IRB #:
Date:
Principal Investigator:
Study Title:
INSTITUTE OF TRANSLATIONAL HEALTH SCIENCES (ITHS) CLINICAL
RESEARCH CENTER NETWORK (CRCN) UW REGISTRATION
*Fill in header information.
Instructions:
 Complete this registration if you wish to use the ITHS CRCN and/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 registration, please email ithscrc@uw.edu or contact Laurie Chowayou, CRC Nursing Manager at 598-8933.

Please email completed registration packet to iths-crc@uw.edu. Make sure to
include the other necessary review elements:
o
Copy of your previously provided cost estimate for CRC services (if you
do not have this, please contact us at iths-crc@uw.edu to obtain one prior
to completing this registration packet.
o
Protocol (if you do not already have one, you may view a sample basic
protocol containing the minimal required elements for our review)
o
Approved IRB application including all stamp-approved consent/assent
forms and HIPAA Authorization form
o
Investigator’s Brochure or device manual (for all investigational products)
if your study is being conducted under an IND or IDE
o
Copy of your Data Monitoring Committee (DMC) charter and membership
roster, if applicable
Thank you for providing this important information. We look forward to working with you!
ITHS UW CRC Registration form V3 11/09/12
Page 1 of 10
IRB #:
Date:
Principal Investigator:
Study Title:
1. ITHS Responsibility for Study Conduct
If this study is to be conducted utilizing ITHS resources including the UW Clinical
Research Center (CRC), 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 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.
 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 understand that I will be required to provide information on an annual basis for the
ITHS Annual Progress Report to NIH.
 I understand that ITHS requires active collaborators to 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 University of Washington
Medical Center (UWMC). The licensed provider named below must be a member of
the research team and have admitting privileges at UWMC.
As a licensed provider, I have reviewed the materials associated with this
registration 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:
ITHS UW CRC Registration form V3 11/09/12
Date:
Page 2 of 10
IRB #:
Date:
Principal Investigator:
Study Title:
3. Active Collaborators
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: See link below for NIH definition:
http://www.uth.tmc.edu/osp/OSP_files/NIH_Personnel_Defined_2006_01_10.pdf.
Active Collaborators listed in this section will be approached annually to submit
information for the NIH/NCATS annual report submission. Active Collaborators must
have an NIH eRA Commons user name and UW User Net ID. Please contact your
department administrator or designated institutional contact to obtain an eRA
Commons user name. For information about eRA Commons please go to:
http://era.nih.gov/commons/faq_commons.cfm.
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,
coordinators and clinical research associates are usually not considered active
collaborators.
Research support staff (e.g. clinical research associates, research nurses,
study coordinators) and co-investigators included in the IRB application only
for consenting purposes should not be included here.
Primary Investigator
Name (Last, First, Degrees)
eRA Commons
Username
ITHS Member?
Yes
Title
Phone
Department or Division
Fax
Email
No
School
Mailbox
Co-Investigator(s)
Name (Last, First, Degrees):
ERA Commons User Name:
UW Net ID or Protect Net ID:
Name (Last, First, Degrees):
ERA Commons User Name:
UW Net ID or Protect Net ID:
ITHS UW CRC Registration form V3 11/09/12
Page 3 of 10
IRB #:
Date:
Principal Investigator:
Study Title:
Contact Person for all CRCN related matters
Role in Research
Department/
Name &
(e.g.
Research
Nurse,
Study
Degree
Division
Coordinator)
Phone
Mail Stop/
Address
Email
4. Study Categories
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.
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
Please provide the Study Sponsor(s):
Clinical Trial Phase: Mark all that apply
Phase I
Multi-Center?
Phase II
IND Study?
Phase III
NIH Funded?
Phase IV
HIV?
IDE study?
Please provide your UW Budget Number:
ITHS UW CRC Registration form V3 11/09/12
Page 4 of 10
IRB #:
Date:
Principal Investigator:
Study Title:
5. Facility Utilization
5.1. Check the Core services you wish to use:
UWMC CRC Nursing (clinical unit for adult participants > 14 years of age)
Nutrition & Body Composition Services: Contact Holly Callahan – hcal@uw.edu
Gene/Cell Therapy Services: Contact Ponni Anand – ponnia@uw.edu
5.2. Core and Services Utilization: Please complete the following tables to summarize
the utilization for your study.
Services
Utilization
Total Number of Outpatient Visits per
subject in CRC unit per year
Yr1
Yr2
Yr3
Yr4
Total Number of Inpatient Days per
subject per year
Yr1
Yr2
Yr3
Yr4
5.3. Protocol Visits on the CRC: Please indicate the corresponding visits (e.g. visit
numbers or visit days) from your protocol that will occur on the CRC (example – Visits 1,
2, 9 from protocol).
Helpful Links:
Biomedical Informatics Services: https://www.iths.org/CBS
Research Coordinator Services: https://www.iths.org/RSB#/rcc
Clinical Research and Billing Support (CRBB): crbb@uw.edu
Investigational Drug Services (IDS): idssam@uw.edu
Research Testing Services (RTS): (206) 616-8979
Other questions, please contact ITHS Navigator: ithsnav@uw.edu
ITHS UW CRC Registration form V3 11/09/12
Page 5 of 10
IRB #:
Date:
Principal Investigator:
Study Title:
6.
DATA AND SAFETY MONITORING PLAN (DSMP)
Prior to completing this section you are encouraged to check out the ITHS crossinstitutional tool on developing an appropriate Data and Safety Monitoring Plan at:
http://www.iths.org/sites/www.iths.org/files/forms/RCC/CrossinstitutionalDSMPguidelines.doc
NOTE: Studies under the review of Seattle Children’s or Fred Hutchinson/Cancer Consortium
IRBs do not need to complete this section.
1. Assess Risk Level.
Please review below and provide your assessment of the level of risk associated with
this study. Your selection should help you determine the appropriate level of monitoring
for your study. Final decision of risk level resides with the Regulatory Support &
Bioethics core.
Risk Level
Description
Observational studies using procedures generally considered as
minimal/low risk– for example, infrequent peripheral blood draws, nasal wash,
nutritional assessments, questionnaires, behavioral surveys, imaging (not using
sedation), use of left over samples from clinically indicated procedures, EKGs,
gait assessments.
Risk Level I
Adverse events: No adverse events are anticipated; if any occur, the PI or
Physician of Record will report them to the approving Institutional Review Board
(IRB) and ITHS Regulatory Support & Bioethics (RSB) core according to
applicable IRB guidelines. Adverse events will be graded as Mild, Moderate or
Severe, and as Related / Possibly Related / Not Related to study procedures.
Safety review: The PI or designated study personnel will review all data,
including completeness of study data, enrollment, protocol deviations, dropouts, adverse events on a regular basis and an annual report of all adverse
events and a summary of the investigation will be submitted to the approving
IRB and the ITHS RSB core.
For Risk Level I studies, STOP HERE. You do not need to complete the rest of
the DSMP section.
Risk Level II
Clinical trials and observational studies using procedures or treatments
with well established risk profiles– for example, behavioral trials, psychiatric
surveys, nutritional therapies, low risk procedures (e.g., endoscopy, glucosetolerance tests, induced sputum, skin or muscle biopsy, lumbar puncture, bone
marrow biopsy, imaging requiring sedation), as well as therapeutic trials
involving licensed agents with known safety profiles and without any reason to
suspect that the safety profile would be different for the proposed indication or
age group.
ITHS UW CRC Registration form V3 11/09/12
Page 6 of 10
IRB #:
Date:
Principal Investigator:
Study Title:
Risk Level
Risk Level III
Risk Level IV
Description
Interventional trials and observational studies using procedures or
treatments generally considered to be of moderate-risk – for example,
insulin clamp studies, organ biopsy, or Phase II single site or multi site trials of
agents with available safety data in the same population. Research in
psychologically or neurologically impaired individuals. In general, Risk Level III
trials require review by an external monitor or data monitoring committee
(DMC).
Trials involving investigational agents or devices that present substantial
risk to study participants or observational studies with high-risk clinical
procedures – for example, investigator initiated INDs, Phase I multi-site trials,
gene therapy, Phase III randomized blinded comparative trials, high-risk clinical
procedures if performed solely for research purposes.
Please note: Phase III multi-center comparative trials are considered Level IV
and per NIH policy, generally require a Data Monitoring Committee (DMC).
ITHS UW CRC Registration form V3 11/09/12
Page 7 of 10
IRB #:
Date:
Principal Investigator:
Study Title:
2 Identify who will review study conduct and safety data.
Who will be performing the primary safety monitoring of research participants? Check the
highest level of monitoring that applies for your study.
The PI or Physician of Record
Study team (for multi-center investigations)
External Monitor (an individual not directly involved in the design or conduct of the study).
Name
Affiliation
Area of expertise
Contact Information
External Safety Monitoring Committee (two or more people not directly involved in the design
or conduct of the study). Attach list of committee members with name, affiliation, area of
expertise and contact information.
Full Data Monitoring Committee (DMC), also known as a Data & Safety Monitoring Board
(DSMB) – several independent people with appropriate expertise with access to data from all
centers.
If you checked YES to having a DMC, please attach:
 DMC charter
 DMC Membership Roster to include names and if available, clinical disciplines or
expertise
 Any potential conflicts of interest
What data will the primary individual or committee conducting safety monitoring review?
Check all that apply.
Accrual
Drop-outs
Outcome measures
Adverse events in aggregate, by attribution and grade
Serious adverse events - Click here to indicate timing
Protocol Deviation
Blinded data by treatment group
Unblinded data
Other – please specify:
How often will the data be reviewed?
Click here to select a response
If data review is enrollment dependent, describe:
ITHS UW CRC Registration form V3 11/09/12
Page 8 of 10
IRB #:
Date:
Principal Investigator:
Study Title:
3. Written Safety Reporting Frequency
Will written monitoring reports be generated as a result of the above review? (e.g. a letter
from a DMC or independent monitor)
Yes
If yes, how often will these be provided to the IRB and ITHS RSB core?
Click here to select a response
If you selected other, please specify:
No
4.a. Adverse Event Identification and Grading
Physical exam
How will Adverse
Laboratory or other diagnostic reports
Events be
Review of CRCN nursing notes
identified?
Self-identified by study participant
Check all that apply.
Other:
NCI CTC version 4.0 –  http://ctep.cancer.gov/reporting/ctc.html
NIH NIAID, Division of AIDS toxicity tables
ICH guidelines -  http://www.ich.org/
Other. Please describe or attach supporting documentation:
How will Adverse
Events be graded?
Indicate the
attribution scale
that will be used
for Adverse
Events: (Select one)
Expected / Unexpected and
Related / Possibly related / Not related
Definitely related / Probably related / Possibly related / Unlikely
related / Not related
Other – describe, attach or reference the scale to be used:
Do you have an
Adverse Event data
collection form
specific to your
study?
Click here to select a response
4.b. Adverse Event Reporting
To whom will
Adverse Events be
reported?
IRB (required)
ITHS RSB core (required)
FDA: Click here to select reporting method
Sponsor
DMC or other monitoring entity: Click here to select reporting method
NIH Office of Biotechnology Activities
Other – please identify:
ITHS UW CRC Registration form V3 11/09/12
Page 9 of 10
IRB #:
Date:
Principal Investigator:
Study Title:
Do you agree to report adverse events, including Serious Adverse Events according to the
requirements and timeframes set forth by your IRB, institution, study sponsor, funding
agent and any federal oversight agencies?
Yes
No
5. Data Management
How will your study data be
reviewed for quality and
accuracy on a regular basis?
Check all that apply.
Regular verification of data and protocol compliance by
data manager
Regular verification of data and protocol compliance by PI
Computerized data entry with logical checks and entry
completeness
Formal data audit by external monitor provided by sponsor
To be determined with the aid of the ITHS Biomedical
Informatics (BMI) Core
Other – describe:
 If after filling out this section, you would like help in writing a formal Data & Safety Monitoring Plan
and/or setting up an independent Data Monitoring Committee or Medical Monitor, please contact the
ITHS RSB core to make an appointment: 206-598-6477 or rsbcore@u.washington.edu.
ITHS UW CRC Registration form V3 11/09/12
Page 10 of 10