CLINICAL PHARMACOLOGY FELLOWS

Outline of Goals, Requirements, and Educational Opportunities

(updated 11/07/2016)

OVERVIEW

The Clinical Pharmacology Fellowship training period is usually two years and is weighted towards learning through mentored research. In addition, formal coursework and directed learning provide education in core skills – the weighting of these can be individualized to suit your career path.  Each fellow has an individual vocational trajectory; therefore, more traditional (typically PhD) lab-based postdoc trainees are encouraged to utilize Vanderbilt’s clinical research resources, while clinically trained individuals should in turn become familiar with relevant basic science research concepts.  The past training, career goals and necessary skills varies tremendously across fellows - it is important that each fellow proactively directs his or her training and creates an Individual Development Plan (IDP).  The Fellowship program is directed by Dr. C. Michael Stein (see contacts section) - please feel free to approach him with career, educational or other questions.

Importantly, fellows obtaining training in clinical pharmacology (this includes all the T32 fellows and anyone intending to write the Boards in Clinical Pharmacology) must attend the majority of educational programs and obtain education in all elements of the Core Curriculum described later.  Those wishing to write for the Clinical Pharmacology Board exam must provide an annual written report summarizing their educational progress (detailed herein).

Formal teaching is provided through several resources. The most important are as follows:

A weekly Clinical Pharmacology Grand Rounds. External speakers, faculty and fellows present research or topics that are of interest to clinical pharmacologists. All fellows are expected to attend.

A weekly Fellows Conference.  This is arranged by the Chief Fellow and includes journal clubs, formal lectures by faculty/fellows, biostatistics lectures, and faculty roadshow lectures where faculty give the talks they have recently been invited to deliver at other institutions.  All fellows are expected to attend.

Formal courses – some are provided by the Division of Clinical Pharmacology and the Department of Pharmacology, while others are provided by the Vanderbilt MSCI Program, the Vanderbilt Clinical Research Center (i.e., CRC), and the National Institutes of Health.  Specifically, the courses required of fellows includes:

Research Ethics and IRB Processes
This course covers ethics of research, protection of human subjects, protection of privacy, responsibilities of an investigator, the role and function of the IRB, and data safety monitoring.
Biostatistics and Study Design
This course includes study design, basic statistical methods (parametric and non-parametric), common statistical errors, data presentation, and hands on use of SPSS or a similar package.
Drug Regulation and Development (MSCI)
Covers history of the FDA, the new drug application and approval process, the FDA Advisory Committee process, drug discovery, biomarkers and outcome measures, intellectual property issues, preclinical testing and early clinical development.
Pharmacokinetics/Pharmacodynamics (Pharmacology)

Covers absorption, metabolism and excretion, basic pharmacokinetic calculations, effect of variation in drug metabolizing enzymes and transporters and pharmacogenetics.

The “Principles of Clinical Pharmacology” Course (NIH).  Online course that has a weekly series that covers the fundamentals of clinical pharmacology. http://clinicalcenter.nih.gov/training/training/principles1.html

Vanderbilt provides a rich postgraduate education experience and fellows should check online and attend lectures relevant to career enhancement.  Regular attendance at prearranged seminar series (e.g., grand rounds) will strengthen the fellow’s educational experience at Vanderbilt.  A useful, weekly calendar is provided on the Department of Medicine’s website:  http://medicine.mc.vanderbilt.edu and https://medapps.mc.vanderbilt.edu/bmss/.

A weekly lecture series run by the CRC that covers a range of clinical research topics.  To register for email reminders or view the calendar go to http://www.mc.vanderbilt.edu/crc/workshop.html.

Also, see the Clinical Research Education Lecture schedule on STARBRITE https://starbrite.vanderbilt.edu/education/schedule.html.

The fellows research “Bootcamp,” arranged by the Division of Clinical Pharmacology, includes a 3-4 hour Saturday morning immersion experience for new fellows.  This is particularly focused on Clinical Pharmacology Fellows; however, is open to other institutional fellows at Vanderbilt.  This “Bootcamp” will occur from time to time, but at minimum during the beginning of each academic year (i.e., September), with a focus on training to jumpstart your research.  Example topics include: Choosing your mentor and project, Introduction to IRB and human subjects research, How to start a clinical research project at Vanderbilt; Creating a database - BioVU and the Synthetic Derivative, and Calculating sample size.     

GOAL

The overall goal of the Clinical Pharmacology Fellowship program is to achieve excellence in clinical pharmacology education through mentored research, structured teaching, and self-guided instruction.

EXPECTATIONS OF FELLOWS

Although the Clinical Pharmacology Fellowship is structured around research that is directly supervised by each individual’s mentor, there are several programmatic expectations of fellows:

  • To acquire fundamental research skills through mentored research.
  • To attain competence in the areas outlined by the Clinical Pharmacology Core Knowledge (see attached document) through self-study, as well as structured and informal instruction.
  • To attend all Clinical Pharmacology Grand Rounds.
  • To attend all Fellow Conferences.
  • To develop a portfolio of scholarly work including, published manuscripts, research-based posters, attendance and presentation at national/international meetings, and formal Divisional presentations (from time to time at Clinical Pharmacology Grand Rounds/Fellows Conference).
  • To actively contribute to the success of the Program.
  • To continue to carry and spread the fundamentals of clinical pharmacology with you in your future individual career path.

CORE KNOWLEDGE-BASE

Key skills and knowledge that are integral to clinical pharmacology have been identified, and these are listed below with an outline of resources available to enable Fellows to obtain the required training.  The Core Competencies defined by the CTSA Clinical and Translational Research Groups are attached at the end of this document, and also provide us with an educational framework for research.  These core competencies (www.nationalpostdoc.org) include, scientific knowledge, research skills, communication skills, professionalism, leadership and management, and responsible conduct of research.

For clinical pharmacologists we have identified the following key knowledge objectives:

1. Research Ethics, Responsible Conduct of Research, and the IRB processes

Covers ethics of research, protection of human subjects, research involving animals, protection of privacy, responsibilities of an investigator, data management, the role and function of the Institutional Review Board (IRB), data safety monitoring, conflict of interest, peer review, mentor/trainee relationships and responsibilities, responsible authorship, research misconduct.  All investigators participating in IRB governed research must complete IRB education and be certified before starting clinical research (http://www.mc.vanderbilt.edu/irb/).  In addition to ethics training, trainees should become familiar with the requirements for approval for their type of research and how to apply for these (i.e., how to complete an IRB application).  Holly Waldrop, who handles many of the IRB applications for the Division, provides a bi-annual one hour introduction to the IRB: all fellows who deal with human research subjects must attend.  Training in responsible conduct of research is an integral and essential part of the training program.

Resources

A.  Fellows Bootcamp

The idea for a fellows bootcamp grew out of a need for a focused program directed at new fellows to immerse them in the opportunities at Vanderbilt University and fundamental information needed to be successful conducting research and interacting with colleagues.

B. Fellows’ Conference Series

In the Fellows Conferences we will discuss many issues related to responsible conduct of research - both in the   discussion of study design, data presentation, and interpretation, as well as in the didactic lectures (e.g., mentoring, authorship, peer review).

C. Clinical Research Center (CRC)

The weekly CRC Research-Skills Workshop offers basic instruction and practical advice on commonly encountered clinical research topics (Fridays, 8-9 AM, A3210 Medical Center North) including ethical issues and the responsible conduct of research. Sessions are typically demonstration-oriented and provide an informal setting to learn new skills.  Sessions are available to anyone without registration (http://www.mc.vanderbilt.edu/crc/workshop.html).  To sign up for a weekly e-mail notification of the upcoming topic, go to http://www.mc.vanderbilt.edu/crc/workshop_manage.html.

D. BRET

Each year, the BRET office sponsors a session in August and a Responsible Conduct of Research (RCR) one day workshop entitled “Responsible Conduct of Research.” The program is designed to help scientists identify and deal with ethical issues and dilemmas (https://medschool.vanderbilt.edu/bret/responsible-conduct-research).

These fulfill some of the NIH training grant requirement for instruction in Responsible Conduct of Research (http://grants.nih.gov/grants/guide/notice-files/not92-236.html) and is open to any member of the Vanderbilt University scientific community who wishes to participate.  Fellows must participate each year.

E. IRB

Education workshops are listed at http://www.mc.vanderbilt.edu/irb/education.

IRB online courses, investigators’ handbook, and CITI-RCR modules are available to VUMC faculty, staff, and students (https://www.citiprogram.org/rcrpage.asp?language=english&affiliation=100).

F. STARBRITE

IRB and RCR-related lectures and events are posted through STARBRITE and are typically one hour in length  (https://starbrite.vanderbilt.edu/education/schedule.html).

G. Mentored Research

Learning RCR is an integral, continuing part of the mentored research process. Keep this in mind when you discuss concepts such as, study design, study performance, handling of data, authorship, with your research mentor or during routine lab meetings.

2. Biostatistics, study design, and data analysis

Covers study design, basic statistical methods (parametric and non-parametric), hands on use of SPSS or a similar package, common statistical errors, and data presentation.

Resources

A. Fellows Bootcamp

The idea for a fellows’ Bootcamp grew out of a need for a focused program directed at new fellows to immerse them in the opportunities at Vanderbilt University and fundamental information needed to be successful conducting research and interacting with colleagues.  Introductory concepts for new fellows are delivered in this experience.

A. Biostatistics for Clinical Investigators (concurrent with Fellows’ conference series)

Lecture series developed by Dan Byrne, author and biostatistician at Vanderbilt University Department of Biostatistics.  These lectures will be incorporated in the fellows’ conference series.  Supplementary statistical resources can be found at http://biostat.mc.vanderbilt.edu/wiki.  Certificates will be provided each year to fellows who attend a critical number of these lectures.  The focus of these lectures is on the practical application of statistical tests and more advanced analysis techniques.  Introductory biostatistics is delivered as part of two Bootcamps (see part A) with one Bootcamp entirely devoted to foundational biostatistics content.

B. Journal Clubs (embedded into Fellows’ conference series)

Fellow-led journal clubs are part of the weekly fellows’ conference schedule.  Dr. Stein and other experienced faculty members frequently attend.  As part of the journal club, we encourage a brief “glossary” of terms used in order to increase familiarity of both basic science and clinical science nomenclature and techniques.  The Chief Fellow will coordinate this opportunity and distribute template material.

C. VICTR Research Skills Workshop

The weekly CRC Research-Skills Workshop (see “Resources” under “Research ethics and IRB processes” above) frequently covers statistical concepts and hands-on tutorials.

D. Weekly “clinics” run by the Department of Biostatistics

For schedule, see http://biostat.mc.vanderbilt.edu/twiki/bin/view/Main/Clinics (see below). Daily biostatistics clinics enable faculty, fellows, and students to bring actual data for analysis advice.  These are thematic clinical, divided as follows:  Monday: Health Services Research; Tuesday: High-dimensional Data; Wednesday: Surgery, Anesthesia, Emergency Medicine research; Thursday:  Clinical and Health Research; Friday: Basic and Animal Research.

E. The Clinical and Health Research Statistical Skills Clinic Series

The weekly VICTR Statistical Skills Clinic offers specific instruction and computer demonstrations relating to analysis of your own (or other people’s) medical research data. This series is organized by Dan Byrne, CRC Director of Biostatistics and Study Design. Workshops are held each Thursday from 12:00 to 1:10 PM in 11105 2525 West End Conference Room (http://biostat.mc.vanderbilt.edu/wiki/Main/Clinics).

F. VICTR/ CRC Statisticians

If your project is supported by the CRC, you can request statistical support through a voucher from VICTR statisticians.

3. Clinical Pharmacology as a discipline and its history

This them covers the history of clinical pharmacology (with a focus on Vanderbilt Divisional history), founding and evolution of the FDA, FDA’s new drug application and approval process, ethics of drug discovery, the FDA Advisory Committee process, drug discovery, biomarkers and outcome measures, intellectual property issues, preclinical testing and early clinical development.

Resources

A. MSCI Drug and Device Development Course

This course, directed by Dr. Matt Luther, can be audited by Clinical Pharmacology fellows by arrangement through the Chief Fellow.

B. Fellows’ Conference

Timely lectures, including an embedded biostatistics program, on topics related to the fundamentals of clinical pharmacology.  This conference includes lectures on the history of clinical pharmacology, highlighting the important position Vanderbilt University plays in clinical pharmacology.

4. Pharmacokinetics/Pharmacodynamics

Covers absorption, metabolism and excretion, basic pharmacokinetic calculations, effect of variation in drug metabolizing enzymes, transporters, and pharmacogenetics.

Resources

A. Annual DMPK course taught by Dr. Scott Akers and Dr. Scott Daniels (12-day lecture series, typically in August but varies, Chief Fellow will notify fellows)

B.  Fellows’ conference series (NIH lectures and fellow-led)

5. Drug analytic methods

Outlines the principles underlying drug measurement (GC, HPLC and mass spec) and method development.

Resources

Fellows’ conference series – Dr. Ginger Milne, et al.

6. Pharmacogenetics/Adverse Drug Reactions

Covers the contribution of genetic variation to interindividual variability in drug response. Variability in drug metabolizing enzymes, transporters, and receptors are covered.

Resources

All fellows expected to do Dr Roden’s Coursera series on pharmacogenetics https://www.coursera.org/learn/personalizedmed#

Clinical Pharmacology Rounds and Fellows’ conference series, Faculty “Roadshow” Talks – Drs. Roden, Stein, and Oates

7. Drug safety - surveillance, adverse drugs reactions, and drug interactions

Covers post-marketing surveillance, detection of adverse drug reactions, and drug interactions. 

Resources

A.  Fellows’ conference series – Dr. Donna Seger

B.  MSCI Drug and Device Development Course (Directed by Dr. Luther) - Clinical Pharmacology fellows audit this course (Chief fellow with notify other fellows must register through chief fellow and must attend the whole course if start it  - cannot drop in now and then).

8. Toxicology and poisoning

Principles of toxicology.

Resources

Clinical Pharmacology Rounds and Fellows’ conference series – Dr. Donna Seger.

9. Drug effects and disposition in special populations (elderly, children, pregnancy liver and renal impairment, pregnancy and lactation)  

Summarizes current knowledge regarding the use of drugs in special populations. 

Resources

Fellows’ conference series and NIH Clinical Pharmacology Series / Fellow-led

10. Writing a paper

How to write a scientific paper and interact with journal editors, responsible authorship.

Resources

A. Fellows’ conferences – Dr. Mike Stein, and Dan Byrne

B. CRC Weekly Research Skills Series (See above)

C. Editors’ Club – a free editorial service for students, post-doctoral fellows, and junior faculty.  See https://medschool.mc.vanderbilt.edu/editors_club

D. CLIMB website.  I think everyone writing papers or grants should work through the talks on the Northwestern University CLIMB website. They are short and great. http://www.northwestern.edu/climb/resources/written-communication/index.html

E. Manuscript Sprints – Workshops with fellow researchers designed to quickly write and publish complete research.  These are organized by Rebecca Helton (rebecca.e.helton@vanderbilt.edu) at the Office of the Associate Dean for Clinical & Translational Scientist Development and are generally held in the Fall and Spring.

F. BRET Office: Self-Paced Scientific Writing Training This series of 14 lessons and exercises was developed at Vanderbilt. It covers the structure of manuscripts and proposals, tips for making writing more efficient, and revision techniques to improve organization, logical flow, and sentence structure. Each lesson uses examples to illustrate how to make scientific writing easier to understand, and each exercise guides critique and revision of others' writing or your own. Though some lessons refer to others, each is intended to stand alone. https://medschool.vanderbilt.edu/bret/self-paced-scientific-writing-training-materials.

11. Presenting data, teaching skills

How to give a talk, how to get your teaching point across

Resources

A. Fellows’ conference series – Dr. Mike Stein & Dr. Meena Madhur

B. Fellows’ conference series – Practice “elevator talks”

C. CRC Weekly Research Skills Series (See above)

12. Reviewing a paper

How to review a scientific paper; peer review ethics.

Resources

A. Fellows’ conferences – Dr. Mike Stein

B. CRC Weekly Research Skills Series (See above)

13. Grant writing and strategy

How to write a successful grant. Grant writing ethics.

Resources

A. Fellows’ conferences – Dr. Roden, Dr. Harrison, Dr. Brown

B. MPH/MSCI course on grant-writing

C. CRC Weekly Research Skills Series (See above)

D. Clinical and Translational Scientist Development Program (see Career development seminar series)  

 https://medschool.mc.vanderbilt.edu/ctsd/

E. NIH videos on review process and grant writing tips

http://cms.csr.nih.gov/ResourcesforApplicants/InsidetheNIHGrantReviewProcessVideo.htm

F. CLIMB website.  I think everyone writing papers or grants should work through the talks on the Northwestern University CLIMB website.  http://www.northwestern.edu/climb/resources/written-communication/index.html

14. Career planning & the Mentor-Mentee Relationship

Career options for clinical pharmacologists.  How to optimize the mentor-mentee relationship, whether in academics or in other employment sectors.

Resources

A. Fellows’ conferences – Dr. Brown and Dr. Stein

B. Round table lunches with visiting lecturers and faculty 

C. Clinical and Translational Scientist Development Program (see Career development  seminar series )  

 https://medschool.mc.vanderbilt.edu/ctsd/

D. BRET Office of Career Development https://medschool.vanderbilt.edu/career-development/

E. BRET Career Development Seminars https://medschool.vanderbilt.edu/career-development/calendar

F. BRET Office Aspire Program: The Vanderbilt ASPIRE Program was launched in 2013 as a means to meet the needs of the 21st century scientist.  Through participation in the ASPIRE program, graduate students and postdoctoral fellows will be introduced to broad strategies intended to best prepare them for a wide range of future careers.    https://medschool.vanderbilt.edu/aspire/aspire-program-0

G. American College of Clinical Pharmacology (ASCPT) http://www.ascpt.org/

Individual Development Plan

[Text Box: Reproduced from Slides from Philip S Clifford PhD - Facilitating Career Development through Individual Development Plans] It is important that you take charge of your professional development, plan your career direction, and obtain the skills you need. You and your mentor will be asked to complete an Individual Development Plan (IDP) every year. This is mandatory. The IDP is an opportunity to focus your thoughts on “the big picture” of your career trajectory and to be planning your next position. However, IDP should not just be an annual event - make it part of your regular routine to assess where you are, where you want to be, and how to get there. A useful resource is the FASEB site “MyIDP” (http://myidp.sciencecareers.org/).

Be proactive and timely in planning your next position. It can take more than a year to arrange a job.

15. Molecular Biology

A grasp of the vocabulary of molecular biology is fundamental to the understanding of modern clinical pharmacology.

Resources

A. Fellows’ lecture series and Clinical Pharmacology Rounds

B. Feero WG, et al. Genomic Medicine  - An updated Primer (NEJM 2010;362:2001-11.   

16. Additional Topics and Resources

Clinical Pharmacology as a discipline and its history – Dr. Oates

Population Pharmacokinetics – NIH lecture series,  Annual DMPK course

Clinical Pharmacogenetics/Pharmacogenomic Mechanisms of Drug Toxicity – Drs. Roden and Mosley, Dr Roden’s Coursera lecturese

Physiologic and Laboratory Markers of Drug Effect – Dr. Stein and Drug and Device Course

Imaging in Drug Development – NIH lectures series and Fellows’ lecture series

Personalized Drug Response – NIH lectures series and Fellows’ lecture series

Large Molecule/Antibody-based Therapy – NIH lectures series and Fellows’ lecture series

ADDITIONAL INFORMATION

Lodging Papers in PubMed Central

It is the law that all papers that have any NIH support must be lodged in PubMed Central.  Importantly, this is not the same as PubMed. This is usually the responsibility of the senior author - but junior authors (particularly the first author need to make sure this happens.)  If your PI does not know how to do this - Carol Brannon can start you off (http://publicaccess.nih.gov/citation_methods.htm).

T32 Supported Fellows

1) Cite the T32 for any publications that derive from your time supported by the T32. 

“Research reported in this publication was supported by the National Institute of General Medical Science of the National Institutes of Health under award number T32 GM007569.”

2) Make sure all your publications are lodged in PubMed Central.

3) Create and maintain an NIH biosketch.

4) Make sure to keep in touch - we need to show how successful you have been.

Board Certification in Clinical Pharmacology

The American Board of Clinical Pharmacology offers board exams to qualified candidates (http://www.abcp.net/index.html).  The Clinical Pharmacology Boards are not endorsed by the American Board of Internal Medicine or the American Board of Medical Specialties. Completion of two years of approved fellowship training in clinical pharmacology is one prerequisite for eligibility.  Appointment as a postdoctoral fellow in clinical pharmacology at Vanderbilt, AND participation in and completion of the educational components of our clinical pharmacology fellowship program is required.  

From July 2013 all Fellows wishing to write the Boards are required to submit to Dr Stein an annual report that documents: 1) attendance at Clinical Pharmacology conferences 2) attendance at Fellow conferences 3) progress in research project, with any abstracts or publications listed 4) a document  that   indicates  training in  the core curriculum  topics  listed   on the Table that follows (can use that as a template if so desire). The suggested time to turn these in is end of May/June.

Mentoring Committee

All post-doctoral fellows benefit from a mentoring committee and should consider forming one.  T32 fellows must have a mentoring committee - they can use one of the two standing T32 mentoring committees that are headed by Dr. Italo Biaggioni and Dr. Bjorn Knollmann, with Dr. Cyndya Shibao and Dr. James (Matt) Luther.  Meetings are every six months, are arranged by the mentee, and should use the mentoring committee form that Carol Brannon has (if you establish a mentoring committee, kindly see Dr. Stein for advice and consent).

Other Opportunities

1. The last Wednesday of every month at noon, social hour - please come to room P455 on the P12 the floor of MRB 4, and meet other fellows and faculty.

2. When we have visiting speakers   an email invite will go out to fellows to see who would like to have lunch with the visitor.  I encourage you to go if   you can - it is a wonderful opportunity   to meet leaders in the field.

3. There is a fellows’ library in the clinical pharmacology conference room with pharmacology-related books and a binder of key clinical pharmacology articles that may be helpful to you.  These can be checked out with Carol Brannon.

4. We have a world class faculty in the Division and it is based in a tradition of collegiality and collaboration:   don’t be embarrassed to ask anyone for help.

5. Consider joining the American College of Clinical Pharmacology (ASCPT) as a student member; they have career resources and the meeting is a great place to network.  The meeting is “trainee friendly” with travel awards, and frequent opportunities to present work.

6.  My door is always open - email me or Carol Brannon.

PROGRAM CONTACTS:

Director:                      C. Michael Stein, M.B.,Ch.B., M.R.C.P.

                                    Dan May Professor of Medicine and Pharmacology

                                    542A RRB

                                    (615) 936-3420

                                    michael.stein@vanderbilt.edu

 

Administrator:             Carol Brannon

                                    Sr. Executive Secretary

                                    538 RRB

                                    (615) 936-3420

                                    (615) 936-2746

                                    carol.e.brannon@vanderbilt.edu

 

 

Documentation of Fellow meeting Educational Goals                 Name:

 

Attendance of Clinical pharmacology conferences

% attended

Attendance of Fellow conferences

% attended

Progress in Research

Describe  project  briefly, indicate  skills learnt and progress made  - specifically  your contribution. List abstracts and papers  published, talks  given, any  prizes or awards or grants, and meetings attended outside of Vanderbilt. 

Requirements

Dates

Course attended/source of education

*1. Research ethics/IRB/Responsible Conduct of Research

*2. Biostatistics and

 study design

*3. Drug regulation and development

*4. Pharmacokinetics/

Pharmacodynamics

5. Drug analytic methods

6. Pharmacogenetics

7. Drug safety  - surveillance

8. Toxicology and poisoning

9. Drug in special populations

10. Writing a paper

11. Presenting data, teaching skills

12. Reviewing a paper

13. Grant writing

14.  Career planning

15. Molecular biology vocabulary

16.  Other relevant education

Core Competencies in Clinical and Translational Research Core Thematic Areas Competencies  defined by CTSA

(see https://ccts.osu.edu/sites/default/files/Core%20Competencies%20for%20Clinical%20and%20Translational%20Science.pdf ) 

I. CLINICAL AND TRANSLATIONAL RESEARCH QUESTIONS

Identify basic and preclinical studies that are potential testable clinical research hypotheses.
Identify research observations that could be the bases of large clinical trials.
Define the data that formulate research hypotheses.
Derive translational questions from clinical research data.
Prepare the background and significance sections of a research proposal.
Critique clinical and translational research questions using data-based literature searches.
Extract information from the scientific literature that yields scientific insight for research innovation.

II. LITERATURE CRITIQUE

Conduct a comprehensive and systematic search of the literature using informatics techniques.
Summarize evidence from the literature on a clinical problem.
Describe the mechanism of a clinical problem reviewed in a manuscript.
Use evidence as the basis of the critique and interpretation of results of published studies.
Identify potential sources of bias and variations in published studies.
Interpret published literature in a causal framework.
Identify gaps in knowledge within a research problem.

III. STUDY DESIGN

Formulate a well-defined clinical or translational research question to be studied in human or animal models.
Propose study designs for addressing a clinical or translational research question.
Assess the strengths and weaknesses of possible study designs for a given clinical or translational research question.
Design a research study protocol.
Identify a target population for a clinical or translational research project.
Identify measures to be applied to a clinical or translational research project.
Design a research data analysis plan.
Determine resources needed to implement a clinical or translational research plan.
Prepare an application to an IRB.

IV. RESEARCH IMPLEMENTATION

Compare the feasibility, efficiency, and ability to derive unbiased inferences from different clinical and translational research study designs.
Assess threats to internal validity in any planned or completed clinical or translational study, including selection bias, misclassification, and confounding.
Incorporate regulatory precepts into the design of any clinical or translational study.
Integrate elements of translational research into given study designs that could provide the bases for future research, such as the collection of biological specimens nested studies and the development of community-based interventions.

V. SOURCES OF ERROR

Describe the concepts and implications of reliability and validity of study measurements.
Evaluate the reliability and validity of measures.
Assess threats to study validity (bias) including problems with sampling, recruitment, randomization, and comparability of study groups.
Differentiate between the analytic problems that can be addressed with standard methods and those requiring input from biostatisticians and other scientific experts.
Implement quality assurance systems with control procedures for data intake, management, and monitoring for different study designs.
Assess data sources and data quality to answer specific clinical or translational research questions.
Implement quality assurance and control procedures for different study designs and analysis.

VI. STATISTICAL APPROACHES

Describe the role that biostatistics serves in biomedical and public health research.
Describe the basic principles and practical importance of random variation, systematic error, sampling error, measurement error, hypothesis testing, type I and type II errors, and confidence limits.
Scrutinize the assumptions behind different statistical methods and their corresponding limitations.
Generate simple descriptive and inferential statistics that fit the study design chosen and answer research question.
Compute sample size, power, and precision for comparisons of two independent samples with respect to continuous and binary outcomes.
Describe the uses of meta-analytic methods.
Defend the significance of data and safety monitoring plans.
Collaborate with biostatisticians in the design, conduct, and analyses of clinical and translational research.
Evaluate computer output containing the results of statistical procedures and graphics.
Explain the uses, importance, and limitations of early stopping rules in clinical trials.

VII. BIOMEDICAL INFORMATICS

Describe trends and best practices in informatics for the organization of biomedical and health information.
Develop protocols utilizing management of information using computer technology.
Describe the effects of technology on medical research, education, and patient care.
Describe the essential functions of the electronic health record (EHR) and the barriers to its use.
Explain the role that health information technology standards have on the interoperability of clinical systems, including health IT messaging.
Access patient information using quality checks via electronic health record systems.
Retrieve medical knowledge through literature searches using advanced electronic techniques.
Discuss the role of bioinformatics in the study design and analyses of high dimensional data in areas, such as genotypic and phenotypic genomics.
Collaborate with bioinformatics specialists in the design, development, and implementation of research projects.

VIII. RESPONSIBLE CONDUCT OF RESEARCH

VIII.a. Clinical Research Ethics Competencies

Summarize the history of research abuses and the rationale for creating codes, regulations, and systems for protecting participants in clinical research that requires community input.
Critique a clinical or translational research proposal for risks to human subjects.
Explain the special issues that arise in research with vulnerable participants and the need for additional safeguards.
Determine the need for a risk-benefit ratio that is in balance with the outcomes in clinical and translational research.
Describe the elements of voluntary informed consent, including increasing knowledge about research, avoiding undue influence or coercion, and assuring the decision-making capacity of participants.
Assure the need for privacy protection throughout all phases of a study.
Assure the need for fairness in recruiting participants and in distributing the benefits and burdens of clinical research.
Adhere to IRB application procedures.
Explain how the structural arrangement of science and the research industry may influence the behavior of scientists and the production of scientific knowledge.
VIII.b. Responsible Conduct of Research Competencies
Apply the main rules, guidelines, codes, and professional standards for the conduct of clinical and translational research.
Adhere to the procedures to report unprofessional behavior by colleagues who engage in misconduct in research.
Implement procedures for the identification, prevention, and management of financial, intellectual, and employment conflicts of interests.
Apply the rules and professional standards that govern the data collection, sharing, and protection throughout all phases of clinical and translational research.
Apply elements of voluntary informed consent, of fostering understanding of information about clinical research, and for avoiding undue influence or coercion, and taking into consideration the decision-making capacity of participants.
Explain the need for privacy protection and best practices for protecting privacy throughout all phases of a study.
Explain the need for fairness in recruiting participants and in distributing the benefits and burdens of clinical research.
Explain the function of the IRB.

IX. SCIENTIFIC COMMUNICATION

Communicate clinical and translational research findings to different groups of individuals, including colleagues, students, the lay public, and the media.
Translate the implications of clinical and translational research findings for clinical practice, advocacy, and governmental groups.
Write summaries of scientific information for use in the development of clinical health care policy.
Translate clinical and translational research findings into national health strategies or guidelines for use by the general public.
Explain the utility and mechanism of commercialization for clinical and translational research findings, the patent process, and technology transfer.

X. CULTURAL DIVERSITY

Differentiate between cultural competency and cultural sensitivity principles.
Recognize the demographic, geographic, and ethnographic features within communities and populations when designing a clinical study.
Describe the relevance of cultural and population diversity in clinical research design.
Describe cultural and social variation in standards of research integrity.
Critique studies for evidence of health disparities, such as disproportional health effects on select populations (e.g., gender, age, ethnicity, race).

XI. TRANSLATIONAL TEAMWORK

Build an interdisciplinary/ intradisciplinary/ multidisciplinary team that matches the objectives of the research problem.
Manage an interdisciplinary team of scientists.
Advocate for multiple points of view.
Clarify language differences across disciplines.
Demonstrate group decision-making techniques.
Manage conflict.
Manage a clinical and/or translational research study.

XII. LEADERSHIP

Work as a leader of a multidisciplinary research team. Manage a multidisciplinary team across its fiscal, personnel, regulatory compliance and problem solving requirements. Maintain skills as mentor and mentee. Validate others as a mentor. Foster innovation and creativity.

XIII. CROSS DISCIPLINARY TRAINING

Apply principles of adult learning and competency-based instruction to educational activities.
Provide clinical and translational science instruction to beginning scientists. Incorporate adult learning principles and mentoring strategies into interactions with beginning scientists and scholars in order to engage them in clinical and translational research. Develop strategies for overcoming the unique curricular challenges associated with merging scholars from diverse backgrounds.

XIV. COMMUNITY ENGAGEMENT

Examine the characteristics that bind people together as a community, including social ties, common perspectives or interests, and geography.
Appraise the role of community engagement as a strategy for identifying community health issues, translating health research to communities and reducing health disparities. Summarize the principles and practices of the spectrum of community-engaged research. Analyze the ethical complexities of conducting community-engaged research. Specify how cultural and linguistic competence and health literacy have an impact on the conduct of community engaged research.