Research Navigators

The Navigators regularly receive questions covering a wide range of topics about conducting research studies at Johns Hopkins. It is not uncommon for multiple investigators to submit the same query or raise issues that others in the research community would want to be aware of. Among the inquiries that were submitted to the Navigators during the month of May, we believe that the following would be of interest to you:

I am preparing a budget for a clinical trial with a commercial sponsor.  Is there help available for:

• Creating an accurate and comprehensive budget that includes ALL costs related to a study
• Negotiating the budget with the sponsor

Clinical Research Support Services (CRSS), an office within the Johns Hopkins SOM Office of Research Administration, can provide this help. A detailed description of their Clinical Trial Review Process can be found here. 

There are 2 major steps:

1. Determine if a Prospective Reimbursement Analysis (PRA) is required for a study and carry out the analysis when needed. The purpose of the PRA is to identify study related cost and whether or not they are billed to the sponsor or the patient    

Every protocol reviewed by the Johns Hopkins Medicine IRB is subject to a PRA determination, though teams may email [email protected] to request that this step be started prior to eIRB submission.

Study-related documentation that must be available for CRSS review during the PRA process includes  but is   not limited to: the protocol; investigator’s drug brochure; informed consent form; and contract or grant. 

2. Draft the clinical budget, including PRA costs when applicable, and negotiate final approval with the sponsor

The team first reviews the CRSS provided Budget Checklist and CRSS Budget Template to identify the information that must be available to develop a budget.

After all the information that is required to create a study budget per the CRSS’ Budget Checklist and Budget Template has been obtained, a request for assistance with budget development and negotiation is emailed to [email protected]. 

CRSS’ draft budget will be forwarded to the Principal Investigator and study team for review and approval. Upon internal budget approval, negotiations will begin with the PI and study team copied on all correspondence to the sponsor.

Questions and/or concerns related to Prospective Reimbursement Analyses and/or budget development should be directed to Clinical Research Support Services at 410-361-8372 or [email protected].

The Navigators regularly receive questions covering a wide range of topics about conducting research studies at Johns Hopkins.  It is not uncommon for multiple investigators to submit the same query  or raise  issues  that  others in the research community would want to be aware of.  Among the 19  inquiries that were submitted to the Navigators during the month of April, we believe that the following would be of interest to you:

Is it possible to hire for temporary employment   an individual who has already received study coordinator training?  

Two options are  available to identify potential  candidates for this type of position:

1. The Research Coordinator Support Service (RCSS).

Formerly known as the Study Coordinator Apprenticeship and Mentoring Program (SCAMP),  RCSS is a fee for service program (see RCSS site for current rates) that provides research coordinator support on a temporary basis. RCSS coordinators  are trained to manage a wide range of responsibilities which can be customized to best fit  the needs of individual research teams. 

Requests for support  are submitted via the ICTR Service Request Portal. 

Questions about  using this service can also be submitted to the ICTR Service Request Portal, as well as emailed to Anthony Keyes, MBA, Assistant Director ([email protected]) or Mais Hamdawi, MD, Sr. Research Program Manager, ([email protected] )

2. Medasource

Medasource is a Clinical Research consulting and support firm that  includes Johns Hopkins among the  over 150 research institutions, health systems, academic medical centers, and pharmaceutical companies with whom they partner to  provide  short-term and long-term support in a wide range of  areas. The expertise that is available includes but is not limited to :

• • Research administration (pre and post award)
  • Clinical Trial Project Management
  • Clinical Trial Contracts and Finance
  • Regulatory compliance
  • Medical and Scientific writing
  • Data management

The workflow followed to hire staff from Medasource, is shown here.

All questions about using this resource should be directed to  the Office of Clinical Trials at [email protected]

The Navigators regularly receive questions covering a wide range of topics about conducting research studies at Johns Hopkins. It is not uncommon for multiple investigators to submit the same query or raise issues  that others in the research community would want to be aware of. Among the 24 inquiries that were submitted to the Navigators during the month of  March we believe that the following  would be of interest to you:

I am interested in using Epic’s  SlicerDicer self-service tool  for getting rough patient counts to  determine if a study is feasible. Are there any training  materials available ? 

Information about generating reports with SlicerDicer  can be obtained from  2 sources:

1. The “Fundamentals of SlicerDicer” E-Learning course is accessed from the myLearning website.

This course takes approximately 30 minutes and is designed to familiarize the user with  basic SlicerDicer features and functionality, including:

• Populations
• Data Models
• Criteria
• Slices
• Measures
• Visual Options
• Creating a query

2. Health IT maintains a comprehensive portfolio of resources (documents, PowerPoints and videos) that covers a wide range of topics associated with SlicerDicer reporting. It  can be accessed from  Health IT’s Education Portal on SharePoint. Select “Search the Portal” option and search  using the keyword “Slicer”.

The Navigators regularly receive questions covering a wide range of topics about conducting research studies at Johns Hopkins. It is not uncommon for multiple investigators to submit the same query or raise issues that others in the research community would want to be aware of. Among the 15 inquiries that were submitted to the Navigators during the month of February, we believe that the following would be of interest to you:

My study will be enrolling healthy volunteers, who will be required to provide blood samples. How can I arrange to have these blood draws done? 

With a population of healthy participants, there are 3 options for obtaining research bloods:

• ICTR Clinical Research Units (CRUs)

Phlebotomy services for both pediatric and adult patients are offered at designated CRU locations.

• ICTR Research Coordinator Support Service (RCSS)

Research coordinators who can be hired on a part-time basis through the RCSS, receive some training in clinical skills, which includes phlebotomy.

• ICTR Research Onboarding Personnel Onboarding Program

Your own study team members can receive training in phlebotomy skills through this program.

Please navigate to each program’s website for information about:

• Contacts for questions
• Current fees and charges for using the provided services
• Submitting a request to obtain services

The Navigators regularly receive questions covering a wide range of topics about conducting research studies at Johns Hopkins. It is not uncommon for multiple investigators to submit the same query or raise issues that others in the research community would want to be aware of. Among the  inquiries submitted to the Navigators during the month of January, we believe that the following  would be of interest to you:

I am using eFormS to submit my secondary research protocol for JHM IRB approval. Even with the sample text and examples provided in the “instructional template” version of this form, I’m  still not certain if I am using that information to correctly describe what will be happening in my study.  Is there someone who can help me?

Because the IRB is responsible for determining which regulatory requirements will apply to the data being used in your study, their staff  are in the best position to provide you with the most accurate responses to your questions.

You can submit a request to arrange a complimentary, one-on-one meeting with one of the IRB staff  to discuss this matter here.

The Navigators regularly receive questions covering a wide range of topics about    conducting research studies at Johns Hopkins. It is not uncommon for multiple investigators to submit the same query or raise issues that others in the research community would want to be aware of. Among the inquiries that were submitted to the Navigators during the month of  December, we believe that the following would be of interest to you:

I am planning on using services offered by the ICTR on my  next grant. How can I request a letter of support to include in the application?

• • From any ICTR webpage, navigate to the left side of the lower border on that page and  select the “Letters of Support” button.

    NOTE: This link  may not work  if using a computer that cannot  operate behind the Hopkins firewall. 

  • Complete the Request for ICTR Letter of Support for Grant Applicants form that uploads and select the “Submit” button when finished.
  • Within five business days you will be emailed a link to your printable letter.

It is not uncommon for multiple investigators to submit the same query or raise similar issues that others in the research community would want to be aware of. Here are our top inquiries for the month of November that we believe would be of interest to you:

1. “How do I get help from a biostatistician?”

• • Consultations with the Biostatistics and Study Design Program are requested by completing the form provided in the ICTR Service Request Portal.
  • As shown below, on the second half of the form, prior to the submit button, select “Biostatistics Consulting” under the “Analysis/Biostatistics” heading.

2. “I submitted a request for a consultation with the Biostatistics and Study Design Program, but no one has gotten back to me yet.”

• • The ICTR Navigators can confirm if your request was successfully placed through the ICTR Service Request Portal.
  • Waiting at least 7-10 business days for a response can occasionally occur when a larger than expected number of consultation requests are placed.
  • A Research Navigator will follow-up with the program’s administrative unit to inquire about any delays lasting  longer than 10 business days.