Increasing Recruitment of Underrepresented Cancer Survivors With Awareness Enhancing Interventions
Phase: NA
Conditions: Research Awareness
Sponsor: University of Tennessee

  
Protocol Title 
Awareness Enhancing Interventions (AWEI) 
 
Study Protocol & Statistical Analysis Plan 
 
NCT04683510 
 
 
March 31, 2024  
 
Michelle Martin, PhD, Principal Investigator 
University of Tennessee Health Science Center 
Maria Pisu, PhD, Principal Investigator 
University of Alabama at Birmingham 
Birmingham, AL 35294 
 
 
 

  
Increasing recruitment of underrepresented 
cancer survivors with awareness enhancing 
interventions  
(AWEI) 
 
Principal Investigator: Michelle Martin, PhD, Maria Pisu, PhD 
Sponsor: National Cancer Institute 
National Clinical Trial (NCT) Identified Number:  NCT04683510 
 
Version Number:  v1.0 
March 31, 2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

  
 
Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................................. 1 
1 
PROTOCOL SUMMARY ............................................................................................................................... 1 
1.1 
Synopsis ................................................................................................................................................ 1 
2 
INTRODUCTION ............................................................................................................................................ 2 
2.1 
Study Rationale .................................................................................................................................... 2 
2.2 
Background........................................................................................................................................... 2 
2.3 
Risk/Benefit Assessment .................................................................................................................... 3 
2.3.1 
Known Potential Risks ..................................................................................................... 3 
2.3.2 
Known Potential Benefits ................................................................................................ 3 
3 
STUDY DESIGN ............................................................................................................................................. 3 
3.1 
Overall Design ...................................................................................................................................... 3 
4 
STUDY POPULATION .................................................................................................................................. 4 
4.1 
Inclusion Criteria .................................................................................................................................. 4 
4.2 
Exclusion Criteria ................................................................................................................................. 4 
4.3 
Strategies for Recruitment and Retention ........................................................................................ 4 
5 
STUDY INTERVENTION .............................................................................................................................. 5 
5.1 
Study Intervention(s) Administration ................................................................................................. 5 
5.1.1 
Study Intervention Description ....................................................................................... 5 
5.1.2 
Dosing and Administration .............................................................................................. 5 
5.2 
Measures to Minimize Bias: Randomization .................................................................................... 6 
6 
STUDY INTERVENTION DISCONTINUATION AND SUBJECT 
DISCONTINUATION/WITHDRAWAL ...................................................................................................................... 6 
6.1 
Discontinuation of Study Intervention ............................................................................................... 6 
6.2 
Subject Discontinuation/Withdrawal from the Study ....................................................................... 6 
6.3 
Lost to Follow-Up ................................................................................................................................. 6 
7 
STUDY ASSESSMENTS AND PROCEDURES ....................................................................................... 6 
7.1 
STUDY Assessments .......................................................................................................................... 6 
7.2 
Adverse Events and Serious Adverse Events ................................................................................. 7 
7.3 
Unanticipated Problems ...................................................................................................................... 7 
7.3.1 
Definition of Unanticipated Problems (UP) ................................................................... 7 
7.3.2 
Unanticipated Problem Reporting .................................................................................. 7 
8 
STATISTICAL CONSIDERATIONS ............................................................................................................ 8 
8.1 
Statistical Hypotheses ......................................................................................................................... 8 
8.2 
Sample Size Determination ................................................................................................................ 9 
8.3 
Statistical Analyses............................................................................................................................ 10 
8.3.1 
General Approach .......................................................................................................... 10 
8.3.2 
Analysis of the Primary Efficacy Endpoint(s) ............................................................. 10 
8.3.3 
Analysis of the Secondary Endpoint(s) ....................................................................... 10 
8.3.4 
Safety Analyses .............................................................................................................. 10 
8.3.5 
Baseline Descriptive Statistics ..................................................................................... 11 
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............................. 11 
9.1 
Regulatory, Ethical, and Study Oversight Considerations ........................................................... 11 
9.1.1 
Informed Consent Process ........................................................................................... 11 
9.1.2 
Study Discontinuation and Closure ............................................................................. 11 
9.1.3 
Confidentiality and Privacy ........................................................................................... 11 

  
9.1.4 
Quality Assurance and Quality Control ....................................................................... 12 
9.1.5 
Data Handling and Record Keeping ............................................................................ 12 
9.1.6 
Protocol Deviations ........................................................................................................ 12 
9.1.7 
Conflict of Interest Policy .............................................................................................. 13 
9.2 
Abbreviations ...................................................................................................................................... 14 
 

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STATEMENT OF COMPLIANCE 
The trial is conducted in accordance with International Conference on Harmonisation Good 
Clinical Practice (ICH GCP) and applicable United States (US) Code of Federal Regulations 
(CFR). The Principal Investigator assures that no deviation from, or changes to, the protocol will 
take place without prior documented approval from the Institutional Review Board (IRB), except 
where necessary to eliminate an immediate hazard(s) to the trial subjects. All personnel 
involved in the conduct of this study have completed Human Subjects Protection and ICH GCP 
Training. 
 
The protocol, informed consent form(s), recruitment materials, and all subject materials are 
submitted to the local Institutional Review Board (IRB) for review and approval. Approval of both 
the protocol was obtained before any subject was enrolled. Any amendment to the protocol 
required review and approval by the IRB before the changes were implemented to the study.  
 
1 
 
PROTOCOL SUMMARY 
1.1 SYNOPSIS  
Title: 
Increasing recruitment of underrepresented cancer survivors with 
awareness enhancing interventions (AWEI) 
Study Description: 
This study aims to investigate whether increasing awareness and, 
thus, enhancing positive attitudes about research, prior to 
recruitment attempts, will increase participation in cancer clinical 
research among African American (AA) cancer survivors 
Specifically, we investigate if interventions to raise awareness about 
research can increase the recruitment of African American cancer 
survivors to a web-based diet and physical activity interventions trial, 
known as the Adapting MultiPLe behavior Interventions that 
eFfectively Improve (AMPLIFI) Cancer Survivor Health trial 
(NCT04000880). The study will use a factorial trial design to test the 
effectiveness of the Awareness and Willingness to Engage in 
Research Intervention (AWEI) versus the original AMPLIFI 
recruitment strategy.  
Objectives: 
 
To determine if interventions to raise awareness about 
research can increase the recruitment of African American 
cancer survivors to the AMPLIFY web-based diet and physical 
activity trial 
 
Endpoints: 
– Reached = whether the AMPLIFI recruiter was able to reach 
the potential participant over the phone 
– Screened if reached = whether the survivor who was 
reached by the recruiter was willing to consider the study 
and to be screened to ascertain eligibility for the AMPLIFI 
trial 

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– Consented if eligible = whether the survivor who was 
screened and found eligible to participate in the AMPLIFI 
trial agreed and consented to participate in the AMPLIFI trial  
 
Study Population: 
Adult (age ≥50 years old) African American cancer survivors 
who were eligible for enrollment into the AMPLIFI trial  
- 
Within 1-5 years from a diagnosis of loco-regional 
cancers of the colorectum, female breast, prostate, 
endometrium, localized kidney or ovarian cancer, 
thyroid cancer, multiple myeloma and non-Hodgkin’s 
lymphoma 
 
Phase: 
2 
Description of Study 
Intervention: 
The AWEI interventions were educational interventions that varied 
by:  
- 
delivery channel, i.e., education through a brochure vs. a 
research educator ‘navigator’ 
- 
research emphasis, i.e., highlighting the importance of 
participating in AMPLIFI vs. in research in general 
- 
perspective, i.e., the information reflected the voice of a 
cancer survivor  vs. that of an expert researcher 
Study Duration: 
3 years  
Subject Duration: 
15 days 
 
 
 
 
 
2 
 
INTRODUCTION 
 
2.1 STUDY RATIONALE  
 
African American cancer survivors are often underrepresented in clinical trials, which 
can limit the generalizability of research findings. This study seeks to address this gap 
by testing an intervention designed to increase awareness and willingness to participate 
in a web-based diet and physical activity trial. 
 
2.2 BACKGROUND  
 
As highlighted in the 2022 National Academies of Medicine report on improving 
representation in clinical trials and research, the lack of representation of diverse groups 
has many consequences including hindering innovation and new discoveries, 
generalizability of research findings, access to effective medical interventions, and trust 
in research and medicine. Inadequate representation in research means we have 
limited information and opportunity to advance knowledge to reduce the cancer burden 

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and to understand underlying causes of disparate outcomes across different groups. 
This is highly significant for African Americans who have the highest death rates of all 
racial and ethnic groups for about half of the most common cancers. 
Increasing awareness among cancer survivors about the importance of research 
and study participation may be a key, yet often overlooked approach to achieving more 
racially/ethnically diverse trials.  Many questions exist about the best ways to convey 
the relevant information to potential participants. For example, while lay navigator 
interventions are promising, they are also costly: whether more economical 
interventions, e.g., using brochures conveying the same information, are effective is 
unknown. Other questions are related to whether it would be more effective to raise 
awareness about the specific study recruiting participants or about the importance of 
research in general, and whether this should be done conveying the information from 
the perspective of the survivor or the researchers.  
 
2.3 RISK/BENEFIT ASSESSMENT   
 
2.3.1 KNOWN POTENTIAL RISKS  
 
Risks and discomforts from participation in project activities for the AWEI trial are no greater 
than those associated with day-to-day living. No medical tests or procedures will be conducted, 
and no social, legal or other risks are anticipated.  
 
 
2.3.2 KNOWN POTENTIAL BENEFITS  
 
Survivors participating in this project may benefit from increasing their awareness about 
research, and better understanding the importance of participating. They will be better able to 
make an informed decision about the opportunity to participate in the AMPLIFI trial. The findings 
will benefit the research community as evidence for recruitment methods are scarce especially 
for increasing the recruitment of minorities. 
 
3 
STUDY DESIGN  
 
3.1 OVERALL DESIGN 
  
This is a prospective interventional study using a randomized factorial trial design. Participants 
will be randomized to one of 8 combinations of the AWEI intervention or to the control group (no 
AWEI) (Table 1). The AWEI intervention varies by type of delivery channel (Research Educator 
[RE] and Brochure), information emphasis (research general information vs. AMPLIFI study 
specific information), and type of perspective (information presented from a researcher or a 
survivor perspective). 
 
Table 1: AWEI study design and randomized control trial (RCT) arms  

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Features 
AWEI 
combination 
 
Delivery 
channel 
Information 
emphasis 
Perspective 
 
Awareness 
Enhancing 
Interventions 
(AWEI)  
Research 
Educator 
Research general  Researcher 
1 
Survivor 
2 
Study specific 
Researcher 
3 
Survivor 
4 
Brochure  
Research general  Researcher 
5 
Survivor 
6 
Study specific 
Researcher 
7 
Survivor 
8 
No AWEI  
-- 
-- 
-- 
 
 
 
4 
STUDY POPULATION 
 
4.1 INCLUSION CRITERIA 
 
African American cancer survivors who were eligible for enrollment into the AMPLIFI 
trial 
- 
adults (age ≥50 years old)  
- 
within 1-5 years from a diagnosis of loco-regional cancers of the colorectum, 
female breast, prostate, endometrium, localized kidney or ovarian cancer, thyroid 
cancer, multiple myeloma and non-Hodgkin’s lymphoma 
 
4.2 EXCLUSION CRITERIA 
 
- 
Not identified for recruitment to AMPLIFI trial 
 
 
4.3 STRATEGIES FOR RECRUITMENT AND RETENTION 
 

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The AWEI trial was embedded into the 
AMPLIFI trial’s recruitment process.2  To 
identify the list of eligible survivors, AMPLIFI 
collaborated with the Alabama Statewide 
Cancer Registry (ASCR) and the North 
Carolina Registry (NCR), and followed their 
protocols for the release of contact information 
to the AMPLIFI research team. The AMPLIFI 
process started with survivors receiving a 
recruitment letter informing them about the 
study and of the possibility of receiving a call 
from an AMPLIFI recruiter. Survivors were 
also given the team’s contact information to 
opt-out from the study if they so wished.  
The AWEI trial randomization occurred once 
the recruitment letter was sent. No retention 
strategies were necessary since participation 
in the AWEI trial lasted 15 days. Outcomes 
were assessed as part of the AMPLIFY trial.  
 
 
 
 
5 
STUDY INTERVENTION 
 
5.1 STUDY INTERVENTION(S) ADMINISTRATION 
 
5.1.1 STUDY INTERVENTION DESCRIPTION 
 
AWEI interventions were educational interventions delivered through a research 
educator or a brochure.  
 
5.1.2 DOSING AND ADMINISTRATION 
 
In the AWEI-Research Educator (RE) arm, one of four REs attempted to contact 
survivors by phone starting 5 days after the letter was sent (7 attempts over 10 days) 
and deliver the content of the intervention following a script. Each RE was trained on the 

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script of one of the AWEI-RE combinations differing by Information Emphasis and 
Perspective to avoid contamination across AWEI groups.  If the survivor did not receive 
the recruitment letter, the RE would give more information about the purpose of the call 
and offer to resend the letter.  
In the AWEI-Brochure arm, one of 4 brochures according to AWEI combination was 
sent 4 days after the recruitment letter was sent. The same content was delivered in the 
AWEI-RE and AWEI-Brochure arms.  
 
 
5.2 MEASURES TO MINIMIZE BIAS: RANDOMIZATION 
All participants were randomized to the AWEI (the intervention group) and no AWEI 
(control group) using permuted block randomization. Those who were randomized to 
the AWEI arm were simultaneously randomized to one of 8 combinations using the 
same method (Table 1).   
 
 
6 
STUDY INTERVENTION DISCONTINUATION AND SUBJECT 
DISCONTINUATION/WITHDRAWAL 
 
6.1 DISCONTINUATION OF STUDY INTERVENTION 
 
Not applicable  
 
6.2 SUBJECT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Not applicable  
 
6.3 LOST TO FOLLOW-UP 
 
Not applicable  
 
7 
STUDY ASSESSMENTS AND PROCEDURES 
 
7.1 STUDY ASSESSMENTS  
 
AWEI study outcomes are tracked and recorded by AMPLIFI recruiters who are blind to 
the AWEI random assignment. No other assessments are conducted.  
To allow for the AWEI interventions to be delivered, we allow 15 days from the time 
from when the recruitment letter was sent to when the AMPLIFY recruitment call 
occurred.  

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To further ensure that AMPLIFY recruiters remain blind to study assessment, AWEI 
participants, including those in the no AWEI control arm, are “released” to the recruiters 
in a random fashion over the 15 days AWEI period starting at day 8.  For the AWEI RE 
arm, survivors are released after the RE call is completed or the RE completed all 7 
attempts to deliver the intervention.  
Survivors reached by AMPLIFY recruiters are given more information about the study 
and given the option to be screened for participation to verify additional inclusion (e.g., 
completed primary treatment) and exclusion criteria (e.g., conditions that would make 
unsupervised exercise unsafe). If they screen eligible and are interested in joining 
AMPLIFY, they would undergo the informed consent process and enroll in AMPLIFY.  
 
 
7.2 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
Risks and discomforts from participation in project activities for the AWEI trial are no greater 
than those associated with day-to-day living. No medical tests or procedures will be conducted, 
and no social, legal or other risks are anticipated.  
 
Given this low risk there is no independent Data Safety and Monitoring Board (DSMB) for the 
AWEI trial, but will rely on the DSMB established for the AMPLIFI. 
 
7.3 UNANTICIPATED PROBLEMS 
 
7.3.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
The Office for Human Research Protections (OHRP) considers unanticipated problems 
involving risks to subjects or others to include, in general, any incident, experience, or outcome 
that meets all of the following criteria: 
 
• 
Unexpected in terms of nature, severity, or frequency given (a) the research procedures 
that are described in the protocol-related documents; and (b) the characteristics of the 
subject population being studied; 
• 
Related or possibly related to participation in the research (“possibly related” means 
there is a reasonable possibility that the incident, experience, or outcome may have 
been caused by the procedures involved in the research); and, 
• 
Suggests that the research places subjects or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or 
recognized. 
 
7.3.2  UNANTICIPATED PROBLEM REPORTING  
 
To minimize the risk of breach of confidentiality, we will take the following precautions:  
1. Investigators, recruiters, interviewers, the navigator and other study personnel, are, or 
will be, HIPAA and IRB certified prior to the handling of any personal data from study 
participants and must maintain current HIPAA and IRB certification as a requirement for 
continued employment.  

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2. Data on potential participants will be obtained from AMPLIFI.  Identifiable data (name, 
addresses, phone numbers, emails) will be imported in Studytrax. Studytrax is an Electronic Data 
Capture system designed for clinical trials (Phase I – IV), observational studies and patient 
registries. Studytrax tracks subject enrollment and captures data elements via a secure web 
portal, and facilitates the transfer of data into statistical packages for analysis. Studytrax uses MS 
SQL Server as the back end relational database. In compliance with HIPAA privacy rules and 
HIPAA security rules, database security features target multiple levels including the data element 
(e.g., restricted access to fields), user (e.g., password authentication access), application (e.g., 
role-based access to features, access audit trails), and hosting services (e.g., firewall, secure 
sockets layer). Some of the most important features related to data security include: SSL 
enforced access, Strong authentication, All passwords are individually salted and hashed, 
Account locking after 5 failed attempts, Inactive user session time out, Role-based security, and 
User activity auditing. These features ensure access control, audit control, data integrity, user 
authentication, and transmission security.  
The investigator will report unanticipated loss of confidentiality problems to the Institutional 
Review Board (IRB) of the University of Alabama at Birmingham (relying IRB) and the University 
of Tennessee Health Science Center. The report will include the following information: 
 
• 
Protocol identifying information: protocol title and number, PI’s name, and the IRB 
project number; 
• 
A detailed description of the loss of confidentiality event;  
• 
A description of any changes to the protocol or other corrective actions that have been 
taken or are proposed in response to the loss of confidentiality event. 
 
To satisfy the requirement for prompt reporting, loss of confidentiality events will be reported 
within 10 working days of the investigator becoming aware of the problem.  
 
8 
STATISTICAL CONSIDERATIONS  
 
8.1 STATISTICAL HYPOTHESES 
 
• 
Primary Efficacy Endpoint(s):  
Recruitment yield assessed by:  
1) Consented if eligible: Binary indicator of whether the survivor who is screened and 
found eligible to participate in the AMPLIFY trial agrees and consents to participate in 
the AMPLIFY trial.  
 
• 
Secondary Efficacy Endpoint(s): 
 
Interest in participating in the AMPLFY study and returned their consent assessed by: 
 
Same as recruitment yield.  
 
Post Hoc Outcomes: 

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1) Reached: Binary indicator of whether the AMPLIFY recruiter is able to reach the 
potential participant over the phone, regardless of whether the survivor is willing to 
receive information about AMPLIFY 
2) Screened if reached:  Binary indicator of whether the survivor who is reached by the 
recruiter is willing to consider the study and to be screened to ascertain eligibility for the 
AMPLIFY trial  
 
8.2 SAMPLE SIZE DETERMINATION 
Hypothesis 1: AWEI (any combination) will have a significantly higher recruitment yield than 
the basic AMPLIFI recruitment strategy (no AWEI control group). 
With a minimum of 1,600 in the AWEI intervention group, and 400 in the no AWEI 
control group, a two-sided chi-square test (for unequal sample sizes), and a 5% 
significance level, we will have > 95% power to detect a statistically significant 
difference in recruitment yield of 10% vs. 20%.  
Hypothesis 2 - Delivery channel: AWEI-Research Educator will have a significantly higher 
recruitment yield than AWEI-brochure 
Hypothesis 3 - Information emphasis:  Education content with study-specific emphasis will 
have a significantly higher recruitment yield than with research general emphasis  
Hypothesis 4 - Perspective: Education content delivered from the survivor perspective will 
have a significantly higher recruitment yield than education content delivered from the 
researcher perspective. 
For these hypotheses, with a minimum of 800 per group, a two-sided chi-square test, 
and a 5% significance level, we will have > 95% power to detect a statistically significant 
difference in recruitment yield of 10% vs. 20%.  
Hypothesis 5: AWEI-Research Educator with study-specific emphasis and cancer survivor 
perspective (combination #3, Table 1) will be the most efficacious.  
The same sample size calculation applies to the comparison of any two combinations. 
With a minimum of 200 per group, a two-sided chi- square test, and a 5% significance 
level, we will have 80% power to detect a statistically significant difference in 
recruitment yield of 10% vs. 20%.  
Calculations were performed using nQuery Advisor + nTerim, version 3.0.  
Thus, the trial is fully powered with a sample of 2,000 survivors, 200 in each AWEI 
combination, and 400 in the no AWEI arm. However, we will randomize all survivors 
identified from the cancer registries. If these are less than 2000, we will expand to other 

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cancer registries (estimated numbers from these registries exceed 2000 survivors). If 
these are more than 2000, we will randomize all.  
 
8.3 STATISTICAL ANALYSES 
 
8.3.1 GENERAL APPROACH 
 
An intent-to-treat approach is used for statistical analyses. Descriptive statistics, 
including frequencies and proportions, are obtained for study variables. Differences 
between the group and sub-group proportions are examined using the chi-square test; if 
the assumptions for the chi-square test are not satisfied, Fisher’s exact test is used.  
Logistic regression compared outcomes for three groups: Control, AWEI Brochure and 
AWEI Research Educator. Future analyses will include logistic regression analysis to 
test hypotheses 3, 4, and 5. Odds ratios and their corresponding 95% confidence 
intervals are obtained. Statistical tests are two-sided, and a significance level of 0.05 is 
assumed for all tests.  
 
8.3.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
 
Imbalances in randomization groups if any will be adjusted in analysis.  
 
Outcome variables are categorical. We will logistic to test for differences in outcomes across the 
randomized groups. 
Hypothesis 1 will be tested using all randomized individuals. We will test differences in 
outcomes for 2 groups: AWEI (any combination) vs. no AWEI (control group). 
Hypothesis 2 will be tested within the AWEI group. We will test differences in outcomes for 2 
groups: AWEI-Research Educator vs. AWEI-brochure. 
Exact 95% confidence intervals based on the binomial distribution will be determined for each 
proportion.  
 
All statistical analyses will be conducted using SAS, version 9.4 (SAS Institute, Cary, 
NC). 
 
8.3.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
 
We will use the same statistical approach for secondary endpoints.  
 
8.3.4 SAFETY ANALYSES 
 

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None 
 
8.3.5 BASELINE DESCRIPTIVE STATISTICS 
 
We will first conduct descriptive analyses to describe the study population and verify that the 
randomization groups are balanced in age, gender, cancer type and stage, time since 
diagnosis, and rural/urban status. 
 
9 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
9.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
9.1.1 INFORMED CONSENT PROCESS 
 
9.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS 
PROVIDED TO SUBJECTS 
A waiver of informed consent and documentation is approved by the IRB for this trial, given that 
the purpose is to test recruitment strategies before enrollment in a study (before consent to a 
study occurs). 
 
9.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
Not applicable  
9.1.2 STUDY DISCONTINUATION AND CLOSURE 
 
Given this low risk there is no independent Data Safety and Monitoring Board (DSMB) for the 
AWEI trial, but will rely on the DSMB established for the AMPLIFI. The AMPLIFI DSMB may 
temporarily suspend or prematurely terminate the trial if there is sufficient reasonable cause.  
Written notification, documenting the reason for study suspension or termination, will be 
provided by the suspending or terminating party to regulatory authorities.  If the study is 
prematurely terminated or suspended, the Principal Investigators will promptly inform the IRB, 
and will provide the reason(s) for the termination or suspension.   
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
• 
Demonstration of efficacy that would warrant stopping    
• 
Insufficient compliance to protocol requirements 
• 
Data that are not sufficiently complete and/or evaluable 
• 
Determination of futility 
 
Study may resume once concerns are addressed, and satisfy the IRB. 
 
9.1.3 CONFIDENTIALITY AND PRIVACY  
Subject confidentiality and privacy is strictly held in trust by the participating investigators and 
their staff. Therefore, the study protocol, documentation, data, and all other information 
generated will be held in strict confidence. No information concerning the study or the data will 
be released to any unauthorized third party without prior written approval of the Principal 
Investigator.  
 

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All research activities will be conducted in as private a setting as possible. 
 
IRB representatives may inspect all documents and records required to be maintained by the 
investigators. The clinical study site will permit access to such records. 
 
The study subject’s contact information will be securely stored for internal use during the study. 
At the end of the study, all records will continue to be kept in a secure location for as long a 
period as dictated by the reviewing IRB and/or Institutional policies. 
 
Study subject research data, which is for purposes of statistical analysis and scientific reporting, 
will be stored at UAB. This will not include the subject’s contact or identifying information. 
Rather, individual subjects and their research data will be identified by a unique study 
identification number. The study data entry and study management systems used by research 
staff will be secured and password protected.  
 
9.1.4 QUALITY ASSURANCE AND QUALITY CONTROL 
We reviewed recruitment report weekly to ensure that recruitment was done as planned. We 
provided ongoing training to interventionists to ensure that we the intervention was delivered as 
planned and appropriately documented. We oversaw that the intervention was delivered as 
planned (e.g., brochure mailed on the prespecified schedule). We had a detailed manual of 
operations specifying procedures.  
 
The site will provide direct access to all trial related sites, source data/documents, and reports 
for the purpose of monitoring and inspection by local and regulatory authorities. 
 
9.1.5 DATA HANDLING AND RECORD KEEPING  
 
9.1.5.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
Data collection is the responsibility of the clinical trial staff at the site under the supervision of 
the Principal Investigators. The Principal Investigators are responsible for ensuring the 
accuracy, completeness, legibility, and timeliness of the data reported. 
 
All source documents should be completed in a neat, legible manner to ensure accurate 
interpretation of data.   
 
9.1.5.2 STUDY RECORDS RETENTION  
Study documents should be retained for a minimum of 3 years after the completion of the study. 
These documents should be retained for a longer period, however, if required by local 
regulations.  
 
9.1.6 PROTOCOL DEVIATIONS  
A protocol deviation is any noncompliance with the clinical trial protocol requirements. The 
noncompliance may be either on the part of the subject, the investigator, or the study site staff. 
As a result of deviations, corrective actions are to be developed by the site and implemented 
promptly.  
 
It is the responsibility of the Principal Investigator to use continuous vigilance to identify and 
report deviations within 10 working days of identification of the protocol deviation.  Protocol 
deviations must be sent to the reviewing Institutional Review Board (IRB) per their policies. The 

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Principal Investigator is responsible for knowing and adhering to the reviewing IRB 
requirements.  
 
9.1.7 CONFLICT OF INTEREST POLICY 
The independence of this study from any actual or perceived influence is critical.  Therefore, any 
actual conflict of interest of persons who have a role in the design, conduct, analysis, 
publication, or any aspect of this trial will be disclosed and managed. Furthermore, persons who 
have a perceived conflict of interest will be required to have such conflicts managed in a way 
that is appropriate to their participation in the design and conduct of this trial.   
 
 
 

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9.2 ABBREVIATIONS 
 
AE 
Adverse Event 
ANCOVA 
Analysis of Covariance 
CFR 
Code of Federal Regulations 
CONSORT Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DHHS 
Department of Health and Human Services 
GCP 
Good Clinical Practice 
HIPAA 
Health Insurance Portability and Accountability Act  
ICH 
International Conference on Harmonisation  
ICMJE 
International Committee of Medical Journal Editors 
IRB 
Institutional Review Board 
LSMEANS 
Least-squares Means 
NCT 
National Clinical Trial 
NIH  
National Institutes of Health 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 
SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SOA 
Schedule of Activities 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 

AWEI RCT 
Version 1.0 
 
<31 March 2025> 
 
 
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