Tag Archive: Research Navigator

Ask the Research Navigator


The ICTR Navigator is here to help direct investigators to the ICTR services they need and advise them on “next steps” in the clinical and translational research enterprise at Johns Hopkins. If you’re not sure where to start, submit an ICTR Connection Request.     SUBMIT A CONNECTION REQUEST

Template Documents for Regulatory and Participant Binders


To request any of the templates below, please email our research navigators at ICTR_Navigators@jhmi.edu. Regulatory Binders Regulatory Records Checklist Template Adverse Event Tracking Log Template Delegation of Responsibilities and Signature Log Template Financial Interest Disclosure Form Templates Monitoring Visit Summary Log Templates Regulatory Binder Protocol Deviation Log Template Regulatory Binder Note to File Templates Regulatory Binder Pointer Page Templates Screening and Enrollment Log Template Visitor Signature Log Template Participant Binders Informed Consent Checklist Template Participant Binder Protocol Deviation Log Template Participant Binder Note to File Templates Inquiries and Requests for Support Please submit an ICTR Connection Request.

Data and Safety Monitoring Plans and FDA Audits


To request any of the templates below, please email our research navigators at ICTR_Navigators@jhmi.edu. Guidance Documents Guidance for Data and Safety Monitoring Plans FDA Audit Preparation Resource and Checklist Inquiries and Requests for Support Please submit an ICTR Connection Request.

Combination Products


Definition Combination products are defined in 21 CFR 3.2(e). The term combination product includes: A product comprised of two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity; Two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products; A drug, device, or biological product packaged separately that according to its investigational plan or proposed labeling is intended for use only with an approved […]

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 Device Research


To request any of the templates below, please email our research navigators at ICTR_Navigators@jhmi.edu. IDE Application IDE Application Guidance and Template for Significant Risk Devices IDE Application Blank Template for Significant Risk Devices eCopy Instructional Checklist eCopy Instructional Checklist Letters of Authorization for 510(k) or PMA Guidance and Template for Letters of Authorization to 510(k) or PMA Protocol Development Resources Protocol Development Guidance for Clinical Investigations Using Investigational Devices Device Study Reporting Requirements NSR Device Reporting Requirements SR Device Reporting Requirements IDE Study Forms Device Accountability Log Inquiries and Requests for Support Please submit an ICTR Connection Request.

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 […]

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 defined as: At the preclinical stage (i.e. pre-IND or –IDE), a single investigational entity that may be composed of multiple components (i.e. drug and/or biologic and/or device) which are all required to achieve the desired effect. The investigational entity that is identified in a single IND or IDE application. An eight-hour consultation period is available free of charge for each project, as defined above. At the conclusion […]