Professional Regulations and Skills

Understanding professional regulations can be daunting, but we've divided it up into useful topics, such as informed content, ethical standards, and protocol compliance. This page also includes a wealth of information related to translational research skills, from mentoring to writing and presenting. It also covers popular topics such as finding grants and optimizing your translational research career.

Browse the topics and course descriptions by category: 

Responsible Conduct of Research

Courses offered Description Level
Research Participant Compensation: What is Fair?
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Ethical issues associated with paying research participants; the pros and cons of past and current payment model; Overview of how vulnerable groups are affected.
 Basic
What are the challenges of consenting vulnerable populations?
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Three presentations:  1. what factors are relevant in considering consent for individuals with dementia and how to ensure protection of the vulnerable elders? 2. Schizophrenia, Schizoaffective Disorder, Co-morbid Addiction DX: irb considerations; Strategies on how to determine decisional capacity and assess coercion.  3. Adolescent: age range; skills and risk; role of parents.   
 Advanced
CRES: Patient Registries
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Procedure about how to register patient (Disease) and how to set up and maintain registries; typical use and access of registries; Overview of Human subjects regulations. 
 Intermediate
Informed Consent: How to Improve Patient Understanding
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The role that context, content and culture play in an informed consent conversation; Problem areas that decrease engagement and understanding;  Opportunities for improving communication with research participants during the consent process.  
 Intermediate
CRES: Issues around Consenting and Subject Participation in Genetic Studies
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Considerations and cautions in consenting subjects into a genetic study; The implications of genetic data sharing and dbGaP; Cautionary considerations to the return of genetic research results and containing subject expectations.
 Advanced
CRES: Consent, Data Sharing, and Returning Results: Decision Making in Managing Biobanks
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Issues surrounding data sharing, informed consent d managing biobanks; The agreements, procedures, conventions, or policies that define who gets power, how decisions are taken and how accountability is rendered.
 Basic
CRES: Ethical Complexity of Pediatric Research
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The complexity of running clinical trials in pediatrics with discussion of issues about consent and appropriate study design involving children.
 Advanced
CRES: Resolving Ethical Dilemmas in Clinical Research Studies
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Types of ethical issues that can emerge during the course of a research study; Approaches about how to disclose information to research participants and family member; resources to address unanticipated issues.
 Advanced
ITHS Grand Rounds: OVER-THE-COUNTER GENETIC TESTING: What are the technological, ethical, regulatory, legal, and interpretation issues?
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Interpretation of results, state and federal regulations, and the marketing of these home test kits.  
 Basic
CRES: Responsible Conduct of International Research
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Information about finding funding for international research; Overview of US regulations, institutional requirements and ethical standards to international research; Operational checklist and challenges for establishing a research program abroad.
 Basic
CRES: The Nuts and Bolts of Study Start-up
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Overview of Personal Site Assessment; Procedures about obtaining Regulatory Approvals and setting up Systems/Documents to Assist with Study Conduct.
 Basic
CRES: Mid-study Ethical Dilemmas: What to do?
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Types of ethical issues that can emerge during the course of a research study; Approaches about how to disclose information to research participants and family member; resources to address unanticipated issues.
 Advanced
CRES: Data & Specimen Repositories and Data Sharing
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Ethical issues surrounding biorepositories; Overview of the federal regulations governing biorepositories; Introduction about how HIPAA applies to biorepositories.
 Advanced
CRES: Conflict of Interest in Research
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Definition of Conflict of Interest; GIM 10 and the UW process for reviewing disclosures of significant financial interests by researchers; the new UW Medicine Conflict of Interest Policy and how it relates to GIM 10 and the Outside Work Policy; the State Ethics Act and its applicability to UW research and tech transfer activities.
 Basic

FDA Regulation

Courses offered Description Level
Establishment, Care, and Feeding of an Investigator-Sponsored IND
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Role and responsibilities of a Sponsor-Investigator; Submission process of an initial IND application; Ongoing reporting obligations during the IND lifecycle.  
 Intermediate
Tips for a Successful Monitoring Visit
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Overview of the purpose of a monitor's site visit; Tips on preparing for a monitor's visit and forming a collaborative relationship with the monitor.
 Basic
Recognizing and Reporting Adverse Events and Unanticipated Problems
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The new FDA regulations for adverse event reporting; differences between adverse events and unanticipated problems; tools for recording and reporting AEs.
 Basic
CRES: Working with Investigational Drug Services to Meet FDA Expectations
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Policy and FDA regulations and ways in which UW investigators can work with the IDS in order to comply. 
 Basic
CRES: Clinical Trials with Investigational Medical Devices: What do you need to know?
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Definition and classification of medical devices; Regulatory requirements for initiating clinical trials with non-significant risk devices, significant risk devices and drug/device combination products.  
 Basic
CRES: Device Trials; Issues and Experiences
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Investigator initiated device trials- from the application to enrolling the first subject; One PI’s experience with the process of obtaining FDA approval and then operationalizing the study.
 Advanced
CRES: IND Safety Reports
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Safety reporting requirements and responsibilities for investigators initiating IND-studies. 
 Advanced
CRES: Pre-Trial Decisions Regarding Adverse Events for Investigator Initiated Studies
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Policies; definitions and clear illustrations about the relationships among Serious Adverse Events (SAEs) vs. Anticipated vs. Unanticipated; Regulatory background; Tips about including adverse events in data safety monitoring plans.
 Basic
CRES: Research Staff Responsibilities in Clinical Research
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Strategies about promoting research participant safety, supporting protocol compliance and producing quality data. 
 Advanced
2010 - ITHS Clinical and Translational Research Boot Camp
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These mini-courses will typically consist of a series of lectures and serve as an introduction to basic principles in each area. Relevant areas include (but are not limited to) biostatistical concepts, clinical epidemiology and study design, ethical issues in research on human subjects, grantsmanship, randomized clinical trials, regulatory issues, and scientific writing. Note: This has multiple courses that fill the requirements for many learning center areas. Use the Track Your Progress online tool to find all the areas.
 Intermediate
CRES: Investigator Responsibilities in Clinical Research: Insights and Helpful Hints for Researchers
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Overview of federal regulation of clinical research; Commonly encountered problems; Understanding investigator responsibilities. 
 Advanced
CRES: Preparing for an FDA Inspection
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Overview of an FDA inspection including what records, staff, and other resources must be reviewed and available; Guidelines for interacting with the inspector; Understanding what happens after the inspection. 
 Basic
CRES: The IND/IDE Development Process
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The basis of FDA emphasis on safety; Strategies about how to build regulatory science into your research program.
 Intermediate

Mentorship

Courses offered Description Level
Mentoring talk (Dr. Michael Fleming)
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Overview of types of mentoring and characteristics of a good mentor; Tips about how to get the most from the mentor; mentor training for CTS Researchers 
 Basic
Managing a Research Team
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Overview of PI responsibilities and strategies on organizing a research team; hiring research staff; effective training for research support staff; appropriate delegation of tasks to staff; successfully supervising research staff.
 Basic
Making the Most of your Mentor: A Guide for Mentees
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Introduction to mentoring, stages of mentoring; Discussion on special situations.
 Basic
Career Development Seminar Series: Make the connection: How to choose a mentor
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Strategies about how to find a mentor and how to build a good working relationship with a mentor. 
 Basic
CDS: Giving and Receiving Effective Feedback
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The key components of effective feedback as well as techniques for providing feedback in particularly challenging situations (e.g., to a defensive learner, to a superior).
 Basic
How to get the mentors(s) you need
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Expert’s experience in developing mentoring teams for global health initiatives to provide insights and tips into developing successful long-distance mentoring and building multidisciplinary mentoring teams.
 Basic
Translational research - Getting Started - How to find a project and a mentor
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The importance of mentoring and finding a good mentor and their experiences in the agonies and ecstasies of academic research.
 Basic
ITHS Boot Camp - Clinical Epidemiology
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Measures of disease frequency- incidence, prevalence, stratification by person, place, and time characteristics; study designs- case series, cohort, case-control studies, randomized trials, measures of effect; confounding and its control- restriction, matching, stratification, regression; effect modification- likelihood ratio tests; and screening and diagnostic testing- sensitivity, specificity, positive and negative predictive values, likelihood ratios, association versus prediction.
 Intermediate
Effective Feedback: Giving and Getting
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Ways to engender effective feedback from and to both mentor and mentee as well as colleague to colleague.
 Basic

Communication Skills

Courses offered Description Level
Got Results? Communicating with participants and the public about the fruits of research
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Ethical arguments in support of on-going engagement; Barriers to effective communication with participants; Opportunities for result dissemination in clinical research.
 Basic
Conducting Community Based Participatory Research (CBPR) to Effectively Address Health Disparities: Registration Open
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Orientation and theoretical guidance in the field of community based participatory research; Culture issues leading to health disparities; lessons learned about select real life health disparities issues; Recommend approaches through CBPR to improve the science of health disparities and improve health outcomes.
 Basic
Presentation Skills: How to Keep Your Audience Awake, Alert, and Informed
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Techniques to keep audiences interested and engaged in the presentations; Examples of do's and don't using Powerpoint, public speaking skills and personal quirks to avoid.
 Basic
Dissemination and Implementation Research Workshop
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An introduction to the principles and methods of dissemination and implementation research for anyone interested in applying successful, evidence-based strategies to improve health in community, tribal and practice settings.
 Basic
Science Writing: How to Overcome Writer’s Block and Get Your Work Published
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A practical, stepwise approach to overcoming writer's block that may prove especially helpful for researcher-authors without extensive experience with this process.
 Basic
The Art and Science of Poster Presentation
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The key steps in making posters, from the development of the abstract all the way to the presentation of the poster. 
 Basic
A Primer on Making Informative and Impressive Poster Presentations
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Preparing posters and maximizing the effect of your presentations. 
 Basic
Power Point Use and Abuse
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How to give effective presentations, and use Power Point appropriately. 
 Basic
ITHS Boot Camp - Clinical Trials in Community- and Practice-Based Settings
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The goal of the session is to present real-world examples of clinical trials conducted in community-based settings, discuss examples of how communities participate in developing research concepts and design, illuminate how community input can strengthen research, and discuss ways that study teams give back to study participants and communities.
 Intermediate
Scientific Writing: Lessons from Experienced Journal Writers
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Strategies about how to write scientific articles.  
 Basic
Principles of Scientific Writing
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Everything from writing style, journal selection, authorship guidelines and details about what is important to include and what is not the different sections of a scientific paper
 Basic

Grantsmanship

Courses offered Description Level
How to Use Center Grants for Advancing an Academic Research Career
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Overview of the P-series grants; Best practice about how junior faculty applied for and benefited from the P-award.
 Basic
How Do Study Sections Review Grants? A Peek Behind Closed Doors
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The fundamentals of grant review, including an overview of study sections, and grant scoring.
 Basic
How to Successfully Create a Grant Budget
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Key elements of a well prepared budget; Procedures about how federal regulations inform the UW budgeting process; key budgeting terminology and their use in budget preparation.
 Basic
Special CDS event: NIH 101: Grantsmanship
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Overview of the new NIH policies on New & Early Stage Investigators; the increased importance of the Specific Aims page; the steps needed in organizing and writing an effective research grant application.
 Basic
How to Get your Foot in the Door- Tips to Get an Early Investigator Award
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Perspectives and insights into developing a successful K grant application.
 Basic
How to Construct a Research Budget
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Two different perspectives on developing budgets –one from a view of a researcher and the other as a key member assisting the task.
 Basic
Tips for Successful Pilot Grant Applications
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Tips that investigators can use to enhance the likelihood of a successful pilot grant application through the ITHS's Community Outreach and Research Translation (CORT) core.
 Basic
Behind Closed Doors: Secrets of a Study Section
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The fundamentals of grant review, including an overview of study sections, grant scoring and common mistakes of first time grant applicants.
 Basic
Writing a K Award Application: Tips from a Reviewer
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Specific advice from experts on writing the various sections of a successful application.
 Basic
Grant Review Training (Lecture I)
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Overview of how to review grant applications.
 Basic
NIH Study Sections: Secrets and Advice from Study Section Leaders
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Overview of how grants are reviewed, with advice from experienced and successful researchers.
 Basic
What Happens to your Grant - NIH Study Sections Secrets and Insights
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Overview of how grants are reviewed, with advice from experienced and successful researchers.
 Basic
Writing Your First Grant - How to get started
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Techniques, tips and important things to consider when writing your first grant application.
 Basic
Grant Writing Tips from the Experts
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Techniques, tips and important things to consider when writing grant application.
 Basic
Career Development Award (K Award) Seminar
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Learn all about the NIH K Awards from reviewers and awardees.
 Basic
CRES: Research Award Review: What you need to know before you accept
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Overview of the difference between grants and contracts; federal requirements for grant management; rebudgeting and how to carry over funds Tips for how to work more effectively with the UW Office of Sponsored Programs.   
 Basic
Tips and Tricks for Grant-Writing Success: Having Fun While Shaping your Next Application
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Techniques, tips and important things to consider when writing grant application. 
 Basic

Professional Experience

Courses offered Description Level
Career Development Seminar Series: Working with Industry
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Resources that C4C could provide to support you and your research team, e.g., Commercialization Fellows Program and Presidential Entrepreneurial Faculty Fellows Program.
 Basic
Puget Sound K-Awardee Event
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The discussion, which was moderated by Dr. Ian De Boer, ITHS KL2 Faculty Chair and UW Associate Professor of Nephrology, covered topics such as securing and managing research funding, collaborating with peers, getting started with teaching, surviving as research faculty after their K Awards end, and commercializing scientific discoveries.
 Basic
How to Deal with your Department Chair?
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Tips for how to approach issues such as promotion, space, budget and funding.  
 Basic
Introduction to Research Administration
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Overview of key players, terminology, and processes for proposal submission and award management at the UW.
 Basic
Academic Job Search: A Practical Primer
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A practical discussion on tips for finding your first academic position.
 Basic
Think Outside the University: Are you ready for a change?
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The fundamentals of a career change and options for individuals within the health sciences.
 Basic
Academic Careers in Health Sciences: A Perspective
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Academic career advancement that includes promotions, grants, papers, collaborations and research ethics.
 Basic
Lessons from Reality TV: Negotiating for an Academic Position
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A practical approach to searching for an academic job.
 Basic
Make Sure Your CV Reflects Your Accomplishments
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Ways to improve the chances of landing a new position by making sure your curriculum vitae is the best it can be.
 Basic
Preventing and Recognizing Burnout and Creating Better Work-Life Balance
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The factors that impact burnout in academic and clinical careers, how to recognize trouble and what to do to handle the stress and pressures that can lead to burnout and depression.  
 Basic

Domain Specific Resources

Courses offered Description Level
Integrated analysis of genome-scale metabolic and gene regulatory networks
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Overview of integrated analysis of genome-scale metabolic and gene regulatory networks. 
 Advanced
Understanding Renal Cell Carcinoma using a Metabolomics Approach
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Metabolomics-driven biomarker identification in renal cell carcinoma. 
 Advanced
Omics Testing: Lessons Learned and the Path Forward
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A full-day workshop involving many of the IOM committee members and other experts in the field to discuss the report’s findings and recommendations of ways to strengthen omics-based test development and evaluation and also the future of omics-based research.
 Advanced
Introduction Metabolomics: Stories from the Road to Developing Cancer Diagnostics
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Shared experience to develop cancer diagnostics. 
 Advanced
A Short Course on DNA Analysis Technologies
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Methods for producing microarrays, applications for microarrays, sample handling and labeling methods.
 Advanced
Global Biochemical Profiling for Understanding Biology and Disease: a case study in the alterations of host cell metabolism
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A case study in the alterations of host cell metabolism. 
 Advanced
Metabologna: Metabolomic Profiling of Urine in Response to a Controlled Feeding Study of Fruits, Soy, and Vegetables
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Findings on sex differences and UGT1A1 polymorphism on UGT1A1 activity in response to a specific vegaatables and fruit in the diet of human volunteers. 
 Advanced
Suppression of statin effectiveness by copper and zinc in yeast and human cells
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Identification of Metal-Statin Interactions in a Yeast-Based Screen; Ergosterol and Intermediates are Impacted by Statin and Metal; Altered Gene Expression Induced by Statin and Metal;An Integrated Genomic and Metabolomic Model for Metal-Statin Interaction.
 Advanced
Metabolomics and Lipidomics Studies of Diabetes Mellitus and Other Diseases
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Outline of the metabolmics facility at PNNL and discussion about research conducted there into the lipidomics of diabetes.
 Advanced
Oncogene directed integration of “omic” networks
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Application of fluxomics, metabolomic and transcriptomic to the study of Myc regulated metabolism. Results from cell and animal models will be presented.
 Advanced
Silymarin: A botanical medicine for liver disease
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Research findings on Silymarin 
 Advanced
Structural Analogues and “Omics” Studies as Tools in Understanding Drug-Induced Toxicities
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Research findings on Structural Analogues and “Omics” Studies 
 Advanced
Perspectives of Metabolomics Towards Personalized Medicine
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Recent research and the technologies available to explore the potential for personalized medicine.
 Advanced
Metabolomic Approaches to Identification of Endogenous Biomarkers
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Overview of metabolomic approaches to identification of endogenous biomarkers. Note: There is no video or audio accompanying this slide show.
 Advanced
ITHS Grand Rounds: Autism and Childhood Vaccinations: Do vaccinations put children at increased risk to develop autism?
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Overview of autism and childhood vaccinations.
 Advanced
Design and execution of mass spectrometry-based metabolomic investigations using targeted and nontargeted approaches
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Examples of how targeted and nontargeted metabolite profiling analyses generate useful (and sometimes not so useful) results in several contexts. 
 Advanced
Cancer: What People Really Want to Know
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A public one-day workshop to help people engage with cancer and the research process.
 Advanced
Breast Cancer Screening - the New Guidelines
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Discussion about controversy surrounding the new breast cancer screening guidelines.
 Advanced
ITHS Boot Camp - Audacity of OMICS: Premises and Promises
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This session will focus primarily on proteomics.
 Advanced
ITHS Boot Camp - Next and “next next” Generation Sequencers
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Overview and theory about currently available next generation sequencing methods including Illumina/Solexa, Roche/454, ABI’s Solid and the recently released instrument from Helicos.
 Advanced
ITHS Boot Camp - Going Beyond Basic GWAS
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Basic GWAS analysis procedures and fancy ways of getting around the problem.
 Advanced
ITHS Boot Camp - Gene Expression Analysis: From Differential Display to Whole Transcriptome Profiling
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Overview of current gene expression technologies, analysis methods and tools, and will include examples of the use of gene expression profiling in the clinic.
 Advanced
ITHS Boot Camp - Biological Clinical Supplies: Characterization of Drug Substance & Drug Product
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Key elements of cGMP for a biological product, key parameters of cell and process development, assay qualification expectations, cell banking and characterization, and viral validation.
 Advanced
ITHS Boot Camp - Challenges Facing Academic Scientists in Preclinical Biopharmaceutical Development/ Evaluation of Toxicity in an Academic Setting
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This session will discuss why evaluating toxicity is important.
 Advanced

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The Institute is supported by grants UL1TR000423, KL2TR000421, and TL1TR000422 from the NIH National Center for Advancing Translational
Sciences through the Clinical and Translational Science Awards Program (CTSA).

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