FAQs for Sponsors
a. Study information (title, synopsis, patient population, eligibility criteria),
b. Funding information (if available),
c. Confidentiality Disclosure Agreement (CDA) template, and
d. Feasibility questionnaire.
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
• 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.
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.
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/.
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.
Yes. It is available upon request.
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.
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.
No. Payment to affiliate sites is managed by JHU.
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).
The Johns Hopkins Clinical Research Network is a regional translational research organization linking a preeminent academic medical center with a diverse network of community-based health care delivery systems. We collaborate with both the private and public sector to more rapidly and cost effectively expedite scientific discovery through clinical trials and comparative effectiveness research to improve the care and health of patients.
• JOHNS HOPKINS MEDICINE INSTITUTIONS:
o The Johns Hopkins Hospital, Baltimore, MD
o Johns Hopkins Bayview Hospital, Baltimore, MD
o Howard County General Hospital, Columbia, MD
o Sibley Memorial Hospital, Washington, DC
o Suburban Hospital, Bethesda, MD,
o All Children’s Hospital, St. Petersburg, FL
• AFFILIATE MEMBER INSTITUTIONS:
o Anne Arundel Medical Center, Annapolis , MD
o Greater Baltimore Medical Center, Towson, MD
o Inova Health System, Falls Church, VA
o Peninsula Regional Medical Center, Salisbury, MD
o Reading Hospital and Reading Health System, Reading, PA
Clinical Research Scholar
If we are funded, we anticipate appointing approximately 5 new scholars on July 1, 2015.
It varies from year to year but averages 33% for faculty that are eligible have completed all required components of the application.
Yes, of course you may reapply to the program. However, reapplying does not guarantee admittance.
No, but you are welcome to reapply during the following year.
No, all applications are evaluated individually on their merit. Given the quality of the applicant pool, awardees will need to exhibit extraordinary capabilities and potential no matter their department/division/school.
Yes, resources for tuition are available for scholars’ formal degree programs and approved courses that are in alignment with the scholars’ required curriculum, research training, and career development goals. Please be aware that tuition support paid on behalf of faculty is considered taxable income.
Yes, but this is extremely rare. Exceptions to the 80% effort requirement may be made for limited specialties (e.g., surgical specialties requiring greater clinical effort to maintain surgical skills), but any exceptions must be sufficiently justified and approved by both the program and our Grants Management Specialist at NCATS.
The Johns Hopkins Clinical Research Scholars program fosters the development of future leaders in clinical research to generate new knowledge to improve health. We do this by providing individuals with rigorous training leading to an advanced degree, helping them to develop and execute a research project, mentorship in a multidisciplinary and collaborative environment and involvement in career development activities.
No, KL2 Scholars may not receive salary support from other US Public Health Service sources (NIH, CDC, FDA, etc). Non-federal grants can be used to support the remaining effort. Grants from private foundations, voluntary organizations (Heart Association, Cancer Society), and professional societies are all acceptable.
Junior faculty (within their first 5 years) who are interested in developing academic and research expertise and plan to conduct, or are conducting, clinical research. If you are currently in your last fellowship year and have a pending faculty appointment beginning on or prior to July 1, 2015, you may be eligible.
No, appointed KL2 scholars may apply for K08 or K23 support. If successful, they move from one mechanism to the other. However, the total combined K award time can’t exceed 6 years depending upon the guidelines of individual institutes within NIH. The goal is to have KL2 awardees “graduate” as quickly as possible to NIH funding. Typically, this would be an NIH career development award in the K series.
Clinical Research Scholars is a three-year program with the KL2 award providing the first two years and the Scholars’ nominating department/division providing the third.
No, a faculty appointment in Medicine, Public Health, Nursing or Engineering is required for the KL2 appointment. If you are currently in your last fellowship year but will be appointed to the faculty on or before July 1, 2015, you will need to submit a letter from the department/division indicating this pending appointment in your application.
Please see our eligibility requirements. To be eligible for the KL2 award, each of the listed criteria must be met. We are committed to a program that embraces racial, ethnic, gender and disciplinary diversity, and we encourage applications from candidates with diverse backgrounds and clinical disciplines.
There is limited office space available for KL2 scholars in the program office, based on need and availability.
Individuals are not eligible if they have been PI on an R01 award, a subproject of a program project (P01) or center project (P50, P60, U54), a mentored career development (K) award, or other equivalent research grant. However, they are eligible if have had support from a NRSA (F or T) or NIH small grant (R03).
No, the KL2 is an institutional career development award granted to the Johns Hopkins Institute of Clinical and Translational Research. Awards are non-transferrable. Scholars who leave Johns Hopkins will have their award terminated and will not be able to continue to receive funding from the Clinical Research Scholars program.
No, NIH policy does not permit multiple K applications under review simultaneously.
Absolutely, many KL2 Scholars have successfully applied for the Loan Repayment Program. More information about this program is available at http://www.lrp.nih.gov.
U.S. citizens, permanent residents, and non-citizen nationals are eligible, but not those on temporary or student visas. Proof of status will be required prior to official appointment.
Research Coordinator Trainings
Links to online training are provided on the ICTR website. Skills should be practiced in a “hands on” manner and checklists require physically preforming the skill for a trainer to observe and check off.
Will staff receive a certificate upon completing the initial module? If so, where can this be downloaded?
Yes, a certificate is available and can be accessed on MyLearning.
Course completion for the brief module explaining the requirements will be tracked by the IRB through MyLearing. Specific skills training will be the responsibility of the PI and study teams.
First of all, GOOD JOB! No, if your research group provides training and documentation of that training you may continue with that process. The trainings and checklist provided here are for groups that do not already have a training and documentation plan in place.
Yes….log on to MyLearning and click the training link for the course.
You should have copies of 1) statement of the content of the training with the date of training for each skill (this can be a written statement including the name of the training and the link), 2) copy of a completed competency checklist for each skill.
We expect to have a student trainee perform basic assessments, (e.g., blood pressure, weight, temperature) for our study starting this summer. Where can I find criteria needed to assess his/her competency for each assessment?
Competency checklists are on the ICTR website for each skill.
If we train a study assistant to collect blood samples, is that person allowed to collect blood for other studies?
Yes- remember to keep a statement of the training and skills checklist on file!
That would depend on the skills they were going to use as part of the study. If they were doing Blood pressures you would need to have them complete training and competency for that skill. Remember, any person working with study participants must also be named on your IRB application as a study team member and take the required IRB training content.
Where can I get information on the specific policies in the clinical space I use to conduct my research?
You should ask the clinical manager in the specific area that you are working in.
You can consult with the IRB if you have a question about a specific procedure not listed in the training. 410-955-3008
There are no specific requirements for retraining. A good rule of thumb is every two years. If a staff member is not performing the clinical task often (say hasn’t drawn blood for a year) you should consider retraining and/or an updated skills checklist.
To view slides from the September 30 workshop, visit: An Introduction to OpenSpecimen
Presenters; Jim Potter, Matt Marcetich, Bob Lang, Jennifer Parks, Pam Murray and Diana Gumas; shared how OpenSpecimen can enhance the Precision Medicine Initiative.
The OpenSpecimen Team does not store specimens, but the following research cores have specimen storage facilities:
Johns Hopkins Biological Repository
Bloomberg School of Public Health
Director: Dr Homayoon Farzadegan
Hopkins Conte Digestive Diseases Basic and Translational Research Core Center
Translational Research Enhancement Core (Biorepository)
Director: James J. Potter
OpenSpecimen is free to use for JHU SOM investigators and their teams.
Yes. The OpenSpecimen team can help migrate legacy biospecimen data from another database. OpenSpecimen has MS Excel-based forms used to upload legacy data, and the OpenSpecimen team can help with arranging legacy data to fit these forms.
No, not currently. The OpenSpecimen team is working on integrating surgical pathology reports with the OpenSpecimen application to better facilitate annotation of specimens with specimen pathology diagnoses.
Only members of the OpenSpecimen Team have Super Admin privileges. Admin privileges can be granted to study PIs and other members of the study team at the discretion of the PI; additional users can be provisioned by the study team. Users can access data for their studies only.
OpenSpecimen is an open source web application developed by Krishagni Solutions, a software vendor. The application source code is freely available to download, install and even modify under the open source BSD 3-clause license (https://github.com/krishagni/openspecimen/blob/trunk/LICENSE.md). IT@JH has installed an instance of the OpenSpecimen application and underlying database on our own secure servers behind the Hopkins firewall. In other words, your data safely reside on JHU servers.
Yes. A public demo site (non-JHU) is available for testing here: demo.openspecimen.org, and you will be prompted to sign up for an account. JHU has a Test instance available, and the OpenSpecimen Team would be glad to set up a demo with you and explain further.
Yes. OpenSpecimen has a data entry field for barcode values. At this time, these values can be manually entered. Study teams have used second-party barcode software (i.e. BarTender) to print barcoded labels using data exported from OpenSpecimen.
OpenSpecimen is web-based, and the JHU instance resides behind JHU’s firewall. OpenSpecimen can be accessed on nearly any platform, but is best viewed using Google Chrome or Mozilla Firefox.
Center for Clinical Data Analysis
As part of our Honest Broker responsibilities, the CCDA will only deliver data extracts to secure locations approved by the IRB and Data Trust. We recommend requesting a SAFE Virtual Desktop when specifying the location for PHI storage and analysis. The SAFE is a Windows 10 desktop installed with statistical software including R Studio, SAS, Stata, MS Office productivity suite (Excel, Word, Access), and Python. By using this virtual desktop, you can ensure that the data we provide will be secure.
For more information on data trust and the SAFE Desktop, please refer to the following other informational pages.
As you can see in the graph below, a majority of the projects that the CCDA handles are small-medium sized, with a majority of time being spent on medium-large projects. The CCDA is happy to work with you no matter how complex your project is.
- Preliminary, anonymous data for feasibility, grant applications and statistical population sample-size estimates
- IRB-approved case-finding for study enrollment (mailings, phone solicitation), chart review, and cohort/case-control studies
- Natural Language Processing service–Text mining and information extraction methods to identify disease, medications, symptoms, and signs from clinical text, as well as artificial intelligence techniques for sentiment analysis, opinion mining, measuring cognitive ability, and exploring social determinants of health.
- Research data extracts
- Data de-identification services to confirm to HIPAA Privacy standards (link should be over HIPAA and be https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html
- Honest Broker services
- Assistance using Epic’s SlicerDicer self-service tool
We have built an infrastructure that enables data through a secure, repeatable process that meets your needs, the institution’s values, and applicable privacy and security laws and policies. We looked at how comparable research institutions met this demand, and determined to pursue this approach. Similar to the 20+ other service centers at JHU such as the Genetic Core, the Biological Repository, and the Training and Management Development programs, we have developed a no-profit, revenue neutral approach that aims to provide high quality, lowest possible cost service to the research community. This hourly cost includes analysts, database administrators, servers, software, and management.
- First two hours of guidance and feasibility – No Charge
- Analysis and data extract services for IRB-approved research – $84/hour ($100/hr for senior staff)
- Analysis and data extract services for quality improvement – $114/hr
- Ongoing maintenance of established periodic extracts – factored into initial cost
Our customers can include researchers’ IRB-approved research studies, including, but not limited to researchers from the School of Medicine, School of Public Health, and the School of Nursing.
Our team is comprised of trained data analysts with access to multiple data sources including Epic, CaseMix/Data Mart, EPR2020 (Electronic Patient Record), Clinical Research Management System (CRMS), and Sunrise Clinical Manager (POE).
Frequently requested data elements include:
- Demographic data (age, gender, race, ethnicity, contact information)
- Encounters/Visits (dates/times, locations/clinics, visit providers)
- Diagnoses (problem list, recorded at the encounter, billed)
- Lab Results
- Medications (ordered, administered, patient-reported)
- Procedures (surgical, imaging, etc.)
- Flowsheet variables (vitals, etc.)
- Questionnaires (Depression screening, surveys)
To get started you can submit a request to our team using the iLab portal (https://johnshopkins.corefacilities.org/service_center/3796?tab=requests). Please click the login button on the top-right of the window; then, select “JHU user”. The CCDA manager will contact you within two business days to schedule a brief intake meeting to discuss your specific requirements.
In order to prepare for your initial intake meeting, it is often helpful to consider the following components regarding the specific data elements of interest: who, what, when, where, and how often. Please see the graphic below for more information about how to turn your high concept into an actionable request!