1.  We have added additional tests or procedures to the protocol since SAC approval, who do I need to contact about this?

Barbara Bellg, the Administrative Director, and your nurse liaison.  The budget and orders will have to be revised to insure that they reflect what is actually happening.

1. How do I get a NMH Research account number?

• Contact Thomas Akompong (takompon@nmh.org) in the NMH Research office to obtain the submission form. 
• After you complete it, have the GCRC Administrative Director initial the final GCRC budget.. 
• Have the GCRC nurse manager sign the correct department charge form. 
• Submit the form to the NMH Research office.  They will process the form and send you a Research account number. 
• Send this number to the GCRC Administrative Director and the Unit Secretary.

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1. Does the GCRC really need copies of ALL of the things we submit to the IRB?

Yes, you can e-mail or send a copy of ALL IRB submissions and responses to the Research Subject Advocate (RSA) or her assistant.

1. Does the GCRC really need a copy of the CITI certificate for each person listed as key personnel?

Yes, it is a NIH requirement.  Once we have a certificate on file, you don’t have to re-send the certificate.  Send the certificates to the RSA or her assistant.

EXCEPTIONS: 

• If the researcher is a CMH investigator, only an NIH education certificate is needed.
• If the NU IRB doesn’t require a CITI certificate for a researcher, just forward this waiver to the RSA.
• If the researcher is at another institution, their institution’s training certificate will suffice.

1. What is a Data Safety and Monitoring Board (DSMB)?

• An independent board of scientists and statisticians who closely monitor a high risk study for safety and efficacy.
• NIH requires that all GCRC studies with ‘significant risk’ have a DSMB.
• Industry sponsors, research associations (e.g., American Lung Association), and some NU departments (the Cancer Center) provide DSMB’s for high risk studies.

1. What information does the RSA need about a protocol’s DSMB?

• The DSMB charter (how often the board meets).
• The composition of the DSMB (who is on the board).

1. Why does the RSA ask the researcher to make language changes to an IRB approved consent form?

• The NIH wants RSA’s to review consent forms and make suggestions on how to make the consent forms simpler and more subject friendly.
• The requested changes can be made the next time an IRB submission (revision, periodic review, etc) is made.
• The RSA is also working with the NU IRB to simplify the language in the IRB consent form templates.

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1. I have SAC approval, now what do I do and who do I contact?

Contact Marcia Phillips, the Nurse Manager, to find out who your nurse liaison will be so you can send her the draft orders and flow sheet as well as any lists of special materials.  Marcia and the nurse liaison can help you arrange the in service.

1. How long will it take from SAC approval to running my first subject?

Study start-up time can range from 2 to 6 weeks depending on the complexity of the study. Sometimes issues concerning finalizing the budget, working out details with other departments (e.g., interventional radiation or pharmacy), equipment training, and writing up orders and flow sheets can delay study start-up.

1. Where can I find instructions on how to write the orders?

Check under Information for Investigators on our GCRC web-site: http://www.feinberg.northwestern.edu/gcrc/investigators_info.html  for the Investigator Manual which outlines what should be included in the orders and the flow sheet as well as provides sample orders and flow sheets.

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1. I e-mail my inpatient scheduling request to the GCRC and then it takes forever to hear back, how can I speed this up?

• E-mail both, the Nurse Manager, Marcia Phillips and Joan Pasquesi with scheduling requests. Joan works Tuesday, Thursday and Saturday.
• Include the protocol number and submit several possible dates so that if the first option doesn’t work, you won’t waste time submitting other possible times.
• Be specific about the length of stay and the approximate time of admission and discharge.
• Have your phone number and pager number in the e-mail or another person to contact if you will not be available.  

1. How can I get a subject scheduled?  Every time I call the days I want are booked.

We do our best to accommodate requests but our high volume of visits and the high

acuity of many protocols limits our openings.

• To schedule subjects for inpatient beds, e-mail Marcia and Joan (above) two to three weeks in advance, especially if you have a long stay or complicated schedule request.
• To schedule subjects for outpatient visits call Jacqui, the unit secretary, more than one week in advance, earlier for outpatient visits that stay longer than four hours.
• Remember to give several possible dates so if the first option doesn’t work, you have back-up dates.
• There is always a possibility we may have last minute cancellations and be able to accommodate a few days prior. 

1. Where can I find the subject reservation forms?

The forms are on our web-site:  www.feinberg.northwestern.edu/gcrc under

Information for Investigators.

1. What can I do to get subjects to show up for their appointments?

• Make sure you have current contact information for your subjects, call to remind them about their appointment and verify they are coming.
• Provide whatever information the subjects need to get to the visit.  For instance, clear driving or mass transit instructions, information on parking reimbursement, and where the GCRC is located in the hospital.
• Try to schedule the visit for a time that will easily fit into the subject’s schedule.
• Try to develop rapport with the subjects so they are more likely to either attend the visit or to tell you that they aren’t interested.
• Be sure to give them your contact information and the GCRC phone number.

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1. What do I need to take to the inservice?

Make ten copies of the following:

·        One page study summary

·        Physicians orders

·        Flow sheets (if applicable)

·        Study team contact list noting each person’s role, title, phone , pager, & fax numbers

·        Special instructions regarding patient care

·        Information on any medications to be given

1. If I have a site visit, who do I contact to arrange a tour or meeting?

Contact Marcia Phillips and your nurse liaison to make arrangements.

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