Category Archive: 2017 Programs and Resources

Investigational Drug and Biologics Research


To request any of the templates below, please email our research navigators at ICTR_Navigators@jhmi.edu. Guidance and Templates 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 … Continue reading

Drug and Device Resources


The information resources compiled at the various links below are available for use by all investigators and project teams at no cost. Through these documents, the Research Navigators can provide answers to general regulatory questions as well as access to a list of Frequently Asked Questions, templates, and other guidance documents. The list of informational resources will continue to grow as the DDRS develops. **EFFECTIVE IMMEDIATELY** CBER’S new mailing address: U.S. Food and Drug Administration Center for Biologics Evaluation and Research Document Control Center 10903 New Hampshire Avenue W071, G112 Silver Spring, MD 20993-0002 Please disregard any other address for … Continue reading

DDRS Consults–What to Expect


To initiate contact with the DDRS, investigators or team members must complete and submit a Connection Request. Submitting a Connection Request can be done by logging into the ICTR Connection Request website and selecting the DDRS service from the available options. All Connection Requests received will be reviewed by the Research Navigators in the order received in order to determine the basic nature of the request. Initial responses to Connection Requests can be expected within 5 to 7 working days, so please plan accordingly. Requests for general information requests will be answered directly by the Research Navigators wtihin 5 to 7 … Continue reading

DDRS Consultation Service


The Project Specific Consultation Service includes a complimentary eight-hour consultation. Additional regulatory support beyond the eight hours can be obtained at an hourly rate of $72.00. What is a “project”? A project is a single IND or IDE application. If an investigator wishes to utilize the DDRS Consultation Service for more than one IND or IDE, he/she may do so. Each IND or IDE will be considered a separate ‘project’ and each will be provided an eight-hour consultation period free of charge. After the eight-hour consultation period has ended, additional regulatory support can be provided on a fee-for-service basis, for … Continue reading

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.

Drug and Device Resource Service (DDRS)


The Drug and Device Resource Service (DDRS) provides Johns Hopkins University investigators and project teams access to resources needed to help manage the development and use of investigational drugs and devices in research.  The DDRS is comprised of an investigational drug, biologics, and device information repository (Resources) with a Project-Specific Consultation Service available for those who seek a higher level of assistance with management of the regulatory requirements of their research projects. *Please read the disclaimer. For assistance, please submit an ICTR Connection Request . To learn more about the consultation service and available resources, click the links below.

Programs & Resources


We offer a variety of programs and resources to members of the Johns Hopkins research community who are currently preparing or executing clinical research. From clinical infrastructure, nursing and laboratory services, we are prepared to address the most pressing needs of clinical investigators. We strive to support human subject research at all phases of translation Support human subject research at all phases of translation. We strive to: Add value to research activities by making available dedicated staff, facilities, and experts in study implementation. Encourage the research career development of students, nurses, scientists, and physicians through access to resources necessary for … Continue reading

Exercise Physiology and Body Composition


The Exercise Physiology and Body Composition Core’s laboratory provides DEXA measurements for body fat, muscle and bone composition, metabolic stress testing, and also supports exercise-training protocols. The facilities are located at the Bayview Clinical Research Unit. DEXA scanning is also available on the Broadway campus through the Adult Outpatient Unit. Supported studies address issues like exercise testing and training and body composition of patients with chronic health conditions. The Core also provides coronary risk factor assessment and modification for approved users and works closely with CRU Research Nursing, Research Nutrition, and the Research Core Laboratory for sample collection and processing. … Continue reading

Research Nutrition


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 nutritionists, a kitchen supervisor, and research nutrition technicians. The ICTR Research Nutrition staff can perform: In-depth nutrition assessments Diet intake analysis for both macro- and micro-nutrients Nutrition counseling Anthropometric and body composition measurements, Energy expenditure assessments Design and … Continue reading

Cardiovascular Imaging Laboratory


The Cardiovascular Imaging Laboratory is located at the Bayview CRU and is supervised by Pamela Ouyang, MBBS, ICTR Deputy Director and Director of the Johns Hopkins Women’’s Cardiovascular Health Center. The Core provides echocardiographic and carotid imaging for approved CRU protocols, as well as measurement of endothelial function and arterial stiffness. The Cardiovascular Imaging Laboratory provides the following services and equipment: Echocardiogram Echocardiograms are performed on a Toshiba Artida ultrasound system. All cardiac studies are stored digitally and analyzed using the Philips Excelera System. Image acquisition and analysis protocols can be customized to meet the unique needs of the investigator. … Continue reading

Clinical Research Units


Effective May 2018, the CRUs will operate using a service center model and certain associated resources require a CRU Online application and approval.   The Clinical Research Units (CRUs) provide resources at 3 locations throughout the medical campuses–Johns Hopkins Hospital, the Charlotte R. Bloomberg Children’s Center and the 301 Building on the Johns Hopkins Bayview Medical campus. The CRUs are the safest, most efficient way to perform clinical and translational research and offer an indispensable resource that is widely used and required by our NIH funded investigators.  Through protocol review, investigator mentoring, trained nursing staff, protocols performed on the CRUs … Continue reading