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.
Key:
Type in text as appropriate
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/research/applications.
 The IRB-ITHS 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 budgets.
 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 1UL1RR025014 from the National Center for Research Resources
(NCRR), a component of the NIH and NIH Roadmap for Medical Research. The
contents of any publications are solely the responsibility of the authors and do not
necessarily represent the official view of NCRR or NIH. Information on NCRR is
available at http://www.ncrr.nih.gov/.
 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.
 I will be required to provide information on an annual basis for the ITHS Annual
Progress Report to NIH.
 I understand ITHS requires active collaborators have an eRA Commons User Name
and UW Net ID or Protect Net ID for the purposes of providing information on an
annual basis for the ITHS APR to NIH.
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
Name (Last, First, Degrees):
ERA Commons User Name:
UW Net ID or Protect Net ID:
ITHS Member?
Yes
No (ITHS members may receive subsidies for ITHS resources.)
Name (Last, First, Degrees):
ERA Commons User Name:
UW Net ID or Protect Net ID:
ITHS Member:
Yes
No (ITHS members may receive subsidies for ITHS resources.)
Name (Last, First, Degrees):
ERA Commons User Name:
UW Net ID or Protect Net ID:
ITHS Member:
Yes
No (ITHS members may receive subsidies for ITHS resources.)
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
4.1. Please check one:
Category 1: Investigator-initiated Study. Phase I and II Cooperative Group
Studies, with investigator-initiated Correlative Science (includes NIH-initiated
studies).
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. Contact PCRC if you are applying for this category.
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.
ITHS CRCN Services Supplement (short)
3/7/2016
Page 3 of 7
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
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)
UWMC CRC (general unit for adult participants over age 14 years)
5.2. List the number of participants:
Children’s
UWMC
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.
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
conducted by PCRC
personnel outside of the
CRC, both inpatient and
outpatient areas)
Total Number of
Inpatient Days per
year
(overnight research
stays on inpatient unit at
Seattle Children’s
Hospital or UWMC CRC)
PCRC Nursing
Services
PCRC Specimen
Processing Lab
Utilization
(e.g. PCRC, Seattle
Children’s OR,
medical unit,
heme/onc clinic)
Yr
1
Yr
2
Yr
3
Yr
4
Yr
5
Yr
1
Yr
2
Yr
3
Yr
4
Yr
5
Yr
1
Yr
2
Yr
3
Yr
4
Yr
5
Yes
No
Yes
No
ITHS CRCN Services Supplement (short)
PCRC
Additional Form to
complete?
N/A
N/A
N/A
If yes, complete
section 5.4 below.
If yes, complete
Appendix 8.
3/7/2016
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IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
Service
location(s)
Services
Clinical Research Staff
Support Core
Total Number of
Psychometry Visits
Biomedical
Informatics/Data
Management
Nutrition & Body
Composition Service
Utilization
(e.g. PCRC, Seattle
Children’s OR,
medical unit,
heme/onc clinic)
Additional Form to
complete?
Yes
No
Yes
No
If yes, complete
Appendix 7.
If yes, complete
Appendix 6.
Yes
No
If yes, complete
Appendix 4.
Yes
No
If yes, complete
Appendix 3.
ITHS CRCN Services Supplement (short)
3/7/2016
Page 5 of 7
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
5.4. Nursing Services:
Nursing Service
Check if
service
requested
If service requested, provide detailed
information regarding request
(e.g. height and weight at visit 1; IV infusion
of “study drug” over 2 hours with pks at 0, 5
min… )
Anthropometrics
measurements
Body measurements
(e.g. height, weight, head
circumference, etc)
Central venous catheter or
port access
ECG
Glucose tolerance testing
PK/PD studies
Medication distribution or pill
counts
PO, SQ, Topical, IM or IV
medication administration
Questionnaire administration,
interviews, and surveys
Single blood draw
Spirometry
Participant education
Urine pregnancy testing
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
CV of PI
Complete and submit all applicable appendices for ITHS Resource
Utilization
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 onboarding (NEAT process) of non-
ITHS CRCN Services Supplement (short)
3/7/2016
Page 6 of 7
IRB # (if known):
Study Title:
Principal Investigator:
Version Date:
employees.
All research team active collaborators have ERA Commons User
Names as well as UW Net ID or Protect Net ID (Required). If not,
please contact: PediatricCRC-ITHS@seattlechildrens.org.
Does the PI have Membership status from ITHS and or CCTR?
The PI will receive subsidies if a member of CCTR and/or ITHS.
If adults are included, must have Seattle Children’s Medical
Director approval (refer to CHILD Administrative Policy “Patients
21 Years or Older”).
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.
Industry-sponsored studies deemed as Investigator-initiated may
possibly receive subsidies if criteria are met. Please contact:
PediatricCRC-ITHS@seattlechildrens.org.
ITHS CRCN Services Supplement (short)
3/7/2016
Page 7 of 7