Project-Description-Full-Committee-Industry-Trials-PROTECTED

IDE has been issued note the IDE number in the eIRB system FDA has issued a non-significant risk NSR determination upload a copy of the FDA correspondence in the Supporting Document sec

KUMC INSTITUTIONAL REVIEW BOARD FULL COMMITTEE PROJECT DESCRIPTION – INDUSTRY

USE THIS FORM FOR STUDIES THAT ARE:

- GREATER THAN MINIMAL RISK

- THE PROTOCOL WAS DEVELOPED BY INDUSTRY (THE IRB HAS A SEPARATE FORM FOR IITS)

THIS INFORMATION IS A SUPPLEMENT TO INFORMATION ENTERED IN THE EIRB SYSTEM

1 DOWNLOAD , COMPLETE AND SAVE THIS FORM TO YOUR DESKTOP / FILES

2 ACCESS THE E IRB SYSTEM AT : WWW ECOMPLIANCE KU EDU

3 UPLOAD YOUR STUDY PROTOCOL IN THE “B ASIC I NFORMATION ” TAB OF THE ELECTRONIC APPLICATION

4 C OMPLETE THE REQUESTED INFORMATION IN THE OTHER APPLICATION TABS

5 P LEASE UPLOAD THE FOLLOWING IN THE “L OCAL S ITE D OCUMENTS ” TAB

A T HIS COMPLETED FORM

B S IGNED P RINCIPAL I NVESTIGATOR S UPPLEMENTAL F ORM

C CONSENT FORM ( S ), RECRUITMENT MATERIALS , DRUG / DEVICE BROCHURES , OTHER STUDY DOCUMENTS

I STUDY INFORMATION

Principal Investigator:      

Protocol Title:      

Clinical Research Start Up (UKHSRR) ID #      

TO OBTAIN A CLINICAL RESEARCH START UP (UKHSRR) # GO TO HTTPS :// REDCAP KUMC EDU / SURVEYS /?

S =KFJYK87MAJ I F YOU HAVE ANY QUESTIONS , PLEASE CONTACT CRA _ INFO @ KUMC EDU OR THE UKHSRR TEAM AT UKHSRR@ KUMC EDU

II Study Type (Check all that apply)

Phase 1 First in Humans Pilot Study

Phase 1 /2 Trial Investigational Device

Phase 3 Trial Humanitarian Use Device

Open-Label Extension Comparative Effectiveness Trial

Expanded Access Program Observational Study

Single Patient IND Other: Specify      

Phase 4/ Post-marketing

III Intervention type (Check all that apply)

Investigational drug or unapproved use of an approved drug

FDA-approved drug and approved population

Biologic product

Nutritional/dietary supplement

Investigational device

FDA-approved or marketed device

Investigational in-vitro diagnostic device

Other type of intervention Specify      

Indicate whether this research project includes any of the following procedures

(a) Yes NoUse of Radiation or a Radioisotope?

If the study involves any form of radiation or use of a radioisotope, then complete the Radiation Safety Form RS06, posted on the RSC website:

https://kumed.sharepoint.com/sites/mykumc/ehs/forms Upload the RSC form in the “Supporting Documents” tab in the eIRB system

(b) Yes NoTesting for reportable diseases (HIV, Hepatitis, TB, etc.)?

(c) Yes NoTesting for illegal drug use?

(d) Yes NoGenetic Testing?

(e) Yes NoHuman Gene Transfer (protocol terms may include e.g., genetically

modified or reprogrammed immune cells, recombinant DNA, viral-based vectors, retroviral transduction, gene silencing or gene editing)?

(f) Yes NoSubmission of genetic data to national repositories (such as dbGAP)?

(g) Yes NoWhole Genome Sequencing?

(h) Yes NoWhole Exome Sequencing?

(i) Yes NoStorage of Blood / Tissue for purposes not related to this project?

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(j) Yes NoInvestigational surgical procedures?

(k) Yes NoAudio taping or videotaping? (Please be aware of storage requirements

per the KUMC Record Retention Policy)

V Specimen Testing

(a) Does this study use investigational testing on specimens (such as a genetic, proteomics or other test)

that is not FDA-approved?

No

Yes (If yes, continue)

(b) Is an FDA-approved in vitro diagnostic device (IVD) being used to corroborate the results of the

investigational IVD?

No

Yes

(c) Are the results of the investigational IVD being used for enrollment in the study or assignment to a

treatment arm?

No

Yes

(d) Will the results of the IVD be used for monitoring or dose adjustment during the study?

No

Yes

(e) If (c) or (d) is “yes,”

What are the risks to subjects of a false positive test?      

What are the risks to subjects of a false negative test?      

(f) What is the status of the FDA review of this IVD?

IDE has been issued (note the IDE number in the eIRB system)

FDA has issued a non-significant risk (NSR) determination (upload a copy of the

FDA correspondence in the Supporting Document section)

The sponsor is proposing an NSR determination by the IRB (upload a copy of the

sponsor’s justification in the Supporting Document section)

(a) Check all KUMC/UKHS-affiliated study locations under the KUMC principal investigator’s

responsibility:

Facilities owned by The University of Kansas Health System or by KUMC

Wichita-based locations: Specify      

Community sites: Specify      

Midwest Cancer Alliance sites

KU Lawrence campus location

Other universities/Colleges: Specify      

(b) In what states will the KUMC principal investigator conduct the study? (Check all that

apply)

Kansas Missouri

Other states: Specify      

For all studies: what state laws are relevant to your study (such as reporting communicable diseases, use of surrogate decision-makers, or inclusion of minors,

emancipated minors or wards of the state)?      

For pediatric studies: what is the age of majority in the other state(s)?      

VII Subject Selection and Recruitment

(a) Number of Persons Planned to be Enrolled under the KUMC PI      

Age Range       (b) Check any vulnerable populations that are specifically being studied

If selections are made in this section, complete question (c)

Children/Minors (under 7 years of age) Persons with impaired decision-making

Children/Minors (7 – 17 years of age) Economically/educationally disadvantaged Prisoners KUMC Employees

Pregnant women KUMC Students/Residents/Fellows

Fetuses/Neonates

(c) Since the protocol is specifically studying a vulnerable population, discuss the special protections being implemented to minimize risk of coercion or undue influence [Special protections may include parental permission and assent (for children); fulfillment of special conditions for

research with pregnant women and fetuses (for pregnant women); design considerations for jail and prisons (prisoners); assessment of cognitive status, use of surrogate decision-makers and assent (for cognitively impaired persons); modified consent procedures, non-coercive recruitment and retention measures (disadvantaged); institutional permissions (KUMC personnel).]

VIII Consent Process

(a) How will subjects be informed about the possibility of research participation?

(b) Where will the consent interview occur?

(c) Do you anticipate enrolling subjects whose primary language is not English?

No

Yes

If yes, how will you obtain informed consent in the language of those participants?

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If yes, who will be present during study visits to translate instructions, assess adverse events, etc?

(d) How will subjects indicate their agreement to be in the study?

Signatures on paper consent forms

Electronic means (e.g, iPads or websites that use a mouse or stylus to capture signatures)

FOR ADULT STUDIES ONLY:

(e) Will all adult subjects be able to consent for themselves?

(a) Yes

(b) No It is expected that all subjects will need a

surrogate decision-maker

(c) No It is expected that some subjects may need a

surrogate decision-maker

If (c), how will study personnel assess the capacity of the subject to consent and to comprehend

the consent?      

If (c), how will you verify that the surrogate decision-maker is a valid legally authorized

representative under state law?      

If (b) or (c), do you plan to obtain written assent from the subjects?      

FOR PEDIATRIC STUDIES ONLY:

(f) What are your plans for child assent?

Subjects’ assent will be required for enrollment

The study will be discussed with the child subject, but parental permission will

determine enrollment, due to the therapeutic nature of the trial

Subjects will not be capable of providing assent

(g) At what age will you obtain assent?

Not applicable

7 - 17

12 - 17

Other: Specify      

(h) How do you propose to document assent?

Not applicable

By obtaining the child’s/adolescent’s signature on an assent form

By documenting verbal assent in the research or clinical record

Other: Specify      

(i) Will any of the study subjects be foster children or wards of the State or other agency?

No

Yes Contact the IRB Office for guidance if subjects will be foster children or wards and the

research offers no prospect of direct benefit to the child Additional state requirements may apply

**Please note: Starred responses will require review by KUMC Information Security

(a) How will subjects be identified? (Check all that apply)

Selection during the course of usual clinical care

Chart reviews by persons involved in the patients’ care

Chart reviews by persons not involved in the patients’ care

Self-referral in response to IRB-approved ads or Websites

Referrals from outside physicians

Database searches; specify the database:      

HERON Data Repository

Pioneers Research Participant Registry

Other; Specify:      

(b) Who holds the patient/client records you will use or disclose for the study?

The University of Kansas Health system

Outside clinic/collaborator, etc Specify:      

(c) How will electronic data be stored?

High Risk Data - [Note: High risk data must be stored on any of the locations below.

Examples of High risk data include, PHI, financial records, sensitive information related

to HIV status, sexual behaviors, etc., data sets received from government agencies (ResDAC, KDHE, and CMS), etc See the KUMC Data Classification Policy/Guidance for more information.]

Server hosted by a research sponsor or data coordinating center, with which KUMC has an approved sponsored research agreement

KUMC VELOS/CRIS System KUMC REDCap server KUMC P: drive (The principal investigator should request a P: drive location

by emailing kumc-security@kumc.edu) KUSM-Wichita P: drive (The principal investigator should request a P: drive location by emailing itswichita@kumc.edu)

Low to Moderate Risk Data - [Note: Only data categorized as low to moderate risk

should be stored on department drives See the KUMC Data Classification Policy/Guidance for more information.]

KUMC department network drive (e.g., G, K, R, or S drive) KUSM -Wichita department network drives

Encrypted CDs/DVDs – for imaging studies only

Other servers, devices or drives**

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Specify:      

Detailed Description of the Technology that will be used During the Course

of the Study to Capture, Record, or Transmit Data

Please select which technology(ies) will be used in this study (check all that apply and answer the

questions in the relevant required section) If all answers below are ‘no’ proceed to Section XI

Technology Type

Examples (Descriptions of the technology are offered in the respective sections below)

If Yes, Answer the Required Questions

Yes No Mobile technology For example, e-diary, iPhone, Android

devices, iPods, tablets, or other wireless devices

Complete section (d) below

Yes No Website survey, or

similar tool

For example, REDCap survey, surveys on external websites

Complete section (e) below

Yes No Cloud based

storage

Cloud storage is a cloud computing model in which data is stored on remote servers accessed from the internet, or

"cloud." Examples include Dropbox, Google Drive and other Google services, iCloud, Amazon Web Services, Microsoft Azure, etc (This category does not apply

to servers hosted by pharmaceutical sponsors or data coordinating centers.)

Complete section (f) below

Yes No Wearable

Technology

Examples of wearable biosensors include accelerometers, activity trackers, wireless heart rate monitors, pulse oximetry sensors, and glucose sensors.

Complete section (g) below

Yes No Phone, Video or

Web Conferencing

Examples include Zoom, Adobe Connect, Skype for Business, Facetime, Acano, etc

Complete section (h) below

Yes No Text

messaging/secure messaging

Examples include MyChart, Outlook, text, etc

Complete section (i) below

Yes No Mobile

Applications

Examples include electronic patient-reported outcomes (ePRO), Apple health, Garmin connect, Fitbit, etc

Complete section (j) below

(d) MOBILE TECHNOLOGY

Electronic devices that allow for offsite or remote data capture directly from study participants For

example, e-diary, iPhone, Android devices, iPods, tablets, or other wireless devices

Also complete the mobile app section below if a mobile app will be used with the mobile technology

Yes; who does the mobile technology belong to?

Study participant owned device Sponsor-provided device

 Is the mobile technology password protected?

No Yes, password protected

(e) WEBSITE SURVEY, OR SIMILAR TOOL

 Name of the website survey, or similar tool you are using:      

 Who developed the site, survey, or tool?

Commercially available

Study sponsor

Other (specify):      

 Is the data encrypted at rest? No** Yes

Data at rest is data that is sitting on a file server, data stored in a spreadsheet on a desktop or laptop, ultrasound images on the hard drive of the ultrasound machine, files or images on an iPad, tablet or smartphone.

 Is the data encrypted in transit? No** Yes

Data that is being transmitted includes uploading or downloading to a website, sending data via email, using protocols such as FTP to transmit data, etc.

(f) CLOUD BASED STORAGE **

 Name of the cloud based solution:      

Examples include Dropbox, Google Drive and other Google services, iCloud, Amazon Web Services, Microsoft Azure, etc (This category does not apply to servers hosted by pharmaceutical sponsors or data coordinating centers.)

(g) WEARABLE TECHNOLOGY

Wearable technology is simply anything that is worn (on the wrist, clipped to a belt, even imbedded in clothing) that contains sensors that pair with a web connection or Bluetooth to connect wirelessly with a mobile technology Examples of wearable biosensors include accelerometers, activity trackers, wireless heart rate monitors, pulse oximetry sensors, and glucose sensors.

Also complete the mobile app section below if a mobile app will be used with the wearable device

 Name of the device     

 What information must the participant provide when the wearable is registered to them?      

 What type of data will be collected and provided to the KUMC researcher?      

 What type of data will be collected and provided to external parties?      

 Is the data encrypted at rest? No** Yes

 Is the data encrypted in transit? No** Yes

 When and how will the wearable be de-activated from the user?      

 The study team has reviewed the terms of agreement and/or privacy policy and will inform participants on how their data will be collected via the wearable

Yes

No

Examples include Zoom, Adobe Connect, Skype for Business, Facetime, Acano, etc

 Name of the conferencing system:      

 The recordings capture: images video audio

 Will recordings be transmitted over the Internet? Yes No

 How will recordings be secured to protect against unauthorized viewing or recording:      

(i) TEXT MESSAGING/SECURE MESSAGING

Examples include MyChart, Outlook, text, etc

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 What type of messaging will be used: Text Email Other

 How will the messaging be delivered:

Standard text messaging on a mobile device

Separate application; name of the application      

Secure email Unsecure email Other**     

 What is the purpose of the messaging:      

(j) MOBILE APPLICATIONS

Software applications that can be run on a mobile device (i.e., a handheld commercial off-the-shelf computing platform, with or without wireless connectivity) or a web-based software application that is tailored to a mobile platform but is executed on a server Examples include electronic patient-reported outcomes (ePRO), Apple health, Garmin connect, Fitbit, etc

 Name of the application:      

 Who developed the mobile application?

Commercially available Sponsor

Other (specify):      

 Explain how the app will be used in the study:      

 What type of data will be collected within the app and provided to the KUMC team?      

 If applicable, what type of data will be collected and provided to external parties?      

 Is the data encrypted at rest? No** Yes

 Is the data encrypted in transit? No** Yes

 When and how will the data be securely wiped from the device     

 The study team has reviewed the app terms of agreement and privacy policy and will inform participants on how their data will be collected via the mobile app

No

Yes

(a) Has the contract been submitted to the Research Institute?

Yes

No

(b) Does the consent discussion about payment for injury match the contract provisions?

Yes

No; Explain:      

Pending

Thank you for your submission Please ensure this application form is accompanied with the signed Principal Investigator Supplement and the IRB Checklist

For questions, contact the KUMC IRB office at (913) 588-1240 or IRBhelp@kumc.edu

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