Remote Wheelchair Skills Training Efficacy Coordinating Center
Phase: NA
Conditions: Spinal Cord Injuries
Sponsor: University of Pittsburgh

 
 
 
 
Cover page 
 
 
 
 
 
 
 
Official Title on ClinicalTrials.gov: 
ClinicalTrials.gov ID NCT number: 
IRB approved Date: 
 
Remote Wheelchair Skills Training Efficacy 
NCT03499951 
April 10, 2019 

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lJniversity of Pittsburgh 
OSIRIS 
  
!Section: Triage! 
[reviewer notes-,) 
 
 
 
Provide a short title for this study (200 characters or less): 
 
Remote Wheelchair Skills Training Efficacy 
 
Tl,0 
 
Select the type of application: 
New Coordinating Center (CC) Application (do not convert approved CC applications) 
 
T2.0 
 
Is the proposed research study limited to the inclusion of deceased individuals? 
'' No 
 
 
T2.1 
 
Are any research activities being conducted at the VA Pittsburgh Healthcare 
System or with VA funds? 
 
* No 
 
 
 
[reviewer notes-,] 
 
T3.0 
What is the anticipated risk to the research participants? 
 
Minimal Risk 
 
T3.1 
Whydo you feel that all aspects of this research study, including screening and 
follow-up, involve no more than minimal risk to the research subjects? 
 
 
 
 
 
T4.0 
This research protocol involves no more than minimal risk because no research subjects will 
be enrolled in this coordinating center protocol. Breach of confidentiality is the primary risk 
associated with this study. We feel that we have appropriate mechanisms in place to 
minimize this risk. 
 
Does the proposed study qualify for 'exempt' IRB review or for a determination of 
either 'not research' or 'no human subject' involvement? 
 
'" No 
 
TS.O 
 
Does the proposed research study qualify for 'expedited' IRB review status? 
* Yes 

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!section: Triage! 

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rreviewer notes-,J 
  ection: Coordinating Cented 
 
CC1.0 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CC1.1 
Indicate the oversight responsibility of the principal investigator named on this 
IRB application: 
 
Coordinating Center 
 
Briefly describe the role of the Center: 
The University of Pittsburgh will be the coordinating center for the multi-center project 
"Remote Wheelchair Skills Training Efficacy." The University of Pittsburgh will coordinate 
most aspects of this multi-center project. We will be responsible for the design and 
development of the protocol and consent templates and data collection forms. We will also 
assist with the tracking of enrollment. We will be responsible for tracking, reporting, and 
maintaining serious adverse events and unanticipated problems involving risk to subjects or 
others, and dissemination of information to all sites. In addition, we will provide periodic 
updates to sites on the study on enrollment, progress, and any  other relevant information. 
We may also monitor each site to assess study progress, protocol adherence, consenting 
processes, and accuracy of research records. The University of Pittsburgh will also be 
responsible for overseeing the analysis of data collected from this study. 
 
We will also review and moderate the web environment where the training materials are 
hosted. Through this, we will have access to video and/or photographs of training tasks 
being completed by participants. The coordinating center will provide feedback to 
participants on the training tasks. 
 
Note that copies of training records, licenses, certificates should be maintained in the  
study regulatory binder and are subject to audit by the Research Conduct and Compliance 
Office (RCCO). 
 
 
Projected number of subjects to be enrolled at all study sites: 
96 
 
[reviewer notes-,] 
 
 
This application is specific to the coordinating center research activities. It does not include 
the local site research activities. Each site must obtain approval from their respective local 
IRB. 
 
The investigator must upload the applicable protocol and consent templates, drug, device, or 
biologic information for review purposes only. The IRB will determine if the center has 
mechanisms in place to ensure that the management, data analysis, and data/safety 
monitoring systems are adequate. 
 
• DO  NOT list any of the sites in questions CC3.0 or CC4.0 until site 
authorization or local !RB approval has been obtained. List potential sites in the 
Abstract, question CS2.1. 
 
• Once local site approval is obtained, submit a Modification to upload the approval 
notification. 
 
• A Modification must be submitted if revisions to the protocol and/or consent 
form result in changes to the responsibilities of the coordinating center as described 
below. 
° Changes to Exempt projects require use of 'Send comments to IRB staff' so the 
IRB can determine if the project still meets the exemption criteria or if a new 
application needs to be submitted. 

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@ection: Coordinating Cented 
Important: If subjects will be enrolled at this site, a separate local site application must be 
submitted. 
 
 
 
Has the Coordinating Center PI assumed the responsibility for the following? 
 
cc2.1 
CC2.2 
CC2.3 
 
 
 
 
 
 
 
 
 
 
CC2.4 
 
 
 
 
 
 
 
 
 
 
CC2.5 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CC2.6 
Design and development of the protocol and/or consent template: Yes 
* Design and development of case report forms/ data collection tools: Yes 
Randomization, registration, and/or tracking subject enrollment: Yes 
If Yes, describe the process: 
The Coordinating Center will be responsible for developing the study protocol and/or consent 
templates. The templates will then be provided to the participating centers, so that they can 
submit the project to their local IRB. Sites will be instructed  to  modify the templates  to 
include their site specific information and to meet the requirements of their local IRB. The 
executive committee, which will consist of the project directors at each participating  center 
will be responsible for tracking subject enrollment. The executive committee will have 
regularly scheduled conference calls to discuss study progress including enrollment. 
Enrollment will be tracked using a tracking sheet. 
* Tracking, reporting, and maintaining serious adverse events and unanticipated problems 
involving risk to subjects or others, and dissemination of information to all sites: Yes 
* 1) If Yes, the mechanism to be employed and 2) if No, indicate who (by role) is 
responsible: 
All serious adverse events and unanticipated problems involving risks will be recorded on 
paper forms. Participating sites will be asked to  fill out the adverse  event form and send it 
via email to the Coordinating Center PI within 10 working days of learning of the event. This 
e-mail will be forwarded to the University of Pittsburgh IRB and other participating sites to 
notify them of the event within 10 working days of receipt by the coordinating center. 
* Providing periodic updates to all sites on subject enrollment, study progress, amendments 
and relevant scientific advances: Yes 
 
1) If Yes, the mechanism to be employed and 2) if No, indicate who (by role) is 
responsible: 
The coordinating center will have regularly scheduled conference calls with the executive 
committee to discuss overall project direction, problems that arise, and new research  
findings. During each conference call, the progress at each site will be reviewed and 
discussed and potential barriers to project progress and their solutions will be identified. The 
executive committee will also be responsible for any changes to the protocol and 
documentation for human subjects protection. All site Principal Investigators will be held 
accountable for the  progress of their portion of the project.  Minutes  will be taken  during 
each conference call to formally document progress and identify specific action items. A list 
serve will also be created to provide a method of communication with all participating sites. 
 
Sites will be sent periodic emails regarding participant progress through the training 
materials. Emails may occur weekly while the participant is active in the study. 
 
Monitoring/auditing each site to assess study progress, protocol adherence, consenting 
processes, accuracy of research records: Yes 
 
1) If Yes, the mechanism to be employed and 2) if No, indicate who (by role) is 
responsible: 
The coordinating center will have regularly scheduled conference calls with the executive 
committee to assess the study progress and ensure that the participating centers are 
adhering to study procedures outlined in the study manual of operation. It is the 
responsibility of the site Principal Investigators to ensure that their staff are obtaining 
informed consent prior to conducting any study procedures. The original research files will 

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CC2.7 
 
 
 
 
 
 
 
 
 
 
 
CC2.8 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
CC2.9 
 
 
 
CC2.10 
fuection: Coordinating Cented 
be stored at each of the participating sites. Each site will be responsible for ensuring that 
their research data/documents are restricted to associated investigators and research staff. 
Each site will be asked to keep research files under double lock and key and be only 
accessible to authorized study personnel. The coordinating center may conduct site visits to 
monitor protocol implementation, data collection procedures at each site, documentation, 
and to provide consultation on study implementation issues. The coordinating center may 
also complete periodic cross-checks of the data to ensure its quality. 
 
Ensuring that the affiliated sites are using the correct version of the IRB protocol and 
consent documents and maintaining IRB approval throughout the conduct of the study: Yes 
 
1) If Yes, the mechanism to be employed and 2) if No, indicate who (by role) is 
responsible: 
The Principal Investigator at each site will be responsible for ensuring that the correct 
versions of the IRB protocol and consent document are being used throughout the study.  
The site Principal Investigator will also be responsible for maintaining IRB approval by 
ensuring renewals are submitted in a timely manner. Each site will be required to send the 
coordinating center a copy of their initially approved protocol and consent document as well 
as continuing review and modification approvals. 
* Data management, including transmission, storage, and analysis: Yes 
If Yes, indicate if only de-identified data  will be received, describe  the  process and  tools to 
be used to ensure confidential transmission/storage, and analysis of the data: 
The original research files (including the consent forms) will be stored at each of the 
participating sites. Each site will be responsible for ensuring that their research 
data/documents are restricted to associated investigators and research staff. Each site will 
be asked to keep research files under double lock and key and be only accessible to 
authorized study personnel. 
 
Data will be collected using paper and pencil or using the web-based system Qualtrics. 
Security measures including log-in procedures for data entry that will be restricted to 
associated research staff will be implemented. Participant confidentiality will be preserved by 
linking participant names to numeric IDs at the study sites. This linkage code file will be  
stored securely at the study sites. 
 
The coordinating center will receive coded data from the participating centers through 
Qualtrics. We may also receive images and videos of the training tasks from participants 
through Qualtrics. 
* Distributing or storing drugs and/or devices: N/A 
1) If Yes, the process for distribution and 2) if No, indicate who (by role) is responsible: 
* Indicate other responsibilities not listed above: 
The coordinating center will also be responsible for developing the manual of operations for 
this study. 
 
CC2.11 
 
Describe the steps that will be taken to ensure that each external site is fully 
informed of study procedures and requirements prior to its initiation of research 
procedures. Also describe what steps will be taken to ensure regulatory 
compliance. 
To ensure that all sites are fully informed of study procedures and requirements prior to 
clinical testing we will conduct in person training sessions and/or teleconferences to educate 
all sites on the manual of operations developed, ensuring participant confidentiality and data 
security. The training session(s) will educate all investigators to ensure data integrity and 
standardized data collection. Topics for discussion during the training include recruitment 
methods, informed consent, eligibility criteria, and data collection. We will also develop and 
distribute a sample IRB protocol, consent form, recruitment flyer, and data collection  forms  
to all sites. 

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-- 
System 
-- 
System 
 
 
 
 
  
  ection: Coordinating Centerl 
CC2.12 
Is the center responsible for the long-term storage (banking} of biological 
specimens? 
 
No 
 
If Yes, broadly describe the intended future use, storage and distribution process: 
[reviewer notes,) 
 
CC3.0 
 
Will this research be conducted in (a} a foreign country and/or (b} at a site (e.g., 
Navajo Nation} where the cultural background of the subject population differs 
substantially from that of Pittsburgh and its surrounding communities? 
 
No 
 
 
 
 
 
[reviewer notes,) 
 
CC4.0 
 
Address the following for each U.S. site where this 
research will be conducted: 
 
• Name of site or institution 
• Approval letter from a local IRS for this site and date of 
initial approval 
• Append a copy of either a letter of authorization to conduct 
the research at the facility or a signed statement of work 
• Name and qualifications of the local collaborator 
• If Federally funded, provide the Federalwide Assurance 
number (FWA) assigned to the site 
 
 
 
Site 
Date 
Modified 
View  Midwest  Regional  Spinal Cord Injury Care 612512018 
View  Northern  New Jersey  Spinal Cord Injury 
311212018 
View  South Florida Spinal Cord Injury System   6/25/2018 
. 
University of Pittsburgh Model Center on 
-V- iew S  p.inaI  C ord  I . nJury 
Midwest Regional Spinal Cord Injury 
Care System (FWA: FWA: 00001549) 
Has local IRB or ethical review been 
obtained for this site? 
yes 
Has authorization to conduct 
research at this facility been 
obtained? 
Approval Letter(s}: 
Date of Local Approval: 
yes 
 
Approval 
6/22/2018 
513012018 

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fuection: Coordinating Centerl 
Name and qualifications of the local collaborator: 
Allen Heinemann, PhD is the Associate Director of 
Research and the Director of the Center for Rehabilitation 
Outcomes Research at the Rehabilitation Institute of 
Chicago. He is also a Professor in the Department of 
Physical Medicine and Rehabilitation at the Feinberg 
School of Medicine, Northwestern University. 
 
Northern New Jersey Spinal Cord 
Injury System (FWA: FWA: 0001357) 
Has local IRB or ethical review been 
obtained for this site? 
yes 
Has authorization to conduct 
research at this facility been 
obtained? 
Approval Letter(s): 
Date of Local Approval: 
yes 
 
IRB Approval 
letter 
3/6/2018 
Name and qualifications of the local collaborator: 
Trevor A. Dyson-Hudson, MD is the Director of the 
Northern New Jersey Spinal Cord Injury System, the 
Interim-Director of the SCI Research at Kessler 
Foundation, and an Assistant Professor in the Department 
of Physical Medicine and Rehabilitation (PM&R) at the 
University of Medicine and Dentistry of New Jersey - New 
Jersey Medical School (UMDNJ-NJMS). Dr. Dyson-Hudson 
received his medical degree from the Albert Einstein 
College of Medicine (AECOM) in 1995. 
 
South Florida Spinal Cord Injury 
System (FWA: FWA: 00002247) 
Has local IRB or ethical review been 
obtained for this site? 
Has authorization to conduct 
research at this facility been 
obtained? 
Approval 
Letter(s): 
Date of Local Approval: 
 
yes 
 
 
yes 
 
Approval 
5/7/2018 
Name and qualifications of the local collaborator: 
Rachel Cowan, PhD is a Research Assistant Professor at 
the Miami Project to Cure Paralysis, Miller School of 
Medicine, University of Miami. 
 
University of Pittsburgh Model Center 
on Spinal Cord Injury (FWA: FWA: 00006790) 
Has local IRB or ethical review been 
obtained for this site? 
yes 
Has authorization to conduct 
research at  this facility been 
yes 
obtained? 
Approval Letter(s): 
Approval Letter 
Date of Local Approval: 
4/17/2018 

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fuection: Coordinating Cented 
Name and qualifications of the local collaborator: 
Michael Boninger, MD is Professor and Chair for the 
Department of Physical Medicine and Rehabilitation and 
Director of the UPMC Rehabilitation Institute. He is also a 
Professor in the Departments of Bioengineering and 
Rehabilitation Science and Technology and a physician 
researcher in the Department of Veterans Affairs. Dr. 
Boninger is the Medical Director of the Human Engineering 
Research Laboratories. Dr. Boninger received a 
mechanical engineering degree and Doctorate of Medicine 
from The Ohio State University 

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!section: Cover Sheeij 
 
rreviewer notes,l 
 
CS1,0 
What is the reason for this submission? 
 
New Research Protocol Submission 
 
Has this research study been approved previously by the University of Pittsburgh 
IRB? 
 
No 
 
 
CS1.1.1  
Has this research study (or a substantially similar research study} been previously 
disapproved by the University of Pittsburgh IRB or, to your knowledge, by any other 
IRB? 
 
No 
 
 
 
[reviewer notes-,] 
 
CS2.0 
 
Title of Research Study: 
 
Remote Wheelchair Skills Training Efficacy Coordinating Center 
 
cs2.o.1 
 
Requested approval letter wording: 
 
CS2.1 
Research Protocol Abstract: 
 
 
 
 
 
 
 
 
CS2.2 
The University of Pittsburgh Model Center on Spinal Cord Injury is the  coordinating center 
for this multi-site study. This coordinating center protocol outlines how the principal 
investigator, investigators, and associated research staff will coordinate this study and 
ensure its successful implementation. The collaborating sites for this project include the 
Northern New Jersey SCI System, Midwest Regional SCI Care System, and Southern Florida 
Spinal Cord Injury System. 
 
Select the category that best describes your research: 
Social, behavioral, educational, and/or public policy research 
 
[reviewer notes-,] 
 
 
CS3.0 
Name of the Principal Investigator: 
 
Michael Boninqer 
 
 
 

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CS3.1 
 
Affiliation of Principal Investigator: 
 
UPitt faculty member 
fuection: Cover Sheetj 
 
 
If you chose any of the Pitt options, please indicate the specific campus: 
Main Campus - Pittsburgh 
 
If you chose the UPitt faculty member option, provide the Pl's University Faculty Title: 
Professor and Chair in the Department of Physical Medicine & Rehabilitation 
 
CS3.2 
 
 
 
 
 
 
CS3.3 
 
 
 
 
CS3.4 
 
 
 
 
 
CS3.5 
 
 
CS3.6 
 
 
 
 
 
CS3.7 
 
 
CS3.8 
 
 
 
 
 
 
CS3.9 
 
Address of Principal Investigator: 
 
Kaufmann Building 
3471 Fifth Avenue 
Pittsburgh, PA 15213 
 
Recorded Primary Affiliation of the Principal Investigator: 
 
U of Pgh I School of Engineering 
 
Identify the School, Department, Division or Center which is responsible for 
oversight of this research study: 
U of Pqh I School of Medicine I Physical Medicine and Rehabilitation 
 
Telephone Number of Principal Investigator: 
 
412-822-3700 
 
Recorded Current E-mail Address of Principal Investigator to which all 
notifications will be sent: 
 
BONINGER@pitt.edu 
 
Fax Number: 
 
412-822-3699 
 
Does this study include any personnel from Carnegie Mellon University, and/or 
use any CMUresources or facilities (e.g., Scientific Imaging and Brain Research 
Center (SIBR)? 
 
* No 
 
Is this your first submission, as PI, to the Pitt IRB? 
No 
 
 
[reviewer notes-,) 

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  ection: Cover Sheeij 
CS4.0 
List of Co-Investigators: 
 
 
Last 
First 
Organization 
Greenwald Karen 
U of Pgh I School of Medicine I Physical Medicine and Rehabilitation 
ea r lm   an J  
th 
U of Pgh I School of Health and  Rehabilitation  Sciences  I  Rehabilitation 
ona an Science and Technology 
Tempest 
Marshall U of Pgh I School of Medicine I Physical Medicine and Rehabilitation 
Worobey 
Lynn 
U of Pgh I School of Engineering 
 
 
[reviewer notes-,l 
 
css.o 
Name of Primary Research Coordinator: 
 
Marshall Tempest 
 
 
 
CSS.1 
 
 
 
 
 
CSS.2 
 
 
 
 
CS6.0 
 
 
 
 
CS6.1 
 
 
 
 
CS6.2 
 
 
 
CS6.3 
 
 
Address of Primary Research Coordinator: 
 
1400 Locust St, 
Pittsburgh, PA 15219 
 
 
Telephone Number of Primary Research Coordinator: 
 
412-232-7949 
 
 
Name of Secondary Research Coordinator: 
 
Karen Greenwald 
 
Address of Secondary Research Coordinator: 
 
1400 Locust St, 
Pittsburgh, PA 15219 
 
Telephone Number of Secondary Research Coordinator: 
 
412-232-7949 
 
Key Personnel/Support Staff (Only list those individuals who require access to 
OSIRIS): 
Last First  Organization 
There are no items to display 
[reviewer notes-,] 
 
CS10.0 
Is this research study being conducted under a University of Pittsburgh-based, 
sponsor-investigator IND or IDE application? 
 
No 
 
If YES, you are required to submit the IND or IDE application and all subsequent FDA 
P 

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PRO180 I 0289 - Remote Wheelchair Skills Training Efficacy 
 
  
@ection: Cover Sheeij 
correspondence through the Office for Investigator-Sponsored IND and IDE Support 
(03IS). Refer to applicable University policies posted on the 03IS website 
(www.03IS.pitt.edu). 
 
 
[reviewer notes-,) 
 
csu.o 
Use the 'Add' button to upload one or more of the following: 
 
• the sponsor protocol (including investigator initiated studies) and/or 
other brochures 
• the multi-center protocol and consent form template, if applicable 
 
Name 
Modified Date 
Consent template (Trainer) clean 4/17/2018 11:39 AM 
Consent Template (trainee) 
4/17/2018 11:38 AM 
Protocol template (clean) 
4/17/2018 11:39 AM 
Consent Template (trainer) 
4/17/2018 11:38 AM 
Consent template (trainee) clean 4/17/2018 11:38 AM 
Protocol Template 
4/17/2018 11:38 AM 
Is this research study supported in whole or in part by industry? This includes the 
provision of products (drugs or devices). 
 
* No 
Is this a multi-centered study? 
 
Yes 
 
[reviewer notes-,] 
 
CSlS.O  
Indicate the sites where research activities will be performed 
and/or private information will be obtained. 
 
Choose all sites that apply and/or use Other to include sites not listed: 
Sites: 
University of Pittsburgh 
 
 
 
 
 
 
 
 
 
 
 
 
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University of Pittsburgh 
Campus: 
Main Campus - Pittsburgh 
List university owned off-campus research sites if applicable: 

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If you selected School, International or Other, list the sites: 
 
*For research being conducted at non Pitt or UPMC sites, upload a site 
permission letter granting the researcher permission to conduct their 
research at each external site: 
Name Modified Date 
 
 
 
CS15.1 Have you, Michael Boninger, verified that all members of the 
research team have the appropriate expertise, credentials, and if 
applicable, hospital privileges to perform those research 
procedures that are their responsibility as outlined in the IRB 
protocol? 
* Yes 
ection: Cover Shee 
 
CS15.2  
Describe the availability of resources and the adequacy of the 
facilities to conduct this study: 
 
Adequate staff, time and funds have been allocated to coordinate this 
multi-site project. The PI, co-investigators and staff working on this 
project have previous experience coordinating multi-site projects. 

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!Section: Section 1 - Objective, Aims, Background and Significance! 
[reviewer notes-,] 
 
1.1 
Objective: What is the overall purpose of this research study? (Limit response to 1-2 
sentences.) 
The objective of the study is to evaluate the effectiveness of remote training to teach 
clinicians how to train others in wheelchair skills. 
 
 
1.2 
Specific Aims: List the goals of the  proposed  study  (e.g., describe  the  relevant hypotheses or 
the specific problems or issues that will be addressed by the study). 
Evaluate the ability of remotely trained clinicians (trainers) to teach other individuals 
(trainees) using the skills and techniques presented in the Wheelchair Skills Training 
Program (WSTP) by evaluating: 
 
1) Wheelchair skills capacity of trainees. 
 
2) Wheelchair skills confidence of trainees. 

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!section: Section 2 - Research Design and Methodaj 
[reviewer notes,) 
 
2.17 
What are the main outcome variables that will be evaluated in this study? 
 
The main outcome variables are to determine the effectiveness of remote wheelchair skills 
training include the Wheelchair Skills Test Questionnaire questions on capacity (WST-Q 
capacity) and confidence (WST-Q confidence), knowledge questions about wheelchair skills 
(WST knowledge), and remote evaluation through video analysis by the study team on 
capacity to perform skills. Additionally, we will gather feedback on how the training process 
could be improved. 
 
 
2.18 
Describe the statistical approaches that will be used to analyze the study data. 
* Addressed below: 
We will use a paired t-test to evaluate if there is an improvement in knowledge of skills 
following the respective training programs through knowledge based questionnaires for the 
trainees. We will determine if capacity and confidence increases through paired comparisons 
between baseline and follow-up for the WST-Q total scores. Capacity will also be evaluated 
based on whether participants are successful in each task as determined by a remote rater; 
in this success will be determined with at least 75%  of participants achieving  capacity in 
each task. 
 
A power analysis was completed based on the published study completed with Occupational 
Therapy students with a pre-WSTP score of 64.8+/-9.0 and post-WSTP score of 81.0+/-5.2. 
Taking this into consideration, we will need a sample size of 23 individuals for a 95% power 
to detect a difference in the pre-WSTP and post-WSTP scores. We have estimated a sample 
size of 24 trainers and 72 trainees to account for participants who do not  complete the  
study. 

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!Section: Section 5 - Potential Risks and Benefit 
[reviewer notes,] 
 
5.2 
What steps will be taken in the event that a clinically significant, unexpected 
disease or condition is identified during the conduct of the study? 
 
Not Applicable 
 
[reviewer notes,] 
 
5.8 
Will any individuals other than the investigators/research staff involved in the 
conduct of this research study and authorized representatives of the University 
Research Conduct and Compliance Office (RCCO) be permitted access to research 
data/documents (including medical record information) associated with the 
conduct of this research study? 
 
Yes 
 
5.8.1 
Identify the 'external' persons or entity who may have access to research 
data/documents and the purpose of this access: 
 
Collaborators of this multi-site study may have access to coded research data collected by 
other participating sites for data analysis purposes. Images or videos of participants 
completing wheelchair tasks may be shared for the purposes of data analysis with 
collaborators as well. 
 
5.8.2 
Will these 'external' persons or entity have access to identifiable research 
data/ documents? 
 
 
Yes - Describe below: 
 
If Yes, describe how they will protect the confidentiality of the research data: 
Images or videos of participants completing wheelchair tasks may be shared for the 
purposes of data analysis with collaborators as well to assist with the development of the 
training program and for the training of clinicians. These images will be taken by 
participants, and every effort will be made to avoid recording identifiable features. 
Participants will have the option to not participant in the video recording, or to re-record 
tasks to eliminate identifiable features. As the videos will focus on wheelchair skills or 
maintenance tasks, the presence of identifiable images should be limited to parts of the 
wheelchair and/or body positioning. 
5.9 
Has or will a Federal Certificate of Confidentiality be obtained for this research 
study? 
No 
 
5.10 
Question has been moved to 5.17 
 
5.11 
Question has been moved to 5.16 

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!Section: Section 5 - Potential Risks and Benefit 
[reviewer notes-.] 
 
5.12 
Does participation in this research study offer the potential for direct benefit to 
the research subjects? 
 
Not Applicable - This is a Coordinating Center Application 
Describe the benefit: 
5.13 
Describe the data and safety monitoring plan associated with this study. If the 
research study involves multiple sites, the plan must address both a local and 
central review process. 
 
A data safety and monitoring plan will be implemented by having regularly scheduled (at 
least every 6 months) telephone conference calls for this multi-site study to ensure that 
there is no change in the benefit/risk ratio during the study and that confidentiality of 
research data is maintained. In addition, the principal investigator of the coordinating 
center and the executive committee for the project will discuss the study (e.g. study goals, 
progress, modifications, documentation, recruitment, retention, data analysis, and 
confidentiality) and address any issues or concerns. These meetings will be overseen by the 
principal investigator or designee. Minutes will be kept on file for these meetings. Any 
instances of adverse effects will be reported immediately using the standard forms and/or 
procedures set forth by the Institutional Review Board. In addition, investigators and/or 
coordinators may periodically review study documentation and/or consent forms to ensure 
that subject's confidentiality is maintained. 
[reviewer notes-.] 
Section 5 - Potential Risks and Benefits of Study Participation 
 
5.15 
What precautions will be used to maintain the confidentiality of the research data 
during collection, transmission and storage? It is important that you indicate the 
data security measures for all data types. 
 
Upload Data Security Form: 
 
Name Modified Date 
DSF 2/9/2018 11:29 AM 
 
Address what precautions will be used to maintain the confidentiality of the research data 
collected in paper format if applicable: 
Paper-based records will be kept in a secure location and only accessible to personnel 
involved in the study. Computer based files will only be made available  to personnel 
involved with this multi-site project through the use of access privileges and passwords. 
Participant's identity on forms  will be indicated by a  case number  rather than by their 
name, and the code linking their name to the number will be maintained separately with 
limited access to associated research staff. To maintain the confidentiality of all data that is 
transferred to the coordinating center from participating centers, only coded data will be 
transferred. Questionnaires, images and video may be shared with the coordinating center 
and collaborators for the purposes of data analysis, further developing  the  training 
programs and for the training of clinicians. 
 
Participants may record themselves performing wheelchair skills tasks. Every effort will be 
Go to the A-Z Guidance, download the Data Security Assessment Form, complete, and 
upload using the Add button below. Depending on the data type, you may need to consult 
with your data manager to address some of the sections.  Email irb@pitt.edu if you have 
any questions. 

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!Section: Section 5 - Potential Risks and Benefit 
made to avoid recording identifiable features. Participants will have the option to re-record 
or not upload any videos that show images they do not wish to share. As the videos will 
focus on wheelchair skills tasks, the presence of identifiable images should be limited to 
parts of the wheelchair and/or body positioning. Participants will upload the videos into 
Qualtrics, with access limited to research staff. 
 
5.15.1 
Does your research study require a data security review? Answer Yes if any of the 
following conditions are met: 
 
• Identifiable or 'coded data will be collected, stored, or transmitted using any of the 
following technologies: mobile app, web-based site or survey, wearable device, text 
messaging, electronic audio, photographic, or video recording or 
conferencing and/ or 
• The!RBrequested a data security review during their review of the study 
 
* Yes 
 
 
5.16 
 
If the subject withdraws from the study, describe what, if anything, will happen to 
the subject's research data or biological specimens. 
 
No subjects will be enrolled under this protocol. If a participant from any of the participating 
centers withdraws from the study, any information collected prior to the date the subject 
formally withdrew may continue to be used. 
 
5.17 
Following the required data retention period, describe the procedures utilized to 
protect subject confidentiality. (e.g., destruction of research records; removal of 
identifiers; destruction of linkage code information; secured long-term retention) 
 
Following the required d'ata retention period, the linkage code information will be destroyed. 
The coded data collected will be retained  for  an indefinite  period of time and will be stored 
in a secure manner. 
'Coded: Identifying information (such as name) that would enable the investigator to 
readily ascertain the identity of the individual to whom the private information or 
specimens pertain has been replaced with a code (number, letter, symbol, or any 
combination) and a key to decipher the code exists, enabling linkage of the identifying 
information to the private information or specimens 

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!section: Section 6 - Costs and Payment 
[reviewer notes-,) 
 
 
 
6.1 
 
Will research subjects or their insurance providers be charged for any of the 
procedures (e.g., screening procedures, research procedures, follow-up 
procedures) performed for the purpose of this research study? 
* 
No 
 
 
 
rreviewer notes-,J 
 
6.2 
 Will subjects be compensated in any way for their participation in this research 
study? 
 
Yes 
 
6.2.1 
Describe the amount of payment or other remuneration offered for 
complete participation in this research study. 
For complete participation, Trainers may receive $255 or $345, depending on their 
participation history. 
 
For complete participation, Trainees will receive $75. 
 
6.2.2 
 Describe the amount and term of payment or other remuneration that will be 
provided for partial completion of this research study. 
Participants will be compensated for each portion of the study that they complete. 
 
Trainers will be paid $30 for completing baseline questionnaires and reviewing online 
material. They will be paid $60 for practicing the skills in pairs and sending videos for 
remote review. Trainers will also receive $30 for completing the post-training 
questionnaires and providing feedback on the training program(s). If a participant has 
completed the above listed activities as part of the study "Remote Training Coordinating 
Center" (PRO15120300), they will receive $30 for completing the wheelchair skill modules 
and the pre-/post-confidence questionnaire. 
 
Trainers will receive $75 for providing wheelchair skills training to a WSTP Trainee. They  
may provide training to up to 3 Trainees. For complete participation, they may receive $255 
or $345, depending on their participation history. 
 
WSTP Trainees will receive $10 for completing baseline questionnaires. They will be paid 
$60 for attending wheelchair skills training sessions and for sending videos for remote 
review. They will receive $15 for completing the follow up questionnaires. For complete 
participation, Trainees will receive $75. 

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!Section: Section 7 - Qualifications and Source(s) of Supporij 
[reviewer notes,] 
 
7.1 
Summarize the qualifications and expertise of the principal investigator and listed 
co-investigators to perform the procedures outlined in this research 
study. 
 
Michael Boninger, M.D. is a Professor and Chair of the Department of Physical Medicine and 
Rehabilitation at the University of Pittsburgh. Dr. Boninger works as a physician researcher 
for the Department of Veterans Affairs and is the Senior Associate Medical Director of the 
Human Engineering Research Laboratories a VA Center of Excellence. Dr. Boninger has over 
100 peer-reviewed  journal publications and numerous book chapters and extended 
abstracts. He has lectured internationally on biomechanics of  repetitive  strain injury, 
assistive technology, and wheelchair propulsion. 
 
Jonathan Pearlman, PhD is an assistant professor in the Department of Rehabilitation 
Science and Technology and a biomedical engineer at the Department of Veterans Affairs. 
Dr. Pearlman is the Associate Director of Engineering at the Human Engineering Research 
Laboratories. Dr. Pearlman received his BS in mechanical engineering from the University of 
California at Berkeley, M.Sc. in mechanical engineering from Cornell University with a focus 
in biomechanics and PhD in Rehabilitation Science and Technology at the University of 
Pittsburgh. Dr. Pearlman is lead or co-author on twenty-four peer-reviewed journal articles 
and book chapters, and has seven patents awarded or pending. 
 
Lynn A. Worobey, PhD, is a staff member in the Department of Physical Medicine and 
Rehabilitation. She received her BS in  bioengineering from Worcester  Polytechnic Institute 
in 2008. She completed her PhD in bioengineering and a Certificate of Rehabilitation 
Technology from the University of Pittsburgh in 2013. She was the recipient of a National 
Science Foundation Graduate Student Research Fellowship during her doctoral work. Her 
background is in biomechanics and injury prevention. She will be responsible for assisting in 
the development of clinical protocols, monitoring and participating in study implementation, 
subject recruitment and data management. Dr. Worobey has been the lead author or co­ 
author on over 25 manuscripts and abstracts related to wheelchairs and mobility. 
 
Karen Greenwald RN, BSN is an  experienced  clinical  research  coordinator  previously 
involved in a multi-centered NIH grant with GenIMS (Genetic and Inflammatory Markers of 
Sepsis) Pneumonia research  study in CCM. She completed  her  BSN at  California  University 
of PA and is certified through the Association of Certified Research Professionals ACRP as a 
Certified Clinical Research Coordinator CCRC. Ms Greenwald serves as the Lead Coordinator 
on the  Spinal Cord Injury Model System  research  as well as numerous  research  studies  in 
the Department. She is responsible for assisting in the development of clinical protocols, 
monitoring and participating in study implementation, subject recruitment,  and data 
management. 
 
M. Lee Tempest, BS received his degree in Psychology from Kent State. His current position 
in PMR is as a data coordinator for this project. He has been working with individuals with 
disabilities for more than 5 years. 
 
[reviewer notes,] 
 
7.2 
Indicate all sources of support for this research study. 
 
* 
Selections 
Federal: Upload a copy of the entire grant application (including the cover sheet) if our 
site is the awardee institution; for federal contracts, upload a copy of the research plan 

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25D  ED
O 
 
 
 
  
 
!Section: Section 7 - Qualifications and Source(s) of Supporij 
If Federal support, provide the sponsor information: 
 
 
 
View 
Federal 
Grant Title 
Grant 
Awardee 
sponsor 
number 
institution 
Collaboration  on Mobility 
g Q D P00 
University of 
Training  (COMIT) 
 
Pittsburgh 
Federal grant 
application 
COMIT Grant 
.(_Q_,_Q1l 
 
 
For projects not supported by a federal grant, upload the research plan that was submitted 
for funding: 
 
Name Modified Date 
 
 
If Industry support, provide the sponsor information and level of support: 
 
 
 
If Foundation support, provide the sponsor information: 
 
 
If Other support, provide the support information and level of support: 
 
r reviewer notes,J 
 
 
7.3 
 
Is this study funded in part or whole by a PHS Agency? 
 
No 
 
Does any investigator* involved in this study (select all that apply): 
Name 
A. Have equity in a publicly-traded entity that either sponsors** this research or 
0 
owns the technology being evaluated or developed that exceeds a 5% ownership 
interest or a current value of $10,000? 
B. Have equity in a non-publicly-traded entity that either sponsors this research or 
owns the technology being evaluated or developed? 
C. Receive salary, consulting fees, honoraria, royalties or other remuneration from an 
entity that either sponsors this research or owns the technology being evaluated or 
developed that is expected to exceed $10,000 during the past or next 12 months? 
D. Have rights as either the author or inventor of intellectual property being 
evaluated or developed in this research that is the subject of an issued patent or has 
been optioned or licensed to an entity? 
E. Have an officer or management position**** with a Licensed Start-up Company 
0 overseen by the CO! Committee that either sponsors this research or owns the 
technology. being evaluated or developed? 
F. Receive compensation of any amount when the value of the compensation would be 
affected by the outcome of this research, such as compensation that is explicitly  
greater for a favorable outcome than for an unfavorable outcome or compensation in 
the form of an equity interest in the entity that either sponsors  this research  or owns 
the technology being evaluated or developed? 
i;zi None of the above options apply and there are no other financial conflicts of 
interest in the conduct of this research. 

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!section: Section 7 - Qualifications and Source(s) of Supporg 
*Investigator means the PI, co-investigators, and any other member of the study team, 
regardless of title, who participates in the design, conduct, or reporting of this research, as 
well as his/her spouse, registered domestic partner, dependents, or other members of 
his/her household. The PI is responsible for  ensuring  thats/he andall other 
relevant members of the study team review the above questions describing 
Significant Financial Interests. 
 
**through the provision of funds, drugs, devices, or other support for this research 
 
****Such as serving on the Board of Directors or Board of Managers or a position that 
carries a fiduciary responsibility to the company (e.g., CEO, CFO, CTO, or CMO). 

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@ection: Supporting Documentation! 
[reviewer notes-,) 
 
 
 
 
Supporting Documentation Section 
References and Other Attachments 
 
 
 
Additional documents: 
Modified 
ame Date 
Version 
Please use the Add button to the left to upload additional documents if 
needed. 
 
 
(reviewer notes-,) 
 
Clinica/Trials.gov is a registry and results database of publicly and privately supported 
clinical studies of human participants conducted around the world. 
 
"Applicable clinical trials" are required by federal law to be registered in ClinicalTrials.qov. 
Applicable Clinical Trials (ACTs) are studies that meet the following criteria: 
• The study is an interventional study AND 
• The study intervention is a drug, biologic, medical device, radiation or genetic AND 
• The Study is not Phase 0 or 1 AND 
• The study has at least one site in the United States or is conducted under an investigational 
new drug application or investigational device exemption 
 
NIH Policy 
 
Effective January 18, 2017, revised NIH Policy requires that all clinical trials funded in whole or in 
part by the NIH be registered and results information posted on ClinicalTrials.gov. 
 
As defined by the NIH, a clinical trial is: 
 
A research study in which one or more human subjects are prospectively assigned to one or 
more interventions (which may include placebo or other control) to evaluate the effects of 
those interventions on health related biomedical or behavioral outcomes. 
 
 
The NIH Policy extends beyond the Food and Drug Administration Amendment Act (FDAAA 801) 
requirements in that it requires registration and results reporting of: 
 
• clinical trials of behavioral, surgical and other types of health and medical interventions 
• phase 1 studies of drugs and biological products 
• small feasibility studies of device products 
 
Failure to submit all required registration and results information requested on ClinicalTrials.gov can 
jeopardize University grant funding, the future funding of the grantee and subject the University of 
Pittsburgh to future monetary penalties. 
 
In addition, to promote transparency of the clinical trials process, the International Committee of 
Medical Journal Editors (ICMJE) has established a policy requiring the entry of clinical trials in a 
public registry, such as ClinicalTrials.gov, prior to subject enrollment as a condition of consideration 
for publication of the trial results. 
N

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 ection: Supporting Documentation! 
 
* Based on the above information, will this study be registered in ClinicalTrials.gov? 
No 

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