FAQs

FAQs for Sponsors

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).

1. What is the Johns Hopkins Clinical Research Network (JHCRN)?

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

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.

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Clinical Research Scholar

If I am offered an award but cannot accept, may I defer my acceptance to a year later?

No, but you are welcome to reapply during the following year.

Will I be at a disadvantage coming from a division where a Scholar already was selected?

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.

Is tuition paid by the grant?

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.

Are there exceptions to the 80% professional effort requirement?

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.

What is the purpose of the Johns Hopkins Clinical Research Scholars program?

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.

Can KL2 Scholars use other federal grants to support the other 20% of their salary?

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.

What career stage is appropriate for potential KL2 Scholars?

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.

Does receiving a KL2 award make one ineligible to apply for a future K08 or K23?

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.

How long are appointments in the Clinical Research Scholars program?

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.

May I apply if I do not have a faculty appointment yet?

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.

How may I find out if I’m eligible to apply?

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.

Will KL2 Scholars be given office space?

There is limited office space available for KL2 scholars in the program office, based on need and availability.

Am I eligible if I have already had a K23 award or another award?

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).

If I accept a position at another institution, may I transfer my KL2 award there?

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.

Am I eligible if I have a pending K application to NIH?

No, NIH policy does not permit multiple K applications under review simultaneously.

Are KL2 scholars eligible to apply for the NIH Loan Repayment Program?

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.

Are non-U.S. citizens eligible for this KL2 program?

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.

If I have additional questions that are not covered here, who can I contact?

You are hereby encouraged to contact Gregory Thornton, Program Manager, at gthornton@jhmi.edu or 410-614-3997.

How do I apply?

Application materials must be submitted via our online application system, located at http://jhcrs.jhmi.edu.

What is the timetable for applications and selection?

Applications are evaluated by a multidisciplinary selection committee based on prior training, research, and commitment to a clinical research career, as well as potential to excel. Reviews will take place in mid-to-late January, selected candidates will likely be interviewed in February and candidates will be notified of their status by mid-March. Applicants not selected to interview are removed from consideration and will not be waitlisted.

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Research Coordinator Trainings

Who will track the course completion?

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.

My research group has SOPs for clinical training. Do I need to replace those with this training?

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.

Can I watch the presentation again?

Yes….log on to MyLearning and click the training link for the course.

If I am audited, what specific documentation am I required to have?

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.

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!

What kind of compliance training would a summer volunteer need to take to work on our study?

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.

How do I know if a procedure is minimal risk?

You can consult with the IRB if you have a question about a specific procedure not listed in the training. 410-955-3008

How often does my research staff have to re-certify their training?

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.

Can the training be done online?

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.

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OpenSpecimen

Is there additional detailed information about the service?

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.

 

 

Does the OpenSpecimen Team offer storage for specimens?

The OpenSpecimen Team does not store specimens, but the following research cores have specimen storage facilities:

GRCF Core
Biorepository & Cell Center
https://grcf.jhmi.edu/biorepository-cell-center/
Director:  Melissa V. Olson, Ph.D.
410-955-6327, mvolson@jhu.edu

Johns Hopkins Biological Repository
Bloomberg School of Public Health
http://www.jhsph.edu/research/labs/biorepository/contact.html
Director: Dr Homayoon Farzadegan
410-955-3786, JHBRLab@jhsph.edu

Hopkins Conte Digestive Diseases Basic and Translational Research Core Center
http://jhugicc.org/GIConteCenter/pages/cores/translationalResearchEnhancementCore.html
Translational Research Enhancement Core (Biorepository)
Director: James J. Potter
410-614-0130, jpotter@jhmi.edu

Does OpenSpecimen support barcoding?

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.

Is OpenSpecimen web-based or platform-dependent?

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.

How much does OpenSpecimen cost?

OpenSpecimen is free to use for JHU SOM investigators and their teams.

Can I use OpenSpecimen if I currently use another database to manage biospecimens?

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.

Is OpenSpecimen integrated with Epic?

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.

Who has Super Admin privileges and how secure is my data?

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.

Could you tell what open source means? What does that mean for our study?

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.

Is there somewhere I could test OpenSpecimen publicly?

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.

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Center for Clinical Data Analysis

Who is the CCDA?

The Center for Clinical Data Analysis (CCDA) is one of the 10 Data Trust analytic teams responsible for assisting researchers with accessing clinical data for research. Additionally, we are one of the clinical research informatics cores under the Institute for Clinical and Translational Research.

What Services Are Provided?

  1. Preliminary, anonymous data for feasibility, grant applications and statistical population sample-size estimates
  2. IRB-approved case-finding for study enrollment (mailings, phone solicitation), chart review, and cohort/case-control studies
  3. 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.
  4. Research data extracts
  5. 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
  6. Honest Broker services
  7. Assistance using Epic’s SlicerDicer self-service tool

Why is There a Charge?

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.

Rates:

  • 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

Who Are Our Customers?

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.

 

Represents requests completed 7/1/2016-6/30/2017

 

 

 

What Data Sources Are Available?

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).

What Data Do We Provide?

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)

What Data Is Available in Epic?

Data availability in Epic depends on many factors, including clinic/location, specific data elements, and Epic go live at each location. See the graphic below for a timeline of available data.

How Do I Get Started?

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.

What Information Is Considered When Structuring a Request?

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!

 

How Can the CCDA Assist Me in Ensuring Compliance with IRB and Data Trust Best Practices?

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.

Data Trust Overview

SAFE Virtual Desktop

How Long Does a Project Usually Take?

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.

 

Represents requests completed 7/1/2016-6/30/2017

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JHCRN Quick Facts

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.

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.

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.

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).

Who are the network members?

JOHNS HOPKINS MEDICINE INSTITUTIONS:

  • The Johns Hopkins Hospital, Baltimore, MD
  • Johns Hopkins Bayview Hospital, Baltimore, MD
  • Howard County General Hospital, Columbia, MD
  • Sibley Memorial Hospital, Washington, DC
  • Suburban Hospital, Bethesda, MD,
  • All Children’s Hospital, St. Petersburg, FL

AFFILIATE MEMBER INSTITUTIONS:

  • Anne Arundel Medical Center, Annapolis , MD
  • Greater Baltimore Medical Center, Towson, MD
  • Inova Health System, Falls Church, VA
  • Peninsula Regional Medical Center, Salisbury, MD
  • Reading Hospital and Tower Health, Reading, PA

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.

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

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

What are the benefits of using the JHCRN?

We initiate introductions, aid in grant writing and, and help see your research through by providing:

  • Access to a large and diverse pool of patients,
  • Identification of local site collaborative investigator(s)
  • Assistance in setting up meetings
  • Provide information on the demographics, etc. of the population to be studied
  • Assist in grant writing, providing information about the sites and their relevance
  • Administrative help with arranging meetings, collecting biosketches and letters of support (draft, send, collect)
  • Draft recruitment strategies, budget justification, resources, etc.

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.

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.

Does the JHCRN have a site management plan?

Yes. It is available upon request.

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.

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 the quality and integrity of each study

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