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
PediatricCRC-ITHS@seattlechildrens.org 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 PediatricCRC-ITHS@seattlechildrens.org.
ITHS CRCN Services Supplement (short)
3/7/2016
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:
ITHS CRCN Services Supplement (short)
3/7/2016
Page 2 of 7
IRB # (if known):
Study Title:
Principal Investigator:
Version 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 coinvestigators 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:
Name (Last, First, Degrees):
ERA Commons User Name:
UW Net ID:
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/
Degree
Associate, Research
Division
Nurse)
Phone
Mail Stop/
Address
Email
4. Study Categories
ITHS CRCN Services Supplement (short)
3/7/2016
Page 3 of 7
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
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%2
0Guide%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. Kawardees, 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
Children’s
Other
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.
ITHS CRCN Services Supplement (short)
3/7/2016
Page 4 of 7
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
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)
Services
Total Number of
Outpatient Visits in
PCRC unit per year
Total Number of
Scatter Visits per year
(any research visit
(e.g. PCRC,
Seattle
Children’s OR,
medical unit,
Hem/Onc clinic);
Other facilities
Utilization
Yr1
Yr2
Yr3
Yr4
Yr5
PCRC
Yr1
Yr2
Yr3
Yr4
N/A
Yes
PCRC Nursing
Services
Yes
No
PCRC Psychometry
Services
Yes
No
Nutrition & Body
Composition Service
N/A
Yr5
conducted by PCRC
personnel outside of the
PCRC, both inpatient and
outpatient areas)
PCRC Room and/or
Equipment Use Only
(No procedures)
Additional
Form to
complete?
Yes
No
ITHS CRCN Services Supplement (short)
PCRC
N/A
If yes,
complete
section 5.4
below.
If yes,
complete
Appendix 6
located at:
https://www.
iths.org/PC
RC
If yes,
complete
Appendix 3
located at:
https://www.
iths.org/PC
RC
3/7/2016
Page 5 of 7
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
5.4. Nursing Services:
Check if service
requested
Nursing Service
Participant
Parent
Provide detailed information
regarding requests with specific
procedures and visits listed
(e.g. height and weight at visit 1; IV
infusion of “study drug” over 2
hours., PK draws on Day 1 at 3 and
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.
ITHS CRCN Services Supplement (short)
3/7/2016
Page 6 of 7
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
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: PediatricCRCITHS@seattlechildrens.org.
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: CRBA@seattlechildrens.org.
Review of protocol and study budget created by OSR. If not, please
contact an OSR CRBA: CRBA@seattlechildrens.org.
ITHS CRCN Services Supplement (short)
3/7/2016
Page 7 of 7