CRF Health's Electronic Clinical Outcome Assessment (eCOA) solution is currently being leveraged for a study that measures the self-reported health outcomes of standard cigarette usage in comparison with the usage of an electronic cigarette (a trial product). Download this case study to understand the study challenges and how using CRF Health’s eCOA solution: -Improves the participants’ experience -Increases trial enrollment efficiency -Automates the process from start to finish to reach as many participants as possible in a large geographic area

1. Case Study
CRF Health Enables Easy
Participant Consent for
Seamless Trial Enrollment

2. Case Study
CRF Health is the chosen Electronic Clinical Outcome Assessment
(eCOA) provider on a study that measures the self-reported health
outcomes of standard cigarette usage in comparison with the usage
of an electronic cigarette (a trial product). The goal of studying this
comparison is to determine the perception and likelihood that the
electronic cigarette reduces or improves health outcomes for
smokers.
Marketing materials are being used to recruit and direct potential
participants to an online landing page where, upon reviewing the
study specifications, they would register and enroll themselves in
the study.
While the trial allows participants to self-enroll, there are inclusion
and exclusion criteria questions that determine whether each
interested participant can partake in the trial.
This case study examines the study scope, challenges, and how
using CRF Health’s eCOA solution improves the participants’
experience, increases trial enrollment efficiency, and automates the
process from start to finish to reach as many participants as possible
in a large geographic area.
Study Overview
Study Challenges
There were 3 main challenges in this study:
Trial enrollment Informed consent Questionnaire logic1 2 3
The sponsor wanted to reach a broad, diverse range of cigarette smokers and trial product users for this study. To do that, it was
important to the sponsor that participants could easily enroll themselves. This required the sponsor to find a solution that made
it easy for participants to do, otherwise recruitment would not be successful.
Trial Enrollment in a Large Geographic Area
An extremely important part of any study is informed consent. On this study, it is important that the materials recruiting
participants clearly stated the benefits, risks, and level of involvement / responsibility because no sites are involved. The
participant needed to understand what it meant to consent to participate in the study.
No Physical Sites for Informed Consent
The questionnaire that is provided to each participant asks specific questions related to that participant’s smoking habits. For
example, if the participant said that they do not smoke, the sponsor wanted to ensure that the questionnaire did not ask them
how many cigarettes they smoke per day. It was necessary to enable participants to easily respond to questions without
confusion.
Questionnaire Logic that Avoids Confusion

3. Case Study
Study Design
The Solution
The sponsor chose to use CRF Health’s
web-based solution, TrialMax Web®, because it
resolves their challenges and enables them to
achieve their end result: successfully
self-enrolled cigarette and trial product users.
The TrialMax Web® solution allowed for:
Large geographical region
5+Year study duration
1Language
CRF Health designed and hosted the website
where participants self-enroll. Participants can
find the website using one of three methods:
through the consumer database, market
research and recruitment, or through public
advertisements in which potential participants
can log into the study database for screening
and then receive an invitation to participate in
the study if deemed eligible.
Self-enrollment allows the study to be more
accessible for interested participants. By simply
logging onto the website, participants can
completely manage their trial participation
themselves, without the hassle of attending site
visits and reviewing lengthy paper forms.
Easy Participant
Self-Management
Observational study
Thousands of participants:
Participants using the trial product,
an electronic cigarette
Participants using standard cigarettes

4. Case Study
TrialMax Web® allows participants to remotely consent from anywhere, provided that they have internet access. Interested participants simply log
onto the website and review the consent information regarding their involvement and responsibilities, risks and benefits, and other consent
criteria. If they agree to these conditions, they will proceed with trial enrollment. Participants are required to be at least 20 years old to participate.
Remote Informed Consent
CRF Health’s TrialMax Web® solution was designed to avoid asking participants irrelevant questions to provide the sponsor with cleaner, more
accurate data. Additionally, CRF Health designed the solution with a built-in schedule that outlines when participants need to complete the
questionnaire, and sends them reminders to complete their assessment over the 5+ year period. This feature allows data to be collected on time,
which is important to maintain over the years-long study duration.
Advanced Questionnaire Logic for a Simple, Efficient Enrollment Experience
This study was awarded to CRF Health as a result of outstanding work on five (5) similar studies prior to this one with the same client.
CRF Health’s solution is the reason this study allows participants to self-enroll through an automated, efficient website. As a result, it was and will
be easy for thousands of participants to participate in the clinical study. Providing consent is easy for participants and they are able to understand
what is required of them at every stage of the study.
Study Results
For more information, email us at info@crfhealth.com

5. About CRF Health
CRF Health is the leading provider of patient-centered eSource technology and service solutions for the
life sciences industry. With experience in more than 800 trials, over 100 languages and across 74
countries, CRF Health’s TrialMax® platform consistently demonstrates the industry’s highest data
accuracy, patient and site compliance, and patient retention.
CRF Health’s eSource solutions improve trial engagement by fitting into the lives of patients and
seamlessly integrating into sites to maximize protocol compliance. The integrated TrialMax platform
includes eCOA solutions for collecting PROs (Patient Reported Outcomes), ObsROs (Observer Reported
Outcomes), ClinROs (Clinician or Rater Reported Outcomes), and PerfOs (Performance Outcomes), and
features TrialConsent™, an electronic solution for collecting informed consent in clinical trials.
For more information, please visit www.crfhealth.com
or email info@crfhealth.com