Tag Archive: Connection Request

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 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.

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 […]

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 […]

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, biologics devices and software in clinical research. The DDRS offers the following: DDRS Consultation Service This service includes a complimentary eight-hour consultation for those seeking help with managing the external (i.e. FDA) regulatory requirements of their research projects. For assistance, please submit an ICTR Connection Request . Read more. Drug and Device Resources Information about complying with and managing the regulatory requirements for studies with investigational drugs, biologics, devices and software, […]