Center for Applied Research Sciences
Application Form
Clinical Research Unit (CRU) Clinical Trials Unit (CTU)
Pediatric Clinical Research Unit (PCRU) Lifestyle Intervention Research Core (LIRC)
Inpatient services are available through the Clinical Research Unit. The Clinical Trials Unit and the Pediatric Research Unit are outpatient units only.
Who Initiated Protocol/Study? Investigator Industry
Name of Funding Source:
Federal/Foundation Funds
Industry Support (please specify):
Funds & Drugs
Funds Only
Drug Only
Other (e.g. Department)
Principal Investigator
ICTS Member Yes No if No please join @
Principal Investigator Information
PhoneHRPO Status
Submitted PendingDate Approved ______
HRPO Number
Project Title
Funding Source for this Research Project
Federal and Non-Federal Grants, Contracts or Other Support
Funding Source/Industry / Grant # and/or FIS Account #Target Enrollment (total)
# of overnight patients # of outpatients
# of overnight patient days* per subject # of outpatient visits per subject
*each overnight stay = 1 visit day
Is this a Clinical Trial as Defined by the NIH?
No YesNCT#: ______
Single Center Multicenter
Phase Non-phased Pilot I II III IV
The NIH defines a clinical trial as a prospective biomedical (to evaluate safety, efficacy, and/or effectiveness of drugs, treatments, devices, or new ways of using known drugs, treatments, or devices) or behavioral (interventions that modify behavior) research study conducted in human subjects. Human subjects research to develop or evaluate clinical laboratory tests (e.g. imaging or molecular diagnostic tests) might be considered a clinical trial if the test will be used for medical decision making for the subject, or the test itself imposes more than minimal risk for subjects.
Are children included? (Defined by NIH as less than 21 years of age)
Yes No
AIDS Research focused?
Yes No
Cancer Research?
Yes No
Use of Resources (check all resources requested, and complete specific information below)
Body Composition: Dual Energy X-ray Absorptiometry (DXA)
Whole Body Forearm Hip & Spine
Pea Pod Bod Pod
Research Nursing and Coordination:
CRU:Biopsy Infusions Phlebotomy
Bronchoscopy (Pre/Post) IVGTT PK Study
Clamp LP Serial Sampling
ECG OGTT Supplies (please list)
Space
CTU: Space only Consent Data Collection/Entry
Phlebotomy QuestionnairesSample processing
PFTVS/ht/wt/waist Sponsor provides ECG machine
ECG –single ECG triplicate PK Serial Sampling
PCRU: ClampECGIVGTT
MMTOGTTPhlebotomy
QuestionnairesSample processingSpace only
VS/ht/wt/waist Urine collectionUrine pregnancy test
LIRC (Contact: Adult Units: Jina Loduca 747-3595; Pediatric Unit: Elizabeth Beach 454-6221)
Behavioral Therapy Assessments Weight Management
Questionnaires Nutritional Assessment (nutrient requirements, etc.)
Food Service Education/Lifestyle Counseling
Menu/Recipe Development Taste Perception
Other
Please provide additional information for the requested clinical services:
Submission Instructions: Email the CARS Application, Research Protocol, Consent Documents, and Research Agreement and Itemized Budget (Industry Studies) as attachments to:
RCAST (To obtain an insurance plan for each IRB approved clinical trial for services provided at BJC facilities, the research team must complete and submit the BJC RCAST form).If you have any questions regarding this form, please contact Dayna Herndon at , or by phone 314-454-8760.
BJH Hospital Privileges for CRU admissions contact: Terra Mouser 314-454-8087 Medical Staff Services.
Questions? Call Cheryl Robbins 314-747-1309
Application completed and submitted by:______
PI Signature Date
November 2012
January 2013
October 2014
March 2017
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