Tag Archive: Clinical Research

Computational Genomics Consulting and Education

The multidisciplinary Johns Hopkins Center for Computational Genomics was established by the Provost office in 2008 and integrates the work of basic scientists (biologists and clinicians), statisticians, and computer scientists. Initiatives include: Annual Practical Genomics: From Biology to Biostatistics Workshop Annual Young Investigators Symposium on Genomics and Bioinformatics Focused Workshops University Courses Data analysis and sequencing through the Next Generation Sequencing Core and the Division of Biostatistics For more information, visit: http://www.genomics.jhu.edu The Computational Biology Consulting Core (CBCC) is led by Liliana Florea with Steven Salzberg within the University’s Center for Computational Biology founded by Salzberg. The Core’s mission is […]

Investigational Botanical Drug Products

To request any of the templates below, please email our research navigators at ICTR_Navigators@jhmi.edu. IND Application IND Application Guidance and Template for Lawfully Marketed Botanical Products with No Known Safety Concerns IND Application Guidance and Template for Unmarketed Botanical Products and Botanical Products with Known Safety Concerns

Investigational Drug and Biologics Research

To request any of the templates below, please email our research navigators at ICTR_Navigators@jhmi.edu. FDA Formal Meeting Requests FDA Formal Meeting Request Guidance and Template FDA Formal Meeting Request Blank Template IND Exemption Request IND Exemption Request Guidance IND Application IND Application Guidance and Template for Drug Products IND Application Blank Template for Drug Products IND Application Guidance Template for Biologic (Somatic Cell Therapy) Products IND Application Blank Template for Biologic (Somatic Cell Therapy) Products Letters of Authorization/Right of Reference for INDs Letter of Authorization Guidance and Template for Drug Master Files Letter of Authorization Guidance and Template for Investigational […]

Drug and Device Resources Disclaimer

The regulatory guidances, templates, and other materials provided at this site are available to the public and are for researchers to use with appropriate acknowledgement of source material. All material provided on this site is for informational purposes only. The Johns Hopkins Institute for Clinical and Translational Research makes no representations as to the accuracy, completeness, correctness, suitability, or validity of any information on this site and will not be liable for any errors, omissions, or delays in this information or any losses, injuries, or damages arising from its display or use.

Introduction to Clinical Research Summer Course

Course Dates: Mon. JULY 15 – Fri. July 19, 2019. Registration is closed because the course is currently FULL. Any questions, please email: Karla McCarthy kmccarthy@jhu.edu Co-Directors: Daniel Ford, MD, MPH and Karen Bandeen-Roche, PhD, MS Contact Person: Karla McCarthy Course Learning Objectives: Define a research question. Understand the steps involved in conducting clinical research. Review and evaluate the main study designs used in clinical research: case-control, cohort, clinical trials, cross-sectional, met-analyses. Understand the basis of statistical analyses of clinical research studies. Understand the methodological basis of diagnostic and prognostic testing. Prepare and review a research project. Location: East Baltimore […]

Science of Clinical Investigation (SOCI) Training Program

The Science of Clinical Investigation (SOCI) Training Program is designed to prepare clinicians and other biological scientists to participate in multidisciplinary clinical research.  Courses are offered on-site and online. Translational clinical research requires a team that can design, analyze, interpret, and implement clinical studies in compliance with ethical and regulatory norms.  Develop this expertise and become a leader in clinical research with the SOCI training program. The SOCI program contains both onsite and online courses including: Database Design and Implementation in Clinical Research Ethical and Regulatory Issues in Clinical Research Design of Clinical Studies Quantitative Analysis of Clinical Data Outcomes […]

Predoctoral Clinical Research Training Program

Advancing future leadership, excellence in clinical research through training and participation, creativity, scholarship and collaboration” NOW ACCEPTING APPLICATIONS FOR 2020-21 DEADLINE JANUARY 6TH, 2020 This predoctoral (TL) training program allows the ICTR to provide training for students interested in pursuing a career in clinical and translational research (combined master and doctoral degrees with MD or nursing degree). This program is a collaborative effort of the Johns Hopkins School of Medicine, Johns Hopkins Bloomberg School of Public, the Johns Hopkins School of Nursing, and the Johns Hopkins University Center for BioEngineering Innovation & Design. Click the links below to learn more: […]

Research Nutrition

If you are an investigator who would like to learn more about how to incorporate ICTR Research Nutrition support into your study, please contact the research nutrition manager as early as possible in your protocol development process. About Us ICTR Research Nutrition was established to support CRU investigators in developing and implementing the best nutritional plans for their research protocols for both pediatrics and adults. Services are located in the clinical research units at both the Johns Hopkins Bayview Campus and the Broadway (main medical) Campus. Research Nutrition staff includes a diverse nutrition team comprised of a research nutrition manager, research […]

We analyze the 24-hour recalls and food records using Nutrition Data System for Research (NDSR).

Nutrition Education

We provide diet counseling and nutrition education for numerous protocols that involve weight loss, food allergies, chronic diseases including diabetes and cardiovascular disease, and a wide range of rare metabolic disorders for both pediatrics and adults.

Anthropometrics and Body Composition

We offer several non-invasive techniques to measure body composition, including:

  • Height and weight,
  • Circumference measurements like waist, hip, head, thigh, and mid-arm,
  • Skinfold measurements to estimate percentage of body fat, arm muscle area, and arm fat area,
  • Bioelectrical Impedance Analysis (BIA): A small current is passed through the body to estimate body fat mass (weight and percent), fat-free or lean body mass (weight and percent), and body water.

Energy Assessment

  • Indirect Calorimetry– The metabolic cart calculates energy expenditure (REE), which accounts for 75-95% of total energy expenditure. The remaining 5-25% is highly variable depending on age, sex, size, disease state, and daily activity.
  • Predictive Equations– These equations calculate energy requirements based on height, weight, age, and activity factor. Examples are the Mifflin St. Jeor equation, the Harris-Benedict equation, DRIs, etc.

Visit Meals and Diets

We can provide standard or protocol-specific meals snacks, and formula.