Application Start Date and Time Now M-D-Y H:M:S
Completed By
Please make sure that the email addresses are entered correctly. Notification emails will be sent to the regulatory or clinical contact, based on the emails entered in these fields. Before you begin the application form, please be sure that you have the following information, as you will need it to submit. KUMC and UKHS reviews will not be able to begin until all information related to study activation is provided. Prior to submitting, you can save the form and return using the form code if needed.
Study Team Contacts
Names of all locations where study activity will occur
Protocol
KUMC IRB #
Informed Consent template
Clinical Trial Agreement
Budget templates
External IRB approval letter (if applicable)
Study manuals- pharmacy, laboratory, imaging, other (if applicable)
For CTO studies only - coverage analysis and billing matrix.
Principal Investigator (PI name only, no credentials) * must provide value
PI Email * must provide value
Primary Study Contact/Clinical Contact This person should have knowledge of the study details. * must provide value
(Study Coordinator, Project Director, etc.)
Primary Study Contact/Clinical Contact Email * must provide value
Local Regulatory Contact Enter the name of the person within your department responsible for the IRB submission preparation. The person identified here will receive the study submission confirmation email with the UKHSRR ID number. * must provide value
Local Regulatory Contact Email * must provide value
* must provide value
Study Title (Short) Acronym or Protocol ID
* must provide value
(May be same as protocol number)
Protocol number (if applicable) If none, include "N/A"
KUMC IRB Number (required) Enter KUMC IRB number in STUDY######## format Video training on how to obtain KUMC IRB number in eCompliance.
* must provide value
Which group will be assisting with study activation? * must provide value
Research Institute (RI) Clinical Trial Office (CTO)
Who will be the IRB of record? * must provide value
KUMC IRB
Advarra IRB
WCG IRB
SMART network
Other IRB
Specify "Other" * must provide value
Type of study? Check all that apply. * must provide value
Investigational Drug study
Investigational Device Study
Post-FDA Approval Study
Registry
Secondary Research (Retrospective Chart Review, etc.)
Other
Specify "Other" * must provide value
Is the drug/device being provided by the Sponsor? yes
no
N/A
How is drug/device being supplied?
How is your study funded? Check all that apply
* must provide value
External - Industry, Pharma
External - Federal Funding / PHS Compliant
External - Private Org. / Non-Profit
Internal - Department/Self-funded, no external funding source, research expenses paid by department funds
Unfunded
PHS Compliant: Organizations that have adopted Public Health Service guidelines (e.g. PCORI, Komen, AHA)
Who is the study sponsor? * must provide value
Industry Federal / Co-op / Consortium Non-Profit / Private Organization Investigator-Initiated
Sponsor name * must provide value
Estimated KUMC patient enrollment * must provide value
How long, in months, do you estimate the study will be enrolling at KUMC? * must provide value
What is the therapeutic area? * must provide value
Cancer Cancer-Related Non-Cancer
Is this a KUMC investigator-initiated trial?
* must provide value
Yes
No
Is this a multi-site IIT?
* must provide value
Yes
No
How many participating sites?
IND status? * must provide value
Active IND
Seeking a new IND
IND exempt
IDE status? * must provide value
Active IDE
Seeking a new IDE
Other
Specify "Other" * must provide value
Enter IND #
Enter IDE #
Who is the IND/IDE holder?
Enter NCT#, if available This refers to the clinicaltrials.gov NCT number. If a study does not have and will not receive an NCT number, enter Not Applicable. If a study will eventually have an NCT number, but does not have one currently, leave blank.
CRO List the contact research organization, if applicable
Name of Central Lab (if applicable)
Does this study apply to any of the following categories? * must provide value
Imminent Patient Need
Competitive Enrollment
Patient Rollover
None of the above
Is this a research study involving patients receiving health system services and/or study visits taking place in UKHS hospital or clinic? This includes the main campus and all outpatient clinics (ex., treatment clinics, Indian Creek ASC, KU Eye Clinic). If you are unsure if something is a UKHS resource, contact UKHSRR@kumc.edu for assistance. * must provide value
Yes
No
UKHS resources include UKHS staff, UKHS space or facilities, and UKHS equipment.
1
2
3
4
5
6
7
8
9
Primary settings where study related activity will occur? * must provide value
Inpatient Outpatient Both
Where are you consenting participants?
Outpatient settings (select all that apply) * must provide value
KUMC Outpatient Clinic
UKHS Outpatient Clinic
UKCC Treatment clinic, Lee's Summit
UKCC Treatment clinic, NKC
UKCC Treatment clinic, North
UKCC Treatment clinic, Overland Park
UKCC Treatment clinic, Westwood
Indian Creek Ambulatory Surgical Center
UKHS Indian Creek
UKHS KU Eye clinic
CTSU Fairway (Clinical and Translational Science Unit)
CTSU Rainbow Sudler
CTSU Rainbow Delp
Hoglund Biomedical Imaging Center
CRC - Clinical Research Center (cancer trials ONLY)
Other
What are the "other" outpatient settings? * must provide value
Is a temporary/observation admission or inpatient admission required for study? Temporary Admission Hospital stay for less than 24 hours for either observation or treatment.* must provide value
No admission required
Yes - Temporary/observation admission ( < 24 hours)
Yes - Inpatient admission ( >24 hours)
Other
Please explain Other admission * must provide value
On what unit(s) might the Temporary Admission take place? * must provide value
If unsure, write "unsure."
On what unit(s) might the Inpatient Admission occur? * must provide value
i.e. patient will be staying on either units 41, 42 or CA11.
Name of Local Labs This is information is used to review coverage analysis and to build RI study Complion binders, so please indicate all local lab location so that all applicable documents will be uploaded from the central regulatory binder . CTSU Fairway
CTSU Rainbow
LabCorp
Physicians Reference
Quest
The University of Kansas Health System CRC
The University of Kansas Health System Main Campus
The University of Kansas Health System Neuro Lab
The University of Kansas Health System Westwood
Other
Not applicable
"Other" Specify
Will equipment, study drug, materials, etc. be provided by an external source? Yes
No
Does the study protocol require electrocardiograms (ECGs) to be performed? * must provide value
Yes
No
You indicated that the study protocol requires electrocardiogram(s) (ECG) to be performed. Who is providing the ECG machine? * must provide value
UKHS (i.e. machine in MAC clinic or on inpatient unit)
Sponsor or study team
Study will use BOTH UKHS-owned and sponsor-/study team-provided ECG machines.
Who will be performing the ECGs? * must provide value
UKHS staff (i.e. clinic staff, nursing staff, etc.)
KUMC staff (i.e. study coordinator, CTSU staff)
Both KUMC and UKHS staff
Who will be performing the echocardiogram(s) (ECHO)? * must provide value
UKHS staff (i.e. clinic staff, nursing staff, etc.)
KUMC staff (i.e. study coordinator, CTSU staff)
Does the study protocol require echocardiograms (ECHO) to be performed? * must provide value
Yes
No
Will the study sponsor provide any clinical equipment* to be used on a patient during the trial? *Clinical Equipment: Fixed and portable equipment used for the diagnosis, treatment, and monitoring of individuals or for the diagnosis, treatment, and direct care of individuals.* must provide value
Yes
No
e.g. syringe pump, ECG machine, glucometer
List all *clinical equipment to be used on patients that Sponsor will provide for this study.* Clinical Equipment: Fixed and portable equipment used for the diagnosis, treatment, and monitoring of individuals or for the diagnosis, treatment, and direct care of individuals . * must provide value
If there is a long list of equipment, use the next field to upload a list
Will this study impact UKHS direct patient care team(s)? We need to know if the study will require UKHS staff to perform any tasks that are being done solely for research purposes. Direct Patient Care Teams: Patient care teams are part of UKHS staff and include, but are not limited to: nurses, patient care techs, lab/phlebotomy, medical assistants, radiology technicians, etc.* must provide value
No, direct patient care team NOT impacted
Yes, direct patient care team IS impacted
Example: if the study requires vital signs to be performed and the study team can/will do them, then the UKHS patient care team will not be impacted. If the study requires a UKHS nurse or MA to perform the vitals, then the UKHS patient care team WILL be impacted.
What UKHS resources are required to conduct this study? Include standard of care/routine procedures. If you are not sure whether UKHS or KUMC operates the resource, we advise you to reach out and verify. Contact UKHSRR@kumc.edu . * must provide value
Laboratory - see note*
Pathology - see note*
Radiology/Imaging
Investigational Pharmacy (Storage, dispensing, and accountability of sponsor/study supplied drug.)
Nursing (drug administration, specimen collection, etc.)
Apheresis
UKHS information technology
Ophthalmology
Other
None
*Local specimens are processed by the hospital lab. Central specimens are sent to a sponsor-designated lab. Bone marrow specimens are analyzed by BOTH lab AND pathology.
Please specify "other" resources * must provide value
e.g. Hoglund Brain Imaging Center, etc.
Where will the study drug be shipped and prepared/dispensed? (study drug must be shipped to one of the three Investigational Pharmacy locations listed) Clinical Research Center Fairway location Westwood Cancer Center Hospital (Main Campus)
Are South Infusion services desired? * must provide value
Yes
No
Will transport of study drug be required from one of the above sites to another? Yes
No
If your study protocol involves laboratory and/or pathology specimens, where will the specimens be processed and/or analyzed? * must provide value
UKHS lab/path (local lab/path)
KUMC lab/path, i.e. CTSU lab, Correlative lab, PI's research lab, etc.
Central lab/path
What types of specimen will be processed/analyzed by UKHS staff? * must provide value
Blood
Tissue
Urine
Bone marrow
CSF
Other
Multiple specimen types (i.e. blood, CSF, tissue, etc.)
Specify Other
Does the study involve PKs and/or other time sensitive lab collections or draws? * must provide value
Yes
No
Will UKHS staff be responsible for collecting or facilitating the PKs and/or other time sensitive lab collections or draws? * must provide value
Yes
No
Study tasks to be performed by TUKHS Staff. Select all that apply. * must provide value
Establishing an IV solely for study (for drug administration or lab samples)
Medication administration, per study protocol (i.e. premeds before treatment)
Vital signs, in addition to what is routine for whatever unit/clinic/dept the patient is in
Post-intervention observation required
Study drug administration
UKHS staff provides patient education/teaching about study
UKHS staff provides staff education/teaching about study
Device management
Data collection/charting/recording information for study (i.e. charting drug start and stop time on a flowsheet)
Heparin lock of an IV, solely for study
Use of supplies from unit stock (i.e. supplies for blood draws)
Use of unfamiliar equipment/supplies -see note
Obtaining study consent
UKHS staff assisting KUMC study staff with study procedures
Collecting specimens for study
Other
Unfamiliar equipment/supplies - examples: device provided by sponsor for use on study, any type of equipment that is not typically used by the UKHS staff but is required to be used for the study, like a new syringe pump.
Define other tasks to be performed by TUKHS Staff
Does the Principal Investigator anticipate that any portion of this study may require 1 to 1 care of the study patient by UKHS staff, solely for research purposes? 1 to 1 Care: Due to study requirements, a UKHS staff member (non-study team member) that would usually care for multiple patients must spend all (or a dedicated portion) of their time caring only for this study patient.Example 1: the study requires vital signs every 15 minutes for an hour after study drug is taken, and a UKHS patient care tech needs to spend extra time with this patient.Example 2: study requires blood samples drawn from a central line every 15 minutes for an hour and a UKHS nurse must draw these.If you need help determining if your study might require 1:1 care, please contact UKHSRR team at UKHSRR@kumc.edu. * must provide value
Yes
No
Unknown
Is there any protocol-required, or study team-required training that TUKHS staff member(s) will need to complete in order to perform study tasks? Example 1: Nurse must complete GCP trainingExample 2: Technician must go through training to use study deviceExample 3: Nurse must complete training to administer study medication* must provide value
Yes
No
Please detail what training you will need TUKHS staff member(s) to complete.
Does the sponsor/protocol require that UKHS nurses have a specialty/certification to assist with study specific tasks? * must provide value
e.g. chemo-certified, ASRT, Critical Care, ACLS
Are you going to be using a third party vendor (e.g., home health, transportation)? * must provide value
Yes
No
Does the study involve Human Gene Transfer* activities (store, manipulate, administer, or dispose) which utilize UKHS resources and/or facilities? *Human Gene Transfer: Research which requires IBC review because of the deliberate transfer of recombinant or synthetic DNA or RNA into human research participants.* must provide value
Yes
No
In what location(s) will the Human Gene Transfer (HGT) activities occur ? (select all that apply)
* must provide value
Unit 41
BMT Apheresis
B506
Investigational Pharmacy - Hospital
Investigational Pharmacy - Westwood
Investigational Pharmacy - CRC
Other
What are the "other" locations where Human Gene Transfer (HGT) activities will occur? * must provide value
In what location(s) will the Human Gene Transfer (HGT) material be stored ? (select all that apply)
* must provide value
Unit 41
BMT Apheresis
B506
Investigational Pharmacy - Hospital
Investigational Pharmacy - Westwood
Investigational Pharmacy - CRC
Other
What are the "other" locations where Human Gene Transfer (HGT) materials will be stored?
* must provide value
Has an internal budget been created? Yes
No
Anticipated number of screen failures?
Would you like to add these to the budget if possible? Yes
No
Do you plan to offer any subject stipends for the visits, pending budget review? Yes
No
How much of a stipend per visit would you like to offer? Example: $50 per clinic visit; $10 per telephone visit, pending budget review
How will you be paying subject stipends? Check all that apply KUMC ClinCard System
Sponsor's ClinCard System
Sponsor-provided Gift Cards
Other
Specify "Other"
Do you plan to offer any subject reimbursements for the visits, pending budget review? Yes
No
What type of travel reimbursements would you like to offer, pending budget review? Meals
Lodging
Local transportation
Mileage
Flight
Other
Specify "Other"
How will travel reimbursements work for subjects? Reimbursement will be provided through KUMC ClinCard
Reimbursement will be provided through a 3rd party affiliate
Other
According to the Principal Investigator (PI) this study involves: * must provide value
Additional outpatient visits required or extended for study purposes
Inpatient stay required for study purposes
Additional time needed in exam/treatment/procedure room for study purposes
None
If the PI thinks the patient will be: 1) admitted to a critical care unit solely for the study OR 2) spend a longer time admitted to a critical care unit than they would normally be admitted for standard of care How many days, or additional days, does the PI anticipate the stay will be? Indicate number of days in response. Write UNKNOWN if unknown.
How many total additional days of inpatient stay does the PI (Principal Investigator) anticipate there will be? Indicate number of days in response. Write UNKNOWN if unknown.
If the study requires more visits to TUKHS clinic/dept than what is considered Routine / Conventional Care, how many additional visits does the Principal Investigator (PI) think there will be? Type number of additional visits. Write UNKNOWN if unknown.
Please provide any other information you'd like to share that you think would be helpful in understanding the impact of this trial on the health system. Example 1: Protocol - "We will only be enrolling into Arm A" or "We are not doing the PK sub-study."Example 2: Study setting - "We will consent them in the lipid clinic but treatment will happen on Unit 15." Example 3: Lab resources - "All PK/PD/biomarkers will be sent to a central lab and the rest of the labs are localHS-
Upload protocol Most recent version/draft. * must provide value
Upload draft Main Informed Consent Form (ICF) * must provide value
Is there another Informed Consent Form (ICF) included on this study? * must provide value
Yes
No
Upload draft Informed Consent Form (ICF)
Is there another Informed Consent Form (ICF) included on this study?
Yes
No
Upload draft Informed Consent Form (ICF)
Is there another Informed Consent Form (ICF) included on this study?
Yes
No
Upload draft Informed Consent Form (ICF)
Upload draft contract * must provide value
Is there a second draft contract for this study?
Yes
No
Upload second draft contract
Upload the Imaging Manual (if applicable) The Imaging Manual will be required to obtain a quote for services from Hoglund or from the Radiology Research Team. If there are multiple other documents, they can be compressed in a Zip file and uploaded here as one document
Upload the Pharmacy Manual (if applicable) The Pharmacy Manual will be required to obtain a quote for services from the Investigational Pharmacy. If there are multiple other documents, they can be compressed in a Zip file and uploaded here as one document
Upload the Investigator Brochure
Upload the draft budget * must provide value
Upload draft budget
CTO Only - Upload coverage analysis with billing matrix, if available
Upload FDA acknowledgment IDE letter
Upload CMS Letter
Upload a study level central IRB approval letter
Complion binder user access Study Start Up- Study Personnel Sheet .3. Upload the saved file here.
Upload other document(s) If there are multiple other documents, they can be compressed in a Zip file and uploaded here as one document
In order for research review to occur efficiently, please ensure that you submit accurate information for how the study protocol will be carried out at KUMC and UKHS. By submitting this form, you are verifying that the information contained in it is true to the best of your knowledge.
If information changes or needs to be updated after submission please contact cra_info@kumc.edu the UKHSRR team at UKHSRR@kumc.edu .
Please enter your name This will serve as your signature. * must provide value
Enter your name
Application Submitted Date and Time
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