ITHS CRCN Services Supplement (Short)

IRB # (if known): Study Title: Principal Investigator: Version Date:

INSTITUTE OF TRANSLATIONAL HEALTH SCIENCES (ITHS) CLINICAL RESEARCH CENTER NETWORK (CRCN) SERVICES SUPPLEMENT

*Fill in header information.

Instructions:  Complete this supplement and associated appendices if you are using the ITHS CRCN or any affiliated cores or resources. Much of the information required below is for the National Institutes of Health (NIH) reporting purposes.  If you have questions regarding completing this supplement, please email [email protected] or call (206) 987-3897.  Detailed information about the ITHS submission process is located on the ITHS Web site at: http://www.iths.org/PCRC.  The IRB application should be submitted along with your completed submission packet to [email protected].

ITHS CRCN Services Supplement (short) 4/21/2018 Page 1 of 7 IRB # (if known): Study Title: Principal Investigator: Version Date:

1. ITHS Responsibility for Study Conduct

If this study is to be conducted utilizing ITHS resources including the Pediatric Clinical Research Center (PCRC), I affirm that:  The protocol will be conducted as approved by the ITHS and IRB.  I will provide the ITHS with IRB-approved status reports and modifications, including updated consents or any other requested materials/information in a timely manner.  If modifications require additional ITHS resources, such as increased visits or procedures or additional core services, it will require review and approval for resource utilization and cost sharing. I will work with the Office of Sponsored Research’s (OSR) Clinical Research Budget Analyst (CRBA) to obtain costs and update the financial responsibility analysis (FRA).  I will report any serious or unanticipated adverse effects, problems or protocol deviations to the ITHS.  I will notify the ITHS if the study is suspended for any reason.  In publications and presentations, I will reference that this project was supported by Grant Number UL1TR000423 from the, National Center for Advancing Translational Sciences (NCATS) a component of the National Institute of Health (NIH). Information on ITHS Citing requirements is available at http://iths.org/cite.  I have reviewed the NIH clinicaltrials.gov registration requirements and affirm that my study either does not require registration or has been registered by myself or the study sponsor. The clinical trials registration number is provided below in #4.1 I will be required to provide information on an annual basis for the ITHS Annual Progress Report (APR) to NIH NCATS.I understand ITHS requires active collaborators have an eRA Commons User Name and UW Net ID for the purposes of providing information on an annual basis for the ITHS APR to NIH NCATS. I will provide eRA Commons User Names and UW Net ID of all active collaborators. My typed name below represents my digital signature and indicates my agreement with the above statements. Signed: Date:

2. Licensed Provider Assurance – Complete this section if the Principal Investigator (PI) is not a licensed provider with admitting privileges at Seattle Children’s. The licensed provider named below must be a member of the research team and have admitting privileges at Seattle Children’s.

As a licensed provider, I have reviewed the materials associated with this application and I agree to supervise and accept responsibility for the conduct of this protocol and the safety of the research participants.

My typed name below represents my digital signature and indicates my agreement with the above statement. Signed: Date:

3. Active Collaborators

3.1. Please list below the Principal Investigator (PI) and the Key Personnel who are active collaborators associated with this trial as defined by NIH.

Investigator Help Active Collaborators listed in this section will be approached annually to submit information for the NIH/NCATS APR. Active Collaborators must have an NIH eRA Commons user name and UW Net ID.

Typically there are only one or two co-investigators that may be considered active collaborators. The PI should make the determination as to who he/she considers to be an active collaborator in their study. Research team members such as nurses and clinical research associates are usually not considered active collaborators.

Research support staff (e.g. clinical research associates, research nurses) and co- investigators included in the IRB-ITHS application only for consenting purposes should not be included here.

Name (Last, First, Degrees): ERA Commons User Name: UW Net ID:

Contact Person for all CRCN related matters Role in Research Name & (e.g. Clinical Research Department/ Mail Stop/ Phone Email Degree Associate, Research Division Address Nurse)

4. Study Categories

4.1 Clinical Trials Registration Number:______4.2 Please check one:

Category 1: Investigator-initiated Study. Phase I and II Cooperative Group Studies, with investigator-initiated Correlative Science (includes NIH-initiated studies). Provide the Funding Grant Number: ______

Category 2: Industry-sponsored studies deemed as investigator-initiated by virtue of orphan disease status, as approved by Scientific Review Committee. Investigator must meet required criteria in order to be considered for Category 2 type study. See Guidelines here:

http://child.childrens.sea.kids/uploadedFiles/Child/Research/Centers/Center_for_Cli nical_and_Translational_Research/Pediatric_Clinical_Research_Center/Category %20Guide%20for%20Investigators%202-9-09.pdf □ I have reviewed the Study Category Guidelines and affirm this study meets the criterion set by the SRC for Category 2 Study.

Category 3: K-Awardees, Pilot Projects (AEF, ITHS, CCTR), and Scholars. Scholars are defined as junior faculty or fellows with mentored funding (i.e. K- awardees, CCTR Mentored Scholars) or an appointment rank of Assistant Professor or below without NIH R21/R01 funding.

Category 4: Industry-sponsored and Industry-initiated Studies.

5. Facility Utilization

5.1. Check the facilities requested: Seattle Children’s PCRC (pediatric unit, participants of all ages and adults with institutional approval) Seattle Children’s PCRC (Administrative Study – No Procedures) – Facilities Use Only Seattle Children’s Other Facilities: ______

UWMC: Please apply directly at: https://www.iths.org/uwcrc#/uwcrc/forms

5.2. List the number of participants:

Seattle Other Children’s Facilities Total number of participants expected to be recruited at

Seattle Children’s or UWMC. Total number of participants expected to be enrolled at

Seattle Children’s or UWMC.

Total Number of Visits for each participant anticipated

5.3. Core and Services Utilization: Please complete the following tables to summarize the utilization for your study.

Service location(s) (e.g. PCRC, Additional Utilization Services Seattle Form to Children’s OR, complete? medical unit, Hem/Onc clinic); Other facilities Total Number of Yr1 Yr2 Yr3 Yr4 Yr5 Outpatient Visits in PCRC N/A PCRC unit per year Total Number of Yr1 Yr2 Yr3 Yr4 Yr5 Scatter Visits per year (any research visit conducted by PCRC N/A personnel outside of the PCRC, both inpatient and outpatient areas) PCRC Room and/or Yes Equipment Use Only PCRC N/A (No procedures) If yes, PCRC Nursing Yes complete

Services No section 5.4 below. If yes, complete Appendix 6 PCRC Psychometry Yes located at:

Services No https://www. iths.org/PC RC

If yes, complete Appendix 3 Nutrition & Body Yes located at:

Composition Service No https://www. iths.org/PC RC

5.4. Nursing Services:

Provide detailed information Check if service regarding requests with specific requested procedures and visits listed Nursing Service (e.g. height and weight at visit 1; IV infusion of “study drug” over 2 hours., PK draws on Day 1 at 3 and Participant Parent 5 hours post dose.) Anthropometrics measurements Body measurements (e.g. height, weight, head circumference, etc) Central venous catheter or port access ECG Glucose tolerance testing (Include specifics e.g. IVGTT or OGTT) PK/PD studies Medication distribution, collection or pill counts PO, SQ, Topical, IM or IV medication administration (include LMX or J-tip) Questionnaire administration, interviews, and surveys Single blood draw Spirometry Participant education (e.g. injection teaching) Urinalysis Urine pregnancy -specimen collection Vital signs (temp, HR, RR, blood pressure, specify if oximetry required) Other Nursing Services, please describe.

6. CRCN Study Submission Checklist

Yes No N/A Submit all documents provided to IRB If your Data Safety Monitoring Plan (DSMP) includes Data Monitoring Committee (DMC) attach the DMC Charter and membership roster. If your study is not using Seattle Children’s or FHCRC IRBs, contact PCRC for a DSMP Form. CV of PI PI is a Seattle Children’s investigator or is collaborating with a Seattle Children’s investigator. PI is a licensed provider with admitting privileges – If not, has provided Licensed Provider Assurance #2 above.

All research staff are Children’s employees – If not, please contact Research HR for on-boarding (NEAT process) of non-employees.

All research team active collaborators have ERA Commons User Names as well as UW Net ID. If not, please contact: PediatricCRC- [email protected]. If adults are considered research participants by the IRB and receiving procedures or providing PHI, institutional approval is required. See PCRC Guidelines and Institutional Policy here: http://child.childrens.sea.kids/Policies_and_Standards/Policies_and_Pro cedures/Administrative.aspx?pg=3

Epic Study Code (RS) is established. If not, please contact an OSR CRBA: [email protected].

Review of protocol and study budget created by OSR. If not, please contact an OSR CRBA: [email protected].

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