Introductory Clinical Trial for Measuring Patients Before, During, and After an Electrophysiology (EP) Procedure With a Novel, Body-Worn Sensor
Phase: NA
Conditions: Atrial Fibrillation, Ventricular Tachycardia
Sponsor: NYU Langone Health

Study number: S17-01618 
 
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Tool Revision History: 
 
Version Number 
Version Date 
Summary of Revisions Made 
0.1 
20 Feb 2018 
Original version 
 
 
 
 
Introductory Clinical Trial for Measuring Patients Before, During, and After an 
Electrophysiology (EP) Procedure with a Novel, Body-Worn Sensor 
 
 
Principal Investigator: 
 
Larry Chinitz, M. D. 
Larry.Chinitz@nyumc.org 
 
Department of Medicine 
New York Medical Center 
Electrophysiology 
550 First Ave, New York, NY 10016 
Additional Investigators: 
 
N/A 
NYULMC Study Number: 
S17-01618 
ClinicalTrials.gov 
NCT03657134  
Funding Sponsor:  
N/A 
IND/IDE Number: 
CoVaTM 2 is a Class 2 medical device (K160899) that received 
510(k) approval from the FDA in June 2017 for measurments of 
HR, HRV, RR, TEMP, FLUIDS, SV, and CO.  
Regulatory Sponsor:  
N/A 
Study Product: 
CoVa Monitoring System 2 
Study Product Provider: 
toSense, Inc.  
 
Initial version: A 
 
 

Study number: S17-01618 
 
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List of Abbreviations 
 
AE 
Adverse Event/Adverse Experience 
CFR 
Code of Federal Regulations 
CO 
Cardiac Output 
CoVaTM 2 
CoVaTM Monitoring System 2 
DHHS 
Department of Health and Human Services 
DSMB 
Data and Safety Monitoring Board 
ECG 
Electrocardiogram Waveform 
EP 
Electrophysiology 
FLUIDS 
Thoracic Fluids Measured with Impedance 
GCP 
Good Clinical Practice 
HR 
Heart Rate 
HRV 
Heart Rate Variability 
ICH 
International Conference on Harmonisation 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
MOP 
Manual of Procedures 
N 
Number (typically refers to participants) 
NIH 
National Institutes of Health 
OHRP 
Office for Human Research Protections 
OHSR 
Office of Human Subjects Research 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
RR 
Respiration Rate 
SOP 
Standard Operating Procedure 
SV 
Stroke Volume 
TBI 
Thoracic Bioimpedance Waveform 
 
 

Study number:  
 
Version: 
 
 
Protocol Summary 
Title 
Introductory Clinical Trial for Measuring Patients Before, During, and 
After an EP Procedure with a Novel, Body-Worn Sensor 
 
Short Title 
NA 
 
Brief Summary 
Subjects will be consented to wear the CoVaTM 2 prior to, during, and 
after after an Electrophysiology Procedure. During this time, the system 
will measure the following parameters from subjects: HR, HRV, RR, 
TEMP, FLUIDS, SC, and CO.  Data will be retrospectively analyzed to 
determine if the system effectively operates under these conditions, 
and can effectively monitor subjects and allow them to be discharged 
early from the hospital. Subjects will not be measured while transferred 
in and out of the operating room.  Approximate sample size is 20 
subjects.  
 
Phase 
N/A  
Objectives 
The primary objective of this study is to show that, when used before, 
during, and after an EP procedure, CoVaTM 2 is able to successfully 
measure vital signs, waveforms, and hemodynamic parameters from 
patients, indicate the efficacy of the EP procedure, and show any signs 
of patient decompensation or complications.  An additional objective of 
this study is to show that, through use of CoVaTM 2, patients can be 
discharged relatively early from the hospital after undergoing an EP 
procedure. 
Methodology 
No randomization or blinding methods will be used for this study.  
Endpoint 
The primary endpoint will be if at least 50% of subjects studied in this 
trial are able to be discharged relatively early from the hospital if they 
are monitored with CoVaTM 2. A detailed retrospective statistical report 
will be the determining factor in meeting this success criteria.  
Study Duration 
Approximately 6 months 
Participant Duration 
Up to 7 days (until hospital discharge). 
Duration of IP 
administration 
N/A 
Population 
Approximate sample size: 20 subjects. Subjects are those which need 
an EP procedure,, including atrial fibrillation and SVT, pacemaker or 
ICD implant.  
Study Sites 
NYU Medical Center 
Electrophysiology 
550 First Ave,  
Level 5 
New York, NY 10016 
Number of 
participants 
20 subjects across one site 

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Description of Study 
Agent/Procedure 
Subjects will be measured with CoVaTM 2 before and after an EP 
procedure. 
 
Reference Therapy 
N/A 
Key Procedures 
EP 
Statistical Analysis 
Statistical comparison (e.g. correlations) of measurements made 
before, during, and after the EP procedure to prove or disprove the 
above-mentioned study hypothesis. 
 
 
 

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Schematic of Study Design 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
1 
Key Roles 
 
Principle Investigator 
Larry Chinitz, MD 
larry.chinitz@nyumc.org 
 
Sub Investigator 
Lior Janelson MD 
lior.jankelson@nyumc.org 
 
Introduction, Background Information and Scientific Rationale 
Current hospital monitoring typically involves manually measuring conventional vital signs—
such as blood pressure, heart rate, respiration rate, temperature, and pulse oximetry—initially 
every 15 minutes and than every few hours.  This entire suite of vital signs is necessary, as it is 
rare that a single parameter can predict patient decompensation; more often, especially with 
complex disease states, all the vital signs (and often even more parameters) are required.  And 
while not overly complicated, this process can be time consuming and inefficient. A clinician 
(typically a nurse, although increasingly someone with less training) enters the patient’s room, 
straps to the patient a blood pressure cuff (around the brachium), an oximeter (on the finger), a 
thermometer (in the ear), and sometimes ECG leads (affixed to the chest), takes a series of 
Total N: Obtain informed consent. Screen potential subjects by inclusion and exclusion 
criteria; obtain history, document. 
Study Procedure per Protocol Summary 
Follow-up assessments of study end points and safety 
 
Visit 1 
EP 
Prior to  
Enrollment 
Visit 3 
Time 
Point 

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measurements, and then removes these sensors. The entire process takes about 5-10 
minutes.  Often measurement values are simply written down and transcribed later. 
Moreover, measurement of more sophisticated parameters, or measurements made outside of 
the hospital, are rarely done.  In the hospital setting, parameters like stroke volume and cardiac 
output are typically only made with highly invasive or complicated devices requiring specialty-
trained technicians, such as a pulmonary-arterial catheter or Doppler ultrasound 
machine.  Patients are almost never discharged early and measured in the home, as the 
devices and infrastructure to enact such protocols do not exist. 
The sensor used in this clinical trial, is a low-cost, easy-to-use, body-worn system that cures the 
deficiencies listed above. It will ultimately measure all vital signs, along with stroke volume, 
cardiac output, and fluids, non-invasively and from a single location on the patient’s body. This 
sensor can be coupled to a cloud-based system for data analytics that generates timely, 
actionable information for clinical staff regardless of patient setting (e.g. in either the home or 
hospital). With such a system, patients could be discharged early or monitored at home to 
prevent readmissions.  This may improve patient outcomes, since delays in recognition of a 
change in status often lead toward longer hospital stays and, in some cases, patient morbidity 
and mortality.  
  
Name and Description of the Investigational Agent  
toSense’s CoVaTM 2 features a body-worn Sensor, Gateway, and Web-based System. The 
Sensor perform measurements by non-invasively sensing and processing single-lead ECG and 
TBI waveforms.  Algorithms on the device processes these two waveforms to measure HR, 
HRV, RR, TEMP, FLUIDS, SV, and CO.    
The Sensor has a form factor similar to a conventional necklace, with the electronics built into its 
strands and base. To make a measurement, a pair of customized disposable Electrodes—each 
featuring two electrode regions—snaps into a magnetic interface on the backside of the base 
and then attaches to the patient’s chest.  The Sensor is typically used for measurement periods 
less than 5 minutes but can also be used for longer periods (e.g. several hours or days).   
Using a Bluetooth™ transceiver, the Sensor wirelessly transmits measurement information from 
the patient to a Gateway, such as a tablet computer or mobile phone running the Android 
operating system.  These systems receive information from the Sensor, and then forward it to 
the Web-based System through either a local-area network (e.g., network based on 802.11), or 
a wide-area cellular network (e.g. AT&T).  The Web-based System displays information and can 
forward it to a third-party system through a web-services interface. 
CoVaTM is FDA-cleared (K160899) for the measurements described above. 
Clinical Data to Date 
See attached documents. 
Known Potential Risks 
Electrodes placed on the body may cause a slight redness or irritation. In rare cases, there is an 
allergic reaction or sensitivity to the adhesive that is used to stick the electrode patch. However, 
the adhesive that is used is not unique to this study, and is used in many medical applications. 
Discomfort could also occur when the adhesive patches are removed.  
Known Potential Benefits 
Subjects involved in this study will receive additional monitoring and may be discharged from 
hospital earlier as a result.    

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Objectives and Purpose 
Primary Objective 
When used before, during, and after an EP procedure, CoVaTM 2 is able to successfully 
measure vital signs, waveforms, and hemodynamic parameters from patients, indicate the 
efficacy of the EP procedure, and show any signs of patient decompensation or complications. 
Related to this primary objective is the goal of answering the following questions: Can data 
generated by CoVaTM 2 allow patients to be discharged from the hospital relatively early and 
monitored at home?  
Secondary Objectives (if applicable) 
In addition to the primary study objective, investigate the following questions: 1) can 
measurements made by the CoVaTM 2 (particularly stroke volume (SV), cardiac output (CO), 
fluid status, arrhythmia detection, and basic vital signs) be successfully made before, during, 
and after an EP procedure?; 2) is there correlation between CoVaTM 2-measured parameters 
(particularly volume status, heart rate and arrhythmia, SV, and CO) before, during, and after an 
EP procedure?; 3) does RF ablation during an EP procedure interfere with CoVaTM 2 
measurements?; 4) does a 200-300 Joule shock during a DC cardioversion procedure interfere 
with CoVaTM 2 measurements?; and 5) is the CoVaTM 2’s usability suitable for hospital 
clinicians?  
Description of Study Design 
Study subjects scheduled for an EP procedure who have signed an informed consent form (ICF) 
will be admitted to the study. Prior to the EP procedure (e.g. in a hospital room or operating 
room at NYU Medical Center), an employee of NYU will prep the subject’s skin with an alcohol 
wipe, apply the CoVaTM 2 Sensor using a pair of disposable electrodes, connect it to the 
Gateway Device using Bluetooth, and ensure that it is transmitting information from the 
CoVaTM 2 Sensor through the Gateway Device to the Cloud-based System. All transmitted 
information will be de-identified.  All subjects will continue to be monitored with standard of care  
equipment. 
Once this data pathway is verified, measurements will be made from the subject for a period of 
approximately 2 hours prior to the EP procedure. More specifically, measurements will be made 
continuously for a period of about 90 seconds, and then, as described above, information will be 
transferred from the CoVaTM 2 to the Gateway Device, and from the Gateway Device to the 
Cloud-based System. This process will take roughly 120 seconds. Once it is complete, this ‘duty 
cycle’ will be repeated for the duration of the 2-hour period, i.e. measurements will again 
commence for a period of about 90 seconds, and then paused for about 120 seconds while data 
is wirelessly transmitted as described above. 
Measurements will be temporarily halted as the subject is moved into the operating room and 
prepped for the EP procedure. Prior to the procedure, the CoVaTM 2 sensor will be attached to 
an external power supply as described above. Once the procedure is started, measurements 
will be made in the same manner as described above. 
Once the EP procedure is complete, the subject will be transferred from the operating room to a 
hospital room, where they will stay overnight.  Measurements will be made during this period, 
but not while the subject is being transferred. Once the subject is situated in the hospital room, 
the CoVaTM 2 Sensor will be applied to the subject and connected to the external power supply 
in the same manner as described above. Then measurements will commence according to the 
same duty cycle as described above.   

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The patient will continuously wear the CoVaTM 2 system until they are discharged for a period of 
about 24 hours.  During this period, data from the sensor will be sent to the Gateway and Cloud-
based System, and then analyzed retrospectively. 
During the course of the study, scientists at toSense will use the Data Analytics Software to 
process measurement information from CoVaTM 2, with a focus of proving or disproving the 
study’s primary hypothesis, i.e. when the CoVaTM 2 Sensor is used before, during, and after an 
EP procedure, can it successfully measure patients, indicate the efficacy of the EP procedure, 
show any signs of patient decompensation or complications, and allow a patient to be 
discharged relatively early? 
More detailed analyses will investigate the study’s secondary objectives, i.e.:1) can 
measurements made by the CoVaTM 2 Sensor be successfully made before, during, and after 
an EP procedure; 2) is there correlation between parameters such as volume status, heart rate 
and arrhythmia, SV, and CO before, during, and after an EP procedure; 3) does RF ablation 
during an EP procedure interfere with CoVaTM 2 Sensor measurements?; 4) does a shock 
during a DC cardioversion interfere with CoVaTM 2 Sensor measurements?; and 5) is the 
usability of the CoVaTM 2 Sensor adequate before, during, and after an EP procedure suitable 
for clinicians? 
Upon completion of the study, a report will be drafted describing the above-described 
information.  The report may evolve into a peer-reviewed publication if this is determined by the 
PI to be an appropriate course of action. 
This measurement protocol will be performed for a period of at approximately 6 months. 
Study Endpoints 
Primary Study Endpoints 
The primary endpoint will be if at least 50% of subjects studied in this trial are able to be 
discharged relatively early from the hospital if they are monitored with CoVaTM 2, as determined 
through a retrospective analysis. A detailed retrospective statistical report will be the 
determining factor in meeting this success criteria.  
Study Enrollment and Withdrawal 
Inclusion Criteria 
In order to be eligible to participate in this study, an individual must meet all of the following 
criteria: 
1. Patients with arrhythmias and other cardiac conditions that are scheduled for EP 
procedures. 
2. Subject is over 22 years of age at the time of consenting 
3. Subject and/or legally authorized representative is willing to undergo the informed 
consent process prior to enrollment in the study 
Exclusion Criteria 
An individual who meets any of the following criteria will be excluded from participation in this 
study: 
1. Pregnant subjects 
2. Subjects who are participating in another clinical study that may affect the results of 
either study 

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3. Subjects who are unwilling or unable to wear the sensor (and electrodes) for a period of 
up to 14 hours 
4. Subjects who are considered by the principle investigator to be medically unsuitable for 
study participation 
Vulnerable Subjects 
Vulnerable subjects will not be utilized in this study.  In the case of a vulnerable population 
patient being identified; they will not be included in the study or analysis.. 
Strategies for Recruitment and Retention 
No NYULMC media will be used to recruit subjects. Subjects that are scheduled for an EP 
procedure and meet the inclusion criteria will be approached for enrollment.  
 
Subjects will be consented in a quiet and private environment. Subjects will be given the 
opportunity to take the written consent form home to review overnight.     
Use of DataCore/Epic Information for Recruitment Purposes 
This study will utilize EPIC to identify subjects.  Once potential subjects have been identified, 
the study team will notify the treating physician (TP) that they have patients eligible to 
participate.  The study team will obtain approval from the treating physician to approach the 
eligible patient for the study.   
Duration of Study Participation 
The total duration of study participation is about 1.5 days.  This includes: 
Written Informed Consent Process: 1 day 
Study Procedure: 1 day 
Measurement prior to EP Procedure: 1-3 hours 
Measurement after EP procedure: Patient will be measured until they are discharged from 
hospital (approximately 24 hours). 
Subjects may be contacted for a follow-up interview.  
Total Number of Participants and Sites  
This is a single-site study. Recruitment will end when approximately 20 participants are enrolled. 
It is expected that approximately 20-30 participants will be recruited in order to produce 20 
evaluable participants. 
Reasons for Withdrawal or Termination 
Participants 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 participant 
• 
The participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
 

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Handling of Participant Withdrawals or Termination 
Withdraw criteria:  
• 
The Principle Investigator will review whether a withdrawal of a subject affects the 
success criteria of the study. A subject may be replaced if it is determined that more 
subjects are needed based on this criterion 
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 
terminationIf 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 participants 
• 
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 IRB. 
Study Agent (Study drug, device, biologic, vaccine etc.) and/or Procedural Intervention  
Study Agent(s) and Control Description 
Acquisition 
toSense will ship CoVaTM 2 systems directly to the Electrophysiology supplies team at the NYU 
medical center.  
 
New York Medical Center 
31st street and East River Drive, 
TCH 576, EP Lab 
New York, NY 
10016 
 
Devices will only be shipped once. The sensors should be kept as instructed in the product and 
stability section of this protocol.  
 
Formulation, Appearance, Packaging, and Labeling 
Devices are labeled with the follow symbols: 

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Each device is labeled with a unique identifier (UID). The proposed product is available to 
human use in its current form.  
Product Storage and Stability 
 
 
Device Specific Considerations 
Physical Characteristics:  
 

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• 
Dimensions: 1cm H x 18.0 cm W x 30 cm L (0.4 in H x 6.5 in W x 13 in L) 
• 
Weight: 0.127 kg (4.5 oz) 
• 
Battery Type: Li-ion 
Administration of Intervention 
Devices will be placed on consented subjects either directly by the PI or qualified research staff.  
Procedures for Training Interventionalists and Monitoring Intervention Fidelity 
toSense will provide CoVaTM 2 on-site training to the PI, study staff and Co-Investigators. 
 
Study Procedures and Schedule 
Study Specific Procedures 
CoVaTM 2 systems will be set up and attached to patients according to procedures described in 
toSense’s FDA-cleared documentation.   
Screening  
 
The study team will screen for eligible patients using EPIC.  Approval to approach eligible 
patients will be obtained from the TP.   No research related activites will be conducted until 
eligible patient’s have signed the consent form. 
Enrollment/Baseline 
The PI will confirm prior to enrollment that each subject qualifies for the study.   The eligible 
subject will be approached by the research team.  All patients willing to participate will 
personally sign and date the latest IRB approved version of the consent form.  Written and 
verbal versions of the participant information and informed consent will be presented to the 
participants detailing no less than: the exact nature of the study; the implications and constraints 
of the protocol; the known side effects and any risks involved in taking part.  It will be clearly 
stated that the participant is free to withdraw from the study at any time for any reason without 
prejudice to future care, and with no obligation to give the reason for withdrawal.  The 
participant will be allowed as much time as wished to consider the information, and the 
opportunity to question the Investigator, their general practitioner or other independent parties to 
decide whether they will participate in the study.  Written Informed Consent will then be obtained 
by means of participant dated signature and dated signature of the person who presented and 
obtained the informed consent.  A copy of the signed Informed Consent will be given to the 
participants.  The original signed form will be retained at the study site, in a research binder 
maintained by the study team in a locked cabinet.  All documents will be stored safely in 
confidential conditions.  On all physical and electronic study-specific documents, other than the 
signed consent, the participant will be referred to by a study participant number/code, not by 
name. 
 
Visit 2 (Day of EP procedure)  
• 
Ensure the subject has no additional questions regarding the study 
• 
Once the subject has been prepped for surgery, apply the sensor to the subject’s upper 
chest using the toSense approved electrodes 
• 
Connect the device to the power source 
• 
Study participant will be assigned a study number/code 

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• 
All data transmitted by the CoVa2 device will be de-identified. 
• 
Run several test measurements on the sensor to ensure that the device is actively 
measuring on the subject 
• 
Explain to the subject that the sensor will measure for a 90 seconds period, with 120 
second pause in between measurements 
• 
Measurements will not be made while the subject is transferred to and from the surgery 
room 
• 
Measurements will be made until the patient is discharged 
• 
Immediately prior to discharge, a study team member will remove the CoVaTM 2 device 
from the patient, and ensure a final data transmission.   
Withdrawal/Early Termination Visit 
If the subject withdraws from the study: 
• 
A reasonable attempt should be made to find out why the subject dropped out of the 
study 
• 
Subjects may be replaced in the study 
• 
Record the whether to withdrawal was from either the subject or principle investigator 
Ethics/Protection of Human Subjects 
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. 
Institutional Review Board 
The protocol, informed consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval. Approval of both the protocol and the consent 
form must be obtained before any participant 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 participants need to be re-consented. 
Informed Consent Process 
Consent/Assent and Other Informational Documents Provided to Participants 
Consent forms describing in detail the study procedures, and risks are given to the participant 
and written documentation of informed consent is required prior to starting 
intervention/administering study product. The following consent materials are submitted with this 
protocol: 
• 
Informed Consent Form 
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 participants and their families. 
Consent forms will be IRB-approved and the participant will be asked to read and review the 
document. The investigator will explain the research study to the participant and answer any 
questions that may arise. All participants will receive a verbal explanation in terms suited to their 

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comprehension of the purposes, procedures, and potential risks of the study and of their rights 
as research participants. Participants will have the opportunity to carefully review the written 
consent form and ask questions prior to signing. The participants should have the opportunity to 
discuss the study with their surrogates or think about it prior to agreeing to participate. The 
participant will sign the informed consent document prior to any procedures being done 
specifically for the study. The participants 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 
participants for their records. The rights and welfare of the participants 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.  
The consent process will take place at NYU medical center. Subjects will be consented in a 
private office prior to discussing any parts of the study. Subjects will be given an opportunity to 
read  the consent form prior to signing. Those who are trained to consent will ensure the subject 
understands that this study is completely voluntary and will not affect the relationship with the PI 
or medical center. The informed consent form will be written in such a way that the subjects 
understands the language and procedures involved in the study. 
Subjects who do not speak English are not specifically targeted in this study.  
Participant 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. 
Participant confidentiality is strictly held in trust by the participating investigators an study staff. 
This confidentiality is extended to cover testing of biological samples and genetic tests in 
addition to the clinical information relating to participants. 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  
Study members, and representatives of the IRBmay inspect all documents and records required 
to be maintained by the investigator, including but not limited to, medical records (office, clinic, 
or hospital) and pharmacy records for the participants in this study. 

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The study participant’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 participant research data, which is for purposes of statistical analysis and scientific 
reporting, will be transmitted to and stored at NYU Langone Medical Center. This will not include 
the participant’s contact or identifying information. Rather, individual participants 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 Medical Center 
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 Medical Center. 
Data Collection and Management Responsibilities 
Data collection is the responsibility of the clinical trial staff under the supervision of the site PI. 
The investigator is responsible for ensuring the accuracy, completeness, legibility, and 
timeliness of data. 
The data file will include password protection  
Study Records Retention 
Study documents will be retained for 5 years after final reporting/publication 
Costs to the Participant 
There are no costs to participants in this study 
Participant Reimbursements or Payments 
Subjects will not be compensated for participating in this study. 
 
 

Study number:  
 
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