Step 3: Study Startup

Study Startup at Northwestern University

After the protocol has received CRU approval, the following steps must be completed:

1. Obtain a Northwestern Memorial Hospital research account number.
2. Finalize research orders.
3. Schedule an in-service.

Helpful Information:

    Inpatient Study Checklist
    Outpatient Study Checklist

1. Obtain a Northwestern Memorial Hospital research account number:

a. The paperwork for this was probably initiated when you submitted your protocol via eIRB.
b. The NMH Office of Research will need the completed Research Protocol Review Form (RPRF) and Classification of Charges Budget Form (CCBF).
c. Contact Madeline Dones for more information.

    Madeline Dones
    mdones@nmh.org
    (312) 926-0051

2. Finalize research orders:

Your nurse liaison will assist you with finalizing research orders and scheduling an inservice:   
    
If your study is a core lab only study, contact Mariquita Sumague to arrange core lab research   orders:

    Core Laboratory Head Research Technologist
    Mariquita Sumague, C (ASCP)
    msumague@nmh.org
    (312) 926-3194 

3. Schedule an in-service:

An in-service is a chance for CRU staff to learn about the study and clarify questions. It is also an opportunity for the principal investigator and CRU staff to carefully review research orders for completeness.  In-services generally take about 30 minutes and are held in the break room on Feinberg 10.

Who should attend:

• CRU nurse liaison and relevant nursing staff (inpatient or outpatient).
• Laboratory staff, if applicable.
• Nutrition staff, if applicable.
• Principal investigator.
• Study coordinators.
• Research Subject Advocate.
• Ancillary staff (e.g. pharmacy), if applicable.

Be prepared to address the following:

• Purpose of study.          
• Patient population and number of subjects.
• Special instructions regarding subject care.
• When first subject is expected.
• Length of study, number of visits, estimated length of visit or admission, and probable time of day of visits or admission.
• Procedures: research orders, flow sheets and lab processing instructions.
• Special instructions regarding subject care.
• Who will conduct H & P and time frame (for IP visits).
• Information regarding any medications to be given.
• Ancillary involvement (radiation, cath lab, etc).
• Safety issues (fall risk, infection issues).
• Training needs of CRU staff.
• Parts of the protocol that are CRU vs. researcher responsibility.
• Plan for medical coverage.

What to bring to the in-service:

• One page study summary.
• Research orders.
• Flow sheets, if applicable.
• Lab processing instructions, if applicable.
• Study team contact list noting each person’s role, title, phone , pager and fax number.
• NMH research account number.

Post-In-service:

• Make final edits to research orders.
• Have PI sign the final orders and give to nurse liaison.
• E-mail final orders to nurse liaison.  
• Obtain sample registration forms from the nurse liaison.