Research Intake ApplicationNew Study Submission/Feasibility Resubmission Form

Date:

Study Contact Last Name: First Name: Phone:

UA Email Address:

Study Overview

Study Protocol Number / Nickname:

Type of Study: If you selected OTHER, provide project/study type:

DEVICE trials: Is the sponsor providing the device?

Yes No

Does the Institution need to purchase the device? If yes, please upload the Purchasing Agreement (required for Feasibility review)

Yes No

Submission Type:

Protocol Title:

Funding Source: If you selected OTHER, please provide funding source:

Sponsor / Funder Name: Sponsor-provided protocol number:

IND number (if applicable): Required for Coverage Analysis (CA) approval

IDE number (if applicable): Required for Coverage Analysis (CA) approval

Will Protected Health Information (PHI) be transferred or shown to a party outside the UA or Banner Health?

Yes No

Will UA and/or Banner Health receive PHI from an outside party?

Yes No

v19May2020

Which HIPAA methods(s) will be implemented to access, use, and disclose PHI? Select all that apply

☐ N/A – No PHI will be accessed,used, or disclosed

☐ Decedents

☐ Activities Preparatory toResearch

☐ Authorization

☐ Waiver or alteration ofAuthorization

☐ Transition Provisions

☐ Limited data set(Data Use Agreement required)

☐ Business Associate(Business Associate Agreement required)

☐ De-identification

Is the project sponsor, CRO, or other vendor based in the EU?

Yes No

Will UA collect/receive data from subjects in the EU?

Yes No

If yes, will the data received be completely deidentified?

Yes No

PI Information PI Name: (first last, credentials)

PI UA Email Address:

Investigator Type: If you selected OTHER, please list PI type:

If Fellow/Resident with mentor, provide their name:

College: If Other UA College, specify:

Clinical Department (COM only): PI Center or Institute:

Enrollment Information Anticipated number of study participants: Anticipated number of study visits (per patient):

If the project has multiple cohorts, please specify which one(s) you will participate in. If the study only has one part/cohort, please enter “N/A”

Anticipated first participant/visit date: Anticipated study completion date:

Clinicaltrials.gov Information Most industry-sponsored studies are registered on ClinicalTrials.gov by the sponsors. You can find the NCT# by searching for the protocol number on ClinicalTrials.gov.

Registration on ClinicalTrials.gov is required by law for most drug, biological, and device studies. It may also be a requirement for journal publication.

Review information at this link to determine if your study should be registered on ClinicalTrials.gov.

If you need a UA ClinicalTrials.gov account to register a non-oncology study, contact regulatory@email.arizona.edu. If you are affiliated with the UA Cancer Center, contact the UACC ClinicalTrial.gov administrator,

aselegue@email.arizona.edu. NCT (Clinicaltrials.gov) Number: If Interventional study, NCT # will be required for final Coverage Analysis (CA) approval. If not applicable, leave BLANK. For information

on clinicaltrials.gov information at UA, visit this link.

If this project does not need to be entered into ClinicalTrials.gov, please specify why:

Primary Study Contact/ Primary Coordinator Information

*Additional Staff must be listed on UA HSPP Research Personnel List*

First Name: Last Name: Phone:

UA Email Address: Role:

Banner/Dignity Information Which Banner/Dignity medical facility will the study utilize? Select all that apply

☐ BUMC - Tucson

☐ BUMC – NorthClinics

☐ None

☐ BUMC - South

☐ BUMC - Phoenix

☐ BUMG SatelliteClinics

☐ UA Cancer CenterPhoenix

☐ UA Cancer CenterNorth

☐ Dignity Health St.Joseph

☐ UA Cancer CenterOrange Grove

☐ Other

If you selected BUMG Satellite Clinics, please list clinics:

If you selected OTHER, please list Banner/Dignity facilities:

Additional email address(es) to be copied on study-related emails: (If more than one, separate email addresses with commas)

Banner/Dignity units affected by Research: Please list the units/wards affected by research (Blood bank, Emergency Department, ICU, Arthritis Clinic, etc.)

The following research activities will occur in Banner/Dignity medical facilities:

☐ Recruitment/Enrollment

☐ Drug Administration

☐ Treatment

☐ Follow-up Visits

☐ Labs/ Phlebotomy

☐ Data Collection

☐ Diagnostics

☐ None

☐ Drug Dispensing

☐ Other

Which Banner/Dignity resource will the study use?

☐ Medical Records

☐ Pharmacy

☐ Personnel

☐ None

☐ Radiology

☐ OtherPlease explain below

☐ Hospital/ClinicSpace

☐ Supplies

☐ Cerner Data Warehouse(19 Sept 2017 – Present) Please complete CRDW Request Form: https://research.uahs.arizona.edu/clinicaltrials/resources

If you selected OTHER, please list resources:

UA Information Which University of Arizona facilities will the study utilize?

☐ CATS ☐ None ☐ OtherPlease explain below

If you selected OTHER, please list UA facilities:

The following research activities will occur in the University of Arizona facilities:

☐ Recruitment/Enrollment

☐ Drug Administration

☐ Treatment

☐ Follow-up Visits

☐ Labs/ Phlebotomy

☐ Data Collection

☐ Diagnostics

☐ None

☐ Drug Dispensing

☐ Other

If you selected OTHER, please list research activities:

Medical Imaging Will the study be using medical imaging?

Yes No

If yes, what imaging system(s) will be utilized for this study?

☐ CT

☐ X-RAY

☐ MRI

☐ Mammography

☐ PET-CT

☐ N/A

☐ SPECT ☐ US

Does the imaging protocol use non-standard imaging techniques that require special set up by the imaging facility and staff?

Yes No

Is non-clinical image interpretation required by DMI physicians?

Yes No

Are Dept of Medical Imaging staff or resources required to upload images to study site?

Yes No

Comments/Special Instructions:

Study Agreement/Contract

Budget Negotiator Email: Budget Negotiator Phone Number:

Study/Organization Budget Negotiator Name:

Contract Negotiator Email: Contract Negotiator Phone Number:

Study/Organization Contract Negotiator Name:

Study sponsor/organization name: If a sponsor or other organization is negotiating the contract and budget, enter that name

Study Sponsor/Organization Information

Who will manage the post-award finances for this project?

Last Name: First Name: Phone:

UA Email Address:

Website Information Studies can be posted to appear on studies.medicine.arizona.edu.Would you like this study to be submitted to the public-facing UA Clinical Studies website to assist in subject recruitment and/or community physician referrals?

If yes, please complete the information below. If no, your RIA application is complete, please see list of required documents at the end of the application.

Yes No

Did the sponsor/funder provide a template agreement?

Will UArizona need to provide a template agreement?

What type of UArizona agreement is needed?

Cancer sub-categories: Brain sub-categories: Heart/Cardiovascular sub-categories:

Will this study enroll healthy volunteers?

Yes No

Study Contact to be listed on website:

Contact Email Contact Phone Number

Study Phase

Brief study description for the website:

Eligibility Criteria:

Please provide an abbreviated study title in non-clinical terms that the general public will understand:

Secondary Research Category If you would like to select a sub-category for Brain/Nervous System, Cancer or Heart/Cardiovascular, you can do so below.

Additional information to be listed on website:

Primary Research Category

External Link (only 1 per field, please):

External Link (only 1 per field, please):

Study Sites

☐ BUMC - Tucson

☐ BUMC – NorthClinics

☐ None

☐ BUMC - South

☐ BUMC - Phoenix

☐ BUMG SatelliteClinics

☐ UA Cancer CenterPhoenix

☐ UA Cancer CenterNorth

☐ Dignity Health St.Joseph

☐ UA Cancer CenterOrange Grove

☐ Other

If Other Sites, please specify:

Document Title Description

Application for Human Research

Research Personnel

Consent, Appendix EFIC or Appendix Waivers

Schedule of Events (SOE)

Relevant Appendix-Drugs

Relevant Appendix-Devices

Relevant Appendix- Vulnerable Populations

Required

Required

Required

Required

Required

Documents

Please attach the following required and applicable documents to your email:

Relevant Appendix-Waivers

Relevant Appendix-EFIC

Application for review of a proposed study involving collection of data from or interaction with human subjects, study involving existing records review, data abstraction, and analysis and requests that IRB oversight be deferred to a non- University of Arizona IRB.

Senior/Key personnel, as defined by the National Institutes of Health, must be included on the list and have current CITI training.

Consent Form(s), Appendix EFIC or Appendix Waivers is required for all projects. The ICF should be a complete draft. If applicable, please email final IRB approved ICF upon receipt to: crc@email.arizona.edu.

Required for all projects.

Appendix for investigational drug(s)

Appendix for investigational device(s)

Includes Children, Pregnant Women, Neonates, Native Americans or International Indigenous Population, Prisoners

Appendix for Alterations/Waivers of Consent or PHI

Appendix for Exceptions from Informed Consent (EFIC)

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Clinical Research Data Warehouse Request Form

Reimbursement Guide For Device trials ONLY

Purchasing Agreement For Device trials ONLY

Data Collection Documents Please upload any relevant data collection documents for the project.

PI Photo Optional (for studies.medicine.arizona.edu website)

Relevant Appendix-Waivers

Relevant Appendix-EFIC

Protocol

Sponsor Budget Template

Draft Contract

Sponsor Documents/Correspondence

Appendix for Alterations/Waivers of Consent or PHI

Appendix for Exceptions from Informed Consent (EFIC)

Required for all projects (if no protocol is available, please upload the Application for Human Research).

Required for projects with a budget (Excel format preferred).

Required for projects with an external sponsor (Word version that is fully editable and not password-protected).

If Applicable: Please include any sponsor correspondence or other sponsor- provided documents that will facilitate budgeting/contracting processes.

Please complete the CRDW Request Form if you need patient data from the Data Warehouse. The form is located at: https://research.uahs.arizona.edu/clinical-trials/resources#data

Required for use of Banner Honest Broker