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ACDM19 Speaker Details

Lorena Rodriguez Santaren

Lorena Rodriguez Santaren



Lorena Rodriguez 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 18 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.

Title of Session: A Novel Approach to Protocol Deviation Handling within the eCRF

Description of Session:

Protocol Deviations collection is always a challenging part of a Clinical Trial, since it 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; 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).

Learning Objectives:

Handling of protocol deviations


Risk based monitoring

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