A Novel Approach to Protocol Deviation Handling Within the eCRF

Sponsored by: OmniComm Systems, Inc.

Focused on:

  • Protocol Deviations
  • First Patient In

Date: 18 January


Time: 3PM London/10AM New York

Learn how a clinical study team efficiently manages Protocol Deviations within the eCRF, from First Patient In (FPI).

This webinar will describe how a clinical study team efficiently manages Protocol Deviations (manual and automatic) within the eCRF, from First Patient In (FPI). The format will include an open discussion about how to benefit from having this relevant information in eCRF for risk-based monitoring (RBM) purposes, trends, patient safety, study decisions, definition of study populations, etc.

Protocol Deviations collection is always a challenging part of a clinical trial, since the process involves many functions during study conduct, such as safety, data management, statistics or clinical monitoring. A clear definition of the process should be established from study start-up. Our team at TFS has developed a complete flow within the eCRF that allows the handling of Protocol Deviations from collection to final decision.

The process would be as follows: appropriate team members (i.e. monitor, data manager, etc.) would include the potential Protocol Deviations in the eCRF; notifications would be sent to reviewers, (i.e. study lead, medical reviewer), who would evaluate them and provide a final decision, (i.e. “patient needs to be discontinued,” “protocol has to be amended,” “not a Protocol Deviation, only an observation”).

The whole process can be completed within minutes. Protocol Deviations reports and graphs are available at real-time in the eCRF and can be reviewed by any team member; they serve as a powerful tool to detect trends, safety breaches, site issues, etc. Ultimately, all Protocol Deviations would have already been processed and classified at the time of LPO (Last Patient Out).

Presented by

Lorenza Cretarola,

Senior Clinical Data Manager

Lorenza Cretarola has been working in clinical research for six years. During that time, she has enjoyed working both as a biostatistician and clinical data manager. Her experience as a clinical data manager and statistician encompasses all biometrics processes. Since 2016, she has focused mainly on management and validation of clinical data management systems and DB design, especially within TrialMaster®.

Her deep knowledge of OmniComm’s EDC solutions has been key for TFS to develop the Protocol Handling tool, which has earned great acceptance among TFS customers. Her innovation was a significant factor in OmniComm’s decision to honor TFS with an “Excellence in Innovation” award. Lorenza was educated at University of Rome (Sapienza), where she received a M.Sc. in “Statistics for Biomedicine, Environment and Technology.”

Lorena Rodríguez ,

Associate Director Data Management

Lorena Rodríguez is an associate director of data management based in Barcelona’s TFS office. She has focused her career on clinical research since she got her bachelor’s degree in Statistics. During the last 16 years, she has worked in both pharmaceutical and CRO environments, from which she has gained extensive experience in all phase studies.

With her in-depth and first-hand understanding of the regulatory processes, she has lead international and multidisciplinary teams made up of data managers, programmers, biostatisticians and safety personnel, effectively helping clinical teams and managing vendors and third parties. Lorena aims her day-to-day activities toward improving processes and strategies for the company.

Rich Davies,

Executive Director Business Solutions

Richard joined OmniComm in February 2014 and is based in the UK. As Executive Director of Business Solutions his role is to support organizations’ adopting OmniComm solutions from a technical, functional and business process perspective, particularly as they execute their vendor selection programs. Additionally he has product management responsibilities and provides a bridge between customers, prospects and ongoing product development.

Mr. Davies joined OmniComm from Oracle/Phase Forward, where he held multiple roles in the sales and implementation of many types of e-clinical, drug safety, warehousing and healthcare technologies. He has worked for technology vendors for nearly 20 years but prior to this, he worked in data management with Fisons Pharmaceuticals and Astra. Mr. Davies earned his Bachelor of Science degree in Computer Science from DeMontfort University in the UK.

Key Learning Objectives

  • How to optimize TrialMaster eCRF for the collection of Protocol Deviations
  • How early management of Protocol Deviations can help the study conduct
  • Protocol Deviations and the relationship with risk-based monitoring


  • Head of Data Managers
  • Head of Clinical Research
  • Clinical Research Analysts
  • Clinical Operations
  • Head of Clinical IT
  • Head of Medical Affairs
  • Head of Clinical Systems
  • Head of Clinical Innovation