Oral Pathology Asynchronous Telementoring Pilot Study
Phase: NA
Conditions: Oral Cancer
Sponsor: NYU Langone Health

 
 
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Oral Pathology Asynchronous Tele-mentoring Pilot Study 
 
Principal Investigator: 
 
Nathalie Mohadjeri-Franck, DMD, MA 
New York University (NYU) Langone Dental Medicine – 
Brooklyn 
Postdoctoral Residency Program  
Hansjörg Wyss Department of Plastic Surgery 
NYU School of Medicine 
5800 Third Avenue, 3rd Floor 
Brooklyn, NY 11220 
Natalie.Mohadjeri-Franck@nyulangone.org 
(718) 630-8224 
Additional 
Investigators: 
 
Robert B. Bowe, DDS 
Hansjörg Wyss Department of Plastic Surgery 
Robert.Bowe@nyulangone.org 
(718) 630-7383 
 
Steven Gargano, BS 
Hansjörg Wyss Department of Plastic Surgery 
Steven.Gargano@nyulangone.org 
(347) 377-4520 
 
Tina Littlejohn, MSW 
Hansjörg Wyss Department of Plastic Surgery 
Tina.Littlejohn@nyulangone.org 
(718) 630-8483 
 
Mary E. Northridge, PhD, MPH 
Hansjörg Wyss Department of Plastic Surgery 
Mary.Northridge@nyulangone.org 
(347) 377-4342 
 
Andrea B. Troxel, ScD 
Department of Population Health 
Andrea.Troxel@nyulangone.org 
(646) 501-3654 
 
Yinxiang Wu, MA 
Department of Population Health 
Yinxiang.Wu@nyulangone.org 
(646) 501-3654 
NYULH Study Number: 
S19-01268 
NCT Number: 
NCT04166214 
Funding Sponsor:  
PHS/Health Resources and Services Administration (HRSA) 
Program Contact: Jesse Ungard 
5600 Fishers Ln Rm 15N146C 
Rockville, MD, 20857 
Email: jungard@hrsa.gov 

 
 
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Phone: (301) 443-6249  
Fax: (301) 443-3323 
IND/IDE Number: 
N/A 
Regulatory Sponsor:  
N/A 
Study Product: 
Version or Model: CAMERA S950 NTSC SOPROCARE 
Brand Name: ACTEON 
Study Product 
Provider:  
SOPRO (France) 
https://www.acteongroup.com/en/products/imaging/diagnostic-
camera/soprocare 
ClinicalTrials.gov 
Number                 
N/A 
 
Initial version: 10/29/2019 
Version 1 
 
 

Study number: s19-01268 
 
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Statement of Compliance 
 
This study will be conducted in accordance with the Code of Federal Regulations on the Protection of 
Human Subjects (45 CFR Part 46), 21 CFR Parts 50, 56, 312, and 812 as applicable, any other applicable 
US government research regulations, and institutional research policies and procedures. The International 
Conference on Harmonisation (“ICH”) Guideline for Good Clinical Practice (“GCP”) (sometimes referred to 
as “ICH-GCP” or “E6”) will be applied only to the extent that it is compatible with FDA and DHHS regulations. 
The Principal Investigator will assure that no deviation from, or changes to the protocol will take place 
without prior agreement from the sponsor and documented approval from the Institutional Review Board 
(IRB), except where necessary to eliminate an immediate hazard(s) to the trial subjects. All personnel 
involved in the conduct of this study have completed Human Subjects Protection Training. 
 
 

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Table of Contents 
 
STATEMENT OF COMPLIANCE ................................................................................................................. III 
LIST OF ABBREVIATIONS ........................................................................................................................ VI 
1 
KEY ROLES .......................................................................................................................................... 1 
2 
INTRODUCTION, BACKGROUND INFORMATION AND SCIENTIFIC RATIONALE ....................... 1 
2.1 
BACKGROUND INFORMATION AND RELEVANT LITERATURE ................................................................ 1 
2.2 
NAME AND DESCRIPTION OF THE INVESTIGATIONAL AGENT  .............................................................. 2 
2.2.1 
Preclinical Data ........................................................................................................................ 3 
2.2.2 
Clinical Data to Date ................................................................................................................ 3 
2.3 
RATIONALE ..................................................................................................................................... 3 
2.4 
POTENTIAL RISKS & BENEFITS ........................................................................................................ 3 
2.4.1 
Known Potential Risks ............................................................................................................. 3 
2.4.2 
Known Potential Benefits ......................................................................................................... 3 
3 
OBJECTIVES AND PURPOSE ............................................................................................................ 4 
3.1 
PRIMARY OBJECTIVE ....................................................................................................................... 4 
3.2 
SECONDARY OBJECTIVES (IF APPLICABLE) ....................................................................................... 4 
4 
STUDY DESIGN AND ENDPOINTS .................................................................................................... 5 
4.1 
DESCRIPTION OF STUDY DESIGN ..................................................................................................... 5 
4.2 
STUDY ENDPOINTS ......................................................................................................................... 5 
4.2.1 
Primary Study Endpoints.......................................................................................................... 5 
4.2.2 
Secondary Study Endpoints ..................................................................................................... 5 
4.2.3 
Exploratory Endpoints .............................................................................................................. 6 
5 
STUDY ENROLLMENT AND WITHDRAWAL ..................................................................................... 6 
5.1 
INCLUSION CRITERIA ....................................................................................................................... 6 
5.2 
EXCLUSION CRITERIA ...................................................................................................................... 6 
5.3 
VULNERABLE SUBJECTS .................................................................................................................. 6 
5.4 
STRATEGIES FOR RECRUITMENT AND RETENTION ............................................................................ 7 
5.4.1 
Use of DataCore/Epic Information for Recruitment Purposes ................................................. 7 
5.5 
DURATION OF STUDY PARTICIPATION ............................................................................................... 7 
5.6 
TOTAL NUMBER OF SUBJECTS AND SITES ........................................................................................ 7 
5.7 
SUBJECT WITHDRAWAL OR TERMINATION ........................................................................................ 7 
5.7.1 
Reasons for Withdrawal or Termination .................................................................................. 7 
5.7.2 
Handling of Subject Withdrawals or Termination ..................................................................... 8 
5.8 
PREMATURE TERMINATION OR SUSPENSION OF STUDY .................................................................... 8 
6 
STUDY AGENT (STUDY DRUG, DEVICE, BIOLOGIC, VACCINE ETC.) AND/OR PROCEDURAL 
INTERVENTION ............................................................................................................................................ 8 
6.1 
STUDY AGENT(S) AND CONTROL DESCRIPTION ................................................................................ 9 
6.1.1 
Acquisition ................................................................................................................................ 9 
6.1.2 
Device Specific Considerations ............................................................................................... 9 
6.1.3 
Procedures for Training Interventionalists and Monitoring Intervention Fidelity ...................... 9 
6.1.4 
Assessment of Subject Compliance with Study Intervention................................................... 9 
6.2 
STUDY PROCEDURAL INTERVENTION(S) DESCRIPTION ...................................................................... 9 
6.2.1 
Administration of Procedural Intervention ................................................................................ 9 
6.2.2 
Procedures for Training of Clinicians on Procedural Intervention ......................................... 10 
6.2.3 
Assessment of Clinician and/or Subject Compliance with Study Procedural Intervention .... 10 
7 
STUDY PROCEDURES AND SCHEDULE ........................................................................................ 10 
7.1 
STUDY PROCEDURES/EVALUATIONS .............................................................................................. 10 
7.1.1 
Study Specific Procedures ..................................................................................................... 10 

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7.1.2 
Standard of Care Study Procedures ...................................................................................... 11 
7.2 
LABORATORY PROCEDURES/EVALUATIONS .................................................................................... 11 
7.2.1 
Clinical Laboratory Evaluations .............................................................................................. 11 
7.3 
STUDY SCHEDULE ........................................................................................................................ 11 
7.3.1 
Screening ............................................................................................................................... 11 
7.3.2 
Enrollment/Baseline ............................................................................................................... 11 
7.3.3 
Intermediate Visits .................................................................................................................. 12 
7.3.4 
Final Study Visit ..................................................................................................................... 12 
8 
CLINICAL MONITORING ................................................................................................................... 12 
9 
STATISTICAL CONSIDERATIONS ................................................................................................... 12 
9.1 
SAMPLE SIZE ................................................................................................................................ 12 
10 
SOURCE DOCUMENTS AND ACCESS TO SOURCE DATA/DOCUMENTS ................................. 13 
11 
QUALITY ASSURANCE AND QUALITY CONTROL ........................................................................ 13 
12 
ETHICS/PROTECTION OF HUMAN SUBJECTS ............................................................................. 14 
12.1 
ETHICAL STANDARD ...................................................................................................................... 14 
12.2 
INSTITUTIONAL REVIEW BOARD ..................................................................................................... 14 
12.3 
INFORMED CONSENT PROCESS ..................................................................................................... 14 
12.3.1 
Consent/Assent and Other Informational Documents Provided to Subjects .................... 14 
12.3.2 
Consent Procedures and Documentation ......................................................................... 19 
12.4 
SUBJECT AND DATA CONFIDENTIALITY ........................................................................................... 15 
12.4.1 
Research Use of Stored Human Samples, Specimens, or Data....................................... 15 
12.5 
FUTURE USE OF STORED HUMAN SAMPLES, SPECIMENS, OR DATA ................................................ 16 
13 
DATA HANDLING AND RECORD KEEPING ................................................................................... 16 
13.1 
DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES .............................................................. 16 
13.2 
STUDY RECORDS RETENTION........................................................................................................ 16 
13.3 
PROTOCOL DEVIATIONS ................................................................................................................ 16 
13.4 
PUBLICATION AND DATA SHARING POLICY ..................................................................................... 17 
14 
STUDY FINANCES ............................................................................................................................. 17 
14.1 
FUNDING SOURCE ........................................................................................................................ 17 
14.2 
COSTS TO THE SUBJECT ............................................................................................................... 17 
14.3 
SUBJECT REIMBURSEMENTS OR PAYMENTS ................................................................................... 17 
15 
STUDY ADMINISTRATION ................................................................................................................ 17 
15.1 
STUDY LEADERSHIP ...................................................................................................................... 17 
16 
CONFLICT OF INTEREST POLICY ................................................................................................... 17 
17 
REFERENCES .................................................................................................................................... 18 
18 
ATTACHMENTS ................................................................................................................................. 18 
 
 
 
 
 
 
 
 
 

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List of Abbreviations 
 
AE 
Adverse Event/Adverse Experience 
CFR 
Code of Federal Regulations 
CRF 
Case Report Form 
CSOC 
Clinical Study Oversight Committee 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data and Safety Monitoring Board 
EHR 
Electronic Health Record 
FFR 
Federal Financial Report 
FHC 
Family Health Centers at NYU Langone 
FWA 
Federalwide Assurance 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act 
HRSA 
Health Resources and Services Administration 
ICF 
Informed Consent Form 
ICH 
International Conference on Harmonisation 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
MOP 
Manual of Procedures 
N 
Number (typically refers to subjects) 
NIH 
National Institutes of Health 
NYU 
New York University 
OHRP 
Office for Human Research Protections 
OHSR 
Office of Human Subjects Research 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event/Serious Adverse Experience 
SOP 
Standard Operating Procedure 
US 
United States 
 
 

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1 Key Roles 
 
Nathalie Mohadjeri-Franck, DMD, MA, Principal Investigator. Dr. Mohadjeri-Franck is the Principal 
Investigator (PI) of the project and the Senior Director of Quality Management and Patient Care at NYU 
Langone Health. She is a recognized organizational leader in monitoring, performing, and managing quality 
assurance processes, including those supporting compliance with regulatory and/or accreditation 
standards. For this project, Dr. Mohadjeri-Franck will serve as the clinical champion, with a particular focus 
on the safety and operational oversight plans to be developed during the pilot study. She also possesses 
dental electronic health record (EHR) expertise, which will assist the study team and the clinical directors 
at the 6 Family Health Centers at NYU Langone (FHC) dental clinics in successfully completing the planned 
scope of work. 
 
Robert B. Bowe, DDS, Sub-Investigator. Dr. Bowe is a Sub-Investigator of the project and the Director of 
Oral Pathology at NYU Langone Hospital – Brooklyn. For the proposed project, he will contribute his clinical 
expertise and scientific understanding to identify oral lesions and mentor dental faculty and residents in oral 
cancer prevention, screening, and treatment. 
 
Steven Gargano, Health Information Technology Specialist. Mr. Gargano is the Health Information 
Technology (HIT) Specialist for the project and the Manager of Dental Technology at NYU Langone Health. 
He will be responsible for installing the intraoral cameras and software in the 6 FHC dental clinics, and 
storing, extracting, and transferring the requisite Dentrix EHR data to REDCap for the planned analyses. 
 
Tina Littlejohn, MSW, Research Associate. Ms. Littlejohn is the Research Associate for the project and 
the Research Program Coordinator for NYU Langone Dental Medicine – Brooklyn. She will be responsible 
for assuring study compliance with all NYU School of Medicine IRB requirements and collaborate with Dr. 
Northridge on the qualitative data analysis. 
 
Mary E. Northridge, PhD, MPH, Sub-Investigator. Dr. Northridge is a Sub-Investigator for the project and 
the Director of Dental Research and Research Associate Professor at the Hansjörg Wyss Department of  
Plastic Surgery in the Division of Dental Medicine at NYU School of Medicine. She will be primarily 
responsible for overseeing the qualitative data analysis, and lead the manuscript preparation and mentor 
her clinical colleagues in writing for peer-reviewed publication. 
 
Andrea Troxel, ScD, Sub-Investigator. Dr. Troxel is a Sub-Investigator of the project and Professor of 
Population Health and Director of Biostatistics at the NYU School of Medicine. She will serve as the 
biostatistician on the project, providing guidance on all aspects of study design and analysis. 
 
Yinxiang Wu, MA, Data Analyst. Mr. Wu is the Data Analyst on the project and an Assistant Research 
Scientist working under the direction of Dr. Troxel at the NYU School of Medicine. Mr. Wu will report directly 
to Dr. Troxel and conduct the data analyses for the project, while ensuring that all of the process and 
outcome data are safely stored according to security standards and in formats suitable for analysis. 
 
2 Introduction, Background Information and Scientific Rationale 
2.1 Background Information and Relevant Literature 
 
Distance learning. The Division of Dental Medicine within the Hansjörg Wyss Department of Plastic 
Surgery at the NYU School of Medicine has developed ground-breaking initiatives in order to connect 
remote sites and programs for didactic training. With the assistance of an “Innovative” grant from the Health 
Resources and Services Administration (HRSA) awarded over a decade ago to introduce a live, interactive, 
video-teleconferencing (VTC) system, a distance learning component was added to the NYU Langone 

Study number: s19-01268 
 
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Dental Medicine residency training program. This enabled the NYU Langone Dental Medicine network to 
develop clusters of training sites geographically removed from the primary teaching facilities at FHC in 
Brooklyn, NY, thus ensuring educational equity across geography.  
 
In addition to the traditionally low-income, racial/ethnic minority, and immigrant patient populations of 
community health centers (CHCs), the Division of Dental Medicine places dental residents in Indian Health 
Service facilities as well as other ambulatory care organizations, thus providing care to socioeconomically 
underserved communities in both urban and rural areas. This pioneering distance learning system has 
enabled its hospital-based dental residency program to have a complete electronically-mediated curriculum 
as part of the didactic training program, in addition to clinical experiences at each specific training site. 
Currently, distance learning is delivered through both synchronous (e.g., live interactive video 
teleconferencing) and asynchronous (e.g., on-line educational modules) methodologies.  
 
Tele-dentistry. Dental provider shortages, remoteness, funding challenges, and decreased costs, coupled 
with advances in technology, have increased interest in the use of tele-medicine applications.3 In recent 
years, there have been extensive technological innovations in the field of dentistry. Among the most 
important of these advances are the use of computers, tele-communications technology, digital diagnostic 
imaging services, and specialized hardware and software for patient screening and follow-up. 
Technological capabilities that were considered out of reach 20 years ago are now possible in dental care, 
but implementing and evaluating them in diverse, low-resource dental settings requires the engagement of 
key organizational stakeholders and clinical, technological, and scientific experts.  
 
By exploiting advanced information technologies, the science of dentistry has unprecedented potential to 
progress far more than it has during the previous 20 centuries. New information technologies have not only 
improved the quality of dental patient management, but have also made it possible to achieve partial or 
complete management remotely, even at distances of thousands of miles from health care centers or dental 
experts. Networking, the sharing of digital dentistry information, and distant consultations, workups, and 
analyses are handled by a specific branch of dentistry-related tele-medicine known as tele-dentistry.4,5  
 
Cancer risks in low-income, racial/ethnic minority, and immigrant communities. Cancer risks are 
compounded in low-income, racial/ethnic minority, and immigrant communities by difficulties in accessing 
health care services and multiple linguistic, cultural, economic, and social barriers. Acculturation also plays 
a key role in health status and promotion, as immigrants who have lived in the United States for longer 
periods of time and possess higher degrees of acculturation may have different lifestyles than those who 
report fewer years of US residence or lesser degrees of acculturation.6,7 For all population groups, cultural 
beliefs influence both health care choices and service use. For instance, among certain Asian subgroups, 
a strong sense of group collectivism exists, and individuality is submerged in the interest of group welfare.8 
Friends, neighbors, and family members are often accessed and consulted before turning to formal health 
care services,8 which may delay the identification and diagnosis of oral lesions, especially in remote CHCs 
which often lack oral pathology expertise. 
 
2.2 Diagnostic-imaging multiformat camera  
The SOPROCARE is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and 
fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival 
inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical details 
that are invisible to the naked eye or with a mirror (thanks to its magnification). In CARIO mode, the camera 
helps the dental practitioner to highlight carious warning on pits and fissures of the occlusal side of the 
teeth. In DAYLIGHT mode, the camera enables you to visualize anatomical details invisible to the naked 
eye or with a mirror (thanks to its magnification). In PERIO mode, the camera helps the dental practitioner 
to see the presence of dental plaque but also to highlight gingival inflammations (restricted to gingival 
inflammations which lead to bleeding upon probing). This mode offers to the dentist and/or hygienist a tool 

Study number: s19-01268 
 
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for an improved communication, motivation and education of his/her patients, who will then become aware 
of their oral health condition. 
 
This medical device is classified IIb according to the current applicable European Directive. It is CE marked. 
Notified Body: CE 0459 LNE-GMED. This medical device dedicated to dental cares is restricted to health 
staff; it is not reimbursed by health insurance organizations. This device was developed and manufactured 
according to the EN ISO 13485 quality control certification system. Read carefully the user manual. 
Manufacturer: SOPRO (France).  
2.2.1 Preclinical Data 
N/A 
2.2.2 Clinical Data to Date 
N/A 
2.3 Rationale 
Even as each preventive dental visit includes a screen for oral cancer, detection and identification of lesions 
is hampered by difficulty in visualizing lesions intraorally and lack of expertise among general dentists in 
oral cancer detection. We hypothesize that the oral pathology asynchronous tele-mentoring pilot project 
will both feasible to implement in the dental clinic setting, and acceptable to patients. 
2.4 Potential Risks & Benefits 
2.4.1 Known Potential Risks 
 
The proposed study poses minimal risk to subjects. Loss of confidentiality is the greatest potential risk to 
study subjects. All data entered into the research databases (in REDCap) will be protected by confidential 
entry codes. Locked file cabinets will be used to store materials with identifying information (e.g., consent 
forms). Unique identifiers will always replace patient names in all research databases. All computer systems 
are protected from possible external access. No Internet access is possible with the research systems to 
be used for this study. In addition, computer records will be maintained in such a way that the patient’s 
name or other obvious identifying information is not accessible in the same file or by using the same code. 
Once digital recordings are transcribed and entered into a password-protected database, the recordings 
will be deleted from the study files. Interview subjects will have the right to refuse to participate without any 
compromise of their employment status, reputation, or professional relationships. Records of subjects will 
not be linked to employment records. Also, if a subject is uncomfortable during any interview situation, s/he 
may stop the interview at any time without penalty. The data collected for this study will be used strictly for 
the purposes stated in this application and will only be available to NYU Langone Health research staff.  
 
2.4.2 Known Potential Benefits 
 
By participating in the proposed research, research subjects may gain the benefit of augmented services 
to prevent and/or identify oral cancer. Some patients may individually experience no benefit. This study will 
yield knowledge regarding methods for increasing adherence to evidence-based guidelines for prevention 
of, screening for, and treatment of oral cancer. Overall, the benefits of understanding effective methods for 
helping patients reduce their risk of oral cancer far outweigh the remote possibility of a breach of 
confidentiality.   
 

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3 Objectives and Purpose 
The purpose of the proposed research project is to evaluate and enhance the feasibility and acceptability 
of integrating a tele-mentoring component into the identification of oral lesions at the 6 dental clinics of 
Family Health Centers at NYU Langone (FHC), a Federally Qualified Health Center (FQHC) in Brooklyn, 
NY.  
 
The tele-mentoring intervention involves training dental faculty member subjecs and resident subjects to 
use intraoral cameras to take photographs of oral lesions and place them in the Dentrix electronic health 
record (EHR), along with descriptions of the lesions. This information will then be sent via Dentrix EHR to 
Robert B. Bowe, DDS, the Director of Oral Pathology at NYU Langone Hospital – Brooklyn, and an initial 
dummy code entry will be placed in the Dentrix EHR. For each patient with a detected lesion, Dr. Bowe will 
then review the Dentrix EHR chart and the uploaded photograph(s) of the lesion(s) found and place his 
observations in the Dentrix EHR. Next, Dr. Bowe will discuss his findings with the involved dental faculty 
member / dental resident via secure NYU Langone Health e-mail. The dental provider will then enter an apt 
comment in the Dentrix EHR, using the following template: “Reviewed entry and contacted patient. Follow-
up appointment needed / not needed (+ date) for an appointment on (date).” A second dummy code entry 
will then be placed in the patient chart in the Dentrix EHR. Once a week, Dr. Bowe will receive a Dentrix 
EHR report with the 2 affiliated dummy codes for the tele-mentoring pilot study, and assure that entries for 
both codes are entered, and the loop is closed. 
 
Using a mixed-methods approach, we will evaluate and enhance the feasibility and acceptability of 
integrating a tele-mentoring component into the identification of oral lesions at the 6 FHC dental clinics. 
This will be achieved through: 
 
1. Administering provider surveys (n=12) that consist of a checklist of 10 key components of the 
intervention based on process, and asking the dental provider subjects at each of the 6 FHC 
dental sites if each one was covered.  
 
2. Conducting semi-structured interviews (n=6) with dental resident subjects at each of the 6 FHC 
sites to assess specific barriers to sustaining the intervention and strategies for addressing these 
barriers to facilitate integration of the intervention into the routine workflow of the dental clinics. 
The interviews will be informed by the Consolidated Framework for Implementation Research 
(CFIR)1 and the Implementation Outcomes Framework (IOF).2 
 
3. Administering brief exit interviews (n=30) with patient subjects at each of the 6 FHC dental sites 
regarding the acceptability of the intervention. The survey will assess patient satisfaction with the 
use of intraoral cameras at chairside to screen for and refer patients with oral lesions and 
identification of these oral lesions via tele-mentoring with an oral pathology expert (Dr. Bowe). 
 
Impact: If this pilot study proves successful, NYU Langone Health is well-equipped with both teaching and 
organizational expertise in faculty development activities, as well as the existing NYU Langone Dental 
Medicine national network of video-teleconferencing and web-based educational technology, to scale-up 
the proposed oral pathology asynchronous tele-mentoring educational program for the teaching of dental 
educators and residents, with the ultimate goal of improving patient care. 
 
3.1 Primary Objective 
To assess the feasibility of the oral pathology asynchronous tele-mentoring intervention in the dental 
clinic setting. 
3.2 Secondary Objectives (if applicable) 
To assess the acceptability of the asynchronous tele-mentoring pilot intervention to adult dental patients. 

Study number: s19-01268 
 
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4 Study Design and Endpoints 
4.1 Description of Study Design 
 
This one-year pilot study is composed of 2 parts: 
 
• 
During months 1-6, we will complete the installation of the intraoral cameras in the dental 
operatories at FHC and design the Dentrix EHR screens for entering the information and tracking 
the involved steps of the tele-mentoring intervention. Dentist and resident subjects at all 6 FHC 
dental sites will then be trained by Dr. Mohadjeri-Franck and Mr. Steven Gargano to use the 
intraoral cameras to take photographs of oral lesions and place them in the Dentrix EHR, along 
with descriptions of the lesions.  
 
• 
During months 6-12, dentist and resident subjects will begin screening eligible patients for oral 
lesions and place photographs and descriptions of any found lesions in the Dentrix EHR, along 
with an initial dummy code entry. For each patient with a detected lesion, Dr. Bowe will then 
review the Dentrix EHR chart and the uploaded photograph(s) of any lesion(s) found and place 
his observations in the Dentrix EHR. Next, Dr. Bowe will discuss his findings with the involved 
dental faculty member / dental resident via secure NYU Langone Health e-mail. The dental 
provider will then enter an apt comment in the Dentrix EHR, using the following template: 
“Reviewed entry and contacted patient. Follow-up appointment needed / not needed (+ date) for 
an appointment on (date).” A second dummy code entry will then be placed in the patient chart in 
the Dentrix EHR. Once a week, Dr. Bowe will receive a Dentrix EHR report with the 2 affiliated 
dummy code entries for the tele-mentoring pilot study, thus assuring that entries are made for 
both codes, and the loop is closed. We will also pilot feasibility and acceptability of the 
intervention by completing provider surveys, semi-structured interviews with dental residents, and 
patient exit interviews. 
 
4.2 Study Endpoints 
4.2.1 Primary Study Endpoints 
Feasibility will be assessed using provider surveys, semi-structured interviews, and EHR data. 
 
Feasibility data collection.  
 
We developed a checklist of 10 key components of the intervention based on process and will ask the 
dental resident and dentist subjects at the 6 FHC dental clinics if each was covered. Endorsement of 8 of 
the 10 checklist items (80%) by the dental provider subjects will be considered as the feasibility criterion. 
Specifically, we will estimate the average checklist endorsement score across all providers with its 
associated 95% confidence interval (CI); if the upper bound of the CI exceeds 80%, we will consider the 
process feasible.  
 
Moreover, we will allow for open-ended collection of feedback on the feasibility of using the intraoral 
cameras for identification of oral lesions as part of the tele-mentoring intervention. Semi-structured 
interviews will also be conducted with dental resident subjects. We anticipate conducting 6 interviews before 
obtaining data saturation. The questions will be informed by the IOF and CFIR constructs and will assess 
specific barriers to sustaining the intervention and strategies for addressing those barriers to facilitate 
integration of the intervention into the routine workflow of the FHC dental clinics. 
4.2.2 Secondary Study Endpoints 
Acceptability will be assessed using patient exit interviews (PEIs) conducted right after the dental visit is 
completed. 
 

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Acceptability data collection.  
 
Research staff will conduct a brief exit interview with 5 patients at each of the 6 FHC dental clinics with 
language interpretation services available regarding the acceptability of the intervention. We developed 
five statements on patient satisfaction with the intraoral cameras and the overall tele-mentoring 
intervention that will constitute the PEI. Patients will be asked the extent to which they agree with each 
statement (e.g., “Dentists should discuss with me ways to prevent and screen for oral cancer.”) (strongly 
agree, agree, disagree, strongly disagree). The acceptability criterion of the intervention will be that 80% 
or more of patients rate all five administered acceptability questions as “strongly agree” or “agree.” We will 
evaluate acceptability as described above for feasibility. 
 
4.2.3 Exploratory Endpoints 
N/A 
5 Study Enrollment and Withdrawal 
Any subject may withdraw from the study at any time. This will not affect the services and care received at 
the clinic site. If a subject is uncomfortable during the intervention or survey administration, the subject may 
stop at any time without penalty. If a subject withdraws consent, no further data from that subject will be 
collected. 
5.1 Inclusion Criteria 
 
Dental patients will be eligible for study participation if they meet the following criteria:  
• 
Greater than or equal to 18 years of age. 
• 
Live in any of the 5 boroughs of New York, NY and visit a participating FHC dental clinic for routine 
dental care. 
• 
Able and willing to provide informed consent, have their oral lesion(s) photograph(s) and 
accompanying data entered into the Dentrix EHR, and participate in an exit interview. 
 
Dental providers (non-patient subjects) will be eligible for study participation if they meet the following 
criteria:  
• 
Greater than or equal to 18 years of age. 
• 
Be employed as a dentist or placed as a dental resident at a participating FHC dental clinic. 
• 
Able and willing to provide informed consent and participate in feasibility testing (provider survey 
or semi-structured interview). 
5.2 Exclusion Criteria 
Dental patients will be excluded from study participation if they meet the following criteria: 
• 
Have an acute or terminal illness or a serious mental illness or any other severe health condition(s) 
that might preclude visiting an oral health care provider. 
• 
Are currently participating in another oral health study. 
 
Dental providers (non-patient subjects) will be excluded from study participation if they meet the 
following criteria: 
• 
Have an acute or terminal illness or a serious mental illness or any other severe health condition(s) 
that might preclude them from completing the feasibility testing. 
 
5.3 Vulnerable Subjects 
No students will be involved in this research. Dental residents and dental faculty clinical advisors 
(dentists) will be recruited for this study to determine whether the tele-mentoring component will enhance 
the ability to detect and identify oral lesions in patients during routine dental visits. The voluntary nature of 

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their participation will be principal and without undue influence. All dental providers will be told that they 
have the right to refuse to participate without any compromise to their positions within the NYU Langone 
Dental Medicine network.  
  
5.4 Strategies for Recruitment and Retention 
 
Patient subjects will be dental patients who are visiting any of the 6 FHC dental clinics for their regular 
dental appointments. The dental provider will conduct chairside screening to determine patient eligibility for 
participation. No undue pressure will be given to patients to participate in the study, which is entirely 
voluntary.  
 
Non-patient subjects will be dental residents and dental faculty who supervise them at any of the 6 FHC 
dental clinics. Study staff will meet with potential non-patient subjects during team meetings held in each 
dental clinic to discuss this study No undue pressure will be given to dental providers to participate in the 
study, which is entirely voluntary. 
 
5.4.1 Use of DataCore/Epic Information for Recruitment Purposes 
 
This study will not utilize EPIC to identify subjects.  
 
5.5 Duration of Study Participation 
The duration of study participation for patient subjects will be from 1-2 days, including follow-up. 
 
The duration of study participation for non-patient subjects will be from 3-6 months. 
5.6 Total Number of Subjects and Sites  
All subjects will be recruited at the 6 FHC dental clinics in Brooklyn, NY. 
 
The number of patient subjects will total 30 (5 from each of 6 FHC dental clinics). 
 
The number of non-patient subjects will total 18: 12 dental resident and dentist subjects who will complete 
provider surveys (feasibility checklists), and 6 dental resident subjects who will complete semi-structured 
interviews. 
 
5.7 Subject Withdrawal or Termination 
5.7.1 Reasons for Withdrawal or Termination 
 
Subjects are free to withdraw from participation in the study at any time upon request. An investigator 
may terminate participation in the study if: 
• 
Any clinical adverse event (AE), laboratory abnormality, or other medical condition or situation 
occurs such that continued participation in the study would not be in the best interest of the 
subject 
• 
The subject meets an exclusion criterion (either newly developed or not previously recognized) 
that precludes further study participation 
• 
Patients will have the right to refuse to participate without any compromise of their health or 
dental services 
• 
Non-patient subjects will have the right to refuse to participate without any compromise of their 
employment or standing in the NYU Langone Dental Medicine network 

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• 
If a subject is uncomfortable during an interview or survey administration, s/he may stop at any 
time without penalty 
 
5.7.2 Handling of Subject Withdrawals or Termination 
If a subject withdraws consent, no further data from that subject will be entered into the REDCap database 
for that subject. Depending on the nature of the request to withdraw, it may be necessary to remove existing 
data for that subject from the REDCap database. 
 
5.8 Premature Termination or Suspension of Study 
 
This study may be temporarily suspended or prematurely terminated if there is sufficient reasonable 
cause. Written notification, documenting the reason for study suspension or termination, will be provided 
by the suspending or terminating party to Dr. Mohadjeri-Franck (PI), HRSA, and regulatory authorities. If 
the study is prematurely terminated or suspended, the PI will promptly inform the IRB and will provide the 
reason(s) for the termination or suspension. 
 
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Determination of unexpected, significant, or unacceptable risk to subjects 
• 
Demonstration of efficacy that would warrant stopping 
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination of futility 
 
Study may resume once concerns about safety, protocol compliance, data quality are addressed and 
satisfy the sponsor, IRB, and/or FDA. 
6 Study Agent (Study drug, device, biologic, vaccine etc.) and/or 
Procedural Intervention  
 
The SOPROCARE is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit 
and fissure caries, as an aid to highlight dental plaque and gingival inflammations (restricted to gingival 
inflammations which lead to bleeding upon probing) and as intra-oral camera to visualize anatomical 
details that are invisible to the naked eye or with a mirror (thanks to its magnification). In CARIO mode, 
the camera helps the dental practitioner to highlight carious warning on pits and fissures of the occlusal 
side of the teeth. In DAYLIGHT mode, the camera enables you to visualize anatomical details invisible to 
the naked eye or with a mirror (thanks to its magnification). In PERIO mode, the camera helps the dental 
practitioner to see the presence of dental plaque but also to highlight gingival inflammations  
(restricted to gingival inflammations which lead to bleeding upon probing). This mode offers to the dentist 
and/or hygienist a tool for an improved communication, motivation and education of his/her patients, who 
will then become aware of their oral health condition. 
 
MORE INVENTIVE. PATENTED AUTOFLUORESCENCE TECHNOLOGY. 
The ACTEON® imaging team has patented a technology based on the principle of autoﬂuorescence. 
ACTEON® intraoral cameras provide a real-time ﬂuorescence signal of the tooth superimposed on its 
anatomical image, revealing invisible tissues. 
 
SELECTIVE CHROMATIC AMPLIFICATION. 
Due to the combination of blue light absorption by soft tissue and selective chromatic ampliﬁcation, 
SOPROCARE® improves visibility of all areas of tissue inﬂammation. 

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6.1 Study Agent(s) and Control Description 
Prescription Use (Rx): Yes.  
LESS INVASIVE. HIGHLIGHT PATHOLOGIES AND MOTIVATE PATIENTS. 
The autoﬂuorescence makes it possible to detect decay even at its earliest stages, without subjecting the 
patient to any unnecessary radiation. SOPROCARE® also reveals dental plaque without using plaque 
disclosing solutions, and highlights gingival inﬂammation painlessly. 
Improve clinical performance and easily communicate the treatment plan to your patient. The patient is 
involved in making decisions and accept the treatment. 
 
Images can be captured and stored into any imaging software, giving you all of the necessary tools to 
practice minimally invasive dentistry. 
6.1.1 Acquisition 
Commercially via vendor 
 
6.1.2 Device Specific Considerations 
Aceton Soprocare Intraoral Camera 
Catalog Number: S_950_0002 
 
6.1.3 Procedures for Training Interventionalists and Monitoring Intervention Fidelity 
Dr. Mohadjeri-Franck will train and supervise the dental providers, who will administer the intervention. 
 
6.1.4 Assessment of Subject Compliance with Study Intervention 
N/A 
 
6.2 Study Procedural Intervention(s) Description 
The tele-mentoring intervention involves training dental faculty members and residents to use intraoral 
cameras to take photographs of oral lesions and place them in the Dentrix electronic health record (EHR), 
along with descriptions of the lesions. This information will then be sent via Dentrix EHR to Robert B. 
Bowe, DDS, the Director of Oral Pathology at NYU Langone Hospital – Brooklyn, and an initial dummy 
code entry will be placed in the Dentrix EHR. For each patient with a detected lesion, Dr. Bowe will then 
review the Dentrix EHR chart and the uploaded photograph(s) of the lesion(s) found and place his 
observations in the Dentrix EHR. Next, Dr. Bowe will discuss his findings with the involved dental faculty 
member / dental resident via secure NYU Langone Health e-mail. The dental provider will then enter an 
apt comment in the Dentrix EHR, using the following template: “Reviewed entry and contacted patient. 
Follow-up appointment needed / not needed (+ date) for an appointment on (date).” A second dummy 
code entry will then be placed in the patient chart in the Dentrix EHR. Once a week, Dr. Bowe will receive 
a Dentrix EHR report with the 2 affiliated dummy codes for the tele-mentoring pilot study, and assure that 
entries for both codes are entered, and the loop is closed. 
 
6.2.1 Administration of Procedural Intervention 
Dental resident and dentist subjects will administer the study during participating patient routine dental 
visits. 
 

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6.2.2 Procedures for Training of Clinicians on Procedural Intervention 
Dr. Mohadjeri-Frank will train all dental provider subjects on the use of intraoral cameras and the tele-
mentoring procedure. Dr. Bowe will train all dental resident and dentist subjects in the identification of oral 
lesions. 
 
6.2.3 Assessment of Clinician and/or Participant Compliance with Study Procedural 
Intervention 
N/A 
 
7 Study Procedures and Schedule 
7.1 Study Procedures/Evaluations 
7.1.1 Study Specific Procedures 
 
The protocol for the tele-mentoring study was designed by Drs. Bowe and Mohadjeri-Franck, and is 
provided on the following page. This workflow will be refined based upon the results of the planned feasibility 
and acceptability testing. All study activities will take place in the 6 FHC dental clinics and private offices of 
NYU Langone Dental Medicine in Brooklyn, NY. The PEIs with patient subjects and the feasibility checklists 
with provider subjects will take 10-15 minutes to complete. The semi-structures interviews with dental 
resident subjects will take 30-45 minutes to complete, and will be digitally recorded and transcribed. The 
transcriptions will be stored in a secure REDCap database. The digital files will be deleted once they are 
transcribed. No identifying information will be recorded. 
 
 
 
A2.  Data Collection 
Feasibility of the integrated intervention will be assessed through dental provider surveys and semi-
structured interviews. The dental provider survey, which consists of a checklist of 10 key components of 
the tele-mentoring intervention to be implemented, will be completed by 2 dentists at each of the 6 FHC 
dental clinics (n=12) after screening at least 1 patient subject for oral cancer using an intraoral camera, as 
per the tele-mentoring protocol. Furthermore, after we have reached our target of 30 patient participants (5 
patient participants at each of the 6 FHC dental sites), we will engage 6 dental residents (1 at each of the 
6 FHC dental clinics) in a semi-structured interview to assess specific barriers they have encountered to 
sustaining the intervention and strategies for addressing those barriers to facilitate integration of the tele-
mentoring intervention into the routine workflow of the dental clinics. 
 
Acceptability of the integrated intervention will be assessed through brief patient exit surveys. Consented 
participants will be asked to complete a brief patient exit survey at the end of their dental appointments after 
being screening for oral cancer lesions using an intraoral camera.  
 
The protocol for the tele-mentoring study is provided below: 
 

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7.1.2 Standard of Care Study Procedures 
N/A 
 
7.2 Laboratory Procedures/Evaluations 
N/A 
7.2.1 Clinical Laboratory Evaluations 
N/A 
 
7.3 Study Schedule 
7.3.1 Screening  
The participating dental provider will conduct chairside screening to determine patient eligibility for 
participation.  
 
Screening Visit (Day 1)  
• 
Obtain informed consent of potential subject verified by signature on written informed consent for 
screening form. 
• 
Review medical history to determine eligibility based on inclusion/exclusion criteria. 
• 
Review medications history to determine eligibility based on inclusion/exclusion criteria. 
 
7.3.2 Enrollment/Baseline 
 
Enrollment/Baseline Visit (Visit 1, Day 0) 

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The dental resident or dentist subject screens the patient subject for oral cancer via use of an intraoral 
camera and the tele-mentoring protocol during her/his regularly scheduled dental visit. 
 
7.3.3 Final Study Visit 
The dental resident or dentist subject discusses the next steps with the patient subject, including 
scheduling a follow-up visit, where indicated. 
 
7.4 Safety Oversight 
 
It is the responsibility of the Principal Investigator to oversee the safety of the study at her site.  This 
safety monitoring will include careful assessment and appropriate reporting of adverse events as noted 
above, as well as the construction and implementation of a site data and safety-monitoring plan. Medical 
monitoring will include a regular assessment of the number and type of serious adverse events. 
 
No DSMB will be convened for this pilot study. 
 
8 Clinical Monitoring 
 
Clinical site monitoring is conducted to ensure that the rights and well-being of human subjects are 
protected, that the reported trial data are accurate, complete, and verifiable, and that the conduct of the 
trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with applicable 
regulatory requirement(s). 
 
No independent clinical monitor will be assigned for this pilot study. 
 
9 Statistical Considerations 
 
Feasibility Data Analysis 
Provider Survey. All quantitative analyses will be conducted by Mr. Wu under the direction of Dr. Troxel. 
Endorsement of 8 of the 10 checklist items (80%) by the provider subjects will be considered as the 
feasibility criterion. Specifically, Mr. Wu will estimate the average checklist endorsement score across all 
dentists with its associated 95% confidence interval (CI); if the upper bound of the CI exceeds 80%, we will 
consider the process to be feasible. 
 
Provider Semi-Structured Interview. All interviews will be transcribed by a transcription company and coded 
by 2 research staff members (Dr. Northridge and Ms. Littlejohn). The research staff members will code 
individually and then meet to discuss and agree upon the final codes. The analysis of the qualitative data 
will utilize the techniques of narrative analysis and be guided by the constant comparison analytic approach 
to identify themes. 
 
Acceptability Data Analysis 
Patient Exit Survey. The acceptability criterion of the intervention will be that 80% or more of patients rate 
all 5 administered acceptability questions as “strongly agree” or “agree” on a Likert Scale. 
 
9.1 Sample Size 
 
No sample size calculation will be conducted for this pilot study. 
 

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10 Source Documents and Access to Source Data/Documents 
 
Source data is all information, original records of clinical findings, observations, or other activities in a 
clinical trial necessary for the reconstruction and evaluation of the trial.  Source data are contained in 
source documents.  Examples of these original documents, and data records include: hospital records, 
clinical and office charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, 
pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions 
certified after verification as being accurate and complete, microfiches, photographic negatives, microfilm 
or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at 
medico-technical departments involved in the clinical trial. It is acceptable to use CRFs as source 
documents. If this is the case, it should be stated in this section what data will be collected on CRFs and 
what data will be collected from other sources. 
 
The study case report form (CRF) is the primary data collection instrument for the study.  All data 
requested on the CRF must be recorded.  All missing data must be explained.  If a space on the CRF is 
left blank because the procedure was not done or the question was not asked, write “N/D”.  If the item is 
not applicable to the individual case, write “N/A”.  All entries should be printed legibly in black ink.  If any 
entry error has been made, to correct such an error, draw a single straight line through the incorrect entry 
and enter the correct data above it.  All such changes must be initialed and dated.  DO NOT ERASE OR 
WHITE OUT ERRORS.  For clarification of illegible or uncertain entries, print the clarification above the 
item, then initial and date it. 
 
Access to study records will be limited to IRB-approved members of the study team. The investigator will 
permit study-related monitoring, audits, and inspections by the IRB/EC, the sponsor, government 
regulatory bodies, and University compliance and quality assurance groups of all study related 
documents (e.g. source documents, regulatory documents, data collection instruments, study data etc.).  
The investigator will ensure the capability for inspections of applicable study-related facilities (e.g. 
pharmacy, diagnostic laboratory, etc.). 
 
Participation as an investigator in this study implies acceptance of potential inspection by government 
regulatory authorities and applicable University compliance and quality assurance offices. 
 
11 Quality Assurance and Quality Control 
 
QC procedures will be implemented beginning with the data entry system and data QC checks that will be 
run on the database will be generated. Any missing data or data anomalies will be communicated to the 
site(s) for clarification/resolution. 
 
Following written SOPs, the monitors will verify that the clinical trial is conducted and data are generated, 
documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory 
requirements (e.g., Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP)). 
 
The investigational site will provide direct access to all trial related sites, source data/documents, and 
reports for the purpose of monitoring and auditing by the sponsor, and inspection by local and regulatory 
authorities. 
 

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12 Ethics/Protection of Human Subjects 
12.1 Ethical Standard 
 
The investigator will ensure that this study is conducted in full conformity with Regulations for the 
Protection of Human Subjects of Research codified in 45 CFR Part 46, 21 CFR Part 50, 21 CFR Part 56, 
and/or the ICH E6. 
 
12.2 Institutional Review Board 
 
The protocol, key information forms, informed consent form, recruitment materials, and all subject 
materials will be submitted to the IRB for review and approval. Approval of both the protocol and the 
consent forms must be obtained before any subject is enrolled. Any amendment to the protocol will 
require review and approval by the IRB before the changes are implemented to the study. All changes to 
the consent form will be IRB approved; a determination will be made regarding whether previously 
consented subjects need to be re-consented. 
 
12.3 Informed Consent Process 
12.3.1 Consent/Assent and Other Informational Documents Provided to subjects 
 
Consent forms describing in detail the study agent, study procedures, and risks are given to the subject 
and written documentation of informed consent is required prior to starting the study. The following 
consent materials are submitted with this protocol: 
• 
Consent Form 
• 
Research Subject Key Study Information Form 
 
12.3.2 Consent Procedures and Documentation   
 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the study 
and continues throughout the individual’s study participation. Extensive discussion of risks and possible 
benefits of participation will be provided to the subjects and their families. Consent forms will be IRB-
approved and the subject will be asked to read and review the document. The investigator will explain the 
research study to the subject and answer any questions that may arise. All subjects will receive a verbal 
explanation in terms suited to their comprehension of the purposes, procedures, and potential risks of the 
study and of their rights as research subjects. Subjects will have the opportunity to carefully review the 
written consent form and ask questions prior to signing. The subjects should have the opportunity to 
discuss the study with their surrogates or think about it prior to agreeing to participate. The subject will 
sign the informed consent document prior to any procedures being done specifically for the study. The 
subjects may withdraw consent at any time throughout the course of the trial. A copy of the signed 
informed consent document will be given to the subjects for their records. The rights and welfare of the 
subjects will be protected by emphasizing to them that the quality of their medical care will not be 
adversely affected if they decline to participate in this study. 
 
A copy of the signed informed consent document will be stored in the subject’s research record. The 
consent process, including the name of the individual obtaining consent, will be thoroughly documented in 
the subject’s research record. Any alteration to the standard consent process (e.g., use of a translator, 
consent from a legally authorized representative, consent document presented orally, etc.) and the 
justification for such alteration will likewise be documented.  
 

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12.4 Subject and Data Confidentiality 
 
Information about study subjects will be kept confidential and managed according to the requirements of 
the Health Insurance Portability and Accountability Act of 1996 (HIPAA).  Those regulations require a 
signed subject authorization informing the subject of the following:  
 
• What protected health information (PHI) will be collected from subjects in this study 
• Who will have access to that information and why 
• Who will use or disclose that information  
• The rights of a research subject to revoke their authorization for use of their PHI.  
 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, 
retains the ability to use all information collected prior to the revocation of subject authorization.  For 
subjects that have revoked authorization to collect or use PHI, attempts should be made to obtain 
permission to collect at least vital status (i.e. that the subject is alive) at the end of their scheduled study 
period. 
 
Subject confidentiality is strictly held in trust by the participating investigators, their staff, and the 
sponsor(s) and their agents. This confidentiality is extended to cover testing of biological samples and 
genetic tests in addition to the clinical information relating to subjects. Therefore, the study protocol, 
documentation, data, and all other information generated will be held in strict confidence. No information 
concerning the study or the data will be released to any unauthorized third party without prior written 
approval of the sponsor. 
 
The study monitor, other authorized representatives of the sponsor, representatives of the IRB or 
pharmaceutical company supplying study product may inspect all documents and records required to be 
maintained by the investigator, including but not limited to, dental and medical records (office, clinic, or 
hospital) and pharmacy records for the subjects in this study. The clinical study site will permit access to 
such records. 
 
The study subject’s contact information will be securely stored at each clinical site for internal use during 
the study. At the end of the study, all records will continue to be kept in a secure location for as long a 
period as dictated by local IRB and Institutional regulations. 
 
Study subject research data, which is for purposes of statistical analysis and scientific reporting, will be 
transmitted to and stored at NYU Langone Health. This will not include the subject’s contact or identifying 
information. Rather, individual subjects and their research data will be identified by a unique study 
identification number. The study data entry and study management systems used by clinical sites and by 
NYU Langone Health research staff will be secured and password protected. At the end of the study, all 
study databases will be de-identified and archived at the NYU Langone Health. 
 
12.4.1 Research Use of Stored Human Samples, Specimens, or Data 
 
Patient data:  
All data entered into the research database (in REDCap) will be protected by confidential entry codes. 
Locked file cabinets will be used to store materials with identifying information (e.g., consent forms). 
Unique identifiers will always replace patient names in all research databases. All computer systems are 
protected from possible external access. No Internet access is possible with the research systems to be 
used for this study. In addition, computer records will be maintained in such a way that the patient’s name 
or other obvious identifying information is not accessible in the same file or by using the same code. 
 
The digitally recorded interviews will be transcribed. The transcriptions will be kept in a password-
protected computer. The files will be deleted once they are transcribed. No identifying information will be 
recorded. 

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Provider and staff data:  
We will assign a unique identifier (i.e., Subject ID) and remove any personal identifying information from 
each interview record to minimize the risk of breach of confidentiality. All data will be maintained on 
password-protected computers on a secure network accessible only to study investigators and staff. 
 
12.5 Future Use of Stored Human Samples, Specimens, or Data 
 
Data collected for this study will not be stored for future research. 
13 Data Handling and Record Keeping 
13.1 Data Collection and Management Responsibilities 
 
Data collection is the responsibility of the clinical trial staff at the site under the supervision of the site PI. 
The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the 
data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate interpretation of 
data. Black ink is required to ensure clarity of reproduced copies. When making changes or corrections, 
cross out the original entry with a single line, and initial and date the change. DO NOT ERASE, 
OVERWRITE, OR USE CORRECTION FLUID OR TAPE ON THE ORIGINAL. 
 
Copies of the electronic CRF (eCRF) will be provided for use as source documents and maintained for 
recording data for each subject enrolled in the study. Data reported in the eCRF derived from source 
documents should be consistent with the source documents or the discrepancies should be explained 
and captured in a progress note and maintained in the subject’s official electronic study record (EHR). 
 
Clinical data (including AEs, concomitant medications, and expected adverse reactions data) and clinical 
laboratory data will be entered into REDCap, a HIPAA-compliant data capture system provided by the 
Division of Biostatistics. The data system includes password protection and internal quality checks, such 
as automatic range checks, to identify data that appear inconsistent, incomplete, or inaccurate. Clinical 
data will be entered directly from the source documents. 
13.2 Study Records Retention 
 
Study documents will be retained for the longer of 3 years after close-out, 5 years after final 
reporting/publication, or 2 years after the last approval of a marketing application is approved for the drug 
for the indication for which it is being investigated or 2 years after the investigation is discontinued and 
FDA is notified if no application is to be filed or if the application has not been approved for such 
indication. No records will be destroyed without the written consent of the sponsor, if applicable. It is the 
responsibility of the sponsor to inform the investigator when these documents no longer need to be 
retained. 
 
13.3 Protocol Deviations 
 
A protocol deviation is any noncompliance with the clinical trial protocol, GCP, or Manual of Procedures 
(MOP) requirements. The noncompliance may be either on the part of the subject, the investigator, or the 
study site staff. As a result of deviations, corrective actions are to be developed by the site and 
implemented promptly. 
 

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These practices are consistent with ICH E6: 
• 4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3 
• 5.1 Quality Assurance and Quality Control, section 5.1.1 
• 5.20 Noncompliance, sections 5.20.1, and 5.20.2. 
 
All protocol deviations must be addressed in study source documents, reported to Mr. Jesse Ungard, the 
HRSA Project Official. 
 
Protocol deviations must be reported to the local IRB per their guidelines. The site PI/study staff is 
responsible for knowing and adhering to their IRB requirements. Further details about the handling of 
protocol deviations will be included in the MOP. 
13.4 Publication and Data Sharing Policy 
 
The Principal Investigator (Dr. Mohadjeri-Franck), writing mentor (Dr. Northridge), and other research team 
members will be responsible for developing publication procedures and establishing authorship policies. 
This study will comply with the NIH Public Access Policy, namely, that the public will have access to the 
published results of this intervention. Manuscripts will be submitted to peer-reviewed journals and accepted 
manuscripts will be submitted to PubMed Central upon formal acceptance of publication. 
 
14 Study Finances 
14.1 Funding Source 
 
The RN Grant ID for this study is 1003931. The tele-mentoring pilot study titled, Oral Pathology 
Asynchronous Tele-mentoring Pilot Study (PI of the Human Subjects Research Study: Dr. Nathalie 
Mohadjeri-Franck) is part of the HRSA-funded Dental Faculty Development and Loan Repayment 
Program (Grant T93HP30391; PI of the HRSA Grant: Dr. Neal Demby). 
 
14.2 Costs to the Subject 
There are no costs to the subject to take part in this study. 
14.3 Subject Reimbursements or Payments 
There are no incentives budgeted for subjects to take part in the study. 
15 Study Administration 
15.1 Study Leadership 
 
Dr. Modadjeri-Franck, as the PI, will assume leadership of this pilot study. 
 
16 Conflict of Interest Policy 
 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or financial gain 
greater than the minimum allowable by their institution, etc.) must have the conflict reviewed by the NYU 
Langone Conflict of Interest Management Unit (CIMU) with a Committee-sanctioned conflict management 
plan that has been reviewed and approved by the study sponsor prior to participation in this study. All 
NYULH investigators will follow the applicable conflict of interest policies. 

Study number: s19-01268 
 
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This material is the property of the NYU School of Medicine and Langone Medical Center.  Do not disclose or use except as 
authorized in writing by the study sponsor 
Interventional Template Version: 28 APR 2017 
 
17 References 
 
1. Damschroder LJ, Aron DC, Keith RE, Kirsh SR, Alexander JA, Lowery JC. Fostering 
implementation of health services research findings into practice: a consolidated framework for 
advancing implementation science. Implement Sci. 2009;4:50. 
2. Proctor EK, Landsverk J, Aarons G, Chambers D, Glisson C, Mittman B. Implementation research 
in mental health services: an emerging science with conceptual, methodological, and training 
challenges. Adm Policy Ment Health. 2009;36(1):24–34. 
3. Yoshinaga L. The use of teledentistry for remote learning applications. Pract Proced Aesthet Dent. 
2001;13:327-328. 
4. Queyroux A, Saricassapian B, Herzog D, Müller K, Herafa I, Ducoux D, Marin B, Dantoine T, Preux 
PM, Tchalla A. Accuracy of teledentistry for diagnosing dental pathology using direct 
examination as a gold standard: results of the Tel-e-dent Study of older adults living in nursing 
homes. J Am Med Dir Assoc. 2017;18(6):528-532. 
5. Estai M, Kanagasingam Y, Tennant M, Bunt S. A systematic review of the research evidence for 
the benefits of teledentistry. J Telemed Telecare. 2018;24(3):147-156. 
6. US Department of Health and Human Services. Tobacco use among U.S. racial/ethnic minority 
groups--African Americans, American Indians and Alaska Natives, Asian Americans and Pacific 
Islanders, Hispanics. A Report of the Surgeon General. Executive summary. MMWR Recomm Rep. 
1998;47(RR-18):v-xv, 1-16. 
7. Kalra P, Srinivasan S, Ivey S, Greenlund K. Knowledge and practice: the risk of cardiovascular 
disease among Asian Indians. Results from focus groups conducted in Asian Indian communities 
in Northern California. Ethn Dis. 2004;14:497-504. 
8. Esperat MC, Inouye J, Gonzalez EW, Owen DC, Feng D. Health disparities among Asian 
Americans and Pacific Islanders. Annu Rev Nurs Res. 2004;22:135-159. 
18 Attachments 
These documents are relevant to the protocol, but they are not considered part of the protocol. They are 
stored and modified separately. As such, modifications to these documents do not require protocol 
amendments.  

Study number: s19-01268 
 
Page 19 
Version date: 10/29/2019 
 
 
CONFIDENTIAL 
This material is the property of the NYU School of Medicine and Langone Medical Center.  Do not disclose or use except as authorized in writing by the study sponsor 
Interventional Template Version: 05 JAN 2017