Category Archive: Child of Programs & Resources

Informatics Core (i2C)

Data Management/Quantitative Methodologies

Our Quantitative Methodologies team provides resources for quantitative scholarship and services for researchers through biostatistics, epidemiology and research design and computational biology and medicine. We follow best reproducible research practices when developing statistical products for our clinical and translational colleagues. This includes: Preserving raw data and making modifications using syntax files so that changes are documented Use of computer programs that integrate statistical code with word processing packages Creating well documented ‘macros’ and memos that annotate the major analytical steps and scientific decisions made in collaboration with the investigator. We maintain state of the art high performance computing systems allowing … Continue reading

Regulatory Support

The ICTR offers education, expert advice and resources to better equip study teams to conduct research that is ethical, relevant and responsive to the interests of patients and research participants. Our Research Participant Advocacy program provides consulting on human subjects and regulatory issues, including IRB applications, the informed consent process, study feasibility and good clinical practices. Our advocates help to ensure the rights, safety, and well-being of participants. We also provide consultations to assist investigators in resolving ethical issues throughout the entire research process and tools to recruit study participants. Our Drug and Device Resources Service provides tools needed to … Continue reading

Lab Resources

The ICTR laboratories provide coordinated help across several related programs, all focused on the foundational components required to effectively translate new drugs, biologics, vaccines, devices, biomarkers and diagnostics into clinical trials and eventually clinical practice. Program

The program will assist investigators with: The ethical, scientific and legal reasons for clinical trials registration and reporting Which trials are required to be registered and the timelines Tips, tricks and helpful content to improve the process Up-to-date information on institutional and federal policies Direct effort upon request (billable/hr.) Please see the following publication, supported by the ICTR, detailing survey results of academic organizations: Mayo-Wilson E, Heyward J, Keyes A, Reynolds J, White S, Atri N, Alexander C, Omar A, Ford DE, on behalf of the National Clinical Trials Registration and Results Reporting Taskforce Survey Subcommittee.  Clinical trial registration … 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.

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