The WIIA - The Wright Center of Innovation Imaging Archive
Conditions: Medical Imaging Data
Sponsor: University of Cincinnati

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Protocol Title:  
 
The WIIA – The Wright Center of Innovation Imaging Archive 
 
Protocol Project Number:  RP0310 
 
Protocol Date:  
 
December 20, 2017 
 
Principal Investigator:  
 
Michael V. Knopp, MD, PhD 
Professor and Novartis Chair of Imaging Research,  
Vice Chairman of Research 
Department of Radiology 
The Ohio State University Wexner Medical Center 
395 West 12th Avenue, Room 430 
Columbus, Ohio 43210 
Phone: (614) 293-9998 
Fax: 
(614) 293-9275 
E-Mail: knopp.16@osu.edu 
 
OBJECTIVES 
This data bank will serve as a data resource for a multidisciplinary team of clinicians and basic 
scientists. Specifically, this data bank will allow investigators to generate preliminary data for 
competitive consideration in intermural and extramural funding while enabling advanced 
analytical tool development and deep learning methodologies. This effort will enable the use of 
leading edge innovation in biomedical imaging by using clinical imaging studies that otherwise 
could not be used for such developments.  
 
We aim to use these data to improve diagnostics and disease management. With this data bank, we 
hope to improve the quality of imaging and the precision of imaging based analytics to better detect 
potential health risks, predict treatment response, and monitor disease progression in order to guide 
management of future patients.  
 
BACKGROUND AND RATIONALE 
Imaging technology has widespread medical uses. Ultrasound, PET, CT, and MRI techniques are 
used to diagnose and monitor diseases, especially in the areas of oncology, neuroscience, 
cardiovascular, orthopedics, and sports medicine. Therefore, optimizing the use of imaging 
techniques benefits many patients, and unsurprisingly, this is a primary focus of clinical research.  
The Wright Center of Innovation and its researchers explore advancements in imaging 
technologies and techniques to improve patient lives and therapeutic outcomes.  
 
The constant advances in computational capabilities and abilities of deep learning necessitate the 
availability of large imaging data sets that can be further analyzed. We therefore create the WIIA 
– The Wright Center of Innovation Imaging Archive – to serve as a repository for advanced data 

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analytics and simulation. This will provide researchers access to a robust, comprehensive pool of 
imaging data for impactful research.  
 
DATA COLLECTION, STORAGE, AND RELEASE 
Data Collection 
Data collected will include imaging scans, coded demographics, abbreviated medical history, 
current diagnoses, coded medical reports, coded surgical/nonsurgical treatment procedures, and 
follow up information. These data will be collected from Standard of Care (SOC) or investigational 
imaging studies. Specifically, data may be collected directly from the imaging device, directly 
from the imaging network (PACS), or using other electronic data exchange means, such as USB 
device, CD, DVD, or Blu-Ray. The data will be coded and annotated with limited subject and 
clinical information. 
 
The imaging data will be coded using the SOP’s of the Imaging and Radiation Oncology Core 
(IROC) service so that only coded protected health information (PHI) will be included within the 
data sets. The following coding approach will be used: 
 
Patient Name (First, Middle, Last) will be replaced with a WIIA ID code in the form of 
RP310_XXXXXX using leading zeros. Each participant will receive a unique WIIA ID. 
 
The date of the exam will be coded to the first day of the quarter when the study was performed, 
except in cases where follow up studies are performed at a shorter time interval. If a shorter time 
interval exists, the date will be coded in relation to the baseline study that will be coded as the 1st 
of the quarter. For example, a baseline CT scan was performed on 10/5/2017 with a follow up on 
10/7/2017, and the date coding would be 10/1/2017 for the baseline and 10/3/2017, preserving the 
relative time ratio within the quarter, but changing the date to a coded date. 
 
The birthdate will be coded as 1/1/decade; someone born on September 11, 1984 will have a coded 
birthdate of 1/1/1980. It will be always January 1 of the decade. 
 
The gender information will be retained as it is also fairly easy to identify physical gender from 
the medical imaging. 
 
If available, the following information will be coded: 
• Weight in pounds in 20 pound increments based on rounding. 
• Height in feet (rounded) 
• Ethnicity  
• Reason for imaging study (screening, diagnostic, response assessment) 
• Findings of the imaging study  
• Whether participant has been under treatment (Y/N) 
o If yes, whether the participant is currently under treatment or is post-treatment 
o If yes, what kind of treatment (surgery, chemotherapy, immunotherapy, radiation 
therapy) 

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Data Storage 
Data will be coded and stored in the Wright Center of Innovation Imaging Archive, which is a 
secure database of imaging studies. Data will be stored indefinitely. 
 
If the study Principal Investigator were to leave the study or university, the data would remain 
within the Wright Center of Innovation, and management of the repository study would be 
transferred to one of the designated Co-Investigators in this study. The archive will be encrypted, 
password protected, will contain only coded data, and will have limited access restricted to study 
investigators and administrative staff. Administrative staff will construct and maintain the database 
as well as conduct annual quality assurance assessments of bank data.  
 
The oversight structure of the bank is as follows. The Principal Investigator will oversee that only 
appropriately authorized data are collected and distributed. Any data requests must be approved 
by the PI or appropriately delegated authorization person. The Co-Investigators will verify that the 
appropriate authorization was acquired prior to upload and inclusion of data into the database. 
Investigators will also review the de-identification and technology functionality of the dataset.  
 
Data Release  
To maximize the use of this data bank and to promote collaborative, multi-institutional research, 
we are not limiting future data use. Data may be shared with Ohio State or non-Ohio State 
researchers. However, only investigators with sound, hypothesis driven research proposals can 
request data by completing a Data Request Form. These requests will be reviewed by the Principal 
Investigator of the repository. Investigators requesting use of the data will provide copies of all 
study protocols, data acquisition forms, and/or institutional review approval documents prior to 
release of data. Additionally, any data shared with others will be coded and de-identified. Lastly, 
annual auditing processes will be conducted internally by administration personnel to ensure 
proper data release. 
 
PROCEDURES 
Sample  
The patient population under study includes adults who are 18 years of age and older. Children 
will be excluded from this study as they are unable to give voluntary consent. A partial waiver of 
HIPAA authorization will be requested to permit access to and use of PHI for recruitment purposes. 
However, investigational data will only be collected once consent to participate in the study is 
acquired. 
 
Participants can include or donate their imaging data independently if it was performed at OSU or 
outside of OSU. For example, a subject may be willing to donate an imaging study performed 
previously or for different purposes and provides the WIIA with a CD or other data set. 
 
There will be no upper limit to the number of people who participate in this study. We expect 100-
150 participants per year, with plans for the study to continue indefinitely. 

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Selection Criteria 
Inclusion 
1. Patient provides consent 
2. Patient is receiving or has received a SOC or investigational imaging scan 
 
Exclusion 
1. Patient does not wish to or is unable to provide consent 
2. Patient is below the age of 18 
 
Recruitment  
Patient recruitment will take place during their SOC or investigational imaging scan. The patient 
will meet with a qualified personnel who will explain the purpose of the bank, requirements for 
participation, and will provide the combined Informed Consent and HIPAA Authorization Form. 
If the patient is unsure about participating, they will be given the Informed Consent and HIPAA 
Authorization Form to keep. The consenter can approach the patient at subsequent visits to answer 
questions, provide additional information, and seek consent. If the patient consents to have their 
data made available to our data bank, the patient will sign the Informed Consent and HIPAA 
Authorization Form. The original, signed, hard copy consent form will be kept indefinitely by the 
Department of Radiology in a secure location. This clinical trial will also be uploaded to 
clinicaltrials.gov to recruit individuals interested in donating past imaging information. 
Recruitment will not involve the use of patient information or PHI. 
 
Informed Consent 
The patient will meet with a qualified personnel who will explain the purpose of the bank, the 
requirements for participation, and will provide the combined Informed Consent and HIPAA 
Authorization Form. If the patient is unsure about participating, they will be given the Informed 
Consent and HIPAA Authorization Form to keep. The consenter can approach the patient at 
subsequent visits to answer questions, provide additional information, and seek consent. If the 
patient consents to have their data made available to our data bank, the patient will sign the 
Informed Consent and HIPAA Authorization Form. The original, signed, hard copy consent form 
will be kept indefinitely by the Department of Radiology in a secure location. 
 
Patients may choose at any time to discontinue participation in the data bank. Patients will be 
advised in the Informed Consent and HIPAA Authorization Form that if they decide to withdraw 
consent, they simply need to notify the Principal Investigator in writing. Upon withdrawal, the 
individual’s file will be tagged, and no additional data or specimens will be collected. All samples 
and study data will be destroyed and not used in any further research. 
 
Confidentiality 
Patient confidentiality will be fully maintained within this banking protocol. Only for the purpose 
of coding and tracking of the completed informed consent will there be access to PHI. This PHI 
coding list will be kept completely separate from the actual WIIA and the imaging data sets. 
 

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Any personal health information (PHI) will be only accessed in the appropriately authorized 
offices at The Ohio State University Wexner Medical Center. It may be used in a secure email 
communication with appropriately authorized and identified team members or staff that are part 
of the healthcare service process. If any PHI is written in a hard copy document, it will be 
appropriately identified as containing PHI and either securely stored for the temporary purpose in 
locked spaces or securely shredded. The PHI information will be stored at either of these three 
locations: 1) 395 W. 12th Ave., 4th Floor, Imaging Core Lab Suite (key access only) 2) 2050 
Kenny Road, Room 1233 (keycard access only) 3) 1216 Kinnear Rd., secure and monitored 
basement storage facility (keycard access only). 
 
The imaging studies will be scrubbed and coded using the specialized software of the WCIBMI 
ICL, which serves also the National Institutes of Health National Clinical Trial network. This QC 
process ensures that data adhere to the coding requirements of PHI information while securing that 
private imaging systems tags remain accessible. 
 
Risk/Benefit 
This study will impose minimal medical risk to participants. A data leak is the primary risk, which 
will be minimized through precautions to protect PHI. Nevertheless, in the event of a data breach, 
the nature of the collected data ensures minimal financial or professional impact on the patient. 
This study does not confer a direct benefit to the patient. However, society may benefit from 
imaging advancements that arise from future studies using this data.  
 
Incidental Findings 
Incidental findings will not be generated from this study. Participants in the data bank will have 
either already had a standard of care scan accompanied with their research scan, or they would 
have had a diagnostic review as part of the primary research performed. Therefore, this study will 
not generate new incidental findings.  
 
Adverse Event Reporting 
Adverse event reporting will be reported in compliance with the requirements of the overseeing 
IRB and all other applicable regulatory agencies. The most likely adverse event of this study would 
be a privacy breach. However, limited access to and secure storage of PHI will minimize this risk.  
 
Conflict of Interest 
The principal investigator and all other study team members will remain informed and compliant 
with all OSU Conflict of Interest (COI) policies. If a conflict arises that is greater than the 
minimum allowable by OSU COI, a conflict management plan will be developed and approved by 
the University COI Committee.