Feasibility of a Cloud-based Digital Health Navigation Program for Colorectal Cancer Screening
Phase: NA
Conditions: Colorectal Cancer Screening
Sponsor: Digital Health Navigation Solutions, Inc

mPATH STTR (Phase I) 
Wake Forest Baptist Comprehensive Cancer Center 
WFBCCC # TBD || ClinicalTrials.gov: NCT06241768 
 
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Principal Investigator: 
Name and Title 
[name redacted] 
Department / Section Name 
IAS Executive Leadership 
Email Address 
[email redacted] 
Phone Number 
[phone redacted] 
 
Biostatistician: 
Name and Title 
[name redacted] 
Department / Section Name 
Biostatistical Sciences 
Email Address 
[email redacted] 
Phone Number 
[phone redacted] 
Study Coordinator: 
Name and Title 
[name redacted] 
Email Address 
[email redacted] 
Phone Number 
[phone redacted] 
Regulatory Contact: 
Name and Title 
[name redacted] 
Email Address 
[email redacted] 
Phone Number 
[phone redacted] 
 
 
Title: Feasibility of a Colorectal Cancer Screening Web App in Primary Care Patients 
 
ClinicalTrials.gov: NCT06241768 
 
Participating Institution(s): Wake Forest Baptist Comprehensive Cancer Center 
 
Version Date: August 10, 2023 
Amended: January 16, 2024 
 
IRB Protocol Approval Date: January 25, 2024 
 
 
Confidential

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Table of Contents 
Table of Contents ....................................................................................................................... 2 
SCHEMA ................................................................................................................................... 4 
1.0 
Introduction and Background .......................................................................................... 5 
2.0 
Objectives ...................................................................................................................... 6 
2.1 
Primary Objective(s) .................................................................................................... 6 
2.2 
Exploratory Objective ................................................................................................... 6 
3.0 
Study Population ............................................................................................................ 6 
3.1 
Inclusion Criteria .......................................................................................................... 6 
3.2 
Exclusion Criteria ......................................................................................................... 6 
3.3 
Inclusion of Women and Minorities .............................................................................. 7 
4.0 
Methods ......................................................................................................................... 8 
4.1 
Registration Procedures ............................................... Error! Bookmark not defined. 
4.2 
Participant Recruitment ............................................................................................... 9 
4.3 
mPATH™-CRC Intervention ...................................................................................... 10 
4.4 
Control (usual care) ...................................................... Error! Bookmark not defined. 
5.0 
Outcomes Measures .....................................................................................................10 
5.1 
Primary Outcome ....................................................................................................... 10 
5.2 
Exploratory Outcome ................................................................................................. 10 
6.0 
Analytic Plan..................................................................................................................10 
6.1 
Sample Size and Power ............................................................................................ 10 
6.2 
Analysis of Primary Outcome ..................................................................................... 11 
6.3 
Analysis of Exploratory Outcome ............................................................................... 11 
6.4 
Estimated Accrual Rate ............................................................................................. 12 
6.5 
Estimated Study Length ............................................................................................. 12 
7.0 
Data Management ........................................................... Error! Bookmark not defined. 
8.0 
Confidentiality and Privacy ............................................................................................12 
9.0 
Data Safety and Monitoring ...........................................................................................13 
10.0 
Reporting of Unanticipated Problems, Adverse Events or Deviations ............................13 
Appendix A – Eligibility Checklist ................................................ Error! Bookmark not defined. 

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Appendix B – Registration Form ................................................. Error! Bookmark not defined. 
Appendix C - Race & Ethnicity Verification Form ......................... Error! Bookmark not defined. 
Appendix D - Data and Safety Monitoring Committee (DSMC) Serious Adverse Event (SAE) 
Notification SOP  Date: 02/11/2021 ............................................. Error! Bookmark not defined. 
References ...............................................................................................................................14 
 
 
 
 
 
 
 
 

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SCHEMA 
 
 
 
 
 
 
 
 
 
 
  
 
Potential Screening Event 
Potential Use of mPATH Program 
Randomly select up to 300 
patients eligible for CRC screening 
Randomization to receive one of 
four text messages 

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1.0 Introduction and Background 
Screening for colorectal cancer is widely recommended but underused. Colorectal cancer 
(CRC) screening is cost-effective and reduces both CRC mortality and incidence by detecting 
and removing pre-cancerous polyps.1–4 Regular screening for CRC beginning at age 45 is 
widely recommended by several groups, including the United States Preventive Services Task 
Force.5–7 Nonetheless, over 30% of Americans are unscreened.8 
 
Screening rates are even lower among underserved populations, contributing to health 
disparities.9,10 Individuals who are Black, Hispanic/Latinx, have less education, limited income, 
or rural residences are less likely to be screened, and thus more likely to present with 
advanced-stage CRC and die from it.11–16 Limited health literacy, which affects over 33% of 
American adults, further interferes with patients’ ability to access and use health information.17–
21  
 
Our mPATH™ (mobile PAtient Technology for Health) digital health navigator program 
overcomes the multilevel barriers to CRC screening. Barriers to CRC screening include patient 
factors (lack of knowledge, low self-efficacy, fears, negative attitudes)23–29 and 
provider/system factors (lack of time, failure to offer screening options, lack of patient 
support).30–34 mPATH™ addresses these barriers by determining if patients are due for 
screening, educating patients about screening options, and letting patients request a test 
directly via the program. mPATH™ also sends patients supportive text messages to help them 
complete their chosen test. 
 
In a rigorous randomized controlled trial of 450 patients, an iPad version of mPATH™ for CRC 
screening (mPATH™-CRC) doubled CRC screening rates in a population prone to health 
disparities and was well accepted.35–37 Patients used mPATH™-CRC immediately before a 
scheduled primary care visit at one of six community-based practices. Compared to patients 
randomized to usual care, twice as many patients completed a CRC screening test (30% vs 
15%, p=0.0001).35 Patients in this study faced significant barriers to care; over 50% reported 
annual household incomes less than $20,000 and over one-third had limited health literacy. 
Almost all patients rated the user-friendliness of the program as “excellent”(82%) or 
“good”(16%).36 
 
Incorporating patient decision aids like mPATH™ in clinical care is challenging. We are currently 
conducting a hybrid implementation-effectiveness study of the mPATH™-CRC iPad app in 
which office staff hand mPATH™ to patients as part of routine care. As of August 2022, 
mPATH™ has identified over 3600 patients who are overdue for CRC screening, but nursing 
staff have given the mPATH™-CRC app to less than 20% of these patients, resulting in 
tremendous missed opportunities. While our implementation study is still ongoing, we 
have already identified several important variables (time pressures, staff turnover, and the 
COVID19 pandemic) significantly hampering clinics’ ability to implement mPATH™. 
 
Delivering mPATH™ to patients at home on their own devices via the cloud is a promising 
strategy. Over 90% of American adults have internet access at home, including 85% who own a 
smartphone.38 While home broadband access shows a digital divide, smartphone ownership is 
similar across racial/ethnic groups.38 Even among rural residents, those with a high school 
education or less, and individuals with annual household incomes less than $30,000, 
smartphone ownership exceeds 75%.38 The growing ownership of smartphone and tablet 
devices offers new opportunities to reach broadly into patient populations. We previously 

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developed and pilot tested a cloud-based version of mPATH™ for lung cancer (mPATH™-
Lung). In a highly pragmatic feasibility study, we sent 1000 patients electronic invitations to use 
mPATH™-Lung, and 41% (410) visited the mPATH™-Lung Web App and 85% of all visitors 
(365) completed the program. Therefore, a cloud-based version of mPATH™-CRC has great 
potential to reach patients and increase CRC screening independent of a medical visit, which is 
especially important for the 15% of adults who have not seen a doctor in the last year.39 We 
hypothesize that at least 25% of patients who are overdue for CRC screening and use a cloud-
based version of mPATH™-CRC will request a screening test via the program, demonstrating 
the feasibility of this strategy. 
2.0 Objectives 
2.1 
Primary Objective 
2.1.1 Evaluate the feasibility of the cloud-based version of mPATH-CRC in a large health 
system.  
 
2.2 
Exploratory Objective 
2.2.1 Examine the response rates to different versions of the outreach invitation messages 
created with community member input. 
3.0 Study Population 
3.1 
Inclusion Criteria  
3.1.1 Meet the U.S. Preventive Services Task Force (USPSTF) criteria for colorectal cancer 
screening. 
3.1.1.1 Age 45 to 75 years. 
3.1.1.2 No record of current colorectal cancer screening. 
3.1.2 Have a cell phone number listed in the electronic health record. 
3.1.3 Language preference of English in the electronic health record. 
 
3.2 
Exclusion Criteria  
3.2.1 Prior diagnosis of colorectal cancer.  
3.2.2 Prior diagnosis of inflammatory bowel disease. 
3.2.3 Have a record of completing a colonoscopy within the last 10 years, a FIT-DNA test in 
the last 3 years, or a FIT in the last 1 year based on the electronic health record.  

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3.2.4 Patients who may be inappropriate candidates for colorectal screening based on 
comorbidities (electronic Charlson Comorbidity Index > 2). 
 
3.3 
Inclusion of Women and Minorities 
 
Participants of all races and ethnicities who meet the above-described eligibility criteria are 
eligible to participate in this study.  
 
Based on WFBCCC population estimates, we expect approximately 55% of participants to be 
women. We will oversample for non-white patients with the goal of creating a final study sample 
that is approximately 50% non-Hispanic white, at least 20% Black, and at least 20% 
Hispanic/Latinx. We anticipate 2% or less of our sample will identify as American Indian, Asian, 
Hawaiian/Pacific Islanders, or more than one race, reflecting the low prevalence of these 
races/ethnicities in the health system’s older patient population. Translating this to our sample 
size estimate of 240, we plan to enroll at least 132 women. Similarly, we expect approximately 
20% of study participants to be Hispanic/Latino (N = 48). We plan to enroll at least 20% Black or 
African American (N = 48), 2% or less will be American Indian, Asian, Hawaiian/Pacific 
Islanders, or more than one race (N = 4). Should we not meet or exceed these estimates, the PI 
will engage the Office of Cancer Health Equity to discuss strategies to enhance recruitment in 
these target populations. 
 
3.4 
Registration Procedures 
The intervention will be developed with input from focus groups. We will hold two focus groups 
of 8 – 12 patients each (one English speakers and one Spanish speakers) to review the 
animated “core content” of the video and the collected video clips of patient testimonials. We will 
give these participants a study information sheet explaining the purpose of the study, the nature 
of the data to be collected, and the voluntary nature of their participation. 
 
After the intervention is finalized, patients will be participating in a pragmatic trial in which 
patient data collection will occur by retrospective electronic chart review. All patients will receive 
current guideline-recommended care, and we will request a waiver of patient Informed Consent. 
Therefore, it is impractical to register patients with the Cancer Center, and any such registration 
would jeopardize patient confidentiality. 
 

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4.0 Methods for Intervention Creation 
4.1 
Formation of Scientific and Community Advisory Committees 
To ensure the intervention is culturally appropriate and addresses relevant barriers to screening, 
we will form a Scientific Advisory Committee and a Community Advisory Committee to guide our 
work. The Scientific Advisory Committee (SAC) will be comprised of nationally-known 
researchers with deep expertise examining and addressing barriers to CRC screening in racial 
and ethnic subgroups. The Community Advisory Committee (CAC) will have 6 members that 
include leaders of organizations that serve the Black/African American and Hispanic/LatinX 
communities and members of those communities. We will form the CAC in collaboration with the 
Wake Forest Maya Angelou Center for Health Equity and the CTSI Program in Community 
Engagement. Both groups have deep ties to the community. The SAC and CAC will meet at key 
points in the development of the revised mPATH™-CRC decision aid (Figure 2). At the initial 
meeting, the SAC and CAC will review and provide input on: 1) our outline for key content to 
include in the revised mPATH™-CRC decision aid, and 2) the semistructured interview guide 
that will be used to capture patient testimonials to ensure that appropriate questions are asked 
to reveal potential screening barriers and garner culturally appropriate information.  
4.2    Video Testimonial Recruitment 
We will query the EHR to identify patients aged 45 to 75 with a preferred language of Spanish or 
English who: 1) were seen at one of three Atrium Health Wake Forest Baptist primary care 
practices, and 2) completed a screening colonoscopy or FIT in the past 6 months. To help us 
recruit a diverse sample, we will abstract patient gender, race/ethnicity, age, health insurance 
status, preferred language, phone number, date of colonoscopy, date of FIT, screening test 
results. We will give the primary care providers in these three practices a list of their patients 
who met our EHR inclusion criteria, and we will ask the providers to nominate patients who they 
think may be interested in participating in a video interview. A study team member will then call 
the nominated patients to inform them of the study, and if interested, administer a brief eligibility 
questionnaire. Based on responses to the questionnaire, we will exclude patients with a history 
of CRC or inflammatory bowel disease.  
Our goal is to interview up to 18 patients, selected to reflect diversity in age, race/ethnicity, 
gender, and type of screening test completed. We will schedule each participant for an 
individual 20-30 video interview held in a private location. Interviews will be conducted in the 
patient’s preferred language, either English or Spanish. A trained interviewer will conduct each 
interview using a semi-structured interview guide. We will select clips from these interviews for 
potential inclusion in the revised CRC video decision aid.  
4.3    Focus Group Recruitment 
We will query the EHR to identify patients aged 45 to 75 with a preferred language of Spanish or 
English who are seen at one of four Atrium Health Wake Forest Baptist primary care practices 
and serve a racially/ethnically and socioeconomically diverse population. We will exclude 
patients who have a prior diagnosis of CRC or inflammatory bowel disease. We will selectively 

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recruit patients by phone and patient portal messages to ensure good representation of age, 
gender, race, insurance status, and screening status. We plan include between 16-24 
participants in total for these focus groups.  
4.4    Focus Group Sessions 
A trained moderator will lead each focus group using a moderator’s guide developed by the 
study team. Each focus group will first review the animated core content of the CRC screening 
video decision aid. Questions from the moderator’s guide will probe to determine if any parts of 
the video could be improved for clarity or acceptability. Participants will then review the patient 
testimonial clips grouped by theme (motivators, barriers, rationale). We will ask participants to 
identify which testimonials they feel should be included in the final video and why. Next, each 
focus group will be presented with the sample outreach messages generated with the input from 
the Scientific Advisory Committee (SAC) and Community Advisory Committee (CAC). The 
moderator’s guide will explore participants’ reactions to the messages, content/language that is 
viewed favorably or unfavorably, and suggestions for improving the messages. Additionally, 
focus groups will be asked to suggest their own messages that would motivate others to use 
mPATH™. Each participant will receive a $50 gift card. Results from the focus groups will be 
used to finalize the CRC screening decision aid video and outreach messages for the pragmatic 
trial. 
The full moderator’s guide will be submitted to the IRB for review and approval prior to being 
used. 
4.5 Usability Testing 
Patients will be recruited from Atrium Health Wake Forest Baptist Family Medicine – Bermuda 
Run, by flyer as well as community-based sampling. Patients may be eligible to participate if 
they are aged 45 to 75 and have a smartphone. Patients who are interested in participating will 
be asked to use the web app on their own smartphone. They will be asked questions about the 
web app’s usability. Results from the interviews will be used to finalize the program. Patients will 
receive a $50 gift card as a thank you. The study team will interview up to 25 patients.  
5.0 Methods for Pragmatic Trial 
 
5.1 
Participant Recruitment 
We will request a waiver of informed consent from the Wake Forest IRB to allow our highly 
pragmatic testing since the mPATH™-CRC web application delivers guideline recommended 
care and not experimental care.  
Each week we will query the EHR to randomly select 240 potentially eligible patients who have 
no record of current CRC screening. We will oversample by race and ethnicity. We will then 
randomize these 240 patients, to receive one of four outreach messages with equal probability.  
Patients will receive the invitation message as a HIPAA-compliant text message. Each invitation 
message includes an embedded hyperlink to the web app appended with an anonymous study 
identifier that allows us to track who visits mPATH™. A reminder message will be sent once 
weekly for two weeks (no more than 3 messages total). We will continue to send weekly 
outreach messages until 120 patients who are overdue for CRC screening complete the 
mPATH™-CRC web app.  
 

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Low socioeconomic status individuals are more likely to suffer health disparities from colorectal 
cancer. Therefore, it is critically important to include low income participants in colorectal cancer 
screening studies. To avoid coercion, participant incentives will not exceed $50. 
5.2 
mPATH™-CRC Intervention 
The mPATH™ homepage will inform visitors that by using the program, their deidentified data 
may be used in research. The mPATH™-CRC Web App takes approximately 8 to 10 minutes to 
complete. It begins with a brief overview of the importance of CRC screening. Then the Web 
App confirms patients are due for routine CRC screening and have no risk factor that would 
necessitate specialized screening considerations. Patients with a risk factor will be informed of 
their risk status and encouraged to discuss screening with their primary care provider. Patients 
who are confirmed due for CRC screening and are at average risk will then be shown our 
updated animated and narrated CRC screening decision aid video that reviews the CRC 
screening tests offered by each healthcare organization: colonoscopy, FIT-DNA, and FIT. 
Lastly, patients can request a CRC screening test directly through the mPATH™ program. 
mPATH™ automatically transmits test requests to the appropriate personnel (patient navigators 
or clinical staff) at our partnering healthcare organizations via its secure referral dashboard. 
These personnel then ensure requested home-based testing is delivered or colonoscopies are 
scheduled. Patients who request a screening test have the option to sign up for automated text 
message reminders to help them complete their chosen test, as we used in our prior study.35 
5.3 
Usual Care 
Patients who are not randomly selected to receive an invitation will receive usual care, which 
includes the organizations’ standard procedures for addressing CRC screening. At AHWFB, the 
EHR flags patients who are overdue for CRC screening as a “care gap” that is visible to all 
primary care providers. 
6.0 Outcomes Measures 
 
6.1 
Primary Outcome 
6.1.1 Proportion of patients who are confirmed eligible for CRC screening and request a CRC 
screening test within the mPATH-CRC Web App. 
 
6.2 
Exploratory Outcome 
6.2.1 Proportion of participants who complete the CRC screening eligibility questions within 4 
weeks of the initial invitation using the mPATH-CRC Web App.  
7.0 Analytic Plan 
 
7.1 
Sample Size and Power 
We will consider that the cloud-based mPATH™-CRC program is feasible for increasing CRC 
screening uptake if at least 25% of patients who complete the app request a screening test via 

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the program. We chose 25% as our threshold because we acknowledge that patients may not 
complete screening tests they request. If only half of patients complete their requested test 
(which is what we observed in our prior trial), a 25% test-request rate would increase overall 
screening rates by 12.5%, a clinically meaningful effect for a low cost intervention. 
In our ongoing study of the iPad-version of mPATH™-CRC, 38% of patients who complete the 
program are requesting a screening test. Conservatively assuming the actual rate of requesting 
a screening test in the cloud-based version is 30%, a sample size of 120 patients will result in a 
90% probability of demonstrating feasibility by observing a rate of at least 25%. Therefore, 
messages will be sent until 120 patients have completed the app in order to evaluate feasibility. 
Full operating characteristics of this feasibility design for a sample size of 120 are included in 
table below. 
 
In our ongoing trial of the iPad version of mPATH™, 50% of patients who have no record of 
current CRC screening in the EHR report current screening in the mPATH™ app. Based on this 
experience, we will conservatively estimate that 25% of patients will respond to our invitations 
and 50% of patients who use mPATH™ will meet our inclusion criteria of being due for CRC 
screening (with no risk factors) resulting in an overall weekly accrual rate of 30 patients (25% x 
50% x 240). Therefore, while the sample size for our main feasibility outcome of screening 
decisions is 120 patients, approximately 1000 (250 per message) patients will receive an 
invitation for our exploratory analysis of message response rates. With a sample size of 250, the 
proportion who use the web app can be estimated to +/- 6.4% based on a 95% confidence 
interval. Based on oversampling for race/ethnicity, we anticipate that at least 50 patients from 
each race/ethnicity group will receive each message. With a sample size of 50, the proportion 
who use the web app can be estimated to +/- 14.5% based on a 95% confidence interval. The 
precision estimates are based on a 50% response rate as this gives the maximum half-width of 
a confidence interval, and therefore provides the most conservative estimate around precision. 
7.2 
Analysis of Primary Outcome 
Feasibility will be claimed if at least 25% of patients who complete the app (regardless of 
randomization group) request a screening test via the program. Completion of the app is defined 
as using the program to a point of indicating their screening decision. This proportion will be 
reported along with a 95% confidence interval. 
7.3 
Analysis of Exploratory Outcome 
Use of the web app will be defined as completing the web app’s eligibility questions for CRC 
screening. For each of the four messages, we will calculate the proportion who use the web app 

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with a 95% confidence interval. We will also calculate the proportion who use the web app with 
a 95% confidence interval separately for each race/ethnic group for each of the four messages. 
We will assess for differences in response rates between messages using chi-square tests or 
Fisher’s exact tests as appropriate. All tests will be 2-sided with a significance level of 0.05. 
 
7.4 
Estimated Accrual Rate 
Based on our ongoing trial experience, we will conservatively estimate that 25% of patients will 
respond to our invitations and 50% of patients who use mPATH will meet our inclusion criteria of 
being due for CRC screening without any risk factors resulting in an overall weekly accrual rate 
of 30 patients (25% x 50% x 240). We plan to closely monitor the accrual rate and will 
discontinue sending messages once 120 patients have used the app. 
 
7.5 
Estimated Study Length 
Activity / Month 
1 
2 
3 
4 
5 
6 
7 
8 
9 
1
0 
1
1 
1
2 
mPATH tech stack transfer / development 
X 
X 
X 
 
 
 
 
 
 
 
 
 
Develop video interview guide; SAC/CAC 
meeting #1 
X 
 
 
 
 
 
 
 
 
 
 
 
Gather CRC screening patient video 
testimonials 
 
X 
X 
 
 
 
 
 
 
 
 
 
Focus groups and SAC/CAC meeting #2 to 
select content for revised video and draft 
outreach messages 
 
 
 
X 
X 
 
 
 
 
 
 
 
Create final English and Spanish language 
videos; SAC/CAC meeting #3 
 
 
 
 
X 
X 
 
 
 
 
 
 
Usability testing and refinement of mPATH™ 
cloud app 
 
 
 
 
 
 
X 
X 
 
 
 
 
Feasibility testing of mPATH™-CRC cloud 
app 
 
 
 
 
 
 
 
 
X 
X 
X 
 
SAC/CAC meeting #4 to review results 
 
 
 
 
 
 
 
 
 
 
 
X 
8.0 Confidentiality and Privacy  
Confidentiality will be protected by collecting only information needed to assess study 
outcomes, minimizing to the fullest extent possible the collection of any information that could 
directly identify subjects, and maintaining all study information in a secure manner. To help 
ensure subject privacy and confidentiality, only a unique study identifier will appear on the data 
collection form. Any collected patient identifying information corresponding to the unique study 
identifier will be maintained on a linkage file, store separately from the data. The linkage file will 
be kept secure, with access limited to designated study personnel. The linkage file will be kept 
secure, with access limited to designated study personnel. An honest broker will mediate the 
electronic health record data queries to limit the exposure of patient identifying information. All 
personal identifiers (other than dates of service and patient zip code) will be removed from the 
study datasets and only the study ID included. One year after publication of the main study 
findings, the linkage file will be destroyed (electronically deleted or shredded in the case of 
paper forms). Data access will be limited to study staff. Data and records will be kept locked and 

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secured, with any computer data password protected. No reference to any individual participant 
will appear in reports, presentations, or publications that may arise from the study. 
9.0 Data Safety and Monitoring 
The principal investigator will be responsible for the overall monitoring of the data and safety of 
study participants. The principal investigator will be assisted by other members of the study 
staff. 
The only anticipated risks specific to this study are loss of data confidentiality. The research 
team will form an internal Data and Safety Monitoring committee, comprised of the PI from DHN 
Solutions, Site Lead Investigator from Wake Forest, Wake Forest Project Manager, and study 
statistician (Snavely). DHN Solutions’ cloud platform uses Microsoft Azure. Azure has enabled 
the physical, technical, and administrative safeguards required by HIPAA and the HITECH Act 
inside the in-scope Azure services, and offers a HIPAA BAA as part of the Microsoft Product 
Terms to all customers who are covered entities or business associates under HIPAA for use of 
such in-scope Azure services. In the BAA, Microsoft makes contractual assurances about data 
safeguarding, reporting (including breach notifications), data access in accordance with HIPAA 
and the HITECH Act, and many other important provisions. Microsoft adheres to the HIPAA 
Security Rule requirements in its capacity as a business associate. Microsoft Azure is an official 
partner of the NIH STRIDES initiative. 
All of DHN Solutions devices will have encrypted storage. The DHN Solutions PI will convene 
the Data and Safety Monitoring committee if any security breaches are detected. Data quality 
reports will be run weekly to assure fidelity to the study protocol and integrity of the data. The PI 
and Wake Forest Site Lead Investigator will promptly review any participant or other-reported 
concerns regarding the study. The PI will report any loss of data confidentiality or other adverse 
event to the Wake Forest IRB and the NIH within 2 business days of the discovery the event. 
10.0 
Reporting of Unanticipated Problems, Adverse Events or Deviations 
Any unanticipated problems, deviations or protocol changes will be promptly reported by the 
principal investigator or designated member of the research team to the IRB and sponsor or 
appropriate government agency if appropriate. 
 
 
 
 

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References