methods
Summer Session I (July 16 through July 27, 2012)
Time: Daily, 1:00 p.m. to 3:00 p.m. (intensive short course)
0.5 course units
Course Director: John Holmes, PhD
This course is a series of lectures introducing basic principles of epidemiologic research design. Lectures include the following topics: definitions of epidemiology; measures of disease frequency; measures of effect and association; epidemiologic study designs, both experimental and non-experimental; data collection methods; and an overview of analysis of epidemiologic studies.
This course satisfies the research methods requirement for the Certificate Program.
Fundamentals of Biostatistics
Summer Session II (July 30 through August 10, 2012)
Time: Daily, 8:00 a.m. to 10:00 a.m.; T, Th, 1:00 p.m. to 2:30 p.m. (intensive short course)
0.5 course units
Course Director: TBA
This course is designed for collaborative researchers and will provide an overview of the fundamental concepts of biostatistics. Topics covered include descriptive statistics, confidence intervals, and parametric and nonparametric hypothesis testing. Emphasis is placed on the proper selection and application of statistical methods appropriate to clinical data and will include exercises using STATA to organize and analyze data.
This course satisfies the biostatistics requirement for the Certificate Program.
Database Management
Summer Session I (July 16 through July 27, 2012)
Time: Daily, 9:00 a.m. to 11:00 a.m. (intensive short course)
0.5 course units
Course Director: John Holmes, PhD
This course focuses on the practical issues of database management and provides students with an introduction to the techniques of data collection and database management as they apply to clinical research. Students learn how to design and implement computerized databases, perform basic query and reporting operations, migrate data between various file formats, prepare databases for statistical analysis, and perform quality assurance procedures. Two to three hours of work outside of class are required each day.
This course satisfies the practical applications requirement for the Certificate Program.
Clinical Trials and Translational Research
Summer Session II (July 30 through August 10, 2012)
Time: Daily, 10:15 a.m. to 12:15 p.m. (intensive short course)
0.5 course units
Course Director: Angela DeMichele, MD, MSCE
This course will cover methods in the design, conduct, and reporting of clinical trials. Topics to be covered include: study design and biostatistical considerations specific to drug development (with particular emphasis on cancer research); research ethics; regulatory and monitoring issues; data management; and methods for the incorporation of biological endpoints into clinical trial design/implementation. A primer on publishing results is also provided.
This course satisfies the practical applications requirement as well as the scientific and ethical conduct requirement for the Certificate Program.
Economic Evaluation of Medical Therapies
Not offered in 2012
0.5 course units
Course Director: Henry Glick, PhD
This course introduces students to cost-effectiveness analysis by use of decision trees and Markov models. Skills development will focus on the ability to: 1) construct a basic decision tree and Markov model; 2) populate these models with probabilities, costs, and QALYs; and 3) analyze these models. Students should expect 1-2 hours of readings/homework per day.
Fundamentals of Pharmacoepidemiology
Not offered in 2012
0.5 course units
Course Directors: Brian L. Strom, MD, MPH and Sean Hennessy, PharmD, PhD
This course is a series of lectures and workshops, designed to teach basic principles of pharmacoepidemiologic research design. Lectures include the following topics: definitions of pharmacoepidemiology; drug exposure; adverse drug events; case reports; sources of pharmacoepidemiology data; and sources of bias and confounding in pharmacoepidemiology.
Survey of Additional Topics in Biostatistics
Not offered in 2012
0.5 course units
Course Director: Seema Sonnad, PhD
This course serves as an introduction to statistical topics and methods important to clinical research that are not covered or are covered only briefly in EPID 802/803 and EPID 812. Students are exposed to an overview of: ANOVA and repeated measures designs, logistic regression, survival analysis, the log rank test and Cox proportional hazards regression, Bayesian methods, meta-analysis, ROC curves, and measurement of association. This course does not include a lab, so participants are not expected to learn how to perform the analyses covered in this class. Rather, the focus is on understanding the presentation of these materials in the literature and recognizing when these methods are applicable. Prerequisite: an introductory course covering fundamental concepts in biostatistics.
