By Penny Manasco - July 19, 2017
Working in Remote Trial Management and Risked Based Monitoring (RBM), I used sponsor
insights and my many years of clinical development experience to determine what data were
important. That approach is now history. I HAVE SEEN THE LIGHT and it is RISK ASSESSMENT.
What??? Filling out a stupid form to identify study risks? How can that help my trial?
I just finished leading a Risk Assessment Activity for a study. The room was filled with many
different functional teams working on the study (Program Management, Data Management,
Monitoring, Medical/Safety, IP, Site representatives)—each with years of experience. Each confirmed the great value they received by participating in this effort.
Simply put, we all developed a common understanding of the areas of greatest risk for our
project and how each of us would contribute to managing those risks. Here are two concrete
examples as follows:
This study depends on subject diaries for key endpoints. We asked the all-important question:
What can go wrong? From that, we identified all the ways the diary collection could go wrong
and developed a data collection and an oversight plan to assure optimal oversight and to
eliminate loss of valuable subjects due to avoidable issues. Here is a snapshot of some of our
1. Risk: Subjects will not complete the diary daily as needed (Primary Efficacy).
a. We planned a test diary entry at the screening visit to assure the subjects could
access the diary application and enter data as needed on their device (DM
b. We planned subject training to assure the subjects would accurately enter the
correct data in their diaries (Site Responsibility).
c. We worked as a team to determine how we can support the subjects with text
notifications if they were coming close to missing their visit window
d. We incorporated text notifications to the Study Coordinators to alert them to
subjects missing multiple diary days (DM/Technology Responsibility).
e. We planned reports to easily identify subjects ‘at risk’ for not completing diary
entry requirements (DM/Monitoring Responsibility)
f. We planned reports to identify subjects using prohibited medications(DM/Monitoring Responsibility).
2. Risk: The subject does not sign the informed consent prior to any assessments being
performed (Subject Protection).
a. Select an eSource system with eConsent linked and require direct data entry to
align with ALCOA (i.e., Attributable, Legible, Contemporaneous, Original,
Accurate) principles (DM/Technology/ Site responsibilities).
b. Design the eSource so the eConsent must be signed prior to release of any of
the eSource/EDC forms (DM/Technology Responsibilities).
c. Design the eSource to collect all other questions required to document correct
informed consent process (DM/Monitoring Responsibilities)
d. Design eConsent to check the Delegation of Authority form to assure the person
obtaining consent has the appropriate authority to perform the task
e. Design the eSource system so that reconsent can be obtained if a new version of
the consent is released and approved prior to progressing with study
assessments (DM/Monitoring Responsibilities).
I hope this gives you some insight into why performing a Risk Assessment must be a cross
functional team activity and why it is absolutely critical to perform a Risk Assessment early
during trial planning, prior to completion of the protocol.
While adopting an entire quality approach for your trials, as envisioned in the new ICH GCP
Guidance that must be implemented starting July 2017, may seem daunting, you can begin by
at least performing a risk assessment. You will never be sorry.
To help you to get started, we offer several options:
• Free webinar on completing a Risk Assessment
July 26, 2017, Noon EDT
• Attend a Live Training Program
August 24, 2017, 9:00-1:00 EDT, Raleigh, NC (more sites to be added)
This hands-on program will equip users with the tools to conduct Risk Assessments for their
protocols. This session will include developing Risk Assessments and planning for downstream
oversight of risks
Cost is $750/person. Three people from the same organization: $2,000
Class size is limited to 20 participants with two instructors.
• Customized Risk Assessment for Study Team
MANA RBM will lead your project team in conducting a risk assessment for your
protocol. Please contact firstname.lastname@example.org for further information on
this new service.