Category Archive: 2017 Programs and Resources

Training Video Library

The Participant Recruitment and Retention Program has compiled training videos that address common recruitment challenges. Research teams are encouraged to use the information to enhance their recruitment efforts. Note: Some of the materials require a JHED identification to access. Recently Added Talks Building Trust, Engaging Communities & Disseminating Results Measuring the Impact of Recruitment Efforts Electronic Recruitment Methods Digital Recruitment Practical Guidance on the Use of Social Media for Recruitment Community-Engaged Recruitment Innovative Tools to Reach Participants Prior Trainings Budgeting Budgeting for Recruitment  Communication Skill Building Communication Skills to Enhance Recruitment, Part 1 Communication Skills to Enhance Recruitment, Part 2 … Continue reading

Research Participant Recruitment & Retention Support

This program offers investigators and research teams training, consultations and a toolkit of evidence-based, field-tested recruitment practices. Services have been developed and offered in collaboration with experts in information technology, ethics, and patient and community-engagement. Each year, workshops, hands on seminars, and customized support are provided to help researchers achieve their recruitment goals. This includes a broad range of federally funded, multi-site clinical trials and research programs funded by patient and community organizations.

Community & Stakeholder Engagement

  The Community Engagement Program of the Johns Hopkins Institute for Clinical and Translational Research aims to bring researchers, diverse communities, and stakeholders together to share their knowledge, skills and resources with a common goal of improving community health. Community Engaged Research Training We offer introductory and advanced training in community engaged research.  Training topics include:  Planning and evaluating community engagement in research; disseminating research findings to the public; building and sustaining research partnerships. All training is delivered by Johns Hopkins faculty and staff in collaboration with the Community Research Advisory Council. The council includes academic researchers, health care professionals … Continue reading

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: 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 … Continue reading

Biostatistics Program

Submit Request & Join Our Listserv All Clinical Research Unit protocols are reviewed by a member of the Biostatistics Core prior to approval, and consultations with a Core biostatistician are strongly encouraged for all investigators who do not already have biostatistical support as part of their funded protocols. In conjunction with the Biostatistics Center, ICTR offers researchers access to a research-related consulting service. The goal of the service is to promote the appropriate use of biostatistics in the design, implementation, and interpretation of clinical and translational research studies. The Biostatistics Center supports JHU faculty with primary appointments by providing a maximum … Continue reading

Genetics Translational Technology Program

The Genetics Translational Technology Program bridges the gap between clinical genetic testing and research-driven molecular technologies with consulting and laboratory services and assistance with translation of molecular technologies to the clinical environment. The program provides: A consultation for the development and conduct of genetic based sequencing and diagnostic assays for clinical testing Clinical assay development services Exome and whole genome sequencing using next generation sequencing (NGS) technologies Partnership with the Kennedy Krieger Institute’s Cytogenetics Laboratory for SNP Array Analysis   Click here to submit an ICTR Connection Request  

Template Documents for Regulatory and Participant Binders

To request any of the templates below, please email our research navigators at 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 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 … Continue reading

Investigational Botanical Drug Products

To request any of the templates below, please email our research navigators at Guidance and Templates 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 Guidance and Templates 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.