Clinical Studies Resources

Resources for Clinical and Behavioral Research Studies

The following is a list of resources provided for Investigators and research personnel conducting clinical and/or behavioral research studies at Lurie Children's. For more information about each service, and the requirements for submissions, please click on the links and/or contact information provided. 

Educational Resources for Clinical Researchers

  • For more information about Human Subjects Research (HSR) and Good Clinical Practice (GCP) Education and Training requirements please visit the IRB Education page.

Research Safety Reviews

Research at Lurie Children's that includes one or more of the following procedures require written approval prior to the enrollment of participants. This written approval is required to be uploaded with the Initial Submission application in Cayuse IRB.

Radiation Safety Committee (RSC)

Studies which involve administration of radiopharmaceuticals or radioactive materials when the radioactive drug is experimental or is administered for research purposes only. If the research uses ionizing radiation without direct clinical indication, this also requires RSC approval.

Institutional Biosafety Committee (IBC)

Studies which involve administration of recombinant and/or synthetic nucleic acid molecules for research purposes.

​Research Support Services

Research at Lurie Children's often requires collaborations from multiple services, departments, or committees. Letters of support (LOS) and/or reviews may be required prior to enrolling participants in research when using these support services. Please follow guidance provided by these support services for requesting their written support and/or review of your research protocols. 

Investigational Drug Service (IDS) Pharmacy

Studies that involve preparation, storage or dispensing of investigational medications, devices or biologics will require a written LOS. Please complete the LOS form and send to the IDS Pharmacy email.

Once you have received IRB approval and the IDS pharmacy LOS, please follow these steps to activate the study with IDS pharmacy:

  1. Set up Site Initiation Visit (SIV) with sponsor. If no sponsor, set up meeting/phone call with CRP and IDS pharmacy
  2. Provide fund number, most up-to-date protocol, Investigational Brochure (IB) and pharmacy manual to IDS pharmacy
  3. Inform IDS pharmacy of approximate start date of study
  4. Inform IDS pharmacy of patients and appointments dates/times (as soon as appointments are made)

Clinical Research Unit 

Studies requiring the use of CRU space and/or CRU personnel to support study visits will require written LOS. 

Once you have received IRB approval and the CRU LOS, please follow the CRU Activation steps listed on the CRU AllConnect Site to activate your study.

Medical Imaging Research

Studies which will include imaging such as x-rays, MRI/CT scans, etc. for research purposes, and/or deviation from the Medical Imaging standard of care imaging protocols, and/or research imaging that is not being billed to patient insurance will require written LOS. To request an LOS, please complete the "Medical Imaging Application Form", which can be found on the Medical Imaging Research Page. The LOS from the Medical Imaging Department is for the support services within Medical Imaging. If anesthesia is required, the study team will need to reach the Department of Anesthesia seperately for a LOS.

Once you have received IRB approval and the Medical Imaging LOS, please send a copy of the IRB approval letter and the fund number to the MI Research Email to activate the study.

Research Laboratory and Department of Pathology

Studies requiring the Research Laboratory to handle, process and ship samples to external entities, test any specimens, and/or will request and utilize samples from Pathology require written LOS. To request an LOS, please complete the LOS form which can be found on the Research Laboratory AllConnect page.

Once you have received IRB approval and the Research Lab LOS, please follow these steps to activate the study with the Research Lab:

  1. Send the IRB approval letter and the fund number to Research Laboratory email.
  2. Complete the blue requisition request form found on the Research Laboratory AllConnect page.

Cardiopulmonary Lab

Studies that involve cardiology or pulmonary testing for research purposes require a written LOS. To request an LOS, please complete the Cardiopulmonary Research Lab Application

Once you have received IRB approval and the Cardiopulmonary LOS, please send a copy of the IRB approval letter and the fund number to the Cardiopulmonary Email to activate the study.

Infection Prevention and Control 

Written support is required when studies 1) utilize equipment/instrumentation (provided or purchased) that will be used on more than one patient including items that requires sterilization/disinfection before first time use, and/or 2) that involves the administration of a microorganism or a product that contains one or more microorganisms (i.e., bacteria, fungi, or virus; even if attenuated/non-replicable) to a participant.

Nursing Research Council 

Written support is required when studies focus primarily on the nursing profession, nursing care, or includes nurses (APN's or RN's) as the study population and the Principal Investigator or Sub-Investigator is an Advanced Practice Nurse (APN), Registered Nurse (RN) or Nursing Student 

Pediatric Intensive Care Unit (PICU)

Studies that will directly recruit from the PICU or utilize PICU services or staff for research purposes require a written LOS. To request an LOS, please complete the PICU Application Form.

Once you have received IRB approval, please contact the PICU Research Team to activate your study.

Ophthalmology

A written LOS is required when studies require eye exams and ophthalmologic services for research purposes. Please complete the LOS form found on the Ophthalmology Research Page

Once you have received IRB approval and the Ophthalmology LOS, please send a copy of the IRB approval letter and the fund number to Hanta Ralay-Ranaivo to activate the study.

Anesthesiology

A written LOS is required when studies require the use of anesthesia services or staff. Please email John Hajduk to request an LOS, and provide a copy of the protocol attached to the email. Please note, requests for cardiac anesthesia should go to cardiopulmonarylabLOS@luriechildrens.org  Once you have received IRB approval and the Anesthesia LOS, please send a copy of the IRB approval letter to John Hajduk to activate the study.

Emergency Medicine (ED)

Studies looking to directly recruit from the ED, or utilize ED services or staff for research purposes require written support from the Division.

Once you have received IRB approval and the ED LOS, please send a copy of the IRB approval letter to the ED contact. The ED requires a 4 week notice prior to any start of study activities in the ED.