Applying to Use the CRUs

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.

If you need assistance with your budget before you apply, please contact Shernice Madison at smadison@jhu.edu and 410-550-7033) or Nicole Cooper at ncooper2@jhmi.edu and 410-550-1880).

 


First Method

For investigators who apply to the School of Medicine IRB through eIRB.

  1. Begin by submitting an IRB application via the eIRB. When completing your application, you MUST answer “Yes” to Section 9, question #9- “Will you apply to the Bayview CRU or JHH CRU (includes NBRU) for funding or use of facilities? You must also complete Section 10- (Study Location), indicating ALL ICTR-CRU sites you plan to use.
  2. After you have submitted your eIRB application, please wait until you receive an eIRB confirmation that the request has been processed.
  3. Once you have received eIRB notification, please log on to CRUOnline. You will find your new application under the “My Protocols” menu option. Please upload ALL the necessary IRB documents and then follow the instructions online to complete and submit your CRU application. NOTE: If your CRU application is not listed under the “My Protocols” menu, please recheck your eIRB application to be sure Section 9 has been completed.

 

Second Method

For investigators who submit applications to other Johns Hopkins IRBs (Bloomberg School of Public Health, for example).

Please contact Shernice Madison in the ICTR CRU Administrative Office to start the process for generating a new application.

  1. Complete your IRB submission; many of the same documents you use for this process will be needed for your CRU application.
  2. Log on to CRUOnline. Choose the menu option “My Protocols”, and click on the “Add a New Application” button.
  3. Follow the instructions online to complete your application, and upload your supporting documentation.
    • You may save your work at any time as your work on your application.
    • The people you designate as Co-Investigators or Study Coordinators on your application will also have access to your draft application. That way, members of your study team can also work on your application.
    • Finally, you may have a Co-Investigator or Study Coordinator fill out a CRU Application on your behalf through CRUOnline.
  4. When you’ve completed the application, the system will allow you to submit it to the CRU and begin the review process.

Once your application is submitted, it will be pre-reviewed. You will be sent an e-mail detailing the changes necessary and/or questions to be addressed so that your study can be forwarded to the full protocol review committee to begin the Protocol Review Process.

 

How to Access CRUOnline

If you have any questions regarding the CRU application process, please feel free to contact us at 410-550-7033 or by email at crus@jhmi.edu.

 

 

The Review Process

All studies undergo an expedited review, which typically takes 2-4 weeks. The expedited review process consists of a review from CRU administration (Clinical staff, Research Participant Advocate, Administrative staff, and the Medical Director) to assess the feasibility of the study with respect to the ability of the CRU staff to safely perform all study procedures requested and the capacity of the unit to accommodate the volume of participants requested.

 

CRU Fees

All studies will be charges for CRU services used. For details on the these fees, view this page.

 

 

Once a study is fully approved a letter from the committee will be forwarded to the principal investigator. To check on the approval status, contact: crus@jhmi.edu