Tag Archive: Clinical Research

Service Request: Clinical Research Unit (CRU) Online


All investigators must submit an application to a Johns Hopkins Institutional Review Board (IRB) before beginning their ICTR Clinical Research Units (CRUs) application. There are two ways to submit an application to the ICTR Clinical Research Units (CRUs)– one method applies if you are using the School of Medicine eIRB system, while the second applies if you have submitted to another Johns Hopkins IRB. Please read through the materials below. First method: For investigators who apply to the School of Medicine IRB through eIRB. Begin by submitting an IRB application via the eIRB. When completing your application, you MUST answer “Yes” to … Continue reading

Service Request: Core for Clinical Research Data Acquisition


The Core for Clinical Research Data Acquisition (CCDA) assists researchers with accessing clinical data for research purposes. Services include: Preliminary, anonymous data for feasibility, grant applications and statistical sample-size estimates IRB-approved case-finding–for study enrollment (mailings, phone solicitation), chart review, and cohort/case-control studies Research data extracts – monthly/quarterly integrated extracts from Epic, EPR, Sunrise/POE, and CaseMix/Data Mart The CCDA is staffed with experienced data analysts who will assist you with access to data while also helping you comply with Data Trust privacy and security regulations. Here is how it works: Submit a request for CCDA services using our new iLab application: … Continue reading

ClinicalTrials.gov Program


The ClinicalTrials.gov 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

Study Team Training and Resources


Helpful resources for teams looking for tools, information on various research topics and a comprehensive list of available training for study teams, including clinical trainings for non-clinical staff.

Protection of Patient Data


Johns Hopkins has multiple IT policies regarding the protection of patient data. Diana Gumas, Senior Director for Clinical Research Information Technology, is responsible for working with the Johns Hopkins Medicine Data Trust, the Institutional Review Boards, and the clinical research community to facilitate compliance with policies and address and resolve special data protection needs. The goals of our data protection policies are to ensure compliance with all applicable federal, state, and local law; to safeguard and protect all IT Resources from anything other than authorized and intended use; and to provide protection to academic, clinical, financial, research, and all other … Continue reading

Training


This page contains information on various research trainings. Please click on the plus sign for details. [ External website = ]

Anne Arundel Health System


Anne Arundel Medical Center (AAMC), a regional health system headquartered in Annapolis, Md., serves an area of more than one million people. Founded in 1902, AAMC includes a 385-bed not-for-profit hospital, a medical group, imaging services, a substance use treatment center, and other health enterprises. In addition to a 57-acre Annapolis campus, AAMC has outpatient pavilions in Bowie, Kent Island, Odenton and Waugh Chapel. Clinical Research at Anne Arundel Medical Center starts with the dedicated physicians, nurses, and other medical professionals whose interests include the advancement of medical science. It comes together with the support of our team of professional … Continue reading

Peninsula Regional Medical Center


Peninsula Regional Medical Center (PRMC) in Salisbury, Maryland offers the widest array of specialty and subspecialty services on the Delmarva Peninsula. At 275 acute care beds, PRMC is the region’s largest, most advanced tertiary care facility, and has been meeting the healthcare needs of Delmarva Peninsula residents since 1897. Its 3,300 physicians, staff and volunteers provide safe, compassionate and affordable care designed to exceed the expectations of the nearly 500,000 patients who rely on the Medical Center team each year for inpatient, outpatient, diagnostic, subacute and emergency/trauma services. It is the region’s oldest healthcare institution with the most experienced team … Continue reading

Inova Health System


The addition of Inova Health System of Northern Virginia and its five major hospitals provides yet another strength to the Johns Hopkins Clinical Research Network in terms of established research programs, patient population and specialty collaborations, especially in the area of pediatrics, neurosciences, cardiovascular, oncology and genomics medicine. Dr. John E. Niederhuber, Inova’s EVP and CEO of the Inova Translational Medicine Institute and Professor of Oncology and Surgery at the Johns Hopkins University School of Medicine, is co-director of the Johns Hopkins Clinical Research Network and sits on the Executive Committee of the JHCRN. Dr. Niederhuber was formerly Director of … Continue reading

For Sponsors


The Johns Hopkins Clinical Research Network offers industry a unique opportunity to conduct clinical research studies in the Mid Atlantic U.S. region. The following Frequently Asked Questions are intended to provide information for sponsors.

2. Who should sponsors and CROs contact if interested in bringing a study to the JHCRN?

The Johns Hopkins Clinical Research Network can be contacted by any of the following:

• Website: http://ictr.johnshopkins.edu/service/JHCRN
• Phone: 443-287-4000
• E-mail: jhcrn@jhmi.edu
• Director: Dr. Adrian Dobs: adobs@jhmi.edu
• Co-director: Dr. John Niederhuber: John.Niederhuber@inova.org.

3. What information should sponsors and CROs provide for the JHCRN to consider a study?

a. Study information (title, synopsis, patient population, eligibility criteria),
b. Funding information (if available),
c. Confidentiality Disclosure Agreement (CDA) template, and
d. Feasibility questionnaire.

4. How do JHCRN sites decide which studies they would like to participate in?

Each site will review study materials and make a decision regarding their participation based on the following criteria:

• Study population,
• Site resources,
• Investigator interest and experience,
• Protocol complexity, and
• Funding

5. What are the benefits of using the JHCRN?

• One dedicated experienced Network Coordinator for each JHCRN site,
• Access to a large and diverse pool of patients,
• One prime contract with Johns Hopkins,
• One main IRB, Johns Hopkins Medicine IRB, and
• One budget.

6. What is the Network Coordinator role?

Each JHCRN site has an assigned network coordinator who liaisons between the Johns Hopkins investigator, JHCRN site investigator, and their respective research teams. Responsibilities include:

• Facilitating the identification, prioritization, and implementation of clinical trials jointly approved by JH and network site investigators,
• Developing and implementing effective workflow processes between JHU and the network site in opening research studies, and
• Serving as a main point of contact for both institutions.

7. How do sponsors and CROs identify a principal investigator for a study?

A JHCRN network coordinator can help you identify a JHU principal investigator. Coordinator contact information can be found at: http://ictr.johnshopkins.edu/clinical/clinical-resources/human-subjects-research-core/jhcrn/jhcrn-network-coordinators/.

8. Does each JHCRN site have its own principal investigator?

There is one principal investigator for each study who is a Johns Hopkins employee. A lead site investigator is designated at each JHCRN site who is accountable for local study oversight under the direction of the Johns Hopkins principal investigator.

9. Does the JHCRN have a site management plan?

Yes. It is available upon request.

10. How does the principal investigator oversee study conduct at JHCRN sites?

The Johns Hopkins principal investigator and lead site investigator(s) communicate regularly about all study activities to ensure quality and integrity of each study.

11. Who takes responsibility for reporting adverse events from the Network sites to IRB, sponsor, and other regulatory agencies?

The site investigator notifies the principal investigator (PI) of any event meeting expedited reporting requirements as soon as possible. Event reporting to sponsor will first be completed by the principal investigator or site investigator. The PI will determine this reporting responsibility at the onset of a study, and also report to the JHM IRB, and other regulatory agencies as required.

12. Who does the sponsor and CRO correspond with at the affiliate sites, the JHCRN network coordinator or research staff?

Prior to study start-up, the network coordinator will be the main point of contact to help research staff get started. The network coordinator may have some contact with the sponsor/CRO after start up, but it is preferred they correspond with the research staff directly.

13. Do sponsors and CROs negotiate budgets and contracts with each JHCRN site?

No. There is one budget and one contract between sponsor and JHU that includes costs for the JHU principal investigator and JHCRN site(s). A JHU budget specialist develops and negotiates all study budgets for the JHCRN.

15. Where does monitoring take place and where are regulatory documents kept?

Routine study monitoring occurs at both the main Johns Hopkins central site as well as at each participating JHCRN site. The sponsor’s monitor arranges visits with individual sites on mutually convenient dates. Regulatory documents are maintained by the PI’s team at Johns Hopkins for all participating JHCRN sites.

16. Who ensures research staff at JHCRN sites are appropriately trained in the conduct of human subjects’ research?

The Johns Hopkins Medicine IRB requires human subjects research compliance training, both initial and continuing, be completed by each investigator and other study team member(s).

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Research Coordinator Clinical Trainings


The ICTR has secured training  modules for the most common training needs and provides competency checklists for each skill in the content below. If you have questions please review the FAQ on this page. If your research group does not have the resources to provide clinical skill training and skills check off, this is available on a first come first serve basis through the Clinical Research Units. (see contact information at the bottom of the page.) Height and Weight Download Competency Checklist Link for Online Height and Weight Training Specimen Collection: Midstream (Clean-Voided) Urine Download Competency Checklist Link for Online … Continue reading