A See and Treat Paradigm for Cervical Pre-cancer
Phase: NA
Conditions: Cervical Pre-cancer
Sponsor: Duke University

A See and Treat Paradigm for Cervical Pre-cancer
NCT02477124
Document Date: May 19, 2021

DUHS IRB Application (Version 1.10)
General Information
*Please enter the full title of your protocol:
A see and treat paradigm for cervical pre-cancer
*Please enter the Short Title you would like to use to reference the study:
A see and treat paradigm for cervical pre-cancer
* This field allows you to enter an abbreviated version of the Study Title to quickly identify this
study.
Add Study Organization(s):
List Study Organizations associated with this protocol:
Primary 
Dept?
Department Name
DUHS - Duke Default Department
Assign key study personnel (KSP) access to the protocol
* Please add a Principal Investigator for the study:
(Note: Before this study application can be submitted, the PI MUST have completed CITI training)
Ramanujam, Nirmala
3.1 If applicable, please select the Key Study personnel: (Note: Before this study application can be submitted, all Key 
Personnel MUST have completed CITI training)
* Denotes roles that are not recognized in OnCore. Please select an appropriate role that is recognized in all clinical
research applications (iRIS, OnCore, eREG, etc.)
A) Additional Investigators, Primary Study Coordinator (CRC), and the Primary Regulatory
Coordinator (PRC):
Krieger, Marlee 
Primary Regulatory Coordinator
B) All Other Key Personnel
Crouch, Brian 
Regulatory Coordinator
Gallagher, Jennifer 
Study Coordinator (CRC/CRNC/RPL)
Gonzales, Alana 
l

 Graduate Student
Muasher, Lisa 
 Collaborator
Mueller, Jenna 
 Research/Physician Assistant
Skerrett, Erica 
 Graduate Student
Thiele, Bonnie 
 Other
*Please add a Study Contact:
 
Krieger, Marlee 
Krieger, Marlee 
Ramanujam, Nirmala 
The Study Contact(s) will receive all important system notifications along with the Principal 
Investigator. (e.g., The study contact(s) are typically the Principal Investigator, Study Coordinator, 
and Regulatory Coordinator.) 
 
Oncore
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Signoffs available for the protocol. Protocols that require reporting to the NCI (National Cancer Institute), must 
select the Oncology library.
Oncology 
Non-Oncology 
 
Protocol Application Type
Select the type of protocol you are creating:
Please see additional criteria and information in the policy titled “Reliance on the IRB of Another Institution, 
Organization, or an Independent IRB" on the 
.
IRB web site
Regular Study Application - Most common. The IRB will determine if the study is eligible for expedited 
review or requires full board review upon submission. 
Application for Exemption from IRB Review - Includes Exempt, Not Human Subject Research, & Not 
Research. 
External IRB Application - Any study using an external IRB as the IRB-of-Record. 
Trainee Research While Away from Duke - Research conducted by medical students overseen by the 
Office of Curriculum & other student/trainee research away from Duke. 
Individual Patient Expanded Access, Including Emergency Use - Use of an investigational product 
under expanded access, including emergency use of an investigational drug or biologic or emergency 
use of an unapproved device. 
 
Conflict of Interest
Do any of the participating study investigators or other key personnel (or their immediate family/significant 
other) have a financial or intellectual interest in, or are receiving compensation from, the sponsor or the 
drugs, devices or technologies used in this research?
 Yes   
 No

Has this conflict been disclosed to the Duke COI Committee?
 Yes   
 No
Are any key personnel an inventor of any of the drugs, devices or technologies used in this research?
 Yes   
 No
Have you filed an Inventor Disclosure Form?
 Yes   
 No
Do any key personnel have or anticipate (within the year) any financial relationships (e.g., consulting, 
speaking, advisory boards, patents, equity, options) that could be perceived to overlap or present a conflict 
of interest with the current research?
  Yes   
  No
Do any key personnel have a conflict of interest management plan or cautionary memo issued by DOSI-COI 
related to this research?
 Yes   
 No
If Yes, please give the name(s) of the relevant personnel.
Nimmi Ramanujam
 
Oversight Organization Selection
CRU (Clinical Research Unit) or Oversight Organization Selection:
Please select the CRU.
OB/GYN
The Clinical Research Unit that takes responsibility for this study.
Please select 
as the CRU 
if the PI is in one of these Divisions or Institutes: 
Medicine 
only 
Endocrinology, Gastroenterology, General Internal Medicine, Geriatrics, Hematology, Infectious 
Diseases, Nephrology, Pulmonary, Rheumatology & Immunology, Center for Applied Genomics and 
Precision Medicine, Center for the Study of Aging and Human Development, Duke Molecular Physiology 
Institute.
More information on CRUs can be found on the Duke Office of Clinical Research (DOCR) website, 
http://docr.som.duke.edu
Questions concerning CRU selection should be directed to docr.help@dm.duke.edu.
For questions about the Campus Oversight Organization, please visit Campus Oversight 
.
Organization
List all Key Personnel on the study who are outside Duke:
Note: You will also need to attach the documentation of Human Subjects Certification for each 
individual, if they have completed the certification somewhere other than Duke.

If outside key personnel will have access to Duke PHI, a data transfer agreement AND 
external site IRB approval (or IRB authorization agreement) will be needed.  See HRPP 
policy Use of Research Data by Former Duke Students or Former Duke Faculty and 
Employees
In the panel below, “PHI” is Protected Health Information.
       Entry 1       
Name
Olola Oneko
Study Role
Study Physician
Email Address
ololaoneko@gmail.com
Institution / Organization
Kilimanjaro Christian Medical Centre (KCMC)
Will he/she have access to 
Duke P.H.I.?
  Yes   
  No
Is he/she an unpaid 
volunteer at Duke on the 
study?
  Yes   
  No
Indicate the Protocol source below:
The protocol source is the author of the protocol. If the protocol is a joint authorship between multiple 
sources, select the primary author. 
An IRB fee may be assessed for all research that is supported by for-profit entities and requires full board 
review. For additional information, see the IRB fees section of the IRB web site
PI initiated 
Commercial / Industry (for-profit entity) initiated 
Federal Government initiated 
Cooperative Group Initiated 
Foundation (non-profit group) initiated 
Other 
 
Sponsor and Funding Source
Add all funding sources for this study:
View 
Details
Sponsor Name
Sponsor Type
Contract 
Type:
Project 
Number 
Award 
Number 
Duke Endowment 
Institutional 
Grant 
 
 
Sponsor Name:
Duke Endowment 
Sponsor Type:
Institutional 
Sponsor Role:
Funding
Grant/Contract Number:
 
Project Period:
From:   to: 
Is Institution the Primary Grant 
Holder:
No 
if No, then who is the Primary 
Grantee?
 

Contract Type:
Grant 
Project Number:
 
Award Number:
 
Grant Title:
Duke Global Health Fieldwork  
PI Name:
(If PI is not the same as identified 
on the study.)
 
Explain Any Significant 
Discrepancy:
 
National Institutes of 
Health (NIH) 
Externally Peer-Reviewed 
Grant 
1R01CA195500-
01 
 
Sponsor Name:
National Institutes of Health (NIH) 
Sponsor Type:
Externally Peer-Reviewed 
Sponsor Role:
Funding
Grant/Contract Number:
1R01CA195500-01 
Project Period:
From:   to: 
Is Institution the Primary Grant 
Holder:
Yes 
Contract Type:
Grant 
Project Number:
1R01CA195500-01 
Award Number:
 
Grant Title:
 
PI Name:
(If PI is not the same as identified 
on the study.)
 
Explain Any Significant 
Discrepancy:
 
Is this a federally funded study?
 Yes   
 No
Does this study have any of the following?
Industry sponsored protocol
Industry funded Duke protocol
Industry funded sub-contract from another institution
Industry provided drug/device/biologic
SBIR/STTR funded protocol
 
  Yes   
  No
As part of this study, will any samples or PHI be transferred to/from Duke to/from anyone other than the 
Sponsor, a Sponsor subcontractor, or a Funding Source?
  Yes   
  No
Is the Department of Defense (DOD) a funding source?

  Yes   
  No
For Federally funded studies:
Is your funding subject to, and does it comply with, the funding agency's policy for data sharing?
 Yes   
 No
Check all that apply:
 
NIH Genome Sharing - dbGaP
NIH Genome Sharing - GWAS
NIH Genome Sharing - NCI databases
NIH Genome Sharing - other
Non-NIH Genomic
General Data Sharing
Enter the Grant Number or Other Federal Agency Proposal or Application Number:
1R01CA195500-01
Note: The Federal Funding Agency ID Number is the Sponsor's grant number assigned to your project and 
available on your Notice of Award (example: R01HL012345).
 
If known, enter the SPS (Sponsored Projects System) number if applicable:
0
In the Initial Submission Packet, attach the following:
(1) The entire grant, or an explanation of why a grant is not needed. 
(2) NIH institutional Certificate form related to data sharing (if applicable).
The entire grant is needed so that it may be reviewed against the protocol for concordance.
Have you successfully synced your protocol to OnCore by clicking the ‘Sync Data Over API’ button at the top 
of this page?
Please verify that the protocol has been created in OnCore before submitting this application for PI Signoff.
 
Yes, I synced my protocol to OnCore and verified it was successfully sent by logging into OnCore. 
I may have forgotten! I'll click it again right now, just to be sure, and verify it was successfully sent by 
logging into OnCore. 
 
Mobile Devices and Software
Does this study involve the use of a software or a mobile application?
  Yes   
  No
List all software, including third party (non-Duke) and mobile apps, that will be utilized for ascertainment, 
recruitment, or conduct of the research/project: (eg, MaestroCare, DEDUCE):

 
Multi-site Research
Is this a multi-site study?
 Yes   
 No
Is the Duke PI/Co-PI the lead investigator or primary grant awardee?
 Yes   
 No
Is the primary grant awardee a Duke employee?
 Yes   
 No
Is a Duke employee the holder of the IND or IDE?
Yes 
No 
N/A 
Is Duke the central coordinating center for this study?
 Yes   
 No
Is Duke serving as a central statistical center for this study?
  Yes   
  No
Is Duke serving as a central laboratory, reading center, analysis center or other central resource for this 
study?
 Yes   
 No
Do you have ten or more sites?
  Yes   
  No
Complete for each site if Duke is the Primary grant awardee or coordinating center:
       Entry 1       
Site Name:
AIIMS
City:
New Delhi
State/Province:
Country:
India

Site Contact Information
Primary Contact Name:
Neerja Bhatla
Primary Contact Phone:
Primary Contact Email:
neerja.bhatla07@gmail.com
Site Details
Does the site have an IRB?
 Yes   
 No
Site IRB approval expiration 
date:
If date not provided, 
explanation of why:
Approval letter given for the life of the study. No expiration.
Has the site granted 
permission for the research 
to be conducted?
 Yes   
 No
Does the site plan to rely on 
the DUHS IRB for review?
  Yes   
  No
What is the status of the 
study at this site?
Open 
Closed 
Site approval letters or site 
personnel lists:
Attach site approval letters, site closure letterS (if applicable), or site 
personnel lists in the Initial Submission Packet.
       Entry 2       
Site Name:
Kenyatta University
City:
Nairobi
State/Province:
Country:
Kenya
Site Contact Information
Primary Contact Name:
Anthony Wanyoro
Primary Contact Phone:
Primary Contact Email:
wanyoro.anthony@ku.ac.ke
Site Details
Does the site have an IRB?
 Yes   
 No

Site IRB approval expiration 
date:
11/12/2016
If date not provided, 
explanation of why:
Has the site granted 
permission for the research 
to be conducted?
 Yes   
 No
Does the site plan to rely on 
the DUHS IRB for review?
  Yes   
  No
What is the status of the 
study at this site?
Open 
Closed 
Site approval letters or site 
personnel lists:
Attach site approval letters, site closure letterS (if applicable), or site 
personnel lists in the Initial Submission Packet.
       Entry 3       
Site Name:
Kilimanjaro Christian Medical Centre
City:
Moshi
State/Province:
Country:
Tanzania
Site Contact Information
Primary Contact Name:
Bariki Mchome
Primary Contact Phone:
Primary Contact Email:
barikimchome@gmail.com
Site Details
Does the site have an IRB?
 Yes   
 No
Site IRB approval expiration 
date:
03/25/2018
If date not provided, 
explanation of why:
Has the site granted 
permission for the research 
to be conducted?
 Yes   
 No
Does the site plan to rely on 
the DUHS IRB for review?
  Yes   
  No
What is the status of the 
study at this site?
Open 
Closed 
Site approval letters or site 
personnel lists:
Attach site approval letters, site closure letterS (if applicable), or site 
personnel lists in the Initial Submission Packet.

       Entry 4       
Site Name:
Liga Peruana de lucha contra el cancer
City:
Lima
State/Province:
Country:
Peru
Site Contact Information
Primary Contact Name:
Gino Venegas
Primary Contact Phone:
Primary Contact Email:
ginovenegas@hotmail.com
Site Details
Does the site have an IRB?
 Yes   
 No
Site IRB approval expiration 
date:
06/20/2017
If date not provided, 
explanation of why:
Has the site granted 
permission for the research 
to be conducted?
 Yes   
 No
Does the site plan to rely on 
the DUHS IRB for review?
  Yes   
  No
What is the status of the 
study at this site?
Open 
Closed 
Site approval letters or site 
personnel lists:
Attach site approval letters, site closure letterS (if applicable), or site 
personnel lists in the Initial Submission Packet.
       Entry 5       
Site Name:
University Teaching Hospital
City:
State/Province:
Lusaka
Country:
Zambia
Site Contact Information
Primary Contact Name:

Groesbeck Parham
Primary Contact Phone:
Primary Contact Email:
professorparham@gmail.com
Site Details
Does the site have an IRB?
 Yes   
 No
Site IRB approval expiration 
date:
04/07/2019
If date not provided, 
explanation of why:
Has the site granted 
permission for the research 
to be conducted?
  Yes   
  No
Does the site plan to rely on 
the DUHS IRB for review?
  Yes   
  No
What is the status of the 
study at this site?
Open 
Closed 
Site approval letters or site 
personnel lists:
Attach site approval letters, site closure letterS (if applicable), or site 
personnel lists in the Initial Submission Packet.
       Entry 6       
Site Name:
Barranca clinic and San Rafael clinic
City:
State/Province:
Country:
Costa Rica
Site Contact Information
Primary Contact Name:
Alejandro Calderón
Primary Contact Phone:
n/a
Primary Contact Email:
ajcalder@ccss.sa.cr
Site Details
Does the site have an IRB?
 Yes   
 No
Site IRB approval expiration 
date:
05/18/2021
If date not provided, 
explanation of why:

Has the site granted 
permission for the research 
to be conducted?
 Yes   
 No
Does the site plan to rely on 
the DUHS IRB for review?
  Yes   
  No
What is the status of the 
study at this site?
Open 
Closed 
Site approval letters or site 
personnel lists:
Attach site approval letters, site closure letterS (if applicable), or site 
personnel lists in the Initial Submission Packet.
Provide a description of the procedures that will be used to inform sites of unanticipated problems involving 
risks to subjects or others, interim results, protocol modifications and other information that may be 
relevant to the protection of subjects:
Duke IRB procedures regarding the following will be adhered and reported to both Duke and 
external IRBs. Unanticipated problems will be reported to each site PI as soon as possible via 
telephone or email. Unanticipated problems will be promptly reported to both IRBs within ten 
business days of the investigator becoming aware of the event, study personnel will submit to 
the IRB a Notification of a Problem or Event Requiring Prompt Reporting to the IRB as A New 
Risk. The IRBs will be notified immediately (within 24 hours) upon learning of an unanticipated 
study-related death.
How will you ensure that management, data analysis, and data safety and monitoring systems are adequate, 
given the nature of the research involved?
The same procedures in the Duke IRB approved protocol will be followed. Members of the Duke 
University study team will perform the study at collaborating sites. They will ensure the same 
procedures are followed.
How will you ensure that sample protocols and informed consent documents are developed and distributed 
to each collaborating institution?
The study coordinator at Duke will develop and distribute the documents to all sites
How will you ensure that each collaborating institution holds an applicable OHRP-approved Assurance?
OHRP and FWA numbers can be verified here http://ohrp.cit.nih.gov/search/fwasearch.aspx?
styp=bsc
The FWA number for KCMC is FWA00002153 Kilimanjaro Christian Med College
The FWA number for La Liga is FWA 15320
The FWA number for Nairobi is pending
The FWA number for AIIMs is FWA00014191
 The FWA number for Zambia is FWA00000338
How will you ensure that each protocol is reviewed and approved by the IRB at the collaborating institution 
prior to the enrollment of subjects?
The study coordinator at Duke will verify this and make sure all approvals are uploaded to the 
Duke IRB prior to enrollment of subjects.
How will you ensure that any substantive modification by the collaborating institution of sample consent 
information related to risks or alternative procedures is appropriately justified?
The study coordinator at Duke and PIs will review all documents related to this study.

How will you ensure that informed consent is obtained from each subject in compliance with DHHS 
regulations?
A member of the Duke study team will be responsible for consenting patients and will be sure 
to be in compliance with DHHS regulations. Anyone obtaining informed consent will be required 
to take CITI training and Informed Consent Training.  The local sites are responsible for 
compliance for those subjects enrolled.  
 
Research Abstract
Please type your Research Abstract here:
The Research Abstract should summarize the main points of your study in one paragraph. The following 
guidelines may help you:
 
1. Purpose and objective (1-2 sentences)
2. Study activities and population group (2-4 sentences)
3. Data analysis and risk/safety issues (1-2 sentences)
Our goal is to bring the benefits of visual inspection with acetic acid with magnification (VIAM) to the 
primary screening setting in developing countries in an easy to use low-cost device, which we refer to as 
the transvaginal digital colposcope (TVDC). This device consists of a consumer grade digital camera found 
in the commonly used iPhone (Apple iPhone 4) and consumer grade light emitting diodes (LEDs) used in 
standard colposcopes, (Leisegang Optik 2), which all fit into the form factor of a tampon, a ubiquitous 
feminine hygiene product, and is significantly cheaper in cost to cervicography (standard of care used at 
two of the sites, Kilimanjaro Christian Medical Center (KCMC) and University Teaching Hospital (UTH)). The 
system comes with its own light source and requires significantly less training than cervicography as it can 
be simply be placed at the entrance to the speculum for image capture, without the need to adjust the 
light source or camera (focusing, positioning, etc). We will conduct pilot studies at multiple institutions 
where the goal will be to perform a side-by-side comparison of transvaginal colposcopy and the standard 
of care. In addition, to the clinical study objective, we will assess health provider acceptance, opinions, and 
experiences through pre- and post-transvaginal colposcopy surveys. 
 
Research Summary
State your primary study objectives
Our goal is to bring the benefits of visual inspection with acetic acid with magnification (VIAM) to the 
primary screening setting in developing countries in an easy to use low-cost device, which we refer to as 
the transvaginal digital colposcope (TVDC). This device consists of a consumer grade digital camera found 
in the commonly used iPhone (Apple iPhone 4) and consumer grade light emitting diodes (LEDs) used in 
standard colposcopes, (Leisegang Optik 2), which all fit into the form factor of a tampon, a ubiquitous 
feminine hygiene product, and is significantly cheaper in cost to cervicography (standard of care used at 
these international sites. The system comes with its own light source and requires significantly less 
training than cervicography as it can be simply be placed at the entrance to the speculum for image 
capture, without the need to adjust the light source or camera (focusing, positioning, etc). We will conduct 
pilot studies at multiple institutions where the goal will be to perform a side-by-side comparison of 
transvaginal colposcopy and the standard of care. In addition, to the clinical study objective, we will assess 
health provider acceptance, opinions, and experiences through pre- and post-transvaginal colposcopy 
surveys. 
State your secondary study objectives
Please select your research summary form:
Standard Research Summary Template

This is the regular (generic) research summary template which is required  for all regular applications (unless 
your protocol fits under the other research summary templates in this category).  Use of these instructions is 
helpful for ensuring that the research summary contains all necessary elements.
 
Standard Research Summary
Purpose of the Study
 
Objectives & hypotheses to be tested
We have developed a miniature colposcope called the transvaginal digital colposcope (TVDC). The system 
has been designed and constructed and will be used to obtain images of cervical tissue. The system is 
based on the same technology used in a traditional colposcope. This device consists of a consumer grade 
digital camera found in the commonly used iPhone (Apple iPhone 4 and other mobile phones) and 
consumer grade light emitting diodes (LEDs) used in standard colposcopes, (Leisegang Optik 2), which all 
fit into the form factor of a tampon, a ubiquitous feminine hygiene product, and is significantly cheaper in 
cost to cervicography (standard of care used at one of the study sites, The Kilimanjaro Christian Medical 
Center (KCMC)). The form factor of the device was inspired by an endotracheal intubation tube and digital 
tampon applicator
In this work, we will implement the TVDC ultimately intended for trans-vaginal use 
. 
without the need for a speculum. 
 shows comparative images between a commercial clinical 
Figure 1
colposcope and our novel device collected from out Duke University protocol (pro00008173). 
 
Figure 2
describes our novel transvaginal digital colposcope.  The primary objective of this research is to establish 
concordance between our transvaginal digital colposcope and other standard of care screening techniques. 
Our secondary objective is physician assessment of the transvaginal digital colposcope.
 
 
 
Fig. 1: Digital image comparison with a Leisegang Optik 2 clinical digital colposcope (18 megapixel CMOS 
imager) at working distance of ~300mm and 7.5 magnification of 2 different cervixes under white light 
illumination (A) and green filter applied (B) versus the prototype transvaginal digital colposcope (2 MP 
CMOS imager) at working distance of between of 30-40 mm, for ~4X magnification, (Panel C and D), 
both with white LED illumination. Note, panels (A and C) and (B and D) are corresponding to the same 
cervix, with the clinical digital colposcope taking an image of the acetowhitened cervix followed by the 
transvaginal digital colposcope.
Background & Significance
Should support the scientific aims of the research
The most efficient strategy for prevention of cervical cancer in low and middle income countries is to 
screen using Human Papilloma Virus (HPV) testing or visual inspection with acetic acid (VIA), followed 
by treatment of pre-cancerous lesions using cryotherapy. In East Africa, where HPV testing is not 
routinely available, VIA or VIA with low power magnification (VIAM) is used to screen the population at 
a primary health care level, and VIA/VIAM combined with cryotherapy or LEEP is performed at some 
primary and secondary and all tertiary health centers. Significant concerns about embarrassment and 
pain due to screening from the speculum, gender of the health provider, privacy and distance to the 
screening center are some of the main reasons why women do not get screened. Another important 
issue with VIA/VIAM is its low specificity compared to the Pap smear. We believe that the operational 
scaling (labor costs) and issues with acceptability of screening to be major impediments to creating 
widespread cervical cancer prevention in Tanzania and other developing countries. Our program 
strives to address these issues by delivering a high-volume, cost-effective cervical cancer screening 
solution for low resource environments, through partnerships with the following institutions:

1.  
2.  
3.  
4.  
5.  
6.  
7.  
8.  
 
    Duke University Medical Center, Durham, NC
    Kilimanjaro Christian Medical Center (KCMC) in Moshi, Tanzania.  Closed as of 2021
    Cancer Institute WIA, Chennia, India
    Liga Peruana de lucha contra el cancer, Lima, Peru - Closed as of 2021
    Kiambu Hospital, Kenya 
    All India Institute of Medical Sciences (AIIMS), New Delhi, India
    University Teaching Hospital Lusaka,Zambia - Closed as of 2021 
    Barranca clinic and San Rafael clinic within the Seguro Social network  
 
We have IRB approval with Liga Peruana de lucha contra el cancer in Lima, Peru and with Kilimanjaro 
Christian Medical Centre (KCMC).  We have therefore included those approvals and consent forms. The 
other sites will be added through amendments as the studies are approved. Based on our current IRB 
approvals, the total enrollment is 500 subjects (200 at Liga Peruana, 100 at KCMC, 100 at AIIMS, 50 
at UTH).
With the addition of Costa Rica, we will be increasing the enrollment by 800. Target enrollment should be 
completed over an 18-month period. Therefore the new enrollment as of December 2020 will be 1400.  Of 
note, our collaboration with Costa Rica is via IARC not a specific clinic within the country.  We 
will not be consenting subjects for our study.  We will be receiving de-identified images 
only.  We are in the process of working on a DTA with their site.  No enrollment as of 4-19-
2021. 
 
 
 
Design & Procedures
Describe the study, providing detail regarding the study intervention (drug, device, physical 
procedures, manipulation of the subject or the subject’s environment, etc.). Discuss justifications for 
placebo control, discontinuation or delay of standard therapies, and washout periods if applicable. 
Identify procedures, tests and interventions performed exclusively for research purposes or more 
frequently than standard of care. Include alternative therapies, concurrent therapies discontinued per 
protocol, risk benefit ratio, and use of tissue/specimens. Discuss monitoring during washout periods if 
applicable. Include brief description of follow-up, if any.
Fig.3: Gaumard Zoe Gynecologic Simulator used for in-vitro prototype development and for field training 
health providers.
In this multi-site clinical study, we will compare images collected with our TVDC to the standard of care at 
each collaborating institution. Patients undergoing cervical cancer screening or LEEP for the treatment of 
premalignant cervical dysplasia will be enrolled into the study. We will recruit 50-100 patients at each site, 
including DUMC. Before implementation of the clinical protocol, all health providers will be trained on the 
use of the transvaginal colposcope using a life-sized mannequin (Gaumard Zoe Gynecologic Simulator 

S504.100) with different cervices (healthy, dysplastic) (
). This will include implementation of the 
Fig. 3
colposcope and operation of the laptop or tablet to acquire images and positioning of the colposcope to 
optimize image quality. In addition, training in sterilization of device in between patients, maintenance, 
and daily quality control will be conducted.
 
 
The clinical protocol will be as follows. Each enrolled patient will undergo the standard of care for 
cervical cancer screening at each institution followed by the TVDC. The standard of care for each 
institution is provided below.
 
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After screening with standard of care, then images will be acquired with the TVDC. Research 
procedures will be carried out with the use of the speculum. Speculum-free implementation will be 
addressed in a future study. Twenty to forty images will be captured with the TVDC at a rate of 5-15 
frames per second. Twenty to forty images will be captured in order to allow for the auto focus 
mechanism to capture a focused image with the transvaginal colposcope. At maximum, this will add 2 
minutes to the patient procedure. Imaging with the TVDC may be repeated during the same visit for 
until satisfactory (focused, full view of cervix) images are acquired. If biopsies are necessary, as per 
standard of care, they will be collected from suspicious sites. Research biopsies will not be collected 
nor will this study cover biopsy costs. Biopsy must be done after imaging because bleeding at the site 
of biopsy may interfere with the digital images.
 
All physicians and healthcare workers who perform screening for this study will be asked to complete 
the following:
 
       The clinical evaluation table for both the standard of care and transvaginal 
colposcope. This will be completed once for each patient. This table is included under 
the full protocol section.
       A survey before beginning the clinical work with the transvaginal colposcope. 
This will be completed once for each healthcare worker.  This survey is included 
under the full protocol section.
A survey after study completion to assess acceptance, opinions, and experiences with 
This will be completed once for each healthcare worker.  
the system. 
The pre- and 
This survey is included under 
post- assessment surveys are included in the Appendix. 
the full protocol section.
       A mobile phone survey
       In addition, members of the healthcare team and hospital staff will be asked 
think aloud questions and mobile landscape questions.
 
 
 
Selection of Subjects
 
List inclusion/exclusion criteria and how subjects will be identified.
The population will include those who are undergoing cervical cancer screening for the diagnosis of 
cervical cancer. Specific criteria are below:

Inclusion criteria
 Patients undergoing cervicography OR colposcopy OR VIA OR patients undergoing LEEP for the 
treatment of cervical cancer.
Age 25 and greater
Patients of all ethnic will be included.
Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria
Children and subjects under 25.
Since the study poses no discernible risk to a pregnant woman or an unborn fetus, therefore pregnant 
patients will be included in this research. Our transvaginal colposcope is currently being used in 
another DUMC research study where pregnant women are eligible to participate. That research study 
is pro00008173.
Subject Recruitment and Compensation
Describe recruitment procedures, including who will introduce the study to potential subjects. Describe 
how you will ensure that subject selection is equitable and all relevant demographic groups have access 
to study participation (per 45 CFR 46.111(a) (3)). Include information about approximately how many 
DUHS subjects will be recruited. If subjects are to be compensated, provide specific prorated amounts 
to be provided for expenses such as travel and/or lost wages, and/or for inducement to participate.
One of the local collaborating doctors will identify subjects who are eligible for the study from their 
patient population. The physician (or nurse) will introduce the study to potential subjects and, if they 
agree to be contacted, the nurse or a research team member will explain the purpose and background 
of the study, the selection criteria, the patient’s involvement, benefits, risks, compensation (for 
injury), costs, alternatives, confidentiality and disclosure issues with the patient. All external sites may 
not have research coordinators to perform this step; therefore may be performed by a nurse. 
Informed written consent will be obtained from patients who are willing to participate at the time of 
the screening or LEEP visit. Information from each patient’s medical record will be recording, including 
but not limited to cervical pathology, age and menopausal status. Table 1 shows a sample table of 
patient demographical information to be collected. HIV status will be recorded because cervical 
dysplasia is known to progress faster in HIV positive women and it is therefore important to record. A 
total 200 patients will be recruited for the study. HIV status is critical information to collect in this 
study because the progression from low grade to high grade to cancer is faster with patients that are 
HIV positive. We anticipate the ideal screening method for cervical cancer screening would be HPV 
status, HIV status and screening with the TVDC. A sample size of 50-100 patients at each site should 
allow for the potential examination of at least 10 patients who have a positive screening (based on the 
occurrence of positive women in the cervical cancer screening programs). Each participating site will 
retain their original signed informed consent documents. Duke University will not obtain copies of 
informed consent from the collaborating institutions.
 
Consent Process
 
Complete the consent section in the iRIS Submission Form.
Subject’s Capacity to Give Legally Effective Consent
If subjects who do not have the capacity to give legally effective consent are included, describe how 
diminished capacity will be assessed. Will a periodic reassessment occur? If so, when? Will the subject 
be consented if the decisional capacity improves?

Subjects who are not competent to give consent will not be included.
Study Interventions
If not already presented in #4 above, describe study-related treatment or use of an investigational 
drug or biologic (with dosages), or device, or use of another form of intervention (i.e., either physical 
procedures or manipulation of the subject or the subject’s environment) for research purposes.
The patient’s procedure will be carried out according to standard of care. In addition, the trans-vaginal 
colposcope will be used to collect digital images of the cervix.
Risk/Benefit Assessment
Include a thorough description of how risks and discomforts will be minimized (per 45 CFR 46.111(a) (1 
and 2)). Consider physical, psychological, legal, economic and social risks as applicable. If vulnerable 
populations are to be included (such as children, pregnant women, prisoners or cognitively impaired 
adults), what special precautions will be used to minimize risks to these subjects? Also identify what 
available alternatives the person has if he/she chooses not to participate in the study. Describe the 
possible benefits to the subject. What is the importance of the knowledge expected to result from the 
research?
The risk of placing the trans-vaginal colposcope in the vagina is no greater than the risk of performing 
a Pap smear. The system’s outer shell is made out of medical grade ABS plastic with a biocompatible 
heat shrink tubing sleeve made of PTFE or similar material for enhanced waterproofing and 
protection.  Medical grade and biocompatible adhesives (Loctite 4011) are used to seal the device and 
prevent infiltration of water and bodily fluids. Excess body fluids are first removed with a Super Sani-
Cloth Germicidal wipe and then the following the standard sterilization procedure (immersion in 2% 
hydrogen peroxide solution or 10% bleach solution). A fresh Supersani Germicidal wipes are wrapped 
around probes to keep them sterile between patients.  The edges of the probe face are also chamfered 
to avoid a sharp edge so there should be minimal risk of puncture caused by the probe with the 
pressure exerted. The device does not emit ultraviolet light and emits only visible light from 400 to 
700 nm and has been tested to pose minimal eye and tissue risk per IESNA RP-27 and ANSI/IEC 
60825-1 LED safety standards. The device is electrically isolated from the body.  Heating of the tissue 
due to light exposure is minimal and can be neglected compared to much less in magnitude from the 
heat generated by conventional halogen illumination sources used in traditional clinical colposcopes 
due to the utilization of more efficient LEDs.  Optical information obtained through the images will not 
affect decisions regarding the treatment of the patient because it will be analyzed at a later time. 
Participants may experience mild discomfort during use of the probe and there may be risks unknown 
at this time.
Costs to the Subject
Describe and justify any costs that the subject will incur as a result of participation; ordinarily, subjects 
should not be expected to pay for research without receiving direct benefit.
There are no costs to subjects as a result of participating in this research.
Data Analysis & Statistical Considerations

Describe endpoints and power calculations. Provide a detailed description of how study data will be 
analyzed, including statistical methods used, and how ineligible subjects will be handled and which 
subjects will be included for analysis. Include planned sample size justification. Provide estimated time 
to target accrual and accrual rate. Describe interim analysis including plans to stop accrual during 
monitoring. Phase I studies, include dose escalation schema and criteria for dose escalation with 
definition of MTD and DLT.
Lesions observed with the transvaginal colposcope and the standard of care will be assessed using the 
clinical evaluation table of endpoints included in the full protocol section of the IRB submission. In 
addition, we will compare image quality from the data in the clinical evaluation table that compared 
transvaginal colposcopy and standard of care screening. Note that visual inspection with acetic acid 
(VIA) does not require the use of a camera we will therefore be unable to compare images collected to 
the TVDC to the standard of care for sites using only VIA. For the sites that use VIA only, we will 
compare the responses from the clinical evaluation table which includes questions such as: 1) can you 
see aceto-whitening, 2) can you see vasculature, 3) can you see a lesion.  For a full list of questions, 
see the clinical evaluation table in Section 7, Full Protocol.
 
Statistical comparisons between TVDC and standard of care (SOC) images will be done using paired t-
tests (pairs of TVDC and SOC outcomes on the same patient), with non-parametric adjustments, 
based on clinical evaluation table and other outcomes such as procedure time as dependent variables 
(with N=48 to 50 patients).  For example, we postulate that the difference between mean scores 
(TVDC-SOC) will be positive, against the null hypothesis that they are the same.  We expect 
approximately 3-4 physicians to implement SOC and TVDC on the same patients with about 12 to 16 
patients available per physicians. We will also compare TVDC and SOC using a repeated-measure 
ANOVA (implemented using a linear mixed effect model) to account for physician effect. Due to low 
number of physicians available for our study, we will treat physician effect as a fixed effect. 
Alternatively, a simple regression one-way ANOVA model can also be fitted by using the difference 
scores between TVDC and SOC as the dependent variable where physicians are entered as a 3 or 4-
level categorical/group variable (between-patients effect). An overall significance level of 0.050 will be 
used for statistical tests (type III Wald t-tests). 
Physician variability: Our primary outcome measure will be the quadratic weighted 
 [4, 5] 
Kappa
statistic for concordance. Furthermore, cluster adjusted by site and/or clinician) analysis can be used 
to address nested stepwise logistic regression model will be used to determine potential factors for 
disconcordant interpretation of the cervical images using both a backward and forward entry model 
using a p  value of 0.15 backward selection and p
value of 0.10 for forward selection, respectively in 
r
e 
the STATA statistical software package.   
Should we suspect excessive between-physician variability, we will conduct sensitivity analyses by 
treating physicians as random-effects (with pairs of outcomes on the same patient nested within 
physicians) under a range of intra-class correlation coefficients postulated to account for between-
physician heterogeneity (equivalent to varying physician random-effect variance over a suitable 
range). Note that, ignoring physician variability, a sample size of 50 achieves 80% power to detect a 
Cohen’s d of 0.41 (a moderate effect size) with a significance level (alpha) of 0.050 using a two-sided 
Wilcoxon test assuming that the actual distribution is normal.
Data & Safety Monitoring
Summarize safety concerns, and describe the methods to monitor research subjects and their data to 
ensure their safety, including who will monitor the data, and the frequency of such monitoring. If a 
data monitoring committee will be used, describe its operation, including stopping rules and frequency 
of review, and if it is independent of the sponsor (per 45 CFR 46.111(a) (6)).
A Data & Safety Monitoring team will not be used, however, the DUMC Institutional Review Board 
(IRB) will be responsible for monitoring the clinical study for its compliance to National Commission for 
the Protection of Human Subjects of Biomedical and Behavioral Research entitled: Ethical Principles 
.  The researchers will be responsible 
and Guidelines for the Protection of Human Subjects of Research
for reporting any Adverse Events (AEs) and any protocol deviations to the IRB by submitting the 
appropriate paperwork to the IRB. The protocol will also be reviewed and approved by each site’s 
Institutional Review Board.

 
Similar protocols for this research have already been submitted, reviewed and approved by DUMC’s 
IRB.  The protocols are reviewed on an annual basis and amendments to the protocol may be written 
at any time should there be new personnel associated with the research, major/minor changes to the 
research proposal (including changes in PHI and consent forms) or any other change to the protocol 
that must be made to reflect the actual research that is being performed.
 
Duke is the Coordinating Center for this multi-site study. Duke and the study team are committed to 
the protection of all subjects enrolled into this study. The study coordinator, Marlee Krieger, will be 
responsible for promptly reporting important study information to all sites. The PIs of each site will be 
included on the correspondence including any and all coordinators. This will be done electronically via 
email with send receipt confirmation. Important information includes unanticipated problems involving 
risks to subjects or others, interim results and protocol modifications. In addition, the email updates, 
regular meetings will be held via teleconference. This will be done on approximately a monthly basis. 
Finally, site visits will also be made to each location on average annually.
Privacy, Data Storage & Confidentiality
 
Complete the Privacy and Confidentiality section of the iRIS submission form.
Describe Role of External Personnel:
n/a
 
Study Scope
Does this study have a cancer focus?  Cancer focus includes studies that enroll >50% oncology or malignant 
hematology patients; or, preventing, detecting, and diagnosing cancer or understanding the impact of 
cancer on patients and their caretakers.
  Yes   
  No
Are you using a drug, biologic, food, or dietary supplement in this study?
  Yes   
  No
Are you using a medical device, an algorithm (whether computer based or not), an in vitro diagnostic test, or 
using samples to look for biomarkers in this study?
 Yes   
 No
Does this study involve a Humanitarian Use Device (HUD)?
 Yes   
 No
Does this study employ magnetic resonance, including imaging (MRI), spectroscopy (MRS), angiography 
(MRA) or elastography (MRE) beyond the standard of care?
  Yes   
  No

Does this study specify or require the performance of diagnostic procedures using ionizing radiation (x-rays, 
DEXA, CT scans, nuclear medicine scans, etc.) that are beyond the standard of care?
  Yes   
  No
Does this study specify or require the performance of therapeutic procedures using ionizing radiation 
(accelerator, brachytherapy or systemic radionuclide therapy) that are beyond the standard of care?
  Yes   
  No
Will the participant be subjected to increased or decreased ambient pressure?
  Yes   
  No
Do you plan to recruit subjects from Duke Regional Hospital (DRH)?
  Yes   
  No
Do you plan to recruit subjects from Duke Raleigh Hospital (DRAH)?
  Yes   
  No
Does this study utilize the Duke Early Phase Clinical Research Unit (DEPCRU)?
  Yes   
  No
Are you using the Duke logo in any advertisements?
  Yes   
  No
Is this study retrospective, prospective, or both?
"Retrospective" means that data or samples already in existence (collected prior to the study submission) will 
be used.
"Prospective" means there will be data or samples collected in this study for research purposes.
Retrospective 
Prospective 
Retrospective and Prospective 
If the study is both retrospective and prospective: Is this a review soley of information collected for non-
research purposes (i.e. a review of medical records)?
  Yes   
  No
Does this protocol include any research using botulinum toxin, including the FDA-approved clinical product 
(Botox)?
  Yes   
  No
Does this protocol involve the administration of any of the following materials to humans?
   •Any viral vector or plasmid

   •Any cells that have been modified by a viral vector
   •Any other genetically-modified cells
   •Any genetically-modified virus, bacterium, or other agent
   •Any other recombinant or synthetic nucleic acid
  Yes   
  No
 
Subject Population Groups and Enrollment
Population Groups (Select 
 population groups only):
targeted
Note:
If Minors are included, the study will be routed to the Department of Pediatrics for Pediatric Risk 
Assessment. 
Students and Employees over whom Key Personnel have a supervisory role may not be enrolled in this 
study
Adults
Minors who are Wards of State
Minors
Duke Patients
Pregnant Women
Fetuses
Prisoners
Adults incapable of giving consent
Adults with diminished capacity
Handicapped subjects
Students
Employees
Healthy Controls
Deceased subjects
Blanket Protocol
Please select any population groups excluded from participation in this study:
Pregnant women
Maximum number of subjects to be consented at Duke:    
Enter a single number. If you anticipate consenting a range of subjects, enter the 
 limit of the range. 
upper
The number should represent the maximum number of subjects for the life of the study.
50
Maximum number of subjects to be consented at all sites:
Enter a single number. If you anticipate consenting a range of subjects, enter the 
 limit of the range. 
upper
The number should represent the maximum number of subjects for the life of the study.
1400
 
Subject Procedures and Costs
Biobank - Does this study involve the collection, use, tracking, banking (storage) or distribution of human 
biological specimens?

Human biological specimens include blood or its components, healthy or diseased tissue, bodily fluids, DNA
/RNA or human stem cells.
  Yes   
  No
Procedures
Check all the apply:
Genetic Testing
Gene Transfer
DNA Banking
Testing for Reportable Infectious Diseases
Human Cell Banking
*Use of Human Embryonic Stem Cells
*Use of Human-induced Pluripotent Stem Cells
*Use of Other Cells Derived from Human Embryos
*Use of Human/Animal Chimeric Cells
*Specialized Cell Populations for Cell Therapy
Use of Human Tissue
Use of Bodily Fluids
Use of Blood (or its components)
Not Applicable
Will blood be drawn in this study for research purposes?
  Yes   
  No
Will the Operating Room be used in this study?
Include only research time, not clinical care time.
  Yes   
  No
Will there be extra costs to subjects or insurance as a result of the research (e.g. tests, hospitalization)?
  Yes   
  No
Will there be Subject Compensation?
  Yes   
  No
 
Subject Recruitment Materials
For each document to be reviewed, use the table below to provide the following information:
Attach a copy of each advertisement that you will be using with this study in the Initial 
Submission Packet. If any Ad will have multiple wording variations, attach a copy of each version 
of the Ad.
All materials that will be used to advertise the study in order to recruit subjects must be approved by the IRB.

Types of subject recruitment materials include, but are not limited to, the following:
Direct Advertising
Posters 
Billboards 
Flyers 
Brochures
Media Advertising
Newspaper Ads 
Magazine Ads 
Radio Ads 
TV commericals / Video 
Internet website
Social Media
Other Types of Advertising
Newsletter 
Email 
Postcards / Letters
(Note: Doctor-to-Doctor letters do not require IRB approval)
Document name
Material category
Location material 
displayed
Has this material 
previously been 
approved by the IRB?
No records have been added
 
Consent Process
Attach draft consent forms in the Initial Review Submission Packet.
Consent forms must be MS Word documents and follow the specific format outlined by the IRB. 
 to 
Click here
download a copy of the consent form template.
 Please do not edit the section of the footer that contains the Protocol ID, Continuing Review 
Note:
and Reference Date fields. Those fields will be used to stamp the final consent form when it is approved by the 
IRB. If you want to add an internal version date, please put it in the header.
Who will conduct the consent process with prospective participants? 
Give the person's role in this study (PI, Study Coordinator, etc.):
The study coordinator or Duke study team member will obtain informed consent. 
Who will provide consent or permission?
(Select all that apply):
Participant
Parent(s) or Legal Guardian(s)
Legally Authorized Representative (LAR)
How much time will the prospective participant (or legally authorized representative) have between being 
 
approached about participating in the study and needing to decide whether or not to participate?  

If you are not giving the person overnight to consider whether or not to participate, please justify.
The study coordinator or Duke study team member will obtain informed consent. 
Where will the consent process occur?
Patients will not be consented in public. The consent process will occur in a private room with the patient. 
What steps will be taken in that location to protect the privacy of the prospective participant?
Patients will not be consented in public. Consent will be obtained in a private room with a door that shuts.
How much time will be allocated for conducting the initial consent discussion, including presenting the 
information in the consent document and answering questions, with each prospective participant?
Due to the diagnostic nature of this study, patients must be consented day of the procedure. 
Patients will be given about an hour to decide whether or not to participate.
What arrangements will be in place for answering participant questions before and after the consent is 
signed?
The study will first be introduced to the patient by a member of their healthcare team. If they agree to 
be contacted, a clinic nurse (not a member of the research team), or a member of the study team will 
explain the purpose, background of the study, the selection criteria, the patient’s involvement, 
benefits, risks, compensation, costs, alternatives, confidentiality, and disclosure issues with the patient. 
If a patient is interested then written consent will be obtained from them at the time of screening or 
LEEP visit. The study team and specifically those obtaining consent are prepared to answer any study 
related questions.  Participants are encouraged to ask questions at any time. A study team member OR 
the physician is available to answer questions before or after the consent is signed. 
Describe the steps taken to minimize the possibility of coercion or undue influence.
Since patients must consent the day of their procedure, the study team will attempt to make sure that 
each potential participant has as much time as needed to considered participating in the study. It is also 
made clear that there is no benefit or rewards for participation. Compensation will not be offered.
What provisions will be in place to obtain consent from participants who do not read, are blind or who do not 
read/understand English?
The consent form will be translated in the primary language of each country with a participating institution.
Do you plan to obtain written consent for the conduct of research?
 Yes   
 No
 
Protected Health Information (PHI)
Indicate how you intend to use potential subjects' Protected Health Information (PHI):
I will review, but not record, PHI prior to consent. 
I will record PHI prior to consent. 
I do not intend to use PHI prior to consent. 
I will record PHI without consent. (decedent research, database repository, chart review) 
 
Review Preparatory to Research (RPR)

Describe the specific PHI that will be reviewed to prepare a research protocol and/or to ascertain and/or 
recruit subjects:
Various eligibility criteria will be verified prior to consent included age and procedure
Principal Investigator's Affirmation:
The PHI is necessary for the purposes of this activity. 
 Yes   
 No
The PHI will be used solely for this activity.
 Yes   
 No
The PHI will not leave DUHS.
 Yes   
 No
The PHI will not be written down or recorded prior to the subject signing a research consent form.
 Yes   
 No
I will not use the information accessed through this RPR procedure for any other purpose, including for 
presentation or publication.
 Yes   
 No
 
Devices
Include all devices being evaluated in this study:
Include all devices being evaluated in this study to determine their safety or effectiveness, and include 
information about a humanitarian use device where requested.Also dd devices without an IDE here, including 
any Humanitarian Use Device that does not require an IDE because it is to be used according to its FDA 
approved product labeling and its safety or effectiveness is not being evaluated.
 
Complete an 
 as applicable. This can be attached with the Brochure in the Initial Submission 
IDE Billing Notice
Packet.
View 
Details
Device Name
Is the Device FDA 
Approved
Will the device to 
be evaluated or 
the Humanitarian 
Use Device be 
manufactured at 
Duke?
IDE
/Compassionate 
Use Request 
Number
Transvaginal digital 
colposcope 
No 
Yes 
Abbreviated  
Device Source
Duke 
CMS Category
A
B
Is the device provided to subject 
free of charge?
Yes 
Is this a HUD (HDE)?
No 
HDE Number
 
Is the Device FDA Approved
No 
Will the device to be evaluated or 
the Humanitarian Use Device be 
manufactured at Duke?
Yes  

Do you have an IDE number for 
this device?
Yes  
IDE/Compassionate Use Request 
Number
Abbreviated  
IDE Holder
PI holds the IDE  
IDE Details
The FDA determined this to be an abbreviated IDE so there is no 
IDE number
Due to programming issues, the correct response is "NO" to the 
question, "Will the device to be evaluated or the Humanitarian 
Use Device be manufactured at Duke?"  
In the opinion of the sponsor, 
select the level of risk associated 
with this device
No Significant Risk  
Who will be responsible for the storage, inventory and control of the device to be evaluated or the 
Humanitarian Use Device?
Dr. Nimmi Ramanujam
Where will the device to be evaluated or the Humanitarian Use Device be stored?
Dr. Nimmi Ramanujam's lab
Who will be responsible for giving or administering the device to be evaluated or the Humanitarian Use 
Device to the research subject?
The PI or key personnel
From where will the device to be evaluated or the Humanitarian Use Device be dispensed?
Gross Hall
At the completion of this research study, what will be done with the unused or returned device or the 
Humanitarian Use Device? 
The device will be returned to Duke. 
 
Privacy and Confidentiality
Explain how you will ensure that the subject's privacy will be protected:
Consider privacy interests regarding time and place where subjects provide information, the nature of the 
information they provide, and the type of experience they will be asked to participate in during the research.
We are committed to maintaining patient confidentiality. Patient data will always be entered using a 
patient identification number. To protect against the risk of loss of confidentiality, the study will follow the 
procedures specified by the DUMC Institutional Review Board and Institutional Review Boards of the other 
centers for maintaining confidentiality. Data will be stored in a locked, secure location.
Describe how research data will be stored and secured to ensure confidentiality:
How will the research records and data be protected against inappropriate use or disclosure, or malicious or 
accidental loss or destruction? Records and data include, for example, informed consent documents, case 

report forms or study flow sheets, survey instruments, database or spreadsheets, screening logs or telephone 
eligibility sheets, web based information gathering tools, audio/video/photo recordings of subjects, labeled 
specimens, data about subjects, and subject identifiers such as social security number.
Data will be stored in a locked, secure location. Computerized data is accessible only by password, and a 
centralized monitoring system records and reports all access to data. CRFs will be identified by study 
number only to insure subject anonymity. The link between the unique subject number and the subject’s 
identity will be maintained in a secure location at the research site. No subject identifiers will be used in 
the presentation of data. Study records that identify subjects will be kept confidential as required by law. 
Subjects will be informed that their study physician and his/her study team will report the results of study 
related tests to the PI and to the sponsor. Subjects will be informed that their records may be reviewed in 
order to meet federal or state regulations. Reviewers may include the FDA, IRBs, or the NIH. Subjects will 
be informed that if their research record is reviewed, their entire medical record may also need to be 
reviewed.
 
Application Questions Complete
Please click Save & Continue to proceed to the Initial Submission Packet.
The Initial Submission Packet is a short form filled out after the protocol application has been completed.  This 
is an area to attach protocol-related documents, consent forms, and review the application.