Testing the Effectiveness of a Falls Prevention System
Phase: NA
Conditions: High Risk for Falling
Sponsor: Tammy Moore

Tammy Moore, PI, Sponsor 
Confidential 
 
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Clinical Research Protocol 
 
Protocol Title: 
TESTING THE EFFECTIVENESS OF A FALL 
PREVENTION SYSTEM 
Version Date: 
Version 4; 07/29/2019 
Investigational Product: 
PUP™  (Patient is Up) System 
IND Number: 
Not applicable 
Study Design: 
Single Arm intervention 
Sponsor: 
Tammy Moore, RN PhD 
Funding Organization: 
Palarum, LLC 
Principal Investigator: 
Tammy Moore, RN PhD 
Director, Nursing 
Neurological Institute 
The Ohio State University 
Medical Monitor: 
Not Applicable 
Study Site: 
Brain and Spine Hospital 
The Ohio State University 
 
Approval: 
 
 
 
PI or Sponsor Signature (Name and Title)  
 
Date 
This confidential information about an investigational product is provided for the exclusive use of 
investigators of this product and is subject to recall at any time.  The information in this document 
may not be disclosed unless federal or state law or regulations require such disclosure.  Subject to the 
foregoing, this information may be disclosed only to those persons involved in the study who have a 
need to know, with the obligation not to further disseminate this information.   

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PROTOCOL AGREEMENT 
 
I have read the protocol specified below. In my formal capacity as Investigator, my duties 
include ensuring the safety of the study subjects enrolled under my supervision and 
providing [Tammy Moore] with complete and timely information, as outlined in the 
protocol.  It is understood that all information pertaining to the study will be held strictly 
confidential and that this confidentiality requirement applies to all study staff at this site. 
Furthermore, on behalf of the study staff and myself, I agree to maintain the procedures 
required to carry out the study in accordance with accepted GCP principles and to abide 
by the terms of this protocol. 
 
Protocol Title:  Testing and Effectiveness of a Fall Prevention System 
 
Protocol Date: 29 JUNE 2019 
 
 
 
 
Investigator Signature  
 
Date 
Tammy Moore, RN PhD Director of Nursing 
Print Name and Title 
 
 
Site Name 
Brain and Spine Hospital, The Ohio State University 
Address 
300 West 10th Avenue 
 
Columbus, OH 43210 
 
 
 
 
Phone Number 
614-293-7847 

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TABLE OF CONTENTS  
 
PROTOCOL SYNOPSIS……………………………………………………………… 7 
1 BACKGROUND ......................................................................................................13  
      1.1 Overview of Research .......................................................................................13 
2 STUDY RATIONALE .............................................................................................14 
2.1 Risk / Benefit Assessment ................................................................................14 
3 STUDY OBJECTIVES ............................................................................................15 
3.1 Primary Objective .............................................................................................15 
3.2 Secondary Objectives........................................................................................15 
4 STUDY DESIGN ......................................................................................................16 
4.1 Study Overview ................................................................................................16 
      4.2    Research Procedures and Steps……………………………………………….17 
5 CRITERIA FOR EVALUATION ..........................................................................19 
5.1 Primary Effectiveness Endpoint .......................................................................19 
5.2 Secondary Effectiveness Endpoints ..................................................................19 
5.3 Safety Evaluations ............................................................................................19 
6 SUBJECT SELECTION .........................................................................................19 
6.1 Study Population ...............................................................................................19 
6.2 Inclusion Criteria ..............................................................................................19 
6.3 Exclusion Criteria .............................................................................................20 
7 STUDY TREATMENTS .........................................................................................20 
7.1 Method of Assigning Subjects to Placebo or Test Evaluation Groups .............20 
7.2 Formulation of Test and Control Products........................................................20 
7.3 Packaging and Labeling ....................................................................................20 
7.4 Supply of Study Socks and Equipment at the Site ............................................210 
7.5 Regiment ...........................................................................................................210 
7.6 Dispensing.........................................................................................................210 
      7.7    Administration Instructions…………………………………………………...20 
      7.8    Supply of Study Inventory at the Site…………………………………………21 
      7.9    Storage……………………………………………………………………….. 21 
      7.10  Study Accountability………………………………………………………….21 
      7.11  Measures of Treatment Compliance…………………………………………..21 
8 STUDY PROCEDURES AND GUIDELINES ......................................................21 
8.1 Clinical Assessments ........................................................................................21 
8.2 Concomitant Medications .................................................................................22 
8.3 Demographics…………………………………………………………………22 
8.4 Medical History……………………………………………………………….22 

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8.5    Physical Examination………………………………………………………….22 
8.6   Adverse Events…………………………………………………………………22   
 
  
 9 EVALUATIONS BY VISIT .....................................................................................24 
9.1 Pre-Conditions ...................................................................................................24 
      9.2    Day 1 Admission………………………………………………………………22 
9.3 Day 1 through Length of Stay…………………………………………………23 
9.4 Discharge .......................................................................................................... 24 
10. ADVERSE EXPERIENCE REPORTING AND DOCUMENTATION………..24 
10.1 Adverse Events ..................................................................................................25 
10.2 Serious Adverse Experience Reporting .............................................................25 
      10.3  Medical Monitoring……………………………………………………………24 
11 DISCONTINUATION AND REPLACEMENT OF SUBJECTS ........................25 
      11.1   Early Discontinuation of Study……………………………………………….25 
      11.2   Withdrawal of Subjects from the Study………………………………………25 
12 PROTOCOL VIOLATIONS .................................................................................. 25 
13 STATISTICAL METHODS AND CONSIDERATIONS .................................... 26 
13.1 Demographic and Baseline Characteristics ...................................................... 26 
13.2 Analysis of Primary Endpoint ........................................................................... 26 
13.3 Analysis of Secondary Endpoints ..................................................................... 26 
13.4 Sample Size ....................................................................................................... 27 
14 DATA COLLECTION, RETENTION AND MONITORING ............................ 27 
14.1 Data Collection Instruments ..............................................................................27 
14.2 Data Management Procedures ...........................................................................27 
14.3 Data Quality Control and Reporting ..................................................................27  
14.4 Archival of Data .................................................................................................27 
14.5 Availability and Retention of Investigational Records ......................................28 
14.6 Monitoring .........................................................................................................28  
16.7 Subject Confidentiality ......................................................................................28 
15 ADMINISTRATIVE, ETHICAL, REGULATORY CONSIDERATIONS ........28 
15.1 Protocol Amendments ........................................................................................28 
15.2 Institutional Review Boards and Independent Ethics Committees ....................29 
15.3 Informed Consent Form .....................................................................................29 
15.4 Publications ........................................................................................................30 
15.5 Investigator Responsibilities ..............................................................................30  
 
 
 

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APPENDIX A -  PACKAGING AND LABELING…………………………………...35 
APPENDIX B -  STUDY OF SCHEDULE VISITS…………………………………..36 
APPENDIX C – CRF – DISCONTINUATION OF STUDY..……………………….45 
 
 
 
 
 
 

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LIST OF ABBREVIATIONS 
 
AE 
Adverse Event 
BTLE 
CFR 
Blue Tooth Low Energy 
Code of Federal Regulations 
CRF 
Case Report Form 
DMC 
Data Monitoring Committee 
DSMB 
Data Safety Monitoring Board 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
HUC 
ICF 
Health Pod Coordinator/UCA Monitor 
Informed Consent Form 
IEC 
Independent Ethics Committee 
IRB 
Institutional Review Board 
 
IRL 
In Room Locator 
IRT 
In Room Tablet 
PI 
PLS 
PUP™  
RSSI 
RTLS 
PCS 
Principal Investigator 
Palarum Local Server 
Patient is Up Fall Prevention System 
Receive Signal Strength Indicator 
Real Time Location System 
Palarum Cloud Service 
SAE 
WIRB 
Serious Adverse Experience 
Western Institutional Review Board 
 
 
 
 
 
 
 
 

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PROTOCOL SYNOPSIS 
TITLE 
Testing the Effectiveness of a Fall Prevention System 
SPONSOR 
Tammy Moore, RN PhD  
FUNDING 
ORGANIZATION 
Palarum, LLC 
NUMBER OF SITES 
1 Site on 3 floors of the Ohio State University Wexner Center Brain 
and Spine Hospital; ( 8 South, 9 South, 10 South, 8 East, 9 East & 10 
East  
RATIONALE 
Each year, between 700,000 and 1,000,000 people in the United States 
fall in a healthcare environment (Agency for Healthcare Research and 
Quality, 2015).  Falls can have a widespread and significant impact on 
health, can be deadly, and often result in high costs.  Falls with serious 
injury are consistently among the Top 10 sentinel events reported to 
The Joint Commission’s Sentinel Event database (The Joint 
Commission, 2015).  The average 200-bed hospital might log 300 
patient falls a year (based on 5 patient falls per 1000 patient days), 
which results in $10,200 per fall in medical costs annually – or more 
than $3 million.  (Agency for Healthcare Research and Quality) 
The best way to reduce the number of falls is to prevent them. A 
whole marketplace of bed and chair alerts and other devices has been 
developed to address the need, yet the numbers increase. On a busy 
patient floor, nurses lose valuable seconds just figuring out which 
patient’s bed alert is sounding. We expect research to show that the 
Palarum PUP™ System reduces the incidence of falls.  
 
 
STUDY DESIGN 
 Single arm trial 
PRIMARY 
OBJECTIVE 
To determine if the fall rate (as measured by falls per 1000 patient 
days) for patients designated “fall risk” decreases with the use of the 
intervention (Patient is UP fall prevention technology [PUP™ ]) 
when compared to historical NDNQI data for the prior 12 months 
(“Benchmark Data”) from nursing units where the intervention is 
being undertaken. 
 
 

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SECONDARY 
OBJECTIVES 
1. To reduce the incidence of false alerts, <5%.  Our goal is a high 
reliability notification system.   
2. To provide positive alert reliability of 95%.  Our goal is to reduce 
alert fatigue with nurses.  To determine number of alerts sent out; 
what is the frequency of these patient safety events (i.e.), fall risk 
patient up, out of bed, unassisted 
3. To gather compliance data and response times from alert to 
caregiver response.   
 
NUMBER OF 
SUBJECTS 
2500 patients 
SUBJECT 
SELECTION 
CRITERIA 
Inclusion Criteria: All risk fall patients, eighteen years of age or older, 
who are admitted to the OSU Brain and Spine Hospital on Floors 8 
South, 9 South, 10 South, 8 East, 9 East or 10 East.     Patients will 
undergo a pre-assessment as per OSUWMC procedure to determine if 
they are of fall risk.   
 
Exclusion Criteria:  Patients whose medical condition as assessed by 
the PI prohibits their participation in the program, which would 
include among others the following: patients who lack the capacity to 
consent that do not have an Legally Authorized Representative 
(LAR), patients with an anatomy or wound issue on their feet or 
around their calves that would bar them from wearing socks on either 
foot, and/or patients for whom the sock would impede medical 
treatment.  
 
TEST PRODUCT, 
DOSE, AND METHOD 
OF USE 
Test Product:  Palarum LLC’s, PUP™  (Patient is Up) System 
Dose:  N/A  
Method of Use: 
The Study site, the OSU Wexner Center Brain and Spine Hospital, is 
located on three contiguous floors with each floor being made up of 
two units or Pods designated East and South. Following 
commencement of the study, and throughout its duration, Pods 
assigned to the Study will only utilize the Palarum Fall Prevention 
System and a monitored PUP™ sock as the standard of care 
intervention for fall prevention in accordance with its operating 
instructions and procedures.  The Implementation Team for the Study 
will consist of the PI, the Nurse Managers and Staff, allied health 
professionals as may be assigned to the Pods during the course of the 
Study. 
The Palarum Fall Prevention System is made up of seven tangible 
elements connected by Wi-Fi and/or BTLE:  an inpatient room 

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Android tablet (IRT), a nurse station Android monitor (HUC), a local 
server (PLS), a cloud server (PCS), a Bluetooth Low Energy 
beacon(s), an Android smart notification device, and an e-textile sock 
connected sensor transmitter (PUP™ sock).   
 
The PUP™ sock monitors and transmits pressure, force, acceleration 
and motion data to IRT and PLS, and HUC and PCS.  This data is 
evaluated and validated by an Android application on the IRT to 
determine whether or not a fall risk patient is standing unaccompanied 
by a caregiver. If a monitored patient is standing unattended, the PLS 
locates and alerts the Smart Notification Devices of the five (5) 
closest healthcare providers and the HUC using the beacon 
technology.   
 
Alerts are terminated by the Smart Notification Device and PLS based 
on caregiver proximity to the patient. All data, alerts, suspensions, 
terminations and notifications are recorded by the PCS.  On a daily 
basis, PCS reports are produced which contain data for each patient 
enrolled, number of alerts, excessive alerts, and caregiver response 
time, as well as summaries by Pod and entire facility.  
 
All Brain and Spine Hospital patients will be evaluated as to fall risk 
using the current fall risk assessment procedures employed by OSU 
Medical Center and administered in the usual and customary fashion 
upon evaluation on the floor and Pod. 
Any patient fall is to be reported and evaluated following current 
processes and procedures developed by the OSU Brain and Spine 
Institute as maintained with IHIS. 
 
If a fall risk patient is admitted to the unit and is not otherwise 
disqualified by the Study Exclusion Criteria, the patient and/or LAR 
in form of a Patient Consent document, will be given information 
about and the opportunity for the patient to participate in the Study. If 
the patient or legal surrogate declines participation, the patient will 
receive standard of care provided prior to the Study. 
Upon receiving a consent to participate, the patient will be fitted with 
a monitored PUP™ sock sized to the patient’s foot from the Study 
inventory, and thereafter enrolled by a caregiver in the Palarum Fall 
Prevention System using an Android application on the IRT.   The 
Palarum Fall Prevention System and PUP™ sock thereafter monitor 
the patient’s activity 24x7 throughout the patient’s entire length of 
stay.  During the patient’s stay, the PUP™ sock will be evaluated 
daily for proper fit, patient comfort, and patient safety.  Upon 
discharge or transfer, the patient is un-enrolled from the system again 

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utilizing the IRT.  All patient relevant fall data, including system 
performance, is collected and stored in the PCS for future study and 
evaluation.  Any patient fall is to be reported and evaluated following 
current OSU Medical Center processes and procedures independent of 
the Palarum Fall Prevention System. 
Technical support for the Palarum Fall Prevention system is available 
by phone at 844-PALARUM  (844) 725-2786 and email, 
it@palarum.com, 24x7. If there is a Palarum Fall Prevention System 
outage each Intervention Group Pod should follow policies related to 
downtime procedures for fall risk patients. 
 
CONTROL 
PRODUCT, DOSE 
AND ROUTE OF 
ADMINISTRATION 
N/A  
DURATION OF 
SUBJECT 
PARTICIPATION 
AND DURATION OF 
STUDY 
Duration:  Once a patient has been placed in the fall risk protocol, the 
patient will remain in the study until a nurse removes the patient from 
risk fall status or the participant has been discharged from the 
hospital.     
CONCOMITANT 
MEDICATIONS 
Allowed: YES 
 
Prohibited:  NONE 
EFFECTIVENESS 
EVALUATIONS 
Effectiveness evaluation data will be collected by the Palarum Fall 
Risk System, and incorporated and integrated with patient diagnosis, 
co-morbidities, and other medical data within REDCap including: 
1. Enrollment Data 
a. Patient Identifier/MRN 
b. Patient Weight 
c. Patient Sock Size (S-M-L-XL) 
d. Sex 
e. Pod and Room/Bed 
f. Date 
g. Time 
h. Sock Number 
i. Sensor Number 
2. Event Logs 
3. Time of stand alert 
4. Time to clear 
5. Who cleared stand 
6. Manual or Automatic termination 
7. Accelerator and Gyroscopic Data surrounding each stand 
event 

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8. Pressure on foot 
9. Motion of patient 
 
PRIMARY ENDPOINT Fall rate per patient days within the study sample population 
SECONDARY 
ENDPOINTS 
As collected by the Palarum Fall Prevention System, validated by 
manual audits of thereof, and integrated with REDCap, 
 Rate of false alerts 
 Rate of fall related patient safety events 
 Time to respond to alert 
 Pressure on foot 
 Motion of patient 
 Alert fatigue analyzed and measured by alert 
responded/alerts generated over time. 
 Notification system alerts only the closest five caregivers 
when a fall risk patient is up 
 Time to staff notification (latency) when a fall risk patient 
is up and unattended 
 Time to clear data 
 Identification of caregiver clearing alert  
 Determination of manual or automatic termination 
 
 
OTHER 
EVALUATIONS 
N/A 
SAFETY 
EVALUATIONS 
Incidence of adverse events arising use of device 
PLANNED INTERIM 
ANALYSES  
 
 
N/A 
STATISTICS 
Primary Analysis Plan 
The primary endpoint for this study is the number of patient falls.  
This will be expressed as a falls incidence rate, i.e., number of falls 
per patient days where patient days are counted from the initiation of 
the PUP™ System until discharge or removal from the fall risk 
protocol.  Using a one-sided one-sample test for Poisson means, we 
will test whether the observed fall rate is less than the historical rate of 
0.004.  This test will be conducted at the alpha=0.1 level.  Results will 
be presented as the fall rate and the corresponding one-sided 90% 
confidence interval which will provide an upper bound for the fall 
rate. 

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Rationale for Number 
of Subjects 
The primary endpoint of the trial is the patient fall rate per patient 
days.  Comparing to a historical rate of 0.004 using a one-sided test of 
Poisson means, we have at least 70% power to detect a 25% reduction 
in the fall rate at alpha level 0.1 with 2360.  Assuming a dropout rate 
of 5%, we will enroll 2500 patients into the study. 
 

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1 
BACKGROUND 
The PUP™ System is designed to monitor patient activity in a hospital, clinic, nursing 
home, or other facility where a patient may be receiving care.  
The System includes pressure sensors incorporated into the toe and heel of a sock using 
both pressure sensitive fibers and also a Bluetooth transmitter affixed to the exterior of the 
sock in the ankle region.  After the caregiver assists the patient in putting on the PUP™ 
socks, the caregiver will enter the appropriate patient data into the dedicated in-room 
PUP™ tablet to associate the patient with the specific sensor.  When the patient gets out 
of bed and steps on the floor, pressure is detected by the sock sensors which trigger an 
alert signal to the PUP™ tablet.  This alert is displayed locally in the patient’s room on the 
PUP™ tablet and can be dismissed by a caregiver present in the room with the patient, as 
appropriate.  The in-room PUP™ tablet also relays the alert signal to a local Palarum 
server which sends the alert signal to both a monitoring device located at the nursing 
station as well as to notification devices being worn by select caregivers.  The sock also 
includes a sensor for motion detection for power-saving purposes.  If the patient is idle for 
a specified amount of time, the device enters a power-saving mode. Once motion is 
detected, the system ‘wakes’ in order to be able to detect whether pressure is applied to 
the sock indicating that the patient is standing or attempting to get out of bed. 
The system can support monitoring of sensors for multiple patients, allowing display of 
sensor status for multiple patients on the tablet app.  
 
1.1 
Overview of Research 
Each year between 700,000 and 1,000,000 people in the United States fall in a healthcare 
environment (Agency for Healthcare Research and Quality, 2015).  Falls can have a 
widespread and significant impact on health, can be deadly, and often result in high costs.  
Falls with serious injury are consistently among the Top 10 sentinel events reported to 
The Joint Commission’s Sentinel Event database (The Joint Commission, 2015).  The 
average 200-bed hospital might log 300 patient falls a year (based on 5 patient falls per 
1000 patient days), which results in $10,200 per fall in medical costs annually – or more 
than $3 million. 
Falls are one metric that Medicare now uses to measure hospitals on patient safety.  Not 
meeting the fall metric will trigger a reduction in the hospital’s cost reimbursements. 
While one in three hospitalized Americans, aged 65 and over falls every year, elderly 
patients are not the only ones vulnerable to falling in health care facilities.  Any patient of 
any age or physical ability can be at risk for a fall due to medical condition, medications, 
surgical procedures or diagnostic testing.    Falls increase the length of inpatient stays by 
6.3 days and hospital charges by $14,000. (The Joint Commission, 2015). 
Most facilities have tried to address falls with traditional motion detection systems, room 
sitters, and enhanced training, but falls continue to be a quality of care and cost issue.  
Traditional motion detectors can result in a false alert, which can lead to nurses or other 

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hospital workers tuning out alerts or turning them off.   One hospital executive said they 
spent $4.2 million on patient sitters last year 
 
2 
STUDY RATIONALE 
Palarum LLC (“Palarum”) has designed and developed a wireless and “smart” fall 
prevention system and desires to have the effectiveness of the system evaluated by The 
Ohio State University Wexner Medical Center (“OSU”) through a disciplined and 
structured product evaluation process. 
Each year between 700,000 and 1,000,000 people in the United States fall in a healthcare 
environment (Agency for Healthcare Research and Quality, 2015).  Falls can have a 
widespread and significant impact on health, can be deadly, and often result in high costs.  
Falls with serious injury are consistently among the Top 10 sentinel events reported to 
The Joint Commission’s Sentinel Event database (The Joint Commission, 2015).  The 
average 200-bed hospital might log 300 patient falls a year (based on 5 patient falls per 
1000 patient days), which results in $10,200 per fall in medical costs annually – or more 
than $3 million.  (Agency for Healthcare Research and Quality). 
Falls are one metric that Medicare now uses to measure hospitals on patient safety.  Not 
meeting the fall metric will trigger a reduction in the hospital’s cost reimbursements. 
While one in three hospitalized Americans aged 65 and over falls every year, elderly 
patients are not the only ones vulnerable to falling in health care facilities.  Any patient of 
any age or physical ability can be at risk for a fall due to medical condition, medications, 
surgical procedures or diagnostic testing.    Falls increase the length of inpatient stays by 
6.3 days and hospital charges by $14,000. (The Joint Commission, 2015).  
 Falls represent both a patient safety priority and an economic priority for healthcare 
organizations.  A fall may result in fractures, lacerations, or internal bleeding, leading to 
increased health care utilization.  As of 2008, the Centers for Medicare & Medicaid 
Services (CMS) does not reimburse hospitals for the extra care associated with an 
inpatient fall and the trauma associated with it. (The Joint Commission, 2015).  
 
The best way to reduce the number of falls is to prevent them. A whole marketplace of 
bed and chair alerts and other devices has been developed to address the need, yet the 
numbers creep up. On a busy patient floor, nurses lose valuable seconds just figuring out 
which patient’s bed alert is sounding. We expect research to show that the Palarum PUP™ 
System takes back that critical time.  
 
2.1 
Risk / Benefit Assessment 
 
Risks of Product 
 Over-reliance on automation of technology decreasing hourly rounding presence 
 System fails to notify staff of stand alert 
 Possible skin impression from prolonged use of sock 
 

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Mitigation of Each Risk 
 Education 
 Patient Assessments 
 Replacement of Socks 
 Socks come with multiple locations with sock sensor placement 
 
Benefits 
 Improved patient safety by reducing the number of patient falls.  A 25% reduction in 
patient falls will result in 90 less falls per year in a 200-bed hospital. 
 Improved patient outcomes 
 Staff is notified immediately when a patient safety event occurs (fall risk patient is up 
and unattended) 
 Reduced alert fatigue.  Improved accuracy of the stand detection with innovative 
pressure sensitive smart textiles.  New notification system which alerts only the closest  
five caregivers, with an escalation protocol, when a fall risk patient is up and 
automatically terminates the alert when a caregiver enters the room.   
 Data & Analytics.  The PUP™ Fall Prevention System delivers critical new data to 
enhance patient care and improve hospital operations. 
 Cost Savings. The Palarum LLC, alert system could save one 200 bed hospital 
approximately $744,600 dollars each year.  Average 200 bed hospital is expected to 
have 5 patient falls per 1000 patient days.  Therefore, an average 200 bed hospital will 
have 365 falls per year (20% reduction in patient falls (73)/year x $10,200/ fall).   
 
3 
STUDY OBJECTIVES 
3.1 
Primary Objective 
The primary objective of this study is to determine if the fall incidence rate for patients 
with the intervention, Palarum LLC’s, PUP™ (Patient is Up) System is less than the 
historical incidence rate of patient falls in the units under study.   
 
3.2 
Secondary Objectives 
Within the context of the Study 
 Determine the rate of false alert delivered by the PUP™ System 
 Determine the rate of fall related patient safety events 
 Determine the average caregiver response time to an alert delivered by the 
PUP™ System 

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4 
STUDY DESIGN 
4.1 
Study Overview 
 Problem - Falls occur at a rate of 5.5 per 1000 patient days in US hospitals. In 
addition to the human morbidity and mortality costs, falls cost hospitals in excess of 
$8 billion in unreimbursed charges. No intervention to date has been shown to 
significantly reduce that rate.  
 Purpose - To determine the effectiveness, if any, of the PUP™ Fall Prevention 
System.  The hypothesis is that the System will reduce the fall rate by at least 25% of 
prior years’ average fall rate. 
 Population to be studied -  All fall risk patients, eighteen years old or older, admitted 
to OSU Brain and Spine Hospital on Floors 8, 9, and 10 until the sample size is 
reached.  
 Research Design – Single arm trial  
 Extent of Researcher Interference - Minimal, only studying events as they normally 
occur.  The PUP™ System will have been previously evaluated and approved for use 
as the standard of care at the OSU Medical Center Brain and Spine Hospital in 
accordance with the terms of an agreement between Palarum and OSU Medical Center 
dated March 28, 2018. 
 Time horizon - Current. 
 Study setting - Non-contrived. OSU Medical Center Brain and Spine Hospital. 
 Measurement and measures 
o Patient fall rate (measured as number of falls/1000 patient days) data collection 
and reporting forms, criteria and protocols for the three calendar years 
preceding initiation of the research. 
o Patient fall rate data collection and reporting forms, criteria, and protocols for 
the research period calendar year. 
o Data collection standards and protocol for/of; 
 Positive stand detection alert 
 Negative stand detection alert 
 Participant inclusion, exclusion or exemption 
 Sampling methods of 1-3 above 
 Report form(s), structure and content 
 Participant or data exclusion standards, if any. 
 Data Collection Method - Unobtrusive automated physical measurement using the 
PUP™ sock, sensors, wireless technology, and REDCap. 
 
 

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4.2 
Research Procedures & Steps 
 Pre-Conditions 
o All Nurses/applicable staff Trained on Palarum System 
o All Equipment Installed in Rooms 
o At Beginning of Shift Nurses Wearing Smart Notification Devices & Enrolled 
into Unit 
 
 Patient Admission 
o Patient Admitted into Room with Palarum Technology 
 
 Fall Risk Screening 
o Patient undergoes fall risk assessment. 
o If patient is determined to be fall risk, they proceed to next step 
 
 Determination of Inclusion/Exclusion Criteria 
o Containment - Hospital Specific 
o Weight Limit – Hospital Specific 
o Mental Cognizance – Hospital Specific 
o Other Health Conditions – Hospital Specific 
 
 Registration into Study 
o If patient is determined as candidate for study and patient and/or LAR has 
provided written informed consent, then that patient will be registered as a 
study participant. 
 
 Patient Education 
o Patient and/or Patient family will be educated on admission using a video on 
the in-room tablets. 
 
 Fit with Sock 
o Upon registration into study the patient will be fitted for a sock by the nursing 
staff. 
o Nursing staff utilizes sizing chart to correlate patient’s foot size with Palarum 
Sock size. 
o Sock is placed on patient 
 
 Enroll Sock in Application 
o Once sock is successfully fitted on patient the nurse proceeds to enroll the 
patient through Palarum Application. 
o The following categories must be completed before proceeding to a successful 
enrollment: Patient Name/Initials/MRN, Sex, Weight, Sock Size, Sensor. 

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o Upon successful sock pairing to IRT the enrollment process is complete and 
the patient is now being monitored. 
 
 Application Records/Data 
o Enrollment Data 
 
 Event Logs   
o Time of stand alert 
o Time to clear 
o Who cleared stand 
o Manual or Automatic termination 
o Accelerator and Gyroscopic Data surrounding each stand event 
 
 Report Generation 
o At 12am each morning a report is generated detailing the previous day’s 
activity on the system.  
o Two separate reports are sent each morning at 12am (filtered by audience): 
Nurse Manager, Site Executive.  
o The reports show: the Pod the patient is enrolled in, # of Alerts during their 
length of stay, whether a patient has alerted 3 or more times in less than 24 
hours. 
 
 Alert Generation 
o An alert is generated when a patient places their foot on the ground and takes a 
step. 
o False alerts are prevented through the use of a gyroscope and accelerometer. 
o Once an alert is generated it is sent to the IRT, HUC, and Smart Notification 
Devices. 
 
 How to respond to Alerts 
o There are two ways to respond to an alert in the Palarum Fall Prevention 
System 
 Nurse proceeds into the room (wearing Palarum Smart Notification 
Device) and the system automatically turns off do to his/her proximity. 
 Nurse proceeds into the room and manually turns off the system on the 
IRT by touching the red alert Icon on the screen and proceeding to put 
in their initials. 
 
 
 
 

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5 
CRITERIA FOR EVALUATION 
5.1 
Primary Effectiveness Endpoint 
The primary endpoint is the fall rate per patient days within the study population.  A fall is 
defined as “an unplanned descent to the floor with or without injury to the patient. Include 
falls when a patient lands on a surface where you wouldn't expect to find a patient. All 
unassisted and assisted falls are to be included whether they result from physiological 
reasons (fainting) or environmental reasons (slippery floor). Also report patients that roll 
off a low bed onto a mat as a fall.” 
 
5.2 
Secondary Effectiveness Endpoints 
 The rate of false alerts per patient days delivered by the PUP™ System.  We 
define as false alert as an alert generated by other than a physical stand by the 
PUP™ System. 
 The number of patient safety events.  Fall related patient safety events include 
patient standing, walking, and otherwise moving without a caregiver present. 
 We will assess the average time to respond to an alert delivered by the PUP™ 
System. This will be the time from the initiation of an alert until it is silenced 
automatically by RSSI proximity of a caregiver or manually by the caregiver. 
5.3 
Safety Evaluations 
Falls are inherent in healthcare settings and cannot be entirely eliminated.  As such 
they are not an adverse event arising from or related to the use of the Palarum PUP™ 
System. 
6 
SUBJECT SELECTION 
6.1 
Study Population 
 
All fall risk patients, eighteen years old or older, admitted to the OSU Medical Center 
Brain and Spine Institute on Floors 8, 9 and 10. “Fall risk” will be defined by 
OSUWMC standard of care criteria. 
6.2 
Inclusion Criteria 
 
Written informed consent obtained from subject (and/or LAR) and ability for subject 
to comply with the requirements of the study. 
 
All fall risk patients, eighteen years old and older, on Floors 8, 9 and 10 of the 
OSUWMC Brain and Spine Hospital, with “fall risk” as defined by OSU criteria, for 
whom no medical condition prohibits their participation in the program, (see 
Exclusion Criteria).  
  

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6.3 
Exclusion Criteria 
 
Presence of a condition or abnormality that in the opinion of the Investigator would 
compromise the safety of the patient or the quality of the data. 
 
Patients whose medical condition prohibits their participation in the program, which 
would include among others, patients with an anatomy or wound issue on their feet or 
around their calves that would bar them from wearing socks on either foot, and/or 
patients for whom the sock would impede medical treatment.  
 
7 
STUDY TREATMENTS 
7.1 
Method of Assigning Subjects to Placebo or Test Evaluation Groups 
Eligible patients will be enrolled in the PUP™ System treatment.  Pod staff will assess fall 
risk and study team will determine eligibility.  
7.2 
Formulation of Test and Control Products 
Palarum, LLC manufactures the socks and provides the equipment. 
 7.3 
Packaging and Labeling 
The PUP™ System socks will be provided individually wrapped in a plastic package. 
Each pair of socks will be labeled with a unique number and each package will be labeled 
with the name of the sponsors, and directions for patient use and storage.  (Appendix  A) 
7.4 
Supply of Study Socks and Equipment at the Site 
All socks for patients admitted to study will be stocked in the respective floors supply 
closet with their existing socks. All equipment for the study patients will be in place and 
tested before the study begins.  
7.5 
Regimen 
Each patient will be fitted with a sized pair of PUP™ socks and enrolled in the system.  
Socks will be worn continuously throughout the stay unless soiled or identified as 
defective by the self-testing of the PUP™ System.  If soiled or defective, the socks will be 
replaced from the supply. 
7.6 
Dispensing 
All fall risk candidates who provide consent will be enrolled by the caregiver or CRC into 
the PUP™ Fall Risk Solution upon enrollment. 
7.7 
Administration Instructions 
 Nurse will enroll the patient.   
 Sock is fitted to patient.   
 Patient anatomy and foot size will determine the selection of appropriate sock size.   

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 Series of 5-7 dots (size dependent) on top of sock will be aligned with center of foot. 
7.8 
Supply of Study Inventory at the Site 
 Appropriate sizes will be stored in a supply cart on the unit.   
 Sock inventory will be maintained 
7.9 
Storage 
Storage of the PUP™ S equipment will be within the Brain and Spine Hospital. 
7.10 Study Accountability 
 Upon discharge, the patient will be un-enrolled from the PUP™ Fall Prevention 
Solution.   
 Socks will be put in a special recyclable bin that will be returned to the vendor to be 
laundered and inspected for quality assurance. 
 An accurate and current accounting of the dispensing and return of PUP™ socks for 
each subject will be maintained on an ongoing basis by a member of the study site 
staff.   
7.11 Measures of Treatment Compliance 
 Each morning at 12am a report will be generated detailing the previous day’s activity 
on the system.  
 Two separate reports will be sent each morning at 12am (filtered by audience): Nurse 
Manager, Site Executive.  
 The reports will show:  
o The Pod where the patient is enrolled 
o # of alerts during their length of stay 
o Whether a patient has alerted 3 or more times in less than 24 hours. 
 
8 
STUDY PROCEDURES AND GUIDELINES 
 A Schedule of Events representing the required testing procedures to be performed for 
the duration of the study is diagrammed in (Appendix B). 
 Prior to conducting any study-related activities, Pod staff will identify eligible patients 
and notify study staff to consent and enroll.   Written informed consent and the Health 
Insurance Portability and Accountability Act (HIPAA) authorization must be signed 
and dated by the subject or subject’s legal representative.  
8.1 
Clinical Assessments 
Clinical assessment of foot and ankle 

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8.2 
Concomitant Medications 
All concomitant medication and concurrent therapies will be documented at 
Baseline/Screening, at early termination when applicable and at discharge.  Dose, 
route, frequency of administration, and indication for administration and dates of 
medication will be captured. 
8.3 
Demographics  
Demographic information (date of birth, sex, race) will be recorded at Baseline 
Screening and again at enrollment in the PUP™ System. 
8.4 
Medical History   
Relevant medical history, including history of current disease, other pertinent history, 
and information regarding underlying diseases will be recorded at Baseline Screening. 
8.5 
Physical Examination  
Clinical assessment of foot and ankle 
8.6 
Adverse Events 
Information regarding occurrence of adverse events will be captured throughout the 
study. Duration (start and stop dates and times), severity/grade, outcome, treatment 
and relation to study will be recorded on the case report form (CRF – Appendix C).  
 
9 
EVALUATIONS BY VISIT 
9.1 
Pre-Conditions  
 All nurses/applicable staff trained on Palarum PUP™ System 
 All equipment installed in rooms 
 At beginning of shift nurses wearing smart notification devices & enrolled into unit. 
 
9.2 
Day 1 – Admission 
 Patient Admission 
o Patient admitted into a room with the Palarum PUP™ technology 
 Fall Risk Screening 
o Patient undergoes fall risk assessment. 
o If patient is determined to be fall risk they proceed to next step 
 Registration into Study 
o Dedicated trained staff will be notified and will enroll the Patient into the 
Study as soon as medically feasible and reasonable. 
o If patient is determined as candidate for study, they are registered as a study 
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o Review the study with the subject and obtain written informed consent and 
HIPAA authorization and assent, if appropriate. 
o Assign the subject a unique screening number. 
o Record demographics data. 
o Record concomitant medications. 
 Patient Education 
o As noted in “Pre-Conditions” all nursing and related staff are trained on how to 
use the Palarum Fall Prevention Technology before the study starts. 
o Continuous training will be available for new staff through Buckeye Learn. 
 Fit with Sock 
o Upon registration into this study, the patient will be fitted for a PUP™ sock by 
the nursing staff. 
o Nursing staff utilizes a sizing chart to correlate patient’s foot size with PUP™ 
Sock size. 
o Sock is placed on patient 
 Enroll Sock in Application 
o Once sock is successfully fitted on patient the nurse proceeds to enroll the 
patient through Palarum Application. 
o The following categories must be completed before proceeding to a successful 
enrollment: Patient Name/Initials/MRN, Sex, Weight, Sock Size, and Sensor. 
o Upon successful sock paring to IRT the enrollment process is completed, and 
the patient is now being monitored. 
 
9.3 
Day 1 through length of stay  
 System will electronically monitor patient compliance   
 Report Generation 
o Each morning at 12am a report is generated detailing the previous day’s 
activity on the system.  
o Two separate reports are sent each morning at 12am (filtered by audience): 
Nurse Manager, Site Executive.  
o The reports show: the Pod the patient is enrolled in, # of Alerts during their 
length of stay, whether a patient has alerted 3 or more times in less than 24 
hours 
 Alert Generation 
o An alert is generated when a patient places their foot on the ground and takes a 
step. 
o False alerts are prevented through the use of a gyroscope and accelerometer. 
o Once an alert is generated it is sent to the IRT, HUC, and Smart Notification 
Devices. 
 How to respond to Alerts 
o There are two ways to respond to an alert with Palarum’s Fall Prevention 
System 

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o Nurse proceeds into the room (wearing Palarum Smart Notification Device) 
and the system automatically turns off due to his/her proximity. 
o Nurse proceeds into the room and manually turns off the system on the IRT by 
touching the red alert icon on the screen and then entering their initials. 
 Documentation of exceptions. 
 Record any Adverse Experiences and/or Review subject diary for adverse experiences 
and compliance.   
 Perform clinical examination of foot and ankle. 
9.4 
Discharge 
 Upon discharge from the hospital, the nurse will log patient out of the Palarum 
PUP™ System.  The PUP™ socks will be placed in the Palarum laundry receptacles 
located on each hospital floor. 
  
10 ADVERSE EXPERIENCE REPORTING AND DOCUMENTATION 
10.1 Adverse Events 
An Adverse Event has to meet three basic criteria to be reportable; an AE has occurred, 
the device is associated with the AE and the AE led to 1 of 4 outcomes: decline in state of 
health of patient, threat to public health, could lead to death or serious injury if it occurs.   
The Investigator will probe, via discussion with the subject, for the occurrence of AEs 
during each subject visit and record the information in the site’s source documents.  
Adverse events will be recorded in the patient CRF.  Adverse events will be described by 
duration (start and stop dates and times), severity, outcome, treatment and relation to 
study, or if unrelated, the cause. 
 
10.2 Serious Adverse Experience Reporting 
Study sites will document all SAEs that occur (whether or not related to study protocol) 
per UCSF CHR Guidelines.  The collection period for all SAEs will begin after informed 
consent is obtained and end after procedures for the final study visit has been completed. 
In accordance with the standard operating procedures and policies of the local Institutional 
Review Board (IRB)/Independent Ethics Committee (IEC), and OSU’s CH Guidelines, 
the site investigator will report SAEs to the IRB/IEC.   
10.3 Medical Monitoring 
Medical monitoring will be provided by the research team. If further medical assistance 
is determined necessary, then medical assistance will occur through standard of care per 
OSU Brain and Spine Hospital standard operating processing. 
   

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11 DISCONTINUATION AND REPLACEMENT OF SUBJECTS 
11.1 Early Discontinuation of Study   
A subject may be discontinued from study treatment at any time if the subject, the LAR, 
the investigator, or the Sponsor feels that it is not in the subject’s best interest to continue.  
The following is a list of possible reasons for study treatment discontinuation.  
 Subject or LAR withdrawal of consent  
 Subject is not compliant with study procedures including but not limited to 
intermittent wearing of the sock, refusal after enrollment to wear the socks, or 
repeatedly engaging in activity which defeats the integrity of the electronic 
circuitry of the sock. 
 Adverse event that in the opinion of the investigator would be in the best interest 
of the subject to discontinue study treatment 
 Protocol violation requiring discontinuation of study treatment 
 Sponsor request for early termination of study 
 All subjects are free to withdraw from participation at any time, for any reason, 
specified or unspecified, and without prejudice. 
 Reasonable attempts will be made by the investigator to provide a reason for 
subject withdrawals.  The reason for the subject’s withdrawal from the study will 
be specified in the subject’s source documents. Refer to Section 10 for early 
termination procedures. 
11.2 Withdrawal of Subjects from the Study 
 A subject may be withdrawn from the study at any time if the subject, the investigator, 
or the Sponsor feels that it is not in the subject’s best interest to continue.   
 All subjects are free to withdraw from participation at any time, for any reason, 
specified or unspecified, and without prejudice. 
 Reasonable attempts will be made by the investigator to provide a reason for subject 
withdrawals.   
o The reason for the subject’s withdrawal from the study will be specified in the 
subject’s source documents.   
o As noted above, subjects who discontinue study treatment early should have an 
early discontinuation visit. Refer to Section 10 for early termination 
procedures.   
 
12 PROTOCOL VIOLATIONS 
 A protocol violation occurs when the subject or investigator fails to adhere to 
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primary endpoint criteria.  Protocol violations for this study include, but are not 
limited to, the following: 
o Failure to meet inclusion/exclusion criteria 
o Failure to comply with Good Clinical Practice (GCP) guidelines will also 
result in a protocol violation. The Sponsor will determine if a protocol 
violation will result in withdrawal of a subject. 
o When a protocol violation occurs, it will be discussed with the investigator and 
a Protocol Violation Form detailing the violation will be generated. This form 
will be signed by a Sponsor representative and the Investigator. A copy of the 
form will be filed in the site’s regulatory binder and in the Sponsor’s files. 
13 STATISTICAL METHODS AND CONSIDERATIONS 
Prior to the analysis of the final study data, a detailed Statistical Analysis Plan (SAP) will 
be written describing all analyses that will be performed.  The SAP will contain any 
modifications to the analysis plan described below.   
13.1 Demographic and Baseline Characteristics 
Demographic and baseline characteristics will be summarized using appropriate 
descriptive statistics including the mean and standard deviation for continuous values and 
counts and proportions for discrete variables. 
13.2 Analysis of Primary Endpoint 
The primary endpoint for this study is the number of patient falls.  This will be expressed 
as a rate per patient days where patient days are counted from the initiations of the PUP™ 
System until discharge or removal from the fall risk protocol.  Using a one-sided one-
sample test for Poisson means, we will test whether the observed fall rate is less than the 
historical rate of 0.004.  This test will be conducted at the alpha=0.1 level.  Results will be 
presented as the fall rate and the corresponding one-sided 90% confidence interval which 
will provide an upper bound for the fall rate. 
13.3 Analysis of Secondary Endpoints 
 
Secondary outcomes include estimating the incidence of false alerts, the rate of alerts sent 
out per patient days, characteristics of the patient safety events, and time to response. The 
analyses of the secondary endpoints will be descriptive and exploratory with the goal of 
further characterizing the properties of the PUP™ System.  Rates and means will be 
calculated as appropriate.  Confidence intervals will be computed to accompany each 
estimate.  No formal statistical testing will be conducted. 
We will also examine how fall rates may be associated with patient characteristics.  We 
may also explore data related to the activity level of fall risk patients that are collected by 
the PUP™ System.  These descriptive analyses could help to further characterize the fall 
risk patient population. 

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13.4 Sample Size  
The primary endpoint of the trial is the patient fall rate per patient days.  Comparing to a 
historical rate of 0.004 using a one-sided test of Poisson means, we have at least 70% 
power to detect a 25% reduction in the fall rate at alpha level 0.1 with 2360.  Assuming a 
dropout rate of 5%, we will enroll 2500 patients into the study. 
14 DATA COLLECTION, RETENTION AND MONITORING 
14.1 Data Collection Instruments 
The Investigator will prepare and maintain adequate and accurate source documents 
designed to record all observations and other pertinent data for each subject treated with the 
study drug.   
Study personnel at each site will enter data from source documents corresponding to a 
subject’s visit into the protocol-specific electronic Case Report Form (eCRF) OR paper 
CRF when the information corresponding to that visit is available.  Subjects will not be 
identified by name in the study database or on any study documents to be collected by the 
Sponsor (or designee) but will be identified by a site number, subject number, and initials. 
If a correction is required for an eCRF, the time and date stamps track the person entering 
or updating eCRF data and create an electronic audit trail.   
The Investigator is responsible for all information collected on subjects enrolled in this 
study.  All data collected during the course of this study must be reviewed and verified for 
completeness and accuracy by the Investigator.  A copy of the CRF will remain at the 
Investigator’s site at the completion of the study. 
14.2 Data Management Procedures 
The data will be entered into a validated database.  The Data Management group will be 
responsible for data processing, in accordance with procedural documentation.  Database 
lock will occur once quality assurance procedures have been completed. 
All procedures for the handling and analysis of data will be conducted using good 
computing practices meeting FDA guidelines for the handling and analysis of data for 
clinical trials. 
14.3 Data Quality Control and Reporting 
After data have been entered into the study database, a system of computerized data 
validation checks will be implemented and applied to the database on a regular basis. 
Queries are entered, tracked, and resolved through the EDC system directly.  The study 
database will be updated in accordance with the resolved queries.  All changes to the 
study database will be documented. 
14.4 Archival of Data 
The database is safeguarded against unauthorized access by established security 
procedures; appropriate backup copies of the database and related software files will be 

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maintained.  Databases are backed up by the database administrator in conjunction with 
any updates or changes to the database.   
At critical junctures of the protocol (e.g., production of interim reports and final reports), 
data for analysis is locked and cleaned per established procedures. 
14.5 Availability and Retention of Investigational Records 
The Investigator must make study data accessible to the monitor, other authorized 
representatives of the Sponsor (or designee), IRB/IEC, and Regulatory Agency (e.g., 
FDA) inspectors upon request.  A file for each subject must be maintained that includes 
the signed Informed Consent/HIPAA Authorization Form and copies of all source 
documentation related to that subject.  The Investigator must ensure the reliability and 
availability of source documents from which the information on the CRF was derived. 
All study documents (patient files, signed informed consent forms, copies of CRFs, Study 
File Notebook, etc.) must be kept secure for a period of two years following marketing of 
the investigational product or for two years after centers have been notified that the IND 
has been discontinued.  There may be other circumstances for which the Sponsor is 
required to maintain study records and, therefore, the Sponsor should be contacted prior to 
removing study records for any reason. 
14.6 Monitoring 
Monitoring visits will be conducted by representatives of the Sponsor according to the 
U.S. CFR Title 21 Parts 50, 56, and 312 and ICH Guidelines for GCP (E6).    By signing 
this protocol, the Investigator grants permission to the Sponsor (or designee), and 
appropriate regulatory authorities to conduct on-site monitoring and/or auditing of all 
appropriate study documentation. 
14.7 Subject Confidentiality 
In order to maintain subject confidentiality, only a site number, subject number, and 
subject initials will identify all study subjects on CRFs and other documentation submitted 
to the Sponsor.  Additional subject confidentiality issues (if applicable) are covered in the 
Clinical Study Agreement. 
15 ADMINISTRATIVE, ETHICAL, REGULATORY CONSIDERATIONS 
The study will be conducted according to the Declaration of Helsinki, Protection of 
Human Volunteers (21 CFR 50), Institutional Review Boards (21 CFR 56), and 
Obligations of Clinical Investigators (21 CFR 312). 
To maintain confidentiality, all laboratory specimens, evaluation forms, reports and other 
records will be identified by a coded number and initials only.  All study records will be 
kept in a locked file cabinet and code sheets linking a patient’s name to a patient 
identification number will be stored separately in another locked file cabinet.  Clinical 
information will not be released without written permission of the subject, except as 
necessary for monitoring by the FDA.  The Investigator must also comply with all 
applicable privacy regulations (e.g., Health Insurance Portability and Accountability Act 
of 1996, EU Data Protection Directive 95/46/EC). 

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15.1 Protocol Amendments 
Protocol amendments cannot be implemented without prior written IRB/IEC approval 
except as necessary to eliminate immediate safety hazards to patients.  A protocol 
amendment intended to eliminate an apparent immediate hazard to patients may be 
implemented immediately, provided the IRBs are notified within five working days. 
15.2 Institutional Review Boards and Independent Ethics Committees 
The protocol and consent form will be reviewed and approved by the IRB/IEC of each 
participating center prior to study initiation.  Serious adverse experiences regardless of 
causality will be reported to the IRB/IEC in accordance with the standard operating 
procedures and policies of the IRB/IEC, and the Investigator will keep the IRB/IEC 
informed as to the progress of the study.  The Investigator will obtain assurance of 
IRB/IEC compliance with regulations. 
Any documents that the IRB/IEC may need to fulfill its responsibilities (such as protocol, 
protocol amendments, Investigator’s Brochure, consent forms, information concerning 
patient recruitment, payment or compensation procedures, or other pertinent information) 
will be submitted to the IRB/IEC.  The IRB/IECs written unconditional approval of the 
study protocol and the informed consent form will be in the possession of the Investigator 
before the study is initiated.  The IRB/IECs unconditional approval statement will be 
transmitted by the Investigator to the Sponsor or designee prior to the shipment of study 
supplies to the site.  This approval must refer to the study by exact protocol title and 
number and should identify the documents reviewed and the date of review. 
Protocol and/or informed consent modifications or changes may not be initiated without 
prior written IRB/IEC approval except when necessary to eliminate immediate hazards to 
the patients or when the change(s) involves only logistical or administrative aspects of the 
study.  Such modifications will be submitted to the IRB/IEC and written verification that 
the modification was submitted and subsequently approved should be obtained.   
The IRB/IEC must be informed of revisions to other documents originally submitted for 
review; serious and/or unexpected adverse experiences occurring during the study in 
accordance with the standard operating procedures and policies of the IRB; new 
information that may affect adversely the safety of the patients of the conduct of the study; 
an annual update and/or request for re-approval; and when the study has been completed. 
15.3 Informed Consent Form  
Informed consent will be obtained in accordance with the Declaration of Helsinki, ICH 
GCP, US Code of Federal Regulations for Protection of Human Subjects (21 CFR 
50.25[a,b], CFR 50.27, and CFR Part 56, Subpart A), the Health Insurance Portability and 
Accountability Act (HIPAA, if applicable), and local regulations. 
The Investigator will prepare a combined informed consent form and HIPAA 
authorization, and provide the document to the Sponsor or designee for approval prior to 
submission to the IRB/IEC.  The consent form generated by the Investigator must be 
acceptable to the Sponsor and be approved by the IRB/IEC.  The written consent 
document will embody the elements of informed consent as described in the International 
Conference on Harmonization and will also comply with local regulations. The 

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Investigator will send an IRB/IEC-approved copy of the Informed Consent Form to the 
Sponsor (or designee) for the study file. 
A properly executed, written, informed consent will be obtained from each subject and/or 
LAR prior to entering the subject into the trial.  Information should be given in both oral 
and written form and subjects must be given ample opportunity to inquire about details of 
the study.    A copy of the signed consent form will be given to the subject and the original 
will be maintained with the subject’s records. 
15.4 Publications  
The preparation and submittal for publication of manuscripts containing the study results 
shall be in accordance with a process determined by mutual written agreement among the 
study Sponsor and participating institutions.  The publication or presentation of any study 
results shall comply with all applicable privacy laws, including, but not limited to, the 
Health Insurance Portability and Accountability Act of 1996.  
15.5 Investigator Responsibilities 
By signing the Agreement of Investigator form, the Investigator agrees to: 
1. Conduct the study in accordance with the protocol and only make changes after 
notifying the Sponsor (or designee), except when to protect the safety, rights or 
welfare of subjects. 
2. Personally, conduct or supervise the study (or investigation). 
3. Ensure that the requirements relating to obtaining informed consent and IRB review 
and approval meet federal guidelines, as stated in § 21 CFR, parts 50 and 56. 
4. Report to the Sponsor or designee any AEs that occur in the course of the study, in 
accordance with §21 CFR 312.64. 
5. Ensure that all associates, colleagues and employees assisting in the conduct of the 
study are informed about their obligations in meeting the above commitments. 
6. Maintain adequate and accurate records in accordance with §21 CFR 312.62 and to 
make those records available for inspection with the Sponsor (or designee). 
7. Ensure that an IRB that complies with the requirements of §21 CFR part 56 will be 
responsible for initial and continuing review and approval of the clinical study. 
8. Promptly report to the IRB and the Sponsor (or designee) all changes in the research 
activity and all unanticipated problems involving risks to subjects or others (to 
include amendments and IND safety reports). 
9. Seek IRB approval before any changes are made in the research study, except when 
necessary to eliminate hazards to the patients/subjects. 
10. Comply with all other requirements regarding the obligations of clinical investigators 
and all other pertinent requirements listed in § 21 CFR part 312. 
 
 

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APPENDIX A –PUP™ SOCK LABEL 
 
 

Protocol Number 
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APPENDIX B -   SCHEDULE OF STUDY VISITS 
 
 
DAY 1 ADMISSION 
(Day/Week/Month #)a 
VISITS ON DAY 1 & 
EVERY DAY THROUGH 
LENGTH OF STAY 
 
VISIT ON PATIENT 
EARLY WITHDRAWAL 
VISIT ON PATIENT 
DISCHARGE 
Informed Consent 
X 
 
 
 
Medical History 
X 
 
 
 
Complete Physical Exam 
X 
 
 
 
Abbreviated Physical Exam 
 
X 
X 
X 
Weight  
X 
X 
X 
X 
Administration of PUP™ Fall 
Prevention System 
X 
 
 
 
Counting of Returned PUP™  
socks 
 
X 
X 
X 
Initiate Subject Diary 
X 
 
 
 
Subject Diary Review 
 
X 
 
X 
Adverse Experiences 
 
X 
X 
 
a  
2 days

Protocol Number 
Confidential 
 
Version #: 4 – 2018H0303 
Version Date: 07/29/2019 
Page 33 of 34 
 
APPENDIX C -   PUP (PATIENT IS UP) SYSTEM  
CASE REPORT FORM – OHIO STATE UNIVERSITY 
 
 
 
 
 
 
 
 
PARTICIPANT INFORMATION 
Participant ID 
 
Inclusion/exclusion criteria 
*Patient must meet all fall risk criteria to be   
eligible for the study 
Met all ☐ 
Not met* ☐ 
Date of Informed IRB Consent 
 
Gender 
☐ 
Male             ☐    Female 
Date of Enrollment into Fall Prevention System 
 
EARLY DISCONTINUATION OF STUDY  
Date of discontinuation from study 
 
Reason for discontinuation 
☐ 
Subject withdrawal 
☐ 
Subject not compliant 
 
☐     Intermittent wearing of the sock 
             ☐     Refusal after enrollment to wear the sock 
             ☐     Repeatedly engaging in activity which defeats 
                      the integrity of the electronic circuitry of the  
                      sock 
☐ 
Sponsor request for early termination of study 
☐ 
Protocol Violation:___________________________ 
             __________________________________________ 
 

Protocol Number 
Confidential 
 
Version #: 4 – 2018H0303 
Version Date: 07/29/2019 
Page 34 of 34 
 
FINAL STUDY OUTCOME 
Investigator's Statement: I have reviewed the data recorded in this CRF and confirm that the data are 
complete and accurate 
Investigator (Full name): ____________________________________________________________ 
Investigator Signed? ☐                                                               Signature Date:_______________