Please check all Indiana CTSI Clinical Research Services that you are requesting [click on resource listed to learn more]:
Please note:
Monday - Friday from 7A - 7P for outpatient visits, and Monday, Tuesday, and Wednesday for overnight stays If your study requires an outpatient visit or overnight stay outside of the CRC Hours of Operation, please contact the CRC Nurse Manager, Julie Raters, to discuss at jraters@iu.edu or 317-278-3567. CRC approval does not guarantee accommodation outside of the CRC Hours of Operation.
Please note:
Monday - Friday from 7:15A - 3:15P If your study requires an outpatient visit outside of the CRC Hours of Operation, please contact the CRC Nurse Manager, Julie Raters, to discuss at jraters@iu.edu or 317-278-3567. CRC approval does not guarantee accommodation outside of the CRC Hours of Operation.
Your first name
* must provide value
Your last name
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Your email address
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Your phone number
* must provide value
Are you the lead or assigned research nurse / coordinator for this study?
* must provide value
Yes
No
Please provide the name of the lead or assigned research nurse / coordinator
* must provide value
Please provide the email for the lead or assigned research nurse / coordinator
* must provide value
Investigator First Name
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Investigator Last Name
* must provide value
Investigator Email
* must provide value
Investigator Phone Number
* must provide value
Investigator Department / Division
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Investigator Faculty Rank
What resource(s) is being requested the Children's CRC?
* must provide value
What resource (s) is being requested UH CRC?
* must provide value
What resource(s) is being requested for the Neuroscience CRC at Goodman Hall?
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
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Any other special instructions for interpreting ECG?
* must provide value
What resource(s) is being requested [Purdue]?
What resource(s) is being requested at IU Bloomington?
* must provide value
What Administrative Assistance Service(s) is being requested [Purdue]?
What Administrative Assistance Service(s) is being requested at IU Bloomington?
* must provide value
What Nutrition Service(s) are being requested
What Nutrition Service(s) are being requested at IU Bloomington
* must provide value
What Phlebotomy Service(s) is being requested [Purdue]?
What Phlebotomy Service(s) is being requested at IU Bloomington?
* must provide value
What Visit Space is being requested [Purdue]?
What Visit Space is being requested at IU Bloomington?
* must provide value
If other, please specify
* must provide value
What Processing Lab Service(s) is being requested [Purdue]?
What Processing Lab Service(s) is being requested at IU Bloomington?
* must provide value
What Body Composition Services are being requested [Purdue]?
What Body Composition Services are being requested at IU Bloomington?
* must provide value
What Imaging Services are being requested [Purdue]?
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
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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
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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.
If using a separate Authorization Form, please upload the 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 ICDs and/or Assent Documents here.
Upload additional ICDs and/or Assent Documents here.
Upload pharmacy manual here, if applicable.
Upload manual of operations here, if applicable.
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 be reviewed 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 be reviewed 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.
Does this study require Institutional Biosafety Committee approval?
* must provide value
Yes
No
Please upload the Biosafety Committee approval letter. Study will not be given CRC Final Approval until Biosafety Committee approval letter provided. Thank you.
* must provide value
Please upload the Biosafety Committee approval questionnaire. Thank you.
* must provide value
Purdue Grant Account Number [no dashes]
IU Grant Account Number [no dashes]
Study / Division Account Manager
* must provide value
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
Enrollment Type [Purdue]
* must provide value
Rolling intervention All enrolled before Other
Enrollment Type [Bloomington]
* 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
Physician orders are required when CRC nursing support is requested. Orders should contain only information needed by CRC nursing.
Treatment Orders (no risk of cytokine release syndrome or neurotoxicity) : below is a template that can used to assist with orders creation.
Oncology : Please email to ordersetcreations@iuhealth.org . Orders must be finalized by pharmacy before sending to the CRC for review.
Non-Oncology: Please send the orders to the Investigational Drug Services lead pharmacist for review and update PRIOR to sending to the CRC for review.
Treatment Orders (with risk of cytokine release syndrome or neurotoxicity) : below is a template that can be used to assist with orders creation.
Oncology : Please email to ordersetcreations@iuhealth.org . Orders must be finalized by pharmacy before sending to the CRC for review.
Non-Oncology : Please send the orders to the Investigational Drug Services lead pharmacist for review and update PRIOR to sending to the CRC for review.
Non-Treatment Orders: below is a template that can be used to assist with orders creation.
Email orders to crcdocs@iu.edu
Orders Template for study visits with Treatment (including oncology). No risk of cytokine release syndrome.
Orders Template for Treatment with risk of Cytokine Release Syndrome &/or Neurotoxicity.
Orders template for visits without treatment.
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.
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