Please check all Indiana CTSI Clinical Research Services that you are requesting [click on resource listed to learn more]:
CRC at IUPUI - University Hospital
CRC at IUPUI - Riley Hospital for Children
CRC at IUPUI - Goodman Hall
CRC at Purdue
CRC at IUSM-Evansville
ECG Interpretation
DEXA scan at IUPUI - University Hospital (not available until 04/01/2020)
Your first name* must provide value
Your last name* must provide value
Your email address* must provide value
Your phone number* must provide value
Investigator First Name* must provide value
Investigator Last Name* must provide value
Investigator Degree(s) MD
PhD
DDS
DNS
PharmD
Investigator Email* must provide value
Investigator Phone Number* must provide value
Investigator Department / Division* must provide value
Investigator Faculty Rank
Co-Investigator(s)
What resource(s) is being requested the Children's CRC?* must provide value
Participant Room
Phlebotomy
Nutrition
What resource (s) is being requested UH CRC?* must provide value
Participant Room Only
Combination of visits requesting Participant Room Only and visits requiring Nursing Support
Nursing
Nutrition
What resource(s) is being requested for the Neuroscience CRC at Goodman Hall? Participant Room Only
Combination of visits requesting Participant Room Only and visits requiring Nursing Support
Nursing
Nutrition
Will dry ice be needed? Yes
No
Will short term sample storage be needed? Yes
No
For what visits would you like the Phlebotomy Support at the CCRC [eg C1D1, V8, V1-V6, all visits]?* must provide value
For what visits would you like the Participant Room Only resource at the UH CRC [eg C1D1, V8, V1-V6, all visits]?* must provide value
For what visits would you like the Participant Room Only resource at the GH CRC [eg C1D1, V8, V1-V6, all visits]?* must provide value
For what visits would you like Nursing Support at UH CRC [eg C1D1, V8, V1-V6, all visits]?* must provide value
For what visits would you like Nursing Support at GH CRC [eg C1D1, V8, V1-V6, all visits]?* must provide value
Please copy and paste the ECG information section from the protocol* must provide value
Any other special instructions for interpreting ECG?* must provide value
What resource(s) is being requested [Purdue]? Administrative Assistance
Nutrition Services
Patient Care
Plebotomy
Visit Space
Processing lab
Reception Lab
Body Composition
Imaging
Other
What Administrative Assistance Service(s) is being requested [Purdue]? IRB submission
Recruitment
Statistics
Web presence
What Nutrition Service(s) are being requested Snack and/or FS tray
Dietary budget consultation
Research menu development
Meal preparation
Nutritional counseling
Dietary intake analysis
Dietary assessment services
Dietary homogenates
What Phlebotomy Service(s) is being requested [Purdue]? Sample acquisition
Intravenous [IV] access
Observation / Vital signs
Single stick
Multiple blood draws
What Visit Space is being requested [Purdue]? Interview / Counseling
Bed
Chair
Meal Consumption
Other
If other, please specify * must provide value
What Processing Lab Service(s) is being requested [Purdue]? Initial processing
Short term storage
Send out samples
Repository of samples
What Body Composition Services are being requested [Purdue]? Bod Pod
Metabolic cart
D.I. water
DXA
Skinfolds
Anthropometric measurements
Bioimpedance
What Imaging Services are being requested [Purdue]? DXA
pQCT
MicroCT
What Other Services are being requested [Purdue]?* must provide value
What is the project or protocol title?
Is this protocol:* must provide value
Investigator-initiated
Industry-initiated
Sponsor-initiated
Investigator-initiated with Pharma support
What is the funding source?* must provide value
NIH Department of Defense VA Foundation Other Internal None
What is the funding source? Pharmaceutical company Other
Please specify the NIH Agency* must provide value
Please specify the Foundation* must provide value
What is the Project Title [if different from the protocol title]?
What is the grant number?* must provide value
Please specify the pharmaceutical company* must provide value
If other, please specify* must provide value
Is this a multi-center trial?* must provide value
Yes
No
Is this a clinical drug / device trial?* must provide value
Yes
No
What is the phase?* must provide value
I II III IV
Is this phase I study the first in human?* must provide value
Yes
No
Is the I.U. Health Investigational Drug Service being used?* must provide value
Yes
No
Please upload the Protocol here* must provide value
Please upload the Investigator's Brochure here.
Please upload the lab manual / lab instructions, if applicable.
Please upload the DEXA manual, if provided.
Please upload the "Signed Protocol Summary" document from KC-IRB. Please submit this form regardless of what IRB is being used (IU IRB or outside IRB - this form is still provided via Reliance request).
Please upload the Main Informed Consent Document here.* must provide value
For pediatrics, please upload the Main Assent here.
Please upload the Authorization Form here.
Are there additional informed consent and/or assent documents associated with this protocol?* must provide value
Yes
No
Upload additional ICDs and/or Assent Documents here.
Upload additional Documents here.
Upload additional Documents here.
Upload additional Documents here.
Upload additional Documents here.
Upload additional Documents here.
What type of IRB will be used?* must provide value
1) Internal - Indiana University IRB 2) Internal - Purdue University IRB 3) External
Please select which IRB is being used. If not listed, select 'Other'.* must provide value
Advarra Aspire Duke University Pearl New England Solutions WIRB Yale Other
If other, please enter name here:* must provide value
Has the protocol been submitted to the IRB?* must provide value
Yes
No
What is the status?* must provide value
Pending Approved Provisionally Approved Tabled
What is the Institutional IRB number?* must provide value
When was the initial IRB approval received?* must provide value
Today D-M-Y
Please upload the IRB Approval Letter. Study will not receive CRC Final Approval until IRB Approval Letter has been provided. Thank you!
Please upload the "Signed Protocol Summary" document from KC-IRB.
Please upload the IU IRB Notice of Reliance.
Please upload the IU IRB "Signed Protocol Summary" document from KC-IRB.
Please upload the external IRB Approval Letter. Study will not receive CRC Final Approval until IRB Approval Letter has been provided. Thank you!
Does this study require Radiation Safety Approval?* must provide value
Yes
No
Please upload Radiation Safety Approval Letter. Study will not be given CRC Final Approval until Radiation Safety Approval Letter provided. Thank you.
Purdue Grant Account Number [no dashes]
IU Grant Account Number [no dashes]
Study / Division Account Manager* must provide value
Dept Business Manager
Study / Division Account Manager email* must provide value
Dept Business Manager Email
Study / Division Account Manager phone number* must provide value
Dept Business Manager phone number
What is the estimated start date?* must provide value
Today D-M-Y
What is the estimated end date?* must provide value
Today D-M-Y
Visit(s) Type Inpatient
Outpatient
Off-Site
Visit(s) type CRC & PU [includes all F & N space]
On campus
Off campus
Enrollment Type [Purdue]* must provide value
Rolling intervention All enrolled before Other
Number of Inpatients* must provide value
Number of Inpatient Days (per participant)* must provide value
Number of Outpatients* must provide value
Number of Outpatient Visits [per participant]* must provide value
Please upload the Physician Orders here.
Additional Physician Orders to upload? Yes
No
Please upload additional Physician Orders here.
Please upload additional Physician Orders here.
Please upload additional Physician Orders here.
Please upload additional Physician Orders here.
Please upload additional Physician Orders here.
Did you know that the CTSI also offers [click on resource to learn more]?
Regulatory Assistance
Project Development Teams [pilot project program]
Bioethics and Subject Advocacy
Indiana Biobank
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