Application Start Date and Time Now M-D-Y H:M:S
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) Principal Investigator PI Email
Principal Investigator (PI name only, no credentials) * 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 Local Regulatory Contact Email
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
Study Title (Long) Study Title (Short)
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"
Which group will be assisting with study activation?
* must provide value
KUMC Research Administration ( aka RI) Cancer Center- Clinical Trial Office (CTO)
Please select your department and assigned Office of Clinical Trials Administration Portfolio Manager * must provide value
Alzheimer and Memory: Zelimir Bauk Anesthesiology: Sonia McCoy Cardiology: octa@kumc.edu Clinical Pharmacology: Kate Nance Emergency: octa@kumc.edu Epilepsy: Zelimir Bauk Family Medicine: octa@kumc.edu Headache and Stroke: Zelimir Bauk Huntington's Disease: Zelimir Bauk Infectious Disease: Kate Nance Internal Medicine: Sonia McCoy Multiple Sclerosis: Zelimir Bauk Muscular Dystrophy: Zelimir Bauk Neuromuscular: Zelimir Bauk Neurosurgery: Sonia McCoy OB/Gyn: octa@kumc.edu Ophthalmology: octa@kumc.edu Orthopedics: Sonia McCoy Otolaryngology: Kate Nance Parkinson's Disease, Movement Disorders: Zelimir Bauk Pediatrics: octa@kumc.edu Phys. Med & Rehab: octa@kumc.edu Plastic Surgery: Sonia McCoy Population Health: octa@kumc.edu Psychiatry: Kate Nance Pulmonary: Kate Nance Radiology: Kate Nance School of Health Professions: octa@kumc.edu School of Nursing: octa@kumc.edu Surgery, Trauma, Critical Care: Sonia McCoy Urology: Sonia McCoy Wichita: octa@kumc.edu Other: octa@kumc.edu
Is the study cancer or cancer-related? This question is to help identify studies that need to be reviewed by the Clinical Trials Office (CTO) Disease Working Group (DWG) or Protocol Review and Monitoring Committee (PRMC).
* must provide value
Yes
No
You have indicated that this study is cancer or cancer related. The Clinical Trials Office requires this study be reviewed at the Disease Working Group (DWG) and Protocol Review and Monitoring Committee (PRMC). The Research Administration's Research Systems department will enter this study into "TRAX" where you, the study team will upload documents for PRMC review. Questions about the DWG process should be directed to kucctopm@kumc.edu . Questions about the PRMC process should be directed to PRMC-KUCC@kumc.edu .
Disease Working Group (DWG) Date Please enter the date of the DWG meeting this study was reviewed. If questions please contact kuccctopm@kumc.edu .
Today M-D-Y
Protocol Review and Monitoring Committee (PRMC) Meeting Date Please enter the date of the PRMC meeting this study was reviewed. If questions please contact kuccctopm@kumc.edu .
Today M-D-Y
Who will be the IRB of record?
Who will be the IRB of record? * must provide value
KUMC IRB
Advarra IRB
WCG IRB
SMART network
Other IRB
Type of study? * Intervention- Non Drug or Device Study examples include but not limited to diet, cognitive therapy, exercise, development of new habits; prevention strategies; and, diagnostic strategies.
* must provide value
Is there a device involved in this study?
Yes
No
Is this device currently utilized within the University of Kansas Health System (UKHS)?cso_team@kumc.edu
Yes
No
Have this device received FDA approval?
Yes
No
Has this device received CMS approval?
Yes
No
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
PHS Compliant: Organizations that have adopted Public Health Service guidelines (e.g. PCORI, Komen, AHA)
Please provide your funding proposal number (if applicable) FP number in mySponsoredProjects
Please provide your Subaward number (found in myAgreements, if applicable)
Who is the study sponsor? A person/company/entity who takes responsibility for and initiates a clinical investigation. The sponsor may be an individual or pharmaceutical company, governmental agency, academic institution, private organization, or other organization. The sponsor does not actually conduct the investigation unless the sponsor is a sponsor-investigator. The Sponsor and funder may be different from one another.
* must provide value
Industry Federal / Co-op / Consortium Non-Profit / Private Organization Investigator-Initiated
Is this a multi-site IIT?
* must provide value
Yes
No
How many participating sites?
Estimated KUMC patient enrollment Estimated total enrollment from all sites?
Estimated KUMC patient enrollment * must provide value
Estimated total enrollment from all sites? * must provide value
Anticipated number of screen failures?
Will this study involve pediatric participants * must provide value
Yes
No
Does this study apply to any of the following categories? * must provide value
Does this study include Current Areas of Strong Public Health Interest or Rare Disease Initiatives? * must provide value
Yes
No
Does the Study plan to enroll non-English speaking participants?
How long, in months, do you estimate the study will be enrolling at KUMC? * must provide value
What is the overall length of the study for all sites (enrollment through the last follow up visit). * must provide value
Today M-D-Y
Is this a KUMC investigator-initiated trial?
* must provide value
Yes
No
What is the therapeutic area? Cancer Cancer-Related Non-Cancer
Active IND
Seeking a new IND
IND exempt
Active IDE
Seeking a new IDE
Other
Who is the IND/IDE holder?
Will outside vendors be utilized (ex. external imaging, pharmacy or lab)? This does not include TUKHS.
Yes
No
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.
List the Contract Research Organization, if applicable
Name of Central Lab (if applicable)
Does the study plan to enroll non-English speaking participants? * must provide value
Yes
No
Please list language(s) considering.
Please list language(s) considering.
Where are you consenting participants?
Where will study procedures occur? (select all that apply) *Please note that Indian Creek Ambulatory Surgical Center is currently on hold for new studies
* must provide value
What are the "other" outpatient settings? * must provide value
Does your study involve any lab collection or processing? * must provide value
Yes
No
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 .
What types of specimen will be processed/analyzed by UKHS staff? * must provide value
What types of specimen will be processed/analyzed? * must provide value
If your study protocol involves laboratory and/or pathology specimens, where will the specimens be processed and/or analyzed? * must provide value
Does the study involve PKs and/or other time sensitive lab collections or draws? * must provide value
Yes
No
Who will be responsible for collecting or facilitating PK or other time-sensitive labs? * must provide value
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 machine
Who will be performing the ECGs? * must provide value
UKHS staff (i.e. clinic staff, nursing staff, etc.)
KUMC staff (i.e. study coordinator, investigator)
Both KUMC and UKHS staff
CTSU staff
Who will be performing the ECGs reads? * must provide value
UKHS staff (i.e. clinic staff, nursing staff, etc.)
KUMC staff (i.e. investigator, study coordinator, CTSU staff)
Both KUMC and UKHS staff
Does your study protocol require imaging to be performed?
* must provide value
Yes
No
Will pharmaceutical agents be used for imaging? * must provide value
Yes
No
Who will be performing the imaging (ex CT, xray, MRI) reads? * must provide value
UKHS staff (i.e. clinic staff, nursing staff, etc.)
KUMC staff (i.e. investigator, study coordinator, CTSU staff)
Both KUMC and UKHS staff
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, IV pump
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
Are you going to be using a third party vendor (e.g., home health, transportation)? * must provide value
Yes
No
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, 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
UKHS Hospital or Clinic Space and Services 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
*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.
Is there an imaging manual
* must provide value
Yes
No
Pending Sponsor Finalization (Requested from Sponsor)
Unknown
Imaging Manual
* must provide value
Images will be acquired per standard hospital procedures.
Please Note: Study cannot be activated until there is a radiology review of imaging manual/confirmation SOC imaging is completed.
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
Please explain Other admission * must provide value
On what unit(s) might the Temporary Admission take place? * must provide value
If unsure, write "unsure."
Please explain Other admission
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.
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.
Where will the study drug be shipped and prepared/dispensed? (study drug must be shipped to one of the three Investigational Pharmacy locations listed) * must provide value
Clinical Research Center Fairway location Westwood Cancer Center Hospital (Main Campus)
Will transport of study drug be required from one of the above sites to another? Yes
No
Study tasks to be performed by TUKHS Staff. Select all that apply. * must provide value
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.
Primary settings where study related activity will occur? * must provide value
Inpatient Outpatient Both
Will equipment, study drug, materials, etc. be provided by an external source? Yes
No
What types of specimen will be processed/analyzed by UKHS staff? * must provide value
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
Fairway
* must provide value
Rainbow
* must provide value
Swope
* must provide value
Wichita
* must provide value
You indicated that both CTSU locations will be utilized, please clarify which location will be primary support and secondary support * must provide value
Primary Location- Rainbow; Secondary/Backup Location- Fairway
Primary Location- Fairway; Secondary/Backup Location- Rainbow
Preferred CTSU start date
Number of CTSU visits, per participant?
CTSU Resources Only
CTSU Resources and Services
CTSU Services : NURSING PROCEDURE/ASSESSMENT SUPPORT (Check all that apply or Not Applicable) * must provide value
CTSU Services: LAB SUPPORT (Check all that apply or Not Applicable * must provide value
CTSU Services : ADMINISTRATION OF INVESTIGATIONAL PRODUCT (IP) SUPPORT (check all that apply or Not Applicable) * must provide value
CTSU Services: PULMONARY TESTING SUPPORT (Rainbow Only) (Check all that apply or Not Applicable) * must provide value
CTSU Services: EXERCISE PHYSIOLOGY TESTING (Check all that apply or Not Applicable) * must provide value
CTSU Services: OTHER SUPPORT (Check all that apply or Not Applicable) * must provide value
CTSU: Please describe if there any tasks that both the CTSU and study team might share, e.g. vital signs, blood collection, blood processing, etc.?
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
Are South Infusion services desired? * must provide value
Yes
No
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
Does the study involve Human Gene Transfer* activities (store, manipulate, administer, or dispose)? *Human Gene Transfer: Research which requires IBC review because of the deliberate transfer of recombinant or synthetic DNA or RNA into human research participants.Example: Gene Therapy or Cell Therapy studies
* must provide value
Yes
No
In what location(s) will the Human Gene Transfer (HGT) activities occur ? (select all that apply)
* must provide value
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
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
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 will you be paying subject stipends? Check all that apply * must provide value
How much of a stipend per visit would you like to offer? Example: $50 per clinic visit; $10 per telephone visit, pending budget review ***Please complete this information so that myResearchSystems can build the Clincard payment schedule prior to the start up meeting.
* must provide value
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?
How will travel reimbursements work for subjects?
For the questions below, refer to the following definitions:
According to the Principal Investigator (PI) this study involves: * must provide value
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)
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.
Upload finalized pharmacy manual or documentation from sponsor that there will not be a manual for this study. Reach out to Leslie Khan with questions. * must provide value
Have sponsors review and sign the “Investigational Drug Services Policy Acknowledgement Form” found here .Reach out to Leslie Khan with questions * must provide value
Upload the Investigator Brochure
Upload the draft budget (editable version please) * must provide value
CTO Only - Upload coverage analysis with billing matrix, if available
Upload FDA acknowledgment IDE letter
Upload a study level central IRB approval letter
Research Systems user access Study Start Up- Study Personnel Sheet .3. Upload the saved file here. * must provide value
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.
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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