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

outcomes.
 

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

Responsibility).

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

(DM/Technology Responsibility).

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

(DM/Monitoring Responsibilities).

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

https://attendee.gotowebinar.com/register/7140655505300708099
 

• Attend a Live Training Program

August 24, 2017, 9:00-1:00 EDT, Raleigh, NC (more sites to be added)

https://attendee.gototraining.com/r/1173169395314409730

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 pmanasco@manarbm.com for further information on

this new service.